Hep C World News - Week of December 31, 2023

More US teens abstaining from drugs, alcohol

Ann Arbor, MI - More than 60% of 12th graders who responded to a yearly survey of junior high and high school students reported not using alcohol, cannabis or nicotine in the past 30 days — the highest level of abstention in the survey’s history. Rates of lifetime abstention — no history of use of any of the substances — significantly increased in 2023 among 10th and 12th graders and were at or near the highest levels ever recorded by Monitoring the Future, a survey conducted yearly by the University of Michigan and funded by the National Institute on Drug Abuse (NIDA). This year’s report summarized substance use behaviors based on 22,318 surveys collected from students at 235 public and private schools in the United States. According to the respondents, abstention from marijuana, alcohol and nicotine use increased for 12th grade students, with 62.6% reporting not using any of these substances in the last 30 days. That percentage remained stable for 8th graders at 87% and 10th graders at 76.9%. Rates of lifetime abstention were 37.5% for 12th graders, 54.4% for 10th graders and 70% for 8th graders. Increases in these categories “were driven by decreases in nicotine vaping and alcohol use,” the report says. There was not much change in lifetime use of cannabis from 2023 to 2023. “Research has shown that delaying the start of substance use among young people, even by 1 year, can decrease substance use for the rest of their lives,” Nora Volkow, MD, director of the NIDA, said in a press release. “We may be seeing this play out in real time.” Alcohol use remained stable in 8th and 10th graders, and in 12th graders fell from 51.9% last year to 45.7% this year. Use of nicotine vaping remained stable for 8th grade students but did decline from 20.5% to 17.6% among 10th grade students and 27.3% to 23.2% among 12th grade students. Cannabis use and cannabis vaping remained stable for all three grades. For the first time, this year’s survey measured the use of delta-8 THC, a psychoactive substance found in the Cannabis sativa plant. According to the survey, 11.4% of 12th graders reported using it in the last year.  “For 49 consecutive years, the Monitoring the Future survey has closely monitored shifts in substance use trends among young people, helping to identify and track emerging trends with public health relevance,” Richard A. Miech, PhD, team lead of the study, said in the release. “This year’s addition of a measure to assess use of delta-8 is one example of this, and we were surprised to see use levels this high among 12th graders. Moving forward, as policies and access to this drug change, it will be important to continue to monitor use of this drug among teens.” Volkow called the overall downward trend “reassuring.” “It remains crucial to continue to educate young people about the risks and harms of substance use in an open and honest way, emphasizing that illicit pills and other substances may contain deadly fentanyl,” Volkow said. 

For more information: https://tinyurl.com/5br5mwtu

Hep C World News - Week of December 24, 2023

‘Significant gaps’ reported in testing, treatment among pregnant people with HCV

BOSTON — Researchers found “significant gaps” in follow-up testing and treatment among a cohort of pregnant individuals in Canada with a diagnosis of hepatitis C virus infection, according to data presented at The Liver Meeting. “HCV infection among those of childbearing potential has increased,” Andrew B. Mendlowitz, PhD, MBiotech, a postdoctoral fellow at the Viral Hepatitis Care Network and Toronto Center for Liver Disease at University Health Network, told Healio. Mendlowitz and colleagues conducted a population-based, retrospective cohort study of pregnancies in Ontario, Canada, that occurred between 2008 and 2020, which were then linked to HCV testing records from 1999 to 2020, as well as health administrative data. Researchers used algorithms to identify pregnancy loss earlier than 20 weeks, induced abortion, prenatal ultrasound, livebirths and stillbirths, and also determined whether individuals tested positive for HCV antibody, were RNA tested, tested positive for HCV RNA and/or started treatment. According to the abstract, pregnancies occurring after an individual tested positive for HCV antibodies but before subsequent RNA testing, and after a first positive HCV RNA test but before treatment defined study parameters for a missed opportunity for engagement. “Despite diagnosis, there were major drop offs along the HCV cascade of care,” Mendlowitz said. “In particular, over half of the cohort did not receive RNA testing after a positive antibody result, and over half did not initiate treatment after confirmation of viremia.” He continued, “Concerningly, in many people, subsequent pregnancies occurred after an HCV diagnosis with no evidence of treatment, posing a risk for transmission to the infants.” Mendlowitz and colleagues identified 28,761 pregnancies among 13,432 individuals who were positive for HCV antibodies and/or had records of HCV RNA testing. Of these, 21.4% had their earliest HCV antibody test during a pregnancy. Among individuals who ever tested positive for HCV antibodies, 86.9% received RNA testing, with 22.9% receiving their earliest RNA test during a pregnancy. Further, among 4,945 individuals with a record for HCV RNA-positive without spontaneous clearance, 41.6% initiated treatment. Prior to 2012, the time to an RNA test from a positive antibody test was 47.5 weeks (95% CI, 41.7-53.7), which improved to 5.7 weeks (95% CI, 5.2-6.8) after 2018. Moreover, the time to treatment from an RNA-positive test improved from 15.1 years (95% CI, 14.1-16.2) to 1.9 years (95% CI, 1.6-2.2) during that time, according to the abstract. Among individuals with a positive antibody test, 20.1% had at least one pregnancy before receiving a subsequent RNA test and a minority of those with an RNA-positive record received treatment. Of 4,936 individuals who were monitored from their first RNA-positive test, 45.9% had at least one pregnancy before initiating treatment. The data also showed that 1,767 individuals were never linked to an RNA test, which corresponded to an average of 1.6 missed pregnancies per person. According to the abstract, an estimated 195 infants may have been infected as a consequence of missed opportunities for engagement. “Importantly, our estimates were conservative and spoke to only the tip of the iceberg, as they do not account for the significant undiagnosed or not tested fraction,” Mendlowitz told Healio. Researchers noted their analysis highlighted “significant gaps” in follow-up testing and treatment for HCV among pregnant individuals. “We are hopeful that new guidelines recommending universal screening for HCV in each pregnancy and exploration of treatment in late pregnancy will improve HCV care for pregnant people and minimize the risk of transmission of HCV to newborns.” 

For more information: https://tinyurl.com/3u7xk9xm

Hep C World News - Week of December 17, 2023

One in four adults use pharmacologic therapies for chronic pain

Atlanta, GA - One in four adults relied solely on medications to manage chronic pain, highlighting an opportunity to increase use of nonpharmacologic therapies, particularly in men, older adults and those with public insurance, according to researchers. “Findings from this study contribute important information about use of over-the-counter pain relievers, prescriptions nonopioids and exercise, which were found to be some of the most common pain management therapies used by adults with chronic pain,” Stephanie Michaela Rikard, PhD, a health scientist at the CDC, told Healio. Rikard and colleagues noted that the CDC’s guidelines on opioid treatment for pain recommend a mix of nonpharmacologic and pharmacologic therapies. “Whereas previous research reported the prevalence of use of nonpharmacologic and opioid therapies for pain, this study adds information about prescription nonopioids, over-the-counter pain relievers, and exercise,” they wrote in Annals of Internal Medicine. The researchers analyzed 2020 National Health Interview Survey data on 7,422 respondents who reported having pain most days or every day for the past 3 months. They found that 60.2% of adults reported using both pharmacologic and nonpharmacologic therapy. Of those: 50.9% reported nonopioid use and use of both pharmacologic and nonpharmacologic therapies; 50.9% reported nonopioid use and nonpharmacologic therapy use; and 7.7% reported combined use of opioids, nonopioids and nonpharmacologic therapy. Meanwhile, 26.6% of adults said they used pharmacologic therapy alone, of whom 22.4% reported nonopioid use only and 1% reported opioid use only. According to Rikard and colleagues, adults who were older, had more severe pain or had public insurance were more likely to use prescription opioids, whereas younger adults, those uninsured, those who lived in the Northeast and those with higher household incomes were less likely. Meanwhile, non-Hispanic Black adults, Hispanic adults, those aged 45 to 64 years, those who had more severe pain, those who lived in the South and those who had public insurance were more likely to use prescription nonopioids. In contrast, women, non-Hispanic white adults and those who had a higher education level were less likely to use prescription nonopioids. The researchers noted there were several limitations to the study. For example, there was potential recall bias, and the COVID-19 pandemic may have impacted the study’s conduct. “Clinicians should involve patients meaningfully in shared-decision making and provide pain care that is patient-centered and appropriate for the specific condition and patient,” Rikard said. “Health insurers and health systems can contribute to improved pain management and reduce health disparities by increasing access to nonpharmacologic therapies with evidence of effectiveness.”

For more information: https://tinyurl.com/4jbtb236

Hep C World News - Week of December 10, 2023

Low-Dose Aspirin Reduces Liver Fat, Inflammation Markers

BOSTON — Patients with metabolic-associated steatotic liver disease (MASLD, formerly NAFLD) without cirrhosis who took daily low-dose aspirin in a double-blind randomized trial demonstated significant reductions in liver fat content over 6 months compared with similar patients who took a placebo, study results show "In MASLD without cirrhosis, low-dose aspirin, 81 milligrams daily, led to decreases in liver fat and improved markers of hepatic inflammation and fibrosis," reported Robert M. Wilechansky, MD, a transplant hepatology fellow at Massachusetts General Hospital in Boston. "It was safe and well tolerated in this study, but we would like to see larger, longer-term clinical trials to test the efficacy of aspirin for improving histology and preventing adverse outcomes in MASLD," he said here at The Liver Meeting 2023: American Association for the Study of Liver Diseases (AASLD). "We don't have current plans, to my knowledge, to test full-dose aspirin," he told Medscape Medical News. "I'm encouraged by the results with low-dose aspirin, and I think that, given the risk profile, using a lower dose is preferable." Although promising therapies for MASLD are in development, none are currently approved by the US Food and Drug Administration, prompting Wilechansky and colleagues to investigate aspirin, with its anti-inflammatory properties, as a potential treatment. In preclinical studies, aspirin has been shown to have both anti-inflammatory and antitumor effects in the liver through inhibition of cycloxygenase-2 and platelet-derived growth factor signaling, as well as through modulation of bioactive lipids, Wilechansky said. In observational studies, use of aspirin was associated with a reduction in the prevalence of hepatic steatosis and fibrosis progression in patients with MASLD, and there was a decrease in the incidence of hepatocellular carcinoma and liver-related mortality among patients with viral hepatitis, he noted. As for the potential mechanism of action of aspirin for patients with MASLD, Wilechansky noted that there may be some reduction in steatosis, and "if there is a reduction in inflammation, we may see some reduction in steatohepatitis." To see whether the so-called "wonder drug" could work wonders for patients with MASLD without cirrhosis, the researchers recruited 80 adults with MASLD and randomly assigned them to receive either aspirin 81 mg once daily or placebo for 6 months. Patients with baseline cirrhosis or other liver disease, heavy drinkers, those who had used aspirin within 6 months, or those who used other antiplatelet or anticoagulant agents were excluded, as were patients with severe renal or cardiovascular disease, active cancer, pregnancy, were breastfeeding, had thrombocytopenia, or had undergone bariatric surgery within the past 2 years. 

For more information: https://tinyurl.com/2tyc9wff

Hep C World News - Week of December 3, 2023

Risk for cirrhosis 50% higher in young women after first episode of alcoholic hepatitis

Boston, MA -  Female adolescents and young adults have higher rates of liver-related mortality and a 50% higher risk for cirrhosis and decompensation after surviving their first presentation of alcoholic hepatitis, according to data. “Hospital admissions for alcoholic hepatitis are increasing and more so in adolescents and young adults than in other age groups, and recent data has also suggested that rates for liver transplantation for alcoholic hepatitis are rising faster in this age group,” Jennifer A. Flemming, MD, FRCPC, MAS, associate professor of medicine and public health sciences at Queen’s University, said at The Liver Meeting. “It’s also been shown that sex differences exist, and the susceptibility to hepatic injury from alcohol and gender differences in alcohol use and engagement and alcohol use disorder treatment have also been observed.” “Although overall mortality after first presentation of alcoholic hepatitis is similar between sexes, females have higher rates of liver-related mortality than males, and female sex is associated with a 50% higher risk of cirrhosis and decompensation among those who survived their first presentation,” Jennifer A. Flemming, MD, FRCPC, MAS, said at The Liver Meeting. In a retrospective, population-based cohort study, Flemming and colleagues aimed to define the contemporary epidemiology and demographics of adolescents and young adults with alcoholic hepatitis (AH), as well as the association between sex, long-term mortality and development of liver-related complications. Researchers identified 3,340 adolescents and young adults (median age, 33 years; 64% men) in Ontario, Canada, with a first presentation of AH without cirrhosis diagnosed at an emergency department (n = 917) or inpatient admission (n = 2,423) from 2002 to 2021. Of those, 2,374 were alive 6 months after discharge. Within 2 years of AH presentation, 71% had health care encounters related to alcohol, 57% had a history of mental illness and 34% had a history of substance abuse. Analysis of social determinants of health showed 18% lived in a rural area (22% women vs. 15% men), 32% were in the lowest income quintile (37% vs. 30%), 13% were recent immigrants or refugees (7% vs. 16%), 23% were in the highest ethnic diversity quintile (17% vs. 26%) and 30% were in the highest housing instability quintile (31% vs. 30%). After a median follow-up of 5 years, 844 individuals (25%) in the total population died, and less than 1% (n = 23) underwent liver transplantation, which was more commonly performed in men. Over the study period, liver-related mortality was more common in women than men.Among individuals who survived their first presentation of AH without cirrhosis or decompensation, 31% had developed cirrhosis (37% women vs. 28% men) after a median follow-up of 24 months. Across all time points, women were more likely to develop cirrhosis compared with men (5 years: 25% vs. 19%; 10 years: 32% vs. 24%; 15 years: 37% vs. 28%; and 20 years: 37% vs. 30%), the majority of whom were diagnosed with cirrhosis during the first 5 years after first AH presentation. Further, competing risks analysis showed female sex (subHR = 1.47; 95% CI, 1.23-1.76), older age (sHR = 1.04; 95% CI, 1.03-1.06), urban residence (sHR = 1.29; 95% CI, 1.02-1.65) and higher comorbidity (sHR = 1.36; 95% CI, 1.01-1.82) were associated with development of cirrhosis. “The incidence of alcoholic hepatitis is rising among adolescents and young adults, and death is occurring in 25% of these individuals after a median of 5 years of follow-up,” Flemming said. “The young alcoholic hepatitis population is vulnerable, and their social determinants of health and sex differences and underlying sociodemographic factors are present.” She continued: “Although overall mortality after first presentation of alcoholic hepatitis is similar between sexes, females have higher rates of liver-related mortality than males, and female sex is associated with a 50% higher risk of cirrhosis and decompensation among those who survived their first presentation.” 

For more information: https://tinyurl.com/yckjx3xs

Hep C World News - Week of November 26, 2023

City tries hospitality instead of hostility 

London, ON – The Globe and Mail recently reported that instead of clearing tent dwellers out, the city of London, Ontario has built portable toilets and washing stations, and given people resources to keep their shelters clean and safe. Church chaplain Stefan Nichol talks with a woman living at a tent encampment by the Thames River in London, Ont., a city where rising homelessness has led civic leaders to consider a new approach. Like many Canadian cities, London has an encampment problem. The number of people experiencing homelessness in the city has doubled since the pandemic. Many of them have resorted to living outdoors. They pitch their tents and hang their tarps near the banks of the broad Thames River, which flows through the heart of the southwestern Ontario community of 420,000. As the population of tent dwellers has grown, reaching around 300, complaints have been rising. Many Londoners say the encampments are a source of crime, noise, garbage and discarded needles. London could have responded by doing what some other cities have done and sent in police to clear away its encampments and evict their residents. Instead, it is sending in help. Garbage collectors come down to the river to pick up trash. Firefighters come down to coach people on how to keep their campfires from getting out of control. Charity groups deliver food, water, warm clothing and safe-drug-use supplies. The city has even set up portable toilets and washing stations near encampments. Mayor Josh Morgan calls it a compassionate but also a pragmatic approach. Hungry people may turn to crime to get what they need. Give them food to eat and they are less likely to resort to desperate measures. Give them garbage bags and they are less likely to leave their trash strewn about. Some Londoners are skeptical. They say that the city is normalizing the encampments. By supplying the needs of the tent dwellers, it is just making it easier for them to keep living outdoors. Mr. Morgan dismisses that notion. He says that no one really wants to live in a damp tent by the river. With rents soaring and city shelters full up, he says, “encampments are an unfortunate but necessary reality.” Many other cities are coming to the same conclusion. Hamilton is permitting clusters of as many as five tents and giving their residents access to showers and washrooms, as long as the tents are not within 100 metres of daycares, playgrounds or schools. Halifax has designated five locations where encampments are allowed. The city collects their garbage and supplies them with water. Vancouver cleared dozens of tents and structures from East Hastings Street in April, but other encampments persist. A court ruling in January said that tent dwellers could stay in a designated part of CRAB Park on Vancouver Harbour, though police have been removing tents in unsanctioned areas. The ruling was one of several across the country that have put limits on encampments clearances, or “decampments.” Toronto has eased its stand on encampments since carrying out a couple of controversial clearances in 2021, an effort that came in for harsh criticism from the city’s ombudsman in a report earlier this year. The city hasn’t cleared any for six months. It sends outreach workers out every day to distribute blankets and water to residents, offer them inside shelter and tell them about services that might help them deal with mental illnesses or addictions. At one large encampment, in Allan Gardens in the city’s downtown east end, it has even set up a special Information and Help Centre designed to “facilitate relationship building with encampment occupants.” A small cooking fire burns at one encampment. Officials warn residents about fire risks. London has gone farther than most. In July it set up four “depots,” open for 90 minutes a day, close to encampment sites. There, staff started handing out snacks, socks, soap and a host of other everyday items. They also directed visitors to help find housing or getting addiction treatment.

For more information: https://www.theglobeandmail.com/canada/article-london-ontario-homeless-encampment/

Hep C World News - Week of November 19, 2023

Narrow focus on opioids misses big picture

New York, NY A recent editorial in the New York Times, by German Lopez looked at that effect of focusing too much on opioids at the expense of ignoring the other drugs that are causing damage. When political leaders talk about America’s current drug crisis, they are typically referring to opioids like painkillers, heroin and fentanyl. And when they have passed laws to deal with the problem in the past decade, those policies have centered on opioids. They have, for example, focused on boosting access to medications that treat only opioid addiction or reverse only opioid overdoses. That narrow focus has neglected the rise of other drugs, as my colleague Jan Hoffman reports today. In the last five years, overdose deaths involving methamphetamine have tripled. Those linked to cocaine have doubled. People addicted to opioids increasingly use other substances, including meth, cocaine and prescription medications like Valium and Xanax. Meth use, in particular, has also made it difficult to stabilize patients and keep them in treatment for any drug, as one addiction doctor explained, “The paranoia and hallucinations caused by meth disorient them, he said. One patient threw himself in a river to escape nonexistent people who were chasing him. Others insisted that dumpsters were talking to them, that color-coded cars were sending them messages.” approach to drug addiction. More support for opioid addiction medications is important, but so is funding underused treatments that address meth and cocaine addiction (such as paying people to stop using drugs). The changing nature of the drug crisis was predictable, because drug use is historically faddish. In the 1970s, America struggled with heroin. In the ’80s, it was cocaine. In the ’90s and early 2000s, meth. Since then, opioids have taken off. One explanation for this is what’s known as generational forgetting: Young people tend to avoid the drug that is currently causing a crisis. But because they don’t have personal experiences with the drugs that caused harm before their time, they are more willing to use those substances. Different drugs can also complement each other, and so their popularity can rise simultaneously. Opioids, for example, often cause users to doze off, which can leave those who live on the streets vulnerable to theft or rape. So opioid users sometimes use stimulants, like meth and cocaine, to stay awake. And if they receive treatment for opioid addiction, they may continue using stimulants. All of this leads to a revolving door for different kinds of drug crises. It has happened before, and it is happening again.

For more information: https://tinyurl.com/3d8cswep

Hep C World News - Week of November 12, 2023

CDC recommends testing all children exposed to hepatitis C

The CDC this week recommended hepatitis C testing for all infants or children who were perinatally exposed to the virus by a pregnant person with a current or probable HCV infection. The authors of the recommendations defined a current HCV infection as anyone with detectable HCV RNA, and a probable infection as someone with a reactive anti-HCV test and unavailable HCV RNA results. The new recommendations, as outlined by the authors in MMWR, are as follows: Perinatally exposed infants should receive a nucleic acid test (NAT) for HCV RNA at age 2 to 6 months to identify children in whom chronic HCV infection might develop if not treated. Infants with detectable HCV RNA should be managed in consultation with a health care provider with expertise in pediatric hepatitis C management. Infants with an undetectable HCV RNA result do not require further follow-up unless clinically warranted. Infants and children aged 7 to 17 months who are perinatally exposed to HCV and have not previously been tested should receive a NAT for HCV RNA. Children aged 18 months or older who are perinatally exposed to HCV and have not previously been tested should receive an anti-HCV test with reflex to NAT for HCV RNA. Helio spoke with experts Lynn Yee, MD, a maternal fetal medicine specialist and director of the Northwestern Medicine Women’s Infectious Disease Program, and Ravi Jhaveri, MD, division head of infectious diseases at Lurie Children’s Hospital of Chicago, about the new guidance and the risks associated with HCV infection in pregnancy.

Healio: Providers might be unaware of the risks of HCV in pregnancy. What are the health consequences? 

Yee: In addition to the risks of HCV that all people experience — such as liver fibrosis, cirrhosis and cancer — there are some pregnancy-specific risks. First, there is an association between HCV and an increased risk of preterm birth, intrahepatic cholestasis of pregnancy and inadequate fetal growth. In addition, there are some studies that suggest an increased risk of gestational diabetes, although this is less clear. Second, for the fetus and neonate, there is a 5% to 15% risk of transmission of HCV, which poses potential lifelong risks to the child, particularly if unrecognized.

Healio: What are the biggest changes in the CDC’s recommendations, and what have been some of the biggest developments since the last time they were updated? 

Jhaveri: By emphasizing testing early in life for infants with HCV exposure, we hope to capture more infants for testing when they are seeing their doctors for vaccines and well-child check. Eliminating the long delay — 18 months — that existed previously should help minimize the number of infants who are lost to follow-up.

Healio: Can you break down the testing protocol for hepatitis C during pregnancy? 

Yee: Based on the 2020 U.S. Preventive Services Task Force guidelines, it is now recommended that all pregnant people be tested for HCV antibodies during routine prenatal care. This test is typically performed with their baseline prenatal labs — at the same time as testing for HIV, blood type, immunity to rubella and measles, etc. If the antibody is found to be present, then further testing is performed to investigate whether there is virus present in the blood and to evaluate liver function.

Healio: In your opinion, is there anything lacking in these recommendations? 

Jhaveri: The recommendations are clear, but we still need to help pediatricians and other pediatric providers with the logistics of how to do this testing in their offices. These tactical issues will need to be worked out for practices and groups who care for these infants.

We need better coordination between pregnancy care providers and pediatric providers to make sure information is shared between them for parent-infant dyads. This will be critical to help improve on the status quo.

Healio: Why is it so crucial to include pregnant patients when researching HCV? 

Yee: The inclusion of pregnant people in research programs about any condition or therapy is essential to be able to optimize the health of pregnant people and their families — without research to build the evidence on new medications, pregnant people are left behind when medical advances occur. As we learned during the early stages of the COVID-19 pandemic, when pregnant people were excluded from the SARS-CoV-2 vaccine trials, the exclusion of pregnant people leaves doctors and patients without the information we need to safely and comprehensively care for our patients. 

Specific to HCV, the treatment of nonpregnant people is standard of care, and the inclusion of pregnant people in treatment and research programs is necessary to achieve the public health goal of HCV elimination. In addition, pregnant people deserve autonomy and the ability to make their own informed decisions about their health, which, for some people, may include undertaking treatment for HCV during pregnancy. 

For more information: https://tinyurl.com/y67ekhhh

Hep C World News - Week of November 5, 2023

Cocaine use rising in Canada, new data suggests, as researchers link stimulants to drug deaths

Ottawa, ON - Drug overdoses increased overall from 2020 to 2021, and roughly half of the apparent accidental opioid deaths 'also involved a stimulant,' according to Statistics Canada.  More Canadians are using stimulants such as cocaine, new federal data suggests, and experts warn the trend is contributing to a high percentage of drug-related deaths. In most municipalities studied, cocaine levels rose from January to May 2022 compared with the same period in 2020, and early data for 2023 suggests that overall rise is continuing, according to a Statistics Canada report released on Wednesday. And, as drug overdoses increased overall by more than 30 per cent from 2020 to 2021, roughly half of the apparent accidental opioid deaths "also involved a stimulant," said Statistics Canada, citing another report by the Public Health Agency of Canada. The data "shows that in the last few years, things have worsened," said Tara Gomes, a research scientist based out of Unity Health Toronto and a principal investigator with the Ontario Drug Policy Research Network (ODPRN), who wasn't involved in the federal analysis.  "This is really complex," she said. "People are using multiple substances, and need multiple types of programs and services." The Statistics Canada report was based on data from the Canadian Wastewater Survey, which has been regularly collecting wastewater samples from several municipalities across the country since 2019 to test for various types of drugs.  The report also compared Canadian cities with more than 100,000 people to those in Europe, where wastewater monitoring is conducted by the European Monitoring Center for Drugs and Drug Addiction.  That breakdown puts five Canadian cities among the top ten places with the highest levels of cocaine in wastewater, including Montreal, Edmonton, Vancouver, and Toronto. The top Canadian city, ranked third, was Halifax. CBC News recently reported that cocaine was linked to a rise in drug-related deaths and overdoses throughout Nova Scotia. Nearly half of the close to 80 accidental overdose deaths last year there involved cocaine, triple the number from a decade ago.  Nova Scotia's health authority says cocaine and the opioid hydromorphone were among the drugs reported to have been used in one recent "cluster" of suspected overdoses, which included a death. Ontario is also experiencing a rise in people dying from multiple toxic substances, including stimulants, based on the latest available data.  A report by Gomes, released in September by the ODPRN and Public Health Ontario, showed nearly 2,900 Ontarians died from consuming a toxic substance in 2021 — nearly double the number from just three years prior. After the COVID-19 pandemic was declared in March 2020, more deaths occurred as a result of at least two types of substances, Gomes' team found, with most of those people having a mixture of opioids and stimulants in their systems.  Gomes notes the illicit opioid supply has been contaminated with other substances, including benzodiazepines, a class of drugs that slow brain activity, and may be used to treat conditions such as anxiety. Some individuals may use stimulants to counter those sedating effects.  "We're focusing so much on the opioid crisis, which is so important, but people don't understand there's poly-substance use," said Linda Wonitoway-Raw, a nurse practitioner who works at a primary care clinic in a First Nations community northwest of Edmonton. She says her patients "use opioids, which are a downer, and alcohol, which is a downer, then they turn to an upper." Opioids are a class of drugs which include heroin, fentanyl and a variety of legal pain relievers. Stimulants include cocaine, the highly addictive methamphetamine or "crystal meth," MDMA/ecstasy and amphetamines — the last of which can include both illicit drugs and prescription medications used to treat conditions such as attention deficit/hyperactivity disorder (ADHD). Canadian cities also displayed very large levels of methamphetamine compared with cities in other countries worldwide, the StatsCan report noted, though usage has not changed significantly in recent years. Among countries with available wastewater data that use comparable methodology, cities in the U.S., the Czech Republic, Australia, Canada and New Zealand had the highest levels of methamphetamine use in 2022. Wonitoway-Raw says tackling crystal meth is a challenge because it's cheap, easy to produce and readily available. It's also often laced with other toxic substances, leading to potentially deadly overdoses, she says, and even on its own can produce either feelings of extreme euphoria or drug-induced psychosis.  "My patients say it's much more addictive than any opioids they've ever used," she added.  The report also noted the average wastewater levels of amphetamine were much higher in the first half of 2022 compared with the same time period in 2020 in several major cities, including Montreal, Toronto and the Vancouver area. A new report finds that after the COVID-19 pandemic began, overdose deaths in Ontario from multiple substances surpassed deaths from a single substance. However, the authors say that could be due to increased use of amphetamine medications legally prescribed to treat ADHD. (New research out of British Columbia, for instance, has shown rising rates of ADHD medication usage among adults, and experts say it's a broader trend elsewhere.)  "Further research is needed to better understand whether this is primarily from increased prescription or illicit amphetamine drug use," said Statistics Canada. New data from B.C. shows the rate of adults using ADHD medication has gone up dramatically. It can mean a fresh start for many newly diagnosed adults but physicians warn there can be drawbacks of taking medication. On average, both methamphetamine and amphetamine levels have been consistently higher in cities in Western provinces — such as Edmonton, Prince Albert and Saskatoon — compared with the others participating in federal wastewater surveillance efforts. Prince Albert, the third-largest city in Saskatchewan, had the highest average levels for January to May in 2022 and 2023. But experts stress this is a trend that goes beyond any one city or country. American research, for example, also shows that the number of overdose deaths from fentanyl plus a stimulant increased more than 50-fold from 2010 to 2021. This entire family died of suspected overdoses. Those left say parents with addictions need more support. Long-term opioid users suffer with crumbling bones, brain injuries and little hope of treatment Gomes says tackling this issue is complicated, since the usage and harms linked to various drugs are now so widespread, impacting both long-term, regular drug users and those taking illicit drugs on a more casual basis.  Even intermittent use, she said, comes with risks, given the tainted supply. "The reality of the situation is, we are seeing use and associated harms across all populations… these drugs are very unpredictable."

For more information: https://www.cbc.ca/news/health/cocaine-use-canada-1.7015603

Hep C World News - Week of October 29, 2023

Emergent taps ex-NFL star to bring opioid message to college football tailgate parties

Baltimore, Maryland - Emergent BioSolutions is rushing to get the message out about its opioid overdose treatment Narcan, partnering with former NFL star Emmitt Smith to spread the word at college football tailgates. Maryland-based Emergent launched an over-the-counter version of Narcan in August and began to tell consumers that “anyone can save a life” if they are ready “at home, at work or on the go with Narcan nasal spray.” Weeks later, the company has partnered with Smith, a record-breaking running back who played for the Dallas Cowboys from 1990 to 2002, to help get its message to more people. Together, Emergent and Smith are kicking off "Ready to Rescue," a campaign designed to drive discussion about the risks of opioids and the actions that can save lives when someone overdoses. The campaign is personal for Smith.  “Losing teammates to accidental overdose and watching family members struggle with addiction has made me realize how serious the opioid epidemic is,” Smith said in a statement. “As a father of five, I make sure to talk to my kids about the risks associated with opioids, and I want to use my voice to help keep our loved ones and communities safe by urging everyone to have Narcan Nasal Spray on hand.” Emergent is particularly keen to reach younger people. Noting that opioid misuse and dependency are highest among young adults aged 18 to 25 years, the company outlined plans to travel with Smith to talk to people at college football tailgates, events where people gather to eat and drink before games.  The focus on tailgates reflects evidence that student athletes and college campuses are vulnerable to opioid misuse and dependency for reasons such as peer and performance pressure, stress and curiosity. Emergent will hold Narcan demonstrations and distribute Ready to Rescue kits at the events, which will take place across the U.S. this month. Emergent is working to capitalize on its first-mover advantage in the OTC space and grow Narcan sales to between $425 million and $445 million this year. Companies including Teva and Hikma compete for the prescription space, but Emergent has a brief monopoly in the OTC market. Harm Reduction Therapeutics plans to start selling an OTC opioid overdose drug early next year. For more information: https://tinyurl.com/2j5dch7z

Hep C World News - Week of October 22, 2023

UN Backflips on Drug Policy 

New York, NY - A landmark report by the Office of the United Nations High Commissioner for Human Rights (OHCHR) exposes the unintended consequences of drug prohibition. The report pushes for a major rethink of global drug policy by Member States, advocating for a public health and human rights approach rather than criminalization.  After years of endorsing drug prohibition, could this groundbreaking UN report be a harbinger of change in global drug policy? The report ‘Human Rights Challenges in Addressing and Countering all Aspects of the World Drug Problem’ was presented to the 54th session of the Human Rights Council in September 2023.  This controversial report marks a dramatic shift in the United Nations 50 year “war on drugs”.  The recommendations stand in stark contrast to the prohibitionist approach that has defined drug policy for decades. After promoting the “war on drugs” in pursuit of a “drug free world,” the UN has finally acknowledged the unacceptable cost of pursuing the ideal of abstinence.  The three UN drug treaties starting with the ‘1961 Single Convention of Narcotic Drugs’ were originally intended to “protect the health and welfare of humankind”. However, in the following 30 years, a harsh interpretation of these treaties resulted in, over-incarceration, adverse health outcomes and needless deaths. The new report challenges this long held position, arguing that these policies have violated human rights without eradicating the illicit drug trade.  Recently, a more liberal interpretation of these treaties has emerged, with a greater focus on human rights and harm reduction. Some countries have decriminalized drugs, meaning that people can no longer be arrested on the basis of drug use.  More radically, in 2018, Canada became the first country to legalize cannabis, directly challenging the 1961 treaty that required countries to restrict it as a controlled substance.  Now for the first time, the UN has encouraged Members to consider legal regulation as a solution to the human rights violations caused by prohibition.  The OHCHR argues that a “war on people” more accurately describes the impacts of drug prohibition. These policies have failed to stop the illicit drug trade, while hurting civilians who find themselves at the crossfire of the “war on drugs”.  Globally, 3.1 million people have been arrested for drug offences. The OHCHR likens the “war on drugs” to “a system of racial control” , urgently calling for an end to “discriminatory law enforcement … on people of African descent, who are more likely to be stopped, searched, arrested, convicted and severely sentenced for drug crimes”. This powerful recommendation challenges the deeply entrenched racism in countries that are over reliant on incarceration.   The report also urges a repeal of laws that disproportionately target women and calls for an end to the criminalization of drug use during pregnancy. Drug prohibition has raised rates of women’s imprisonment internationally. 35% of women in prison were convicted of drug offences as opposed to 19% of imprisoned men. The OHCHR critiques the gender-blind nature of punitive drug policy which overlooks women’s nuanced experiences of vulnerability. Criminalizing drug use is especially disastrous in States that have not abolished the death penalty. In these States, drug offences account for one third of fatal sentences. The OHCHR strongly condemns this imposition of the death penalty and calls for its universal abolition. Additionally, it encourages States to reallocate resources from law enforcement to health and social services. Over the last 10 years, there has been a 45% increase in the number of people suffering from problematic drug use globally. Out of these 39.5 million people, only 1 in 5 have access to treatment, the OHCHR warns that this breaches human rights.  Even when drug treatment is available, there are often substantial barriers, such as stigma, shame and fear of persecution, which prevent access to these lifesaving services. Legal regulation would dissolve these structural barriers to treatment and "ensure access to justice, strengthen health and social services, and reduce stigma". 

For more information: https://tinyurl.com/2p99np7u

Hep C World News - Week of October 15, 2023

Opioid reversal medication going OTC

New York, NY - Narcan, the first opioid overdose reversal medication approved for over-the-counter purchase, is being shipped to drugstore and grocery chains nationwide, its manufacturer said Wednesday. Big-box outlets like Walgreens, CVS, Walmart and Rite Aid said they expected Narcan to be available online and on many store shelves early next week.  Public health experts have long called for greater accessibility to the drug, which they describe as a critical weapon against rising overdose rates. There were more than 100,000 overdose fatalities in each of the last two years in the United States. Narcan is already a staple for emergency personnel and street outreach teams. Now scientists and health officials are hoping Narcan will eventually become commonplace in public libraries, subways, dorms, corner delis and street vending machines. They also predict it may become a fixture in medicine cabinets, as more people realize that illicit party drugs like cocaine and counterfeit Xanax pills may be tainted with deadly fentanyl, an opioid. Narcan is a nasal-spray version of the drug naloxone, which blocks an opioid’s effects on the brain, rescuing a person overcome by drugs like fentanyl, heroin or oxycodone. An individual may be overdosing if his or her breathing is slowed or stopped, and the pupils of the eyes narrow to a pinpoint. Naloxone is generally considered so safe that experts say that, when confronted with a possible overdose, it is better to risk using it than to hesitate. Drug overdose deaths, largely caused by the synthetic opioid drug fentanyl, reached record highs in the United States in 2021. Understand fentanyl’s effects. Fentanyl is a potent and fast-acting drug, two qualities that also make it highly addictive. A small quantity goes a long way, so it’s easy to suffer an overdose. With fentanyl, there is only a short window of time to intervene and save a person’s life during an overdose. Stick to licensed pharmacies. Prescription drugs sold online or by unlicensed dealers marketed as OxyContin, Vicodin and Xanax are often laced with fentanyl. Only take pills that were prescribed by your doctor and came from a licensed pharmacy. 

For more information: https://tinyurl.com/4z646e6d

Hep C World News - Week of October 8, 2023

Overdoses from smoking toxic drugs outpace B.C. prevention sites 

Vancouver, BC - Nearly two-thirds of the overdose deaths in British Columbia this year came after smoking illicit drugs, yet only 40 per cent of the supervised consumption sites in the province offer a safe place to smoke, and the chief coroner says that needs to change. Lisa Lapointe said the latest data show 65 per cent of overdose deaths in 2023 came after smoking drugs, compared to 15 per cent involving injection, 14 per cent snorting and five per cent from oral consumption. The coroners' office notes that people can consume using multiple methods. Also in the data, the updated overdose death toll since the province declared a public health emergency in April 2016. Almost 13,000 have died since then, more than 1,600 this year. The Ministry of Mental Health and Addictions said of the 47 overdose prevention sites in B.C., only 19 provide the option to smoke drugs. B.C.'s original supervised consumption site is a safe injection site, but Lapointe said methods for consuming drugs have shifted over time. "If we truly want to reduce the risk, and reduce the numbers of deaths, and help make our communities safer, then there needs to be an acknowledgment that providing a safe place for people to use drugs is critically important," Lapointe said. "And that includes a safe place to smoke drugs." Those who study the topic say a combination of stigma, bureaucracy and a lack of political will are all obstacles to setting up more sites for smoking drugs. The latest analysis of the deaths contrasts with data from January 2016 to July 2017, following the declaration of the emergency, which show that one-third of deaths came through injecting drugs, while 36 per cent who died smoked drugs. While Lapointe's office has not made any formal recommendations, she said she's heard from community groups that there are not enough safe spaces generally to use drugs, but particularly not to smoke. "Clearly, smoking drugs is much more popular now than injecting drugs. If we want to keep people safe, if we want to reduce the death toll from the opioid crisis, then we need to be meeting people where they are, and certainly (there's) a need to adapt policies, whatever they may be," she said. Nicole Luongo, the systems change co-ordinator for the Canadian Drug Policy Coalition, based at Simon Fraser University in Burnaby, B.C., said the rules around setting up safe inhalation sites are overly complicated but don't have to be, given the extra powers the government has to act under the emergency declaration. "We are seeing harm reduction sites still being tailored around injection and the ability to introduce inhalation sites being really mired in bureaucracy," Luongo said. "And they're expensive as well, to introduce the kind of equipment that would reduce risk for outside observers." In a statement, the Ministry of Mental Health and Addictions says local health authorities are responsible for the operation of those services and they have been working to increase the number of inhalation sites. It says considerations for implementing inhalation sites include whether there is a suitable outdoor space, particularly during the winter, occupational health and safety concerns and worker safety issues, primarily due to specialized ventilation requirements. 

For more information: https://tinyurl.com/ycxysrk4

Hep C World News - Week of October 1, 2023

Heavy Drinking Not Tied to Lower Response to DAAs for Hepatitis C

London, UK - Alcohol use and alcohol use disorder (AUD) were not associated with lower odds of sustained virologic response to direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection, according to a retrospective cohort study of veterans. Among over 69,000 patients who initiated DAA therapy, there was no evidence that any alcohol use category was significantly associated with decreased odds of sustained virologic response, reported Christopher T. Rentsch, PhD, of the London School of Hygiene & Tropical Medicine, and colleagues. There was also no evidence of interaction by stage of hepatic fibrosis measured by fibrosis-4 score (P=0.30), they noted in JAMA. "Our findings suggest that DAA therapy should be provided and reimbursed despite alcohol consumption or history of AUD," Rentsch and team concluded. "Restricting access to DAA therapy according to alcohol consumption or AUD creates an unnecessary barrier to patients accessing DAA therapy and challenges HCV elimination goals." Historically, clinicians have been reluctant to treat HCV patients with active alcohol use, due to the fact that patients were more likely to discontinue previously used interferon-based therapy, the authors noted. "However, for patients who successfully completed interferon-based therapy, comparable rates of sustained virologic response were achieved regardless of reported alcohol use." While current American Association for the Study of Liver Diseases/Infectious Diseases Society of America HCV treatment guidelines recommend that patients avoid excess alcohol use, they do not recommend restricting access to DAA therapy on the basis of alcohol intake, regardless of any level of consumption, Rentsch and colleagues said. "Despite these recommendations, some clinicians continue to delay or withhold HCV therapy from patients who consume alcohol," they added. "Furthermore, some payers include alcohol abstinence as a requirement for reimbursement of DAA therapy for HCV." For this study, the authors used electronic health record data on 69,229 patients from the Department of Veterans Affairs, which does not restrict access to DAA HCV treatment based on a patient's alcohol use. Participants were born between 1945 and 1965 and were given DAA therapy between January 2014 and June 2018. Of these patients, 84.5% had HCV genotype 1. Mean age was 62.6, 97% were men, 50.1% were white, and 40.6% were Black. The cohort was divided into five groups based on alcohol consumption using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) questionnaire and the International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnoses for AUD: Abstinence without AUD (AUDIT-C score of 0 and absence of AUD diagnosis): 46.6% of patients Abstinence with AUD (AUDIT-C score of 0 and presence of AUD diagnosis): 13.3% of patients Lower-risk consumption (AUDIT-C score of 1-3 and absence of AUD diagnosis): 19.4% of patients Moderate-risk consumption (AUDIT-C score of 4-7 and absence of AUD diagnosis): 4.5% of patients High-risk consumption or AUD (AUDIT-C score of 8 or presence of AUD diagnosis with nonzero AUDIT-C score): 16.2% of patients Sustained virologic response was defined as undetectable HCV RNA for 12 weeks or longer after completion of DAA therapy. Overall, 94.4% of the patients achieved sustained virologic response. Rentsch and team noted that "a degree of uncertainty persists owing to the potential for residual confounding" due to the observational nature of their study. 

For more information: https://tinyurl.com/57emnvy3

Hep C World News - Week of September 24, 2023

Liver disease causes 50% of all deaths in first 5 years after alcohol-related diagnosis

Roskilde, Denmark - Liver disease was the primary cause of death in patients with alcohol-related liver disease several years after diagnosis, with the risk for mortality almost three times higher in those with decompensated cirrhosis, according to research. “Patients with alcohol-related liver disease have a 1-year mortality risk of 25%, despite their young median age of 60 years,” Anna Emilie Kann, MD, of the gastroenterology and hepatology section at Zealand University Hospital in Denmark, and colleagues wrote in The Lancet Gastroenterology & Hepatology. “Knowledge of the causes of death in patients with alcohol-related liver disease is essential in the prevention of these premature deaths.” They added, “Moreover, further knowledge of cause-specific cancer death in patients with alcohol-related liver disease is needed.” Using data from nationwide health registries in Denmark, Kann and colleagues conducted a historical cohort study to investigate cause-specific mortality among 23,385 adults (median age, 58 years; 68% men) diagnosed with alcohol-related liver disease between January 2002 and December 2017, of whom 66% had cirrhosis. Researchers monitored patients through December 2019 to determine an underlying cause of death. During 111,532 person-years of follow-up, 67% of patients died. The overall mortality rate was 14.1 per 100 person-years and 18.6 per 100 person-years among those with decompensated and compensated cirrhosis. All-cause mortality risk for the entire cohort was 26.3% at 1 year (95% CI, 25.7-26.9) and 52.5% (95% CI, 51.8-53.1) at 5 years. Of 11,904 deaths in the first 5 years after alcohol-related liver disease diagnosis, nearly half were caused by liver disease (n = 5,903). The 5-year and 10-year risks for death due to liver disease were 25.8% (95% CI, 25.3-26.4) and 31.4% (95% CI, 30.8-32.1), respectively. In comparison, the 10-year risk for cancer-related death was 11% (95% CI, 10.6-11.4), while the risks for death due to alcohol use disorder and cardiovascular disease were even lower at 5.1% (95% CI, 4.8-5.4) and 4.5% (95% CI, 4.3-4.9), respectively. Of cancer-related causes of death after 10 years, the most common was HCC (2.5%; 95% CI, 2.3-2.7) followed by lung (1.9%; 95% CI, 1.7-2.1) and oropharyngeal (1%; 95% CI, 0.9-1.1) cancers. The 10-year risk for HCC death was 3.2% (95% CI, 2.5-3.9) for decompensated cirrhosis and 0.7% (95% CI, 0.5-1) for steatosis or unspecified liver disease. Researchers noted the 10-year risk for death due to liver disease, which was approximately 30%, “was similar in men and women, for different age groups and irrespective of diabetes,” but was three times higher among patients with decompensated cirrhosis (46.7%; 95% CI, 44.8-48.4) compared with those with steatosis or unspecified liver disease (16.2%; 95% CI, 15.3-17.2). “Patients with alcohol-related liver disease constitute a unique patient group because they have chronic liver disease and the comorbidity of alcohol use disorder,” Kann and colleagues concluded. “We hope our findings will motivate further research into interventions to combat continued alcohol consumption in patients with liver disease.” For more information: https://tinyurl.com/yyzfypkz

Hep C World News - Week of September 17, 2023

End overreliance on punitive measures to address drugs problem – UN report

Geneva, Switzerland – A UN human rights report today calls for a shift from punitive measures to address the global drugs problem to the use of policies grounded in human rights and public health, arguing that disproportionate use of criminal penalties is causing harm. The report urges States to develop effective drug policies, including by considering decriminalization of drug possession for personal use. “If effectively designed and implemented, decriminalization can be a powerful instrument to ensure that the rights of people who use drugs are protected,” it says. “Laws, policies and practices deployed to address drug use must not end up exacerbating human suffering. The drugs problem remains very concerning, but treating people who use drugs as criminals is not the solution,” said the UN High Commissioner for Human Rights, Volker Türk.  “States should move away from the current dominant focus on prohibition, repression and punishment, and instead embrace laws, policies and practices anchored in human rights and aimed at harm reduction. ”The UN Human Rights Office report, mandated by the UN Human Rights Council, finds that disproportionate use of criminal penalties discourages people who use drugs from seeking treatment and feeds stigma and social exclusion. According to the latest available statistics from the 2023 World Drug Report, people who use drugs are disproportionately affected by blood-borne viruses, nearly 660,000 die of drugs-related causes each year, and 10 percent of all new HIV infections globally in 2021 were among people who injected drugs. The ill effects of these policies are profound and far-reaching, the report finds. Militarization of law enforcement in the so-called war on drugs contributes to severe human rights violations, including extrajudicial killings. And disproportionate use of criminal penalties contributes significantly to prison overcrowding. The report highlights that the effects of these policies are most severe for people of African descent, women, indigenous peoples and young people from poor backgrounds. “Today’s drugs policies have the greatest impact on those who are poorest and most vulnerable,” Turk stressed. There has also been an increase in the use of the death penalty for drug-related convictions worldwide, contrary to international human rights law norms and standards. The recorded number of people executed for drug-related offences more than doubled in 2022 compared to 2021, amounting to 37 percent of all executions recorded globally, the report states. “The current overemphasis on coercion and control to counter drugs is fanning an increase in human rights violations despite mounting evidence that decades of criminalization and the so-called war on drugs have neither protected the welfare of people nor deterred drug-related crime,” Türk said. The report shows that an increasing number of countries across regions are adopting policies and practices that decriminalize drug use and treat drug usage as a public health and human rights issue, and applying evidence-based, gender-sensitive and harm reduction approaches. The High Commissioner called on States to build on this positive trend. 

For more information: https://tinyurl.com/6dufdaub

Hep C World News - Week of September 10 2023

Narcon going over the counter

New York, NY - Narcan, the first opioid overdose reversal medication approved for over-the-counter purchase, is being shipped to drugstore and grocery chains nationwide, its manufacturer said Wednesday. Big-box outlets like Walgreens, CVS, Walmart and Rite Aid said they expected Narcan to be available online and on many store shelves early next week.  Public health experts have long called for greater accessibility to the drug, which they describe as a critical weapon against rising overdose rates. There were more than 100,000 overdose fatalities in each of the last two years in the United States. Narcan is already a staple for emergency personnel and street outreach teams. Now scientists and health officials are hoping Narcan will eventually become commonplace in public libraries, subways, dorms, corner delis and street vending machines. They also predict it may become a fixture in medicine cabinets, as more people realize that illicit party drugs like cocaine and counterfeit Xanax pills may be tainted with deadly fentanyl, an opioid. Narcan is a nasal-spray version of the drug naloxone, which blocks an opioid’s effects on the brain, rescuing a person overcome by drugs like fentanyl, heroin or oxycodone. An individual may be overdosing if his or her breathing is slowed or stopped, and the pupils of the eyes narrow to a pinpoint. Naloxone is generally considered so safe that experts say that, when confronted with a possible overdose, it is better to risk using it than to hesitate. Drug overdose deaths, largely caused by the synthetic opioid drug fentanyl, reached record highs in the United States in 2021. Understand fentanyl’s effects. Fentanyl is a potent and fast-acting drug, two qualities that also make it highly addictive. A small quantity goes a long way, so it’s easy to suffer an overdose. With fentanyl, there is only a short window of time to intervene and save a person’s life during an overdose. Stick to licensed pharmacies. Prescription drugs sold online or by unlicensed dealers marketed as OxyContin, Vicodin and Xanax are often laced with fentanyl. Only take pills that were prescribed by your doctor and came from a licensed pharmacy. 

For more information: https://tinyurl.com/4z646e6d

Hep C World News - Week of September 3, 2023

Causes of hepatocellular carcinoma ‘differ remarkably’ by race, ethnicity

Miami, FL - Rates of hepatocellular carcinoma caused by alcohol-related disease and nonalcoholic fatty liver disease are on the rise, especially among Hispanic individuals, according to research in Clinical Gastroenterology and Hepatology. Using the Florida Cancer Data System, Paulo S. Pinheiro, MD, PhD, a research associate professor of epidemiology at University of Miami Miller School of Medicine, and colleagues examined etiology-specific incidence rates and population-based trends for HCC. Of 14,420 HCC cases diagnosed between 2010 and 2018, hepatitis C virus was the main cause (46.6%), followed by NAFLD (27.2%), alcohol-related disease (13%) and hepatitis B virus (4.4%). Puerto Rican men had the highest HCC rates (19.6 per 100,000), while Mexican women born outside of the U.S. had the highest rates (5.9 per 100,000). Overall age-adjusted incidence rates for HCC in Florida were 9.3 per 100,000 (95% CI, 9.2-9.5) among men — nearly fourfold higher than among women (2.4 per 100,000; 95% CI, 2.4-2.5). HCV continues to be the primary cause of HCC among men, while NAFLD has become the leading cause among women. HCV-HCC incidence rates were highest in U.S.-born Puerto Rican men (10.9 per 100,000), followed by African American (8 per 100,000) and U.S.-born Mexican American (7.6 per 100,000) men. Similar trends were reported among women in these ethnic groups. HBV-HCC rates were high among Asian and Haitian Black men (4.9 and 4.6 per 100,000, respectively), while these rates were low among women (< 0.2 per 100,000), with the exception of Asian women (1.2 per 100,000). NAFLD-HCC was more common among Hispanic and Filipino people, while alcohol-related liver disease-HCC was high among Puerto Rican, Hispanic Central American and Mexican men but low among women of all ethnic groups. Population-based rates of HCV-HCC declined 9.6% annually since 2015 in all groups, while alcohol-related disease-HCC and NAFLD-HCC rose 6% and 4.3%, respectively, from 2010 to 2018. 

For more information: https://tinyurl.com/2pbee42t

Hep C World News - Week of August 27, 2023

How the fentanyl crisis' fourth wave has hit every corner of the US

Burlington, Vermont - More Americans than ever are dying from fentanyl overdoses as the fourth wave of the opioid epidemic crashes through every community, in every corner of the country. Sean Blake died from a fentanyl overdose in 2017. He is one of thousands of Americans who lost their lives to the country's staggering overdose crisis. It was six years ago that Kim Blake's son Sean died from an accidental fentanyl overdose in Burlington, Vermont. He was 27 years old. "Every time I hear of a loss to substance use, my heart breaks a little more," Ms Blake wrote in a blog dedicated to her son in 2021."Another family shattered. Forever grieving the loss of dreams and celebrations." That year, the US witnessed a grim milestone: for the first time ever, drug overdoses killed more than 100,000 people across the country in one single year.  Of those deaths, more than 66% were tied to fentanyl, a synthetic opioid 50 times more powerful than heroin.  Fentanyl is a pharmaceutical drug that can be prescribed by a doctor to treat severe pain. But the drug is also illegally manufactured and sold by criminal gangs. Most of the illegal fentanyl found in the US is trafficked from Mexico using chemicals sourced from China, according to the Drug Enforcement Administration (DEA). In 2010, less than 40,000 people died from a drug overdose across the country, and less than 10% of those deaths were tied to fentanyl. Back then, deaths were mostly driven by the use of heroin or prescription opioids. The contrast is outlined in a study released this week by researchers at the University of California, Los Angeles (UCLA) that examines trends in US overdose deaths from 2010-21 using data compiled by the US Centers for Disease Control and Prevention. The data paints a clear picture of how fentanyl has redefined drug overdoses in America over the last decade. "The rise of illicitly manufactured fentanyl has ushered in an overdose crisis in the United States of unprecedented magnitude," the study's authors wrote.  Virtually every corner of the US, from Hawaii to Alaska to Rhode Island, has been touched by fentanyl.  The rise in fentanyl-related deaths was first observed in 2015, the data shows.  Since then, the drug has spread across the US and death rates have grown sharply. "In 2018, around 80% of fentanyl overdoses happened east of the Mississippi river," Chelsea Shover, an assistant professor at UCLA's school of medicine and co-author of the study, told the BBC.  But in 2019, "fentanyl becomes part of the drug supply in the Western US, and suddenly this population that had been insulated from it is exposed, and death rates start to go up," Prof Shover said. In their study, the researchers sound the alarm on another growing trend: deaths related to the use of fentanyl and another stimulant drug, like cocaine or methamphetamine. This trend is being observed across the US, albeit in different ways owing to drug use patterns that differ from region to region. 

For more information: https://www.bbc.com/news/world-us-canada-66826895

Hep C World News - Week of August 20, 2023

Do genetic markers hold the key to understanding substance use disorders?

Drug abuse and addiction are a public health crisis that involve high social, emotional, and financial costs to families and society at large. There is also significant stigma surrounding addiction, despite increasing evidence that addiction is a disease that is preventable and treatable—much like heart disease, for example. But a 2023 NIH study of more than 1 million individuals published in Nature Mental Health found the presence of specific genes associated with addiction. These genes were found to be commonly inherited, regardless of the type of substance use disorder.  Prior research has established that substance use disorders are heritable and can involve multiple genes. A process called genome-wide association has been developed to identify genetic variations in genomes. These variations, called single-nucleotide polymorphisms (SNPs), can be linked with the same disease, disorder, condition, or behavior among multiple people. The NIH study used this method to look for genes associated with general addiction overall, along with specific addiction risks, including alcohol, nicotine, cannabis, and opioids. The sample size was large, with 1,025,550 individuals of European ancestry and 92,630 individuals of African ancestry. The goal was to include globally represented populations. The researchers found 19 independent SNPs that were strongly associated with general addiction risk, and 47 SNPs for specific substances in the European ancestry sample. Many of the genes co-occurred among addiction and mental disorders, indicating the link in these conditions. The researchers note that the findings from the African ancestry portion of the cohort were not useful, most likely due to the small sample size compared with the European cohort. The researchers noted that, taken together, the specific substance risk variants combined with the general addiction-related variants provide strong support for individualized prevention and treatment. These findings can potentially lead to more effective prevention and treatments for substance use disorders. The SNPs identified in the study were also associated with dopamine signals, confirming the role of dopamine in addiction. This finding supports the need for research into biomarker development and treatment targets. This international study was supported by several federal agencies, including the National Institute on Drug Abuse (NIDA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Mental Health (NIMH), the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute on Aging.

For more information: https://tinyurl.com/2749bzm6

Hep C World News - Week of August 13, 2023

HBV vaccine non-responders should be considered for revaccination after HCV cure

Duluth, MN - People who were not responsive to hepatitis B vaccination should be considered for revaccination following hepatitis C cure, researchers reported. “We know that the immune system is disarranged in hepatitis C infection, and our team has published before that individuals with hepatitis C do not mount a great response to the hepatitis B vaccine,” Jose D. Debes, MD, MS, associate professor in the department of medicine at the University of Minnesota, told Healio.  Revaccination for hepatitis B resulted in improved response after patients received hepatitis C treatment. Image: NIAID.  “Recent data also show that upon treating hepatitis C, it seems that the immune system (within the liver at least) returns to a more normal pattern. So, we wanted to address if individuals that did not respond to the HBV vaccine before would respond after treatment of HCV,” Debes said. The FDA in 2021 approved a trivalent HBV vaccine, which was found to be significantly more effective than previous monovalent vaccines. Previous studies have shown that HBV vaccine awareness among primary care physicians is exceedingly low, and that educating clinicians who treat HCV on the vaccine could help improve cure rates of HCV and prevent new cases of HBV. To assess whether revaccination after HCV treatment resulted in improved response, Debes and colleagues prospectively recruited previous HBV vaccine non-responders for revaccination after HCV eradication. According to the study, hepatitis B surface antigen (HBsAb) testing was performed 1 month after series completion. Overall, follow-up HBsAb testing was performed in 31 out of 34 enrolled patients, with 21 (67.7%) yielding reactive results, eight nonreactive (25.8%) and two with equivocal results (6.5%).  The researchers wrote that these are still lower reactivity rates than what are observed among HCV-negative people who typically have rates of seroconversion after revaccination around 90% but were still “significantly better than nonresponse.” Additionally, the researchers explained that isolated HBcAB and advanced age have both been associated with decreased HBV vaccine response in first-time recipients of the vaccine after treatment for HCV. However, they did not find any association between age or presence of HBcAb in response to reapplication of HBV vaccine.  Additionally, they found that there was no association between nonresponse and having advanced fibrosis, being on hemodialysis or having HIV coinfection — although they noted there were few patients in the study on hemodialysis or with HIV coinfection, making it difficult to draw any significant conclusions. “The main message is that providers should check HBV immune-protection in HCV-infected patients, and if negative, these individuals should be offered the HBV vaccine following HCV treatment,” Debes said. “This is of particular importance in those at high risk for HBV infection.” 

For more information: https://tinyurl.com/2s3k6tj5

Hep C World News - Week of August 6, 2023

Record high drug poisonings

Edmonton, AB - Emergency services in Edmonton are responding to drug poisonings in record high numbers.  Ambulances responded to 753 overdose calls in the past month, compared to 306 responses during the same period last year, according to provincial statistics. "I have never seen so many opiate overdoses and out-of-hospital cardiac arrests as a result of drug poisoning in my entire life, and that's saying something for a doctor who has worked 20 years in an inner city hospital," said Dr. Darren Markland, an Edmonton intensive care physician at the Royal Alexandra Hospital. Markland said up to 30 per cent of the overdose patients in his unit are unidentified because they are just found unconscious or dead on streets, alleyways and river valley trails. 'People are dropping dead on the streets," he said. Across the province, emergency workers have responded to 1,321 drug calls since June 26, meaning 57 per cent of those responses were in Edmonton. "I've seen at least nine or 10 overdoses in the last seven days," Marshall Dines, who stays in shelters and carries a naloxone kit with him, told CBC News Wednesday. The UCP government has faced significant criticism from front-line health and outreach workers for its increased focus on a recovery-oriented model as more and more harm reduction services are cut. Alberta's Health Minister Adriana LaGrange declined comment Wednesday, but the province has said it is building a system that uses harm reduction services where appropriate. "This has felt very much like a disaster," said Marliss Taylor, the director of health services for Boyle Street Community Services. Taylor recalled being mortified in 2005, when four overdoses in one week was too much. "We've had up to 18 in a day around the building recently," Taylor said, adding that many of the overdoses are managed on site without calling 911. Doctors and front-line workers say the crisis is rooted in a number of complex issues, including a rise in mental illness and encampment living, the amount and severity of the drugs now available, and a lack of access to safe inhalation sites and testing kits to make sure drugs aren't laced. CBC News requested comment from the Ministry of Mental Health and Addiction about access to drug testing kits from Alberta Health Services. Press secretary Hunter Baril said, "the nation-wide increase in drug use and overdoses further shows the need for a comprehensive, compassionate approach that offers the opportunity for anyone to pursue recovery. "We are focused on expanding treatment capacity by funding more addiction treatment spaces and building 11 new recovery communities throughout the province," Baril said in an emailed statement Thursday. "We are providing services such as drug consumption sites and naloxone distribution alongside services such as the Virtual Opioid Dependency Program, which offers same-day access to life-saving medication for those suffering from the deadly disease of addiction. "These important initiatives will work with recovery communities and treatment programs to form the Alberta Model, which is uniquely focused on helping Albertans pursue recovery, unlike what we see in other jurisdictions." 

For more information: https://tinyurl.com/3e87tx5k

Hep C World News - Week of July 30, 2023

Survey shows only 68% of people with hepatitis C aware of the infection

Atlanta, GA - A nationally representative survey revealed that of the more than 2 million people with current hepatitis C virus infection, only 68% are aware of their infection. “The annual number of new hepatitis C virus (HCV) infections has steadily increased over the past decade,” said Karon C. Lewis, DrPH, MPH, MSBMS, Epidemiologist in CDC’s Division of Viral Hepatitis “This study was conducted to determine the prevalence of HCV infection among people in the United States who are represented in the most current National Health and Nutrition Examination Survey (NHANES), overall and by select characteristics,” Lewis said. Just over one-third of people with HCV in the United States were cured or cleared the virus over the last decade, according to a study published in MMWR in June — a rate that CDC researchers called "jarringly low." Health insurance and access were linked to the low number of people cured of HCV, but further research has shown incomplete screening tests have also contributed to the low rate. Using NHANES, a multistage, stratified probability survey, Lewis and colleagues collected data from between January 2019 and March 2020 and combined them with data from 2017-2018 to create a nationally representative sample of the U.S. citizens during the 39-month period before the COVID-19 pandemic. Blood samples from NHANES participants were tested with an HCV antibody screening test, and participants with a reactive screening test then received an HCV RNA test. Estimates of current HCV infection and awareness of HCV infection were calculated among study participants aged 18 years and older, with additional estimates done by sex, age, race and ethnicity, health insurance type and poverty status. The CDC recently updated it's guidance for HCV screening to recommend that patients receive both the HCV antibody test and an HCV RNA test at the same visit to increase complete HCV screenings. Previously, the antibody test and RNA test were done in separate visits, leaving patients with incomplete tests if they did not return for the second visit. Between January 2017 and March 2020, the estimated prevalence of current HCV infection was 0.9% (95% CI, 0.5%-1.4%), or 2.2 million (95% CI, 1.3-3.6 million), although Lewis said that the actual number of infections is likely higher due to limitations of the NHANES survey, which did not include people who were incarcerated or experiencing homelessness and are thus at an increased risk of HCV exposure. Approximately 67.7% (95% CI, 50.2%-82.2%) of these participants were aware of their infection — but the researchers noted that this estimate was considered unreliable because the absolute confidence interval width was more than 30% based on published National Center for Health Statistics standards. When assessed by age, people aged 55 to 64 years were 6.4 times as likely to have current HCV infection compared with those aged 18 to 40 years (prevalence ratio [PR] = 6.4; 95% CI, 2.5-16.4) and that men were 2.9 times as likely as women to have current HCV infection (PR = 2.9; 95% CI, 1.1-7.7). When assessed by race and ethnicity, the study showed that non-Hispanic white and non-Hispanic Black people were 5 times (PR = 5; 95% CI, 1.6-15.7) and 4.9 times (PR = 4.9; 95% CI, 1.7-14) as likely to have current HCV infection compared with participants of other races and ethnicities. Additionally, the study revealed that prevalence of HCV infection was 5.3 times as high among people experiencing poverty compared with those not experiencing poverty (PR = 5.3; 95% CI, 2.3-12.2). Similar results were seen among people with public insurance and persons with no insurance who were 4.7 times (PR = 4.7; 95% CI, 1.6-14.3) and 5.8 times (PR = 5.8; 95% CI, 1.7-19.8) as likely to have current HCV infection compared with people with private insurance. “Safe and highly effective medicines to cure hepatitis C have been available since 2014, but this estimate reiterates that millions of people still have not been cured — and we estimate there are more than 60,000 new infections every year. National action is urgently needed to reach, test, and treat everyone with hepatitis C,” Lewis said. “We need to work toward making testing and treatment available in all settings where people with hepatitis C receive care,” Lewis said. “All people with hepatitis C should know their status and benefit from treatment.” 

For more information: https://tinyurl.com/bdfmr8w6

Hep C World News - Week of July 23, 2023

People are dropping dead on the streets

Edmonton, AB - CBC reports that ambulances responded to 753 overdose calls in Edmonton over the past month, more than twice last year's number Emergency services in Edmonton are responding to drug poisonings in record high numbers.  Ambulances responded to 753 overdose calls in the past month, compared to 306 responses during the same period last year, according to provincial statistics. "I have never seen so many opiate overdoses and out-of-hospital cardiac arrests as a result of drug poisoning in my entire life, and that's saying something for a doctor who has worked 20 years in an inner city hospital," said Dr. Darren Markland, an Edmonton intensive care physician at the Royal Alexandra Hospital. Markland said up to 30 per cent of the overdose patients in his unit are unidentified because they are just found unconscious or dead on streets, alleyways and river valley trails. 'People are dropping dead on the streets," he said. Across the province, emergency workers have responded to 1,321 drug calls since June 26, meaning 57 per cent of those responses were in Edmonton. "I've seen at least nine or 10 overdoses in the last seven days," Marshall Dines, who stays in shelters and carries a naloxone kit with him, told CBC News Wednesday. The UCP government has faced significant criticism from front-line health and outreach workers for its increased focus on a recovery-oriented model as more and more harm reduction services are cut. Alberta's Health Minister Adriana LaGrange declined comment Wednesday, but the province has said it is building a system that uses harm reduction services where appropriate. "This has felt very much like a disaster," said Marliss Taylor, the director of health services for Boyle Street Community Services. Taylor recalled being mortified in 2005, when four overdoses in one week was too much. "We've had up to 18 in a day around the building recently," Taylor said, adding that many of the overdoses are managed on site without calling 911. Doctors and front-line workers say the crisis is rooted in a number of complex issues, including a rise in mental illness and encampment living, the amount and severity of the drugs now available, and a lack of access to safe inhalation sites and testing kits to make sure drugs aren't laced. CBC News requested comment from the Ministry of Mental Health and Addiction about access to drug testing kits from Alberta Health Services. Press secretary Hunter Baril said, "the nation-wide increase in drug use and overdoses further shows the need for a comprehensive, compassionate approach that offers the opportunity for anyone to pursue recovery. "We are focused on expanding treatment capacity by funding more addiction treatment spaces and building 11 new recovery communities throughout the province," Baril said in an emailed statement Thursday. "We are providing services such as drug consumption sites and naloxone distribution alongside services such as the Virtual Opioid Dependency Program, which offers same-day access to life-saving medication for those suffering from the deadly disease of addiction. "These important initiatives will work with recovery communities and treatment programs to form the Alberta Model, which is uniquely focused on helping Albertans pursue recovery, unlike what we see in other jurisdictions." 

For more information: https://tinyurl.com/3e87tx5k

Hep C World News - Week of July 16, 2023

CDC recommends single-visit testing for hepatitis C

Atlanta, GA - The CDC now recommends offering both testing steps during the same visit. In new guidance, the CDC recommended that the two-step testing process for hepatitis C virus be completed in one visit, eliminating the need for multiple visits, which often leads to incomplete testing. Writing in MMWR, Emily J. Cartwright, MD, and colleagues from the CDC’s Division of Viral Hepatitis said roughly one-third of people who receive a reactive HCV antibody test do not return to receive an HCV RNA test, making their testing incomplete. “This update clarifies that all sites performing HCV screening should ensure single-visit sample collection,” Cartwright and colleagues wrote. “This approach allows for automatic HCV RNA testing when an HCV antibody test is reactive to avoid incomplete testing.” Previous CDC guidelines allowed for the two steps to take place over multiple visits. The change will reduce the number of incomplete tests by reducing the patient burden of a second visit, the authors said. “Complete and accurate testing is the first step to identifying persons with current HCV infection to ensure linkage to care and initiation of curative antiviral therapy,” Cartwright and colleagues wrote. According to recently published statistics, just 34% of people in the United States diagnosed with HCV are cured or cleared of the virus and up to 1 million people are unaware they have HCV. Cartwright and colleagues analyzed data from the Chronic Hepatitis Cohort Study, New York City Department of Health and Mental Hygiene, the Veterans Administration, Cherokee Nation health Services and the Mid-Atlantic Permanente Medical Group, finding that roughly one-third of patients did not complete both steps of HCV testing. In facilities that later implemented single-visit sample collection, test completion increased to between 85% and 98%, according to the authors. “Use of strategies that require multiple visits to collect HCV testing samples should be discontinued,” Cartwright and colleagues wrote. “Automatic HCV RNA testing on all HCV antibody reactive samples will increase the percentage of patients with current HCV infection who are linked to care and receive curative antiviral therapy.” 

For more information: https://tinyurl.com/yc2s46xa

Hep C World News - Week of July 9, 2023

Hepatitis C cure rates ‘jarringly low’ as many lack access to treatment

Atlanta, GA - An analysis of data from 2013 to 2022 showed that only 34% of people diagnosed with hepatitis C in the United States were cured or cleared of the virus, with many still lacking access to highly effective treatments. Among the approximately 2.4 million people in the U.S. who are estimated to have HCV, up to 1 million do not know they have it, said Jonathan Mermin, MD, MPH, director of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention. “It's known as the silent killer because initial infection usually has few to no symptoms, but over time, the virus can slowly cause damage to the liver, causing liver cancer, liver failure and death,” Mermin said during a press briefing Thursday, ahead of the release of the new report in MMWR. Carolyn Wester, MD, MPH, director of the CDC’s Division of Viral Hepatitis, and colleagues used data from Quest Diagnostics to assess the clearance cascade — testing to clearance to subsequent infection — among people with HCV from Jan. 1, 2013 to Dec. 31, 2022 — the decade after safe and highly effective direct-acting antivirals for HCV became available, Wester noted. The analysis identified 1,719,493 people as having been ever infected with HCV between Jan. 1, 2013, and Dec. 31, 2021. During the follow-up period from Jan. 1, 2013 to Dec. 31, 2022, 88% of them received viral testing.  Among those who received viral testing during the follow-up period, 69% had evidence of a detectable HCV RNA. Among these participants, 34% were classified as cured or cleared, whether that be through treatment or spontaneous resolution, which Wester called “jarringly low.”  Among patients who were cured or cleared, 7% had evidence of subsequent viremia, indicating persistent infection or reinfection. Further analysis by age showed that among those ever infected, 29%, 43% and 27% were people aged 20 to 39 years, 40 to 59 years and 60 years or older, respectively. Initial infection was lowest among people aged 0 to 19 years (41%), whereas the prevalence of being cured or cleared was lowest among people aged 20 to 29 years (24%), and highest among those aged 60 years or older (42%). Persistent infection or reinfection was highest among patients aged 20 to 39 years (9%). Additional analysis by insurance type showed that among the more than 1.7 million people ever infected, 50% were covered by commercial health insurance, 23% by another payer — including self-payers — 11% by Medicaid, 9% by an unspecified payer and 8% by Medicare.

For more information: https://tinyurl.com/4k62j43f

Hep C World News - Week of July 2, 2023

FMT shows promise in restoring gut barrier function, immunity in cirrhosis

London, UK - Fecal microbiota transplantation improved gut barrier function, mucosal immunity and ammonia metabolism in patients with cirrhosis, which could reduce hepatic encephalopathy and other infections, according to data from the PROFIT trial. “Patients with cirrhosis have enteric dysbiosis,” Lindsey A. Edwards, BSC, MSc, PhD, research director of fecal microbiota transplant program at the Institute of Liver Studies at King’s College London, said during EASL Congress. “This means they lose beneficial [gut] species and they have enhanced pathogens. These cause damage and you get a leaky gut. Then, those microbes translocate across the gut and their microbial products. This chronic stimulation of your immune system means that you have a dysregulated immune response to infection.” “[FMT] shows great promise for modifying hepatic encephalopathy, deadly infections and possibly tackling antimicrobial resistance," Lindsey A. Edwards, BSC, MSc, PhD, said during EASL Congress. She continued: “Cirrhosis patients are really susceptible to infection, and this can lead to multiorgan failure and sadly death. Because of this chronic stimulation they have immune paralysis, so they are not able to kill and tackle those infections. We aimed to tackle this by doing fecal microbiota transplantation. We wanted to see if we could stop translocation across by improving barrier function and restoring host immunity.” In the placebo-controlled, randomized, single-blinded feasibility PROFIT trial, Edwards and colleagues assessed the use of FMT in 32 patients (mean age, 57.1 years; mean MELD score, 13.1) with advanced cirrhosis. Patients were administered 50 grams of liquid frozen FMT (n = 15) or placebo (n = 6) into the jejunum via endoscopy. At baseline and 7, 30 and 90 days after FMT or placebo administration, researchers collected blood, saliva, stool and urine samples to assess the efficacy of FMT in modulating a patient’s microbiome and inflammatory status, as well as fecal and plasma cytokine production and barrier integrity markers, metabolomics and fecal proteomics. Using deep metagenomic sequencing, researchers confirmed FMT increased fecal microbial richness with donor engraftment. They also reported reduced biomarkers of inflammation and enhanced antimicrobial response and barrier function, including lactic acid and fermenting bacteria. A donor diet high in fiber and protein improved clinical outcomes. “What we are doing with FMT is resetting those host responses to pathogens, but reducing inflammation and damage to the barrier,” Edwards said. Researchers also identified 301 proteins via fecal proteomics, of which 154 were of human origin and 147 were bacterial. FMT also significantly decreased plasma ammonia at 30 days (P = .0006). Compared with placebo, fecal ammonia was higher in patients administered FMT at both days 30 and 90. “We reduced pathogens that produce ammonia in the blood and sure enough, we actually see a reduction in plasma ammonia after FMT and an increase in fecal ammonia,” Edwards said. “We are excreting out that ammonia and that actually correlates with a reduction in hepatic encephalopathy grade.” In addition, researchers reported that FMT may reduce antibiotic-resistant infections and the need for antibiotics. “By changing these species, what we are doing is enriching the enzymes that can metabolize and this is giving us the energy to restore the gut barrier and the energy to fight infection and promote colonization of the microbiome,” Edwards said. “We are enhancing metabolic reprogramming and intestinal barrier function and enhancing responses to infection.” She added: “[FMT] shows great promise for modifying hepatic encephalopathy, deadly infections and possibly tackling antimicrobial resistance.”

For more information: https://tinyurl.com/44nfn7wa

Hep C World News - Week of June 25, 2023

Transplant medicine contends with organ shortage and pandemic-related disruptions

New York, NY - Transplant medicine and the field of transplant infectious diseases have faced numerous disruptions and challenges during the COVID-19 pandemic, according to experts. “The number of transplants declined transiently during the height of the COVID-19 pandemic but are now at the pre-pandemic level and growing overall,” Sarah Taimur, MD, associate professor of medicine at the Icahn School of Medicine at Mount Sinai in New York, told Healio | Infectious Disease News.  Despite incredible challenges brought on by the pandemic and organ shortages, there continue to be exciting developments in transplant ID, including transplants from donors with HIV and hepatitis C, xenotransplantation, and new therapies. We touched base with experts in the field and asked about these issues and more. Like many areas of medicine, transplant ID was disrupted by the COVID-19 pandemic. The disease itself has become the subspecialty’s No. 1 issue, according to Michael G. Ison, MD MS, chief of the NIH’s Respiratory Diseases Branch. “It has kind of trumped everything in the field,” said Ison, who was previously a medical professor of infectious diseases and organ transplantation surgery at the Northwestern University Feinberg School of Medicine.  Because transplant recipients are at an increased risk for COVID-19 and may have a suboptimal immune response to vaccination, they have been prioritized in guidance for COVID-19 vaccines and booster shots. “There are strategies to improve response to vaccines, but so far, no ‘magic bullet’ has been identified,” Ison said. The results of a systematic review and meta-analysis of more than 6,100 solid organ transplant recipients found that only 8.6% and 34.2% had a serologic response after one or two doses of COVID-19 vaccine, according to findings published last year in the journal Viruses. A third dose raised that rate to only 66%. “The vaccines have been a game-changer for the general population and for transplant recipients, although, unfortunately, some of our transplant recipients are not generating robust responses to the vaccines. They still are quite vulnerable to COVID-19,” said Christine Durand, MD, a transplant ID physician at Johns Hopkins University School of Medicine. Antivirals come with their own challenges, according to Durand. Paxlovid, for example, is difficult to prescribe for transplant recipients because of drug-drug interactions, and there is still a need for an oral antiviral for this patient population, she said. However, monoclonal antibodies, which were hugely successful for the nontransplant population, have also been beneficial for transplant recipients, according to Durand. An early study that assessed the first 73 solid organ transplant recipients at the Mayo Clinic to receive infusions of bamlanivimab or casirivimab-imdevimab for the treatment of mild to moderate COVID-19 found that no patients required mechanical ventilation, died or experienced rejection. More recently, a single-center retrospective study examined the effectiveness of casirivimab-imdevimab or sotrovimab for kidney transplant recipients infected with the omicron variant of SARS-CoV-2 and found that only two of the 47 patients were hospitalized to receive oxygen and none died or required ICU admission within 30 days. “Unfortunately, the virus evolves so quickly that [mAbs] tend to only be of benefit for short time frames,” Durand said, “but they certainly have saved many lives [among] our transplant recipients. Taimur said, ”transplant practitioners must keep up with CDC guidance and work with patients to ensure they are up to date on their COVID-19 vaccines, including boosters. “COVID-19 remains an infection to contend with in relation to organ donors and recipients,” she said. The United States is in the midst of an organ shortage crisis, which the pandemic exacerbated, according to experts. “Particularly for transplant patients, COVID-19 had an outsized impact on multiple fronts, including reducing the number of transplants being done transiently at the beginning of the pandemic” because organs from donors with SARS-CoV-2 were underutilized, Ison said. Durand recalled that living donor transplantation was shut down when COVID-19 “first came on the scene” and remained that way while the field worked to get its footing during the initial surges. According to a study published in The Lancet in May 2020, there was a more than 51% decline in deceased donor transplantations in the U.S. in the early months of the COVID-19 pandemic as hospitals diverted resources and staff to respond to the initial surge in cases. The decrease was driven mostly by declines in kidney transplants, researchers found. More than 104,000 people in the U.S. are currently waiting for a transplant, with one new person added to the national list every 10 minutes on average, according to the Health Resources & Services Administration (HRSA). There were around 42,000 transplants performed in the U.S. in 2022. “The organ shortage is still one of our most challenging issues,” Durand said. 

For more information: https://tinyurl.com/58xbc9m8

Hep C World News - Week of June 18, 2023

US drug overdose deaths top 109,000 in the past year

Atlanta, GA - More than 109,000 Americans died from drug overdoses in the 12-month period ending January 2023, a slight increase from the previous year, according to provisional data from the U.S. Centers for Disease Control and Prevention (CDC) released last week. The figure is up 0.7% from 108,825 overdoses recorded in the 12-month period ending January 2022, according to U.S. data. The increase comes despite a push by President Joe Biden's administration for action to tackle drug addiction and overdoses. The Biden administration in May imposed sanctions on 17 people and entities based in China and Mexico it accused of enabling production of counterfeit fentanyl-laced pills. Illicit fentanyl has played an outsized role in the U.S. opioid crisis and drug overdoses. The U.S. drug overdose death toll crossed the 100,000-mark for the first time in 2021, as the COVID pandemic disrupted medical care and increased mental health problems. The effect was exacerbated by the widespread availability of lethal drugs such as fentanyl, which is 50 times stronger than heroin and increasingly mixed in with other illegal drugs. During the pandemic, rates of mental illness, depression and anxiety went up dramatically, and people increasingly began to switch to substances, said Tom Britton, CEO of American Addiction Centers. U.S. drug overdose deaths rose 13.7% between January 2021 and January 2022 and by 31.4% in the prior 12 months at the height of the pandemic. But the surge in overdose deaths began before the pandemic took hold due to abuse of prescription opioid painkillers and illegal drugs like heroin. Stacey McKenna, senior fellow at the R Street Institute, a Washington, D.C.-based independent think tank, said the crackdown on fentanyl and other addictive drugs could be having the opposite of the intended affect. "There's this iron law of prohibition that the harder you crack down on the supply, the more likely you are to get a more potent supply or a more dangerous supply," McKenna said. The CDC noted that the latest numbers represent an estimate to include underreporting and cases pending investigation.
 

For more information: https://tinyurl.com/39ruv85r

Hep C World News - Week of June 11, 2023

Province expands access to opioid agonist treatment medications

Victoria, BC - British Columbia is taking action on the toxic drug crisis by being the first province in Canada to provide universal coverage for eligible medications used for the treatment of opioid-use disorder. “Improving access to medication is an important part of strengthening the public health-care system,” said Adrian Dix, Minister of Health. “By reducing financial barriers to opioid agonist treatment medication, we’re making it easier for people to get the care they need and helping create more equitable health outcomes for people in B.C.” Effective June 6, 2023, opioid agonist treatment (OAT) medications will be covered through Plan Z, the Province’s universal coverage plan, providing full coverage for B.C. residents with an active medical services plan (MSP). OAT, also referred to as medication-assisted treatment, is an option for people struggling with opioid-use disorder. It has been shown to improve retention in treatment, sustained abstinence from illicit opioid use, and helps reduce the risk of death. OAT differs from prescribed safer supply. Safer supply is a harm-reduction model of care in which clinicians prescribe pharmaceutical alternatives to illicit drugs in order to separate people from the toxic illicit street-drug market. However, prescribed safer supply can often be a first step for someone to begin accessing addictions care, including OAT. “The toxic drug crisis continues to claim lives at an unprecedented rate. When people reach out for help, we want them met with support regardless of the size of their pocketbook,” said Jennifer Whiteside, Minister of Mental Health and Addictions. “Removing these cost barriers to medication-assisted treatment will help more people stabilize their lives, prevent deaths and stay on their journey to wellness as our government continues to build a system of mental-health and addictions care that works for everyone.” In fiscal year 2021-22, of the 34,520 patients who utilized OAT medications, 32,882 received coverage through PharmaCare. Effective June 6, 2023, approximately 1,638 patients who paid out of pocket will now be 100% covered for eligible OAT medication costs under Plan Z for residents with MSP coverage. Additionally, eligible B.C. patients who did not access OAT medications due to the cost or because of challenges getting registered for Plan G or getting tax information to register for Fair PharmaCare will now have immediate, barrier-free access to OAT medication. 

For more information: https://news.gov.bc.ca/releases/2023MMHA0036-000933

Hep C World News - Week of June 4, 2023

Evidence Mounts That ‘War on Drugs’ Has Failed 

Melbourne, Australia - Harm Reduction Advocates Call for New Policies. After fifty years into the world “war on drugs”, the drugs are winning. Global levels of drug use and production, as well as drug-related deaths and incarcerations, are at all-time highs. Leading proponents of drug-policy reform who have gathered at the International Harm Reduction Conference in Melbourne this week say the evidence is in that it is time for the world to adopt a new approach.  “The irony of the profound failure of the war on drugs is that it has actually driven the illicit production of more and more substances and has led to more toxic drug supply,” said Naomi Burke-Shyne, executive director of Harm Reduction International, the UK-based drug-policy justice NGO that convened the conference.  “In order to save lives, we must offer overdose prevention and supervised space for people injecting drugs; together with pill testing to understand the potency, adulteration or toxicity of a substance,” she said.  Helen Clark, chair of the Global Commission and Drug Policy and former prime minister of New Zealand, called the war on drugs “a complete failure”. “The war on drugs is completely counterproductive. It has failed, and we need to try new approaches,” she told the conference. “Drug use continues to grow around the world, millions of people are imprisoned for drug possession and millions more are unnecessarily contracting HIV and hepatitis C because of lack of access to effective harm reduction measures.” “Human beings have been using substances, for whatever reason, for thousands of years,” Clarke said. “We’re not dealing with new issues here. We’re dealing with totally inappropriate and wrong ways of tackling them.” Drug overdose in the US continues to climb despite the ‘war on drugs’.  People who inject drugs in medically supervised settings are less likely to overdose, share needles, report emergency room visits, or develop abscesses when compared to people without access to such facilities, according to a new study presented to the conference on Tuesday by researchers from the French Institute of Health and Medical Research (INSERM).  The 12-month study is the first-ever controlled trial on the efficacy and impacts of medically supervised injection rooms, which are hygienic facilities where people struggling with addiction can inject drugs under the watchful eye of medical staff. These facilities are government-operated, stocked with drug-testing kits and overdose-prevention medications like naloxone, and allow patients to access other health services like mental health support, blood tests and essential primary care. “People can get tested for hepatitis and get started on treatment within two hours, there are sexual reproductive health services for women, lawyers dropping around, housing officers,” Burke-Shyne said.  “Yes, the space has drug consumption, but I think that really underplays how important the holistic approach to supporting vulnerable communities is.” The study compared the behaviour of people who injected drugs in the supervised injection sites in Paris and Strasbourg to users in Bordeaux and Marseille, where no centers exist. In addition to the benefits to health and overdose reduction, the study found that people with access to supervised injection services were also far less likely to inject in public spaces or commit crimes. Today, 16 countries around the world officially operate medically supervised injection rooms. These include the Netherlands, the United States, Canada, Australia and Switzerland – which pioneered the approach by legalizing prescription heroin in 1994.  Results from a control study at New York City’s new supervised injection site are expected by the end of June.  “Medically supervised injection rooms, the medicine naloxone to reverse overdoses, and drug checking technology work,” Burke-Shyne said. “They are public health no-brainers.” As the consequences of the push by Purdue Pharma to mainstream the prescription of high doses of the opiate pain-medication, Oxycontin, continues to ravage the United States, a new lethal drug has taken over: fentanyl. The synthetic opiate, which is up to 50 times stronger than heroin and 100 times stronger than morphine, was identified in 66% of US drug overdose deaths in 2021. The growing infiltration of fentanyl in the country’s drug supply has resulted in many users unintentionally taking the drug – with deadly consequences.  In New York City, where drug overdose deaths have nearly tripled since 2015, only 18% of people who inject drugs reported intentional fentanyl use, yet over 80% tested urine-positive for fentanyl, according to new toxicology data presented by researchers from the University of New York (NYU) on Tuesday. Fentanyl is used by cartels and drug-smuggling networks to cheapen their up-front costs for heroin, which is more expensive to produce. Cutting heroin with fentanyl greatly increases their profit margins at the cost of heightened danger for users unaware their supply is mixed with a far more potent drug.

For more information: https://tinyurl.com/53ychj68 

Hep C World News - Week of May 28, 2023 

Alcohol-related cirrhosis worsened during pandemic, remains ‘top public health issue’

Chicago, IL - Hospital admissions for alcohol-related cirrhosis jumped from March 2020 to March 2021, with associated increases in costs and mortality, according to study results presented at Digestive Disease Week. “The most striking finding from our study was the more than doubling in hospital admission for alcohol-related cirrhosis during the post-pandemic time period in both men and women,” Dina Halegoua-De Marzio, MD, associate professor of medicine and director of the Jefferson Fatty Liver Center at Thomas Jefferson University in Philadelphia, told Healio. “This was also associated with increased hospital costs and increased mortality rates. Costs increased in NASH cirrhosis patients, but we did not see increased admissions in this group.” Using the Vizient clinical database, Halegoua-De Marzio and colleagues collected data from 809 U.S. hospitals from March 2019 to March 2021 to determine the impact of the COVID-19 pandemic in adult patients with alcohol-related and nonalcoholic steatohepatitis cirrhosis. They defined March 2019 to February 2020 as the pre-pandemic period and March 2020 to March 2021 as the post-pandemic period, and evaluated the number of hospital admissions, mean length of stay, percent deaths, 30-day readmission rate, mortality index and hospital cost during these times. Researchers included 346,494 patients in the analysis, of whom 243,235 had alcoholic cirrhosis and 103,259 had NASH cirrhosis. Among the alcoholic cirrhosis cases, 75,363 were pre-pandemic and 167,872 were post-pandemic compared with 51,736 and 51,523, respectively, for NASH. For women with alcoholic cirrhosis, researchers reported increases in mean length of stay (7.46 to 7.77), percent deaths (7.13% to 8.42%), mortality index (1.03 to 1.05) and mean direct cost ($13,899 to $15,066), although 30-day readmissions dropped from 22.43% to 22.08%. In men with alcoholic cirrhosis, researchers reported similar increases in mean length of stay (7.4 to 7.67), percent deaths (6.79% to 8.12%), mortality index (1 to 1.05) and mean direct cost ($14,058 to $15,081), with a decrease from 21.71% to 21.26% in 30-day readmission. Among women with NASH cirrhosis, increases also were reported in length of stay (7.1 to 7.53), percent deaths (4.88% to 5.88%), mortality index (0.92 to 0.95) and mean direct cost increased ($14,938 to $16,381), while 30-day readmissions decreased from 20.03% to 19.6%. Men with NASH also had increases in mean length of stay (7.58 to 7.92), percent deaths (5.13 to 6.18), mortality index (0.90 to 0.95) and mean direct cost ($18,325 to $18,875). Thirty-day readmission decreased from 20.17% to 19.47%. “This study emphasized that alcoholic liver disease remains a top public health issue, worsened with the COVID pandemic, and more patient education needs to be devoted to the potential danger of alcohol overuse,” Halegoua-De Marzio said. 

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Hep C World News - Week of May 21, 2023

Dried blood spot test can detect HIV and hepatitis

Copenhagen, Denmark - A dried blood spot test can be used to detect HIV, hepatitis B and hepatitis C in a single drop of blood, researchers reported at the European Congress of Clinical Microbiology & Infectious Diseases. The process, which uses commercial technology already available in many hospitals, can cut down on the need to refrigerate blood samples and time to get test results back, the researchers said. “The motivation to develop this method was to have a more practical and safer method to screen in high-risk settings such as prisons, rehabilitation centers and homeless shelters,” Stephen Nilsson-Møller, MSc, molecular biologist in the department of clinical microbiology at Herlev Hospital in Denmark, told Healio. WHO in 2022 added HBV to a group of infectious diseases — including HIV and HCV — which it aims to eliminate worldwide by 2030. Although efforts to increase screening for all three viruses are in progress for some groups in some nations, it can be logistically challenging. Nilsson-Møller and colleagues sought a method of screening for all three without the need for vials of blood, which need to properly transported. Using 20 plasma samples that were positive for HCV, HBV and HIV, the researchers deposited whole blood on a protein saver card, letting it dry and then transferring it to an Aptima tube containing 2.9 mL of specimen transport medium. The tubes were incubated at room temperature on a rocking table for 30 minutes and then centrifuged. The researchers then analyzed the samples using the Hologic Panther system with commercial Aptima assays.  The process detected a viral load in all samples. Nilsson-Møller said the test has been approved in his department in a team that includes a chief physician and a professor, and that Hologic has validated the HIV portion of the study’s findings but not the findings for HBV and HCV. According to the study, the researchers plan to present data from both ongoing clinical tests and from validation at some point in the future. “The test is now being [used as] part of a PhD project by Jonas Demant, who is screening in prisons, homeless shelters and rehabilitation centers in Copenhagen,” Nillson-Møller said. “There has [also] been a lot of interest, so the department is now looking to open the test so that other clinicians and physicians can order it.” 

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Hep C World News - Week of May 14, 2023

Women, younger injection drug users have a higher risk for HIV, HCV

Bristol, UK - Young people who inject drugs and women who inject drugs had higher risk for HIV and HCV. Limited data on incidence underscores the need to monitor global HIV and HCV epidemics among injection drug users. Results from a systematic review and meta-analysis demonstrated greater risk for hepatitis C virus and HIV infection among women and younger people who inject drugs, according to data reported in The Lancet Gastroenterology & Hepatology. “Globally, around 18% of people who inject drugs (PWID) are living with HIV and more than 50% have been infected with HCV,” Adelina Artenie, PhD, of the department of population health sciences at Bristol Medical School in the United Kingdom, and colleagues wrote. “Over the past two decades, the incidence rates of HIV and HCV have declined among PWID in some high-income countries (HICs). ... Meanwhile, persistently high levels or outbreaks of HIV and HCV among PWID have been reported in other HICs and low-income or middle-income countries (LMICs).” They continued: “A better understanding of these shifting epidemiological patterns and the availability of data globally are needed to orient surveillance and programming efforts. However, no global study has summarized HIV and HCV incidence among PWID.” In a systematic review and meta-analysis, Artenie and colleagues searched Medline, Embase and PsycInfo databases and identified 125 records with data on HIV and HCV incidence among PWID and associations with age and sex. Of these records, 64 estimated HIV incidence (30 HICs, 34 LMICs) from 1987 to 2021 and 66 estimated HCV incidence (52 HICs, 14 LMICs) from 1992 to 2021. Pooled incidence was 1.7 per 100 person-years (95% CI, 1.3-2.3) for HIV and 12.1 per 100 person-years (95% CI, 10-14.6) for HCV. Compared with older PWID, young PWID had a higher risk for HIV (RR = 1.5; 95% CI, 1.2-1.8) and HCV (RR = 1.5; 95% CI, 1.3-1.8). Similarly, women were at greater risk for HIV and HCV (RR = 1.4; 95% CI, 1.1-1.6 and RR = 1.2; 95% CI, 1.1-1.3, respectively) compared with men. “Given the higher risks of HIV and HCV acquisition in young vs. older PWID and in women vs. men who inject drugs, age-appropriate and gender-appropriate prevention and harm reduction measures are also urgently needed to serve these subgroups at high risk,” Artenie and colleagues concluded. “Factors other than age and sex or gender are also likely to be influencing HIV and HCV acquisition risks (eg, types of drugs injected and the context of injection, identifying as men who have sex with men and engaging in sex work) and research is also needed to synthesize the role of these other factors to better strengthen HIV and HCV prevention responses.”
 

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Hep C World News - Week of May 7, 2023

Hepatitis C diagnosis increasing among pregnant women

New York, NY - From 2000 to 2019, the average annual percent change was 12.5% in HCV prevalence in pregnancy. Identifying and treating women at high risk for infection before pregnancy may be important in optimizing care. Hepatitis C virus among the U.S. obstetric population rose nearly 10-fold over 20 years, which might reflect an increase in screening or prevalence, according to researchers. “The opioid epidemic and resultant increasing rates of intravenous drug use are thought to account for a large proportion of the rising incidence of HCV infection. However, 50% of individuals with HCV infection report no history of intravenous drug use,” Brittany Arditi, MD, MSCR, resident physician in the department of obstetrics and gynecology at NewYork-Presbyterian/Columbia University Irving Medical Center, and colleagues wrote. “As such, there is a knowledge gap with regards to other risk factors, demographic and clinical characteristics, and comorbidities associated with HCV infection among pregnant patients.” Researchers analyzed data o 76.7 million delivery hospitalizations using the National Inpatient Sample and assessed trends in both diagnosis of HCV infection and clinical characteristics associated with the infection. Overall, 182,904 delivering women had an HCV infection diagnosis. There was a nearly 10-fold increase in the prevalence of HCV diagnosed in pregnancy, from 0.05% in 2000 to 0.49% in 2019, which came out to an average annual percent change of 12.5%. In addition, researchers observed an increase from 2000 to 2019 in the prevalence of clinical characteristics per 10,000 birth hospitalizations associated with HCV infection: opioid use disorder (10 vs. 71), nonopioid substance use disorder (71 vs. 217), mental health conditions (219 vs. 1,117) and tobacco use (61 vs. 842). Researchers also noted an increase during the study period in the rate of deliveries among women with two or more clinical characteristics associated with HCV, rising from 26 to 377 cases per 10,000 birth hospitalizations, which resulted in an average annual percent change of 13.4%. HCV was also associated with an increased risk for severe maternal morbidity (adjusted OR = 1.78; 95% CI, 1.61-1.96), preterm birth (aOR = 1.88; 95% CI, 1.8-1.95) and cesarean delivery (aOR = 1.27; 95% CI, 1.23-1.31). “These findings support universal screening for HCV infection in pregnancy and that, identifying and treating women at high risk for infection before pregnancy may be an important focus for optimizing care and mitigating perinatal HCV transmission,” the researchers wrote.
 

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Hep C World News - Week of April 30, 2023

Drug overdose deaths highlight racial disparities

Los Angeles, CA - The most recent annual statistics available show that overdose deaths for visible minorities, due to psychostimulants and semi-synthetic and synthetic opioids, rose more than expected. Black people had more fentanyl and psychostimulant deaths compared with white people. There were more drug overdose deaths in 2020 than anticipated based on trends from 2013 to 2019, with more fatalities among Black people compared with white people, according to findings published in PLOS Global Public Health. “The third wave of drug overdose deaths began in 2013 with the arrival of fentanyl on the illicit drug market,” Maria R. D’Orsogna, PhD, an associate adjunct professor in the department of computational medicine at UCLA, said in a press release. “Although overdose deaths have steadily increased since then, the pandemic year 2020 saw a significant rise of fatalities in many states.” D’Orsogna and colleagues reviewed overdose death data from the CDC WONDER database, which includes information on number of deaths, cause of death and demographics. The researchers specifically examined drug poisoning mortality rates among four subclasses of drugs: natural and semi-synthetic opioids such as morphine (termed prescription opioids), synthetic opioids other than methadone (termed fentanyl), psychostimulants with abuse potential (termed methamphetamines) and heroin. From 2013 to 2019, national overdose death rates caused by fentanyl and methamphetamines increased steadily for both men and women. However, in 2020, fentanyl death rates among men were 30% higher than expected and 28% higher than expected among women. For methamphetamines, the death rates exceeded the expected rates by 19% and 18%, respectively. Analyses by race revealed that fentanyl overdose death rates among Black men in 2018 and women first surpassed the rate of fentanyl overdose death among their white counterparts in 2019. In 2020, the rate was 38% greater among Black men compared with white men, and the rate was 19% greater among Black women compared with white women. Methamphetamine deaths were consistently greater among white people compared with Black people from 2013 to 2020. For prescription opioids and heroin, overdose death rates increased from 2013 to 2016 and began decreasing in 2017. In 2020, prescription opioid death rates increased significantly, while heroin overdose death rates continued to decrease. Analyses by census region and jurisdiction revealed further racial disparities in overdose mortalities. “Perhaps most surprising to us were the results for the District of Columbia,” Lucas Böttcher, PhD, an assistant professor of computational social science at the Frankfurt School of Finance & Management in Frankfurt am Main, Germany, said in the release. “Here, the 2020 fentanyl-induced mortality was 134 deaths per 100,000 Black male residents but only 14 deaths per 100,000 white male residents. These disparities existed even prior to the pandemic, and are seen in other states as well, such as Illinois or Missouri.” The findings suggest that pandemic-related anxieties and isolation may have contributed to the increased overdose mortality rates, the researchers said. Moving forward, they emphasized the importance of tailoring prevention programs to at-risk populations such as Black men.
 

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Hep C World News - Week of April 23, 2023

Medical cannabis use rising in US, highlighting need for clinical guidelines

New Haven, CT - The prevalence of U.S. residents who used medical cannabis was 1.2% in 2013-2014 vs. 2.5% in 2019-2020. Researchers said a surveillance system is needed to assess the long-term effects of medical cannabis use. The prevalence of medical cannabis use in the United States has increased significantly from 2013 to 2020, according to study results published in the American Journal of Preventive Medicine. Taeho Greg Rhee, PhD, FACE, an assistant professor of medicine and public health at Yale University, and Robert A. Rosenheck, MD, a professor of psychiatry and of health policy and affiliated faculty at the Yale Institute for Global Health, wrote that medical cannabis has been legalized in 37 states in the United States as well as the District of Columbia. The prevalence of medical cannabis use in the United States increased significantly in recent years, according to the results of a study published in the American Journal of Preventive Medicine. The researchers conducted a study to evaluate correlates and temporal trends of medical cannabis use in the U.S. They used data from the 2013 to 2020 National Survey on Drug Use and Health (NSDUH), which includes a question asking those who had used cannabis in the past 12 months whether any cannabis use was recommended by a physician. They then used a modified Poisson model to approximate the average annual percent change (AAPC) of medical cannabis use from 2013 to 2020 and repeated the analyses for key sociodemographic and clinical subgroups. Rhee and Rosenheck found a continued national increase in medical cannabis use for a variety of medical purposes 2 decades after the first state passed legalizing legislation. In 2013 to 2014, the prevalence of U.S. residents who used medical cannabis was 1.2%. In 2019 to 2020, the prevalence was 2.5%, with an AAPC of 12.9% (95% CI, 10.4-15.5). In the multivariable-adjusted model, residing in a state where medical cannabis was legalized was significantly linked to greater odds of medical cannabis use (adjusted OR = 4.1; 95% CI, 3.68-4.56). The researchers additionally noted that many of the clinical subgroups and sociodemographic groups studied indicated similar significant increases in medical cannabis use. The clinically relevant subgroups that saw significantly greater odds of medical cannabis use included: use of non-prescription pain relievers, poorer self-rated health statuses, cocaine use disorder and a past-year major depressive episode. “The association of medical cannabis use with depression, cocaine use disorder, and nonmedical use of pain relievers suggests that it may have either been prescribed for those conditions or used on patient initiative for these problems,” the researchers wrote. “Because NSDUH is cross-sectional, the findings cannot establish temporality.” Rhee and Rosenheck concluded that “substantially increased use of cannabis for medical purposes warrants further research to assess its diverse potential benefits and risks.” Additionally, they noted two “important implications of the persistent increase in medical cannabis use nationally.” First, medical cannabis is assumed to be primarily used for chronic pain, MS or for nausea among patients with terminal illnesses. However, “there is a wide variation of qualifying medical or psychiatric conditions across states,” they wrote. “Further, there is no consensus across the states or strong therapeutic evidence to support medical cannabis use for specific conditions (e.g., arthritis),” they wrote. “Because medical cannabis use is increasing in the US, clinical practice guidelines should be developed with evidence-based principles to follow in counseling patients about medical cannabis use.” Second, Rhee and Rosenheck noted the lack of available data on any long-term effects medical cannabis might have, “limiting understanding of the cumulative public health effects of medical cannabis use.” “While cannabis does not generally lead to overdose deaths (in contrast to opioids), several unintended consequences (eg, developing psychosis and motor vehicle crashes) have been documented,” they wrote. “Given the increasing medical cannabis use coupled with use for recreational purposes, a comprehensive, longitudinal surveillance system is needed to determine long-term benefits and harms of medical cannabis use.”
 

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Hep C World News - Week of April 16, 2023

Fentanyl vaccine: Could it be a turning point in the opioid pandemic?

Houston, TX - Researchers have developed a fentanyl vaccine, tested in rodents, that generates significant anti-fentanyl antibodies that bind to fentanyl and prevent it from entering the brain. To date, the vaccine has not been tested in humans, but it has the potential to be a game-changer in the opioid epidemic. The risk of adverse events in humans is low, as two components of the vaccine are both utilized in other existing vaccines approved for use in humans. Researchers at the University of Houston have developed a fentanyl vaccine that blocks the synthetic opioid from entering the brain. Not yet tested on humans yet, if effective, the vaccine has the potential to be a major breakthrough in the opioid epidemic.  The number of opioid-related overdose deaths has increased dramatically since 1999, with levels 5 times higher in 2020 than in 1999, according to the CDC. Over those years, more than 564,000 people have died from an opioid overdose. This includes both prescription and illegal opioids.   The CDC reports that the increase in opioid overdose deaths has occurred in three waves. The first wave coincided with the increase in opioid prescriptions beginning in the 1990s. In 2010, the second wave began, with a surge in overdose deaths related to heroin use. Synthetic opioids, such as fentanyl, ushered in the third wave in 2013. Back in 2010, only 14.3% of opioid-related deaths were due to fentanyl use. But by 2017, this proportion was 59%, making fentanyl and other synthetic opioids the most common drugs involved in overdose deaths in the United States. Current treatments for opioid use disorder include methadone, buprenorphine, and naltrexone. The efficacy of these medications depends on many factors, including the kind of opioid, the formulation of the drug, patient compliance, and access to the medications. Fentanyl overdose is treated with naloxone, a short-acting antagonist that works by binding to opioid receptors and reversing the effects of opioid drugs.  One of the drawbacks associated with the use of naloxone is the need for multiple doses in order to counteract the potentially fatal effects associated with fentanyl use.  Researchers at the University of Houston have proposed that, to overcome the treatment challenges, there is a need for immunotherapies capable of blocking fentanyl from entering the brain. Their preclinical studies provide evidence that a fentanyl vaccine is possible. The University of Houston investigators studied an anti-fentanyl conjugate vaccine composed of a fentanyl-like compound that is linked to CRM197, a carrier protein present in various FDA-approved conjugate vaccines. The fentanyl-CRM conjugate is then combined with dmLT, an adjuvant that is found in other vaccines that have been assessed in multiple human clinical trials.  In their previous studies in mice, the research team had discovered that administration of the fentanyl vaccine produced a significant amount of anti-fentanyl antibodies, blocking the analgesic effects of fentanyl. The preclinical results presented in this study have significant implications for the treatment of opioid use disorder and overdose in humans, as discussed in a press release announcing the study.[4] Because CRM and dmLT are both utilized in existing vaccines approved for use, the risk of adverse events to humans is likely low.  In the press release, Colin Haile, MD, PhD, research associate professor of psychology at the University of Houston and the study’s lead author, expressed his opinion on the implications. “We believe these findings could have a significant impact on a very serious problem plaguing society for years—opioid misuse.” Colin Haile, MD, PhD, study author "Our vaccine is able to generate anti-fentanyl antibodies that bind to the consumed fentanyl and prevent it from entering the brain, allowing it to be eliminated out of the body via the kidneys," said Dr. Haile. "Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety.”
 

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Hep C World News - Week of April 9, 2023

HCV elimination represents ‘win-win-win’ for patients, public health, cost savings

Geneva, Switzerland - Every year nearly 3 million patients are diagnosed with hepatitis B and C infections, ultimately leading to 1.1 million deaths worldwide, WHO reported. In response to this immense public health burden, WHO and other international organizations have developed goals and plans for elimination. Although implemented by most countries with many on track to reach their goals, analyses have revealed a persistent reservoir of chronic hepatitis viruses and new infections remain a threat, Sheikh Mohammad Fazle Akbar, MD, PhD, and colleagues wrote in Infectious Diseases & Immunity. In the U.S., only 6% of states are on track to achieve HCV elimination by 2030, according to a 2020 report by Mark Sulkowski, MD, and colleagues. Researchers further reported 35% of states are not expected to meet their margins by 2040. In 2016, WHO outlined HCV elimination goals of 90% reduction in incidence and 65% reduction in mortality by 2030. While challenges persist in meeting those goals, John Ward, MD, director of the Coalition for Global Hepatitis Elimination and senior scientist at the CDC Task Force for Global Health, cited many achievements. “There have been large improvements in infection control and prevention in health care. Blood bank screening has averted contaminated equipment exposure where millions of cases have been prevented that, in the past, were occurring,” Ward told Healio Gastroenterology. “There have also been clear improvements in hepatitis C testing and treatment. It is miraculous that we have the first cure for a chronic viral infection in the history of medicine that has proven incredibly safe and effective with very low rates of resistance.” Although many countries continue to falter in their efforts toward HCV elimination, others have shown that effective programs and health care delivery are possible for reaching this goal. Analysis of data from the Polaris Observatory, which was presented at The Liver Meeting in 2022, showed Australia, Canada, Denmark, Egypt, Finland, France, Georgia, Japan, Norway, Spain and the United Kingdom are all on track to reach 2030 targets. John Ward “We are definitely achieving some of the global goals for hepatitis elimination currently, and countries are demonstrating that elimination is possible, but we need more,” Ward said. “The challenge is to get more countries to make similar commitments to hepatitis elimination and put in place effective, widely available programs to detect and cure patients with hepatitis C.” Healio Gastroenterology spoke with experts across the field to identify barriers to HCV screening and treatment and determine the necessary steps to achieve elimination. Although HCV mortality rates will continue to modestly decline if the U.S. maintains the status quo on current elimination efforts, the Hepatitis C Disease Burden Simulation (HEP-SIM) model — a dynamic microsimulation of epidemic, disease progression and elimination strategies — revealed how an accelerated, nationally organized plan has potential to save more lives and billions in health care costs by 2050. “By 2030, approximately 10,000 deaths can be avoided. ... We expect to find by 2050 this program can result in 90,000 lives saved,” Jagpreet Chhatwal, PhD, director of the Institute for Technology Assessment at Massachusetts General Hospital and associate professor at Harvard Medical School, told attendees at The Liver Meeting. “Very similar story for hepatocellular carcinoma cases: By 2030 we would expect to see 70,000 cases avoided. By 2050, more than 100,000 cases avoided. With decompensated cirrhosis: By 2030 close to 30,000 cases can be avoided. By 2050, 90,000 cases.” While the HEP-SIM model considers various factors, such as advances in therapeutics and diagnostics and rising incidence, it also takes into account the cost of treatment associated with different insurance models. According to Chhatwal, accelerated elimination is estimated to save $59.3 billion in health care utilization with treatment costs dropping from $45.2 billion to $20.3 billion and disease management from $87 billion to $54.1 billion. “We cannot talk about hepatitis C or elimination without talking about the cost,” he said. “The accelerated program can result in approximately $14 billion savings in the next 10 years. ... This is unprecedented. We are not just eliminating a disease as a public health threat, but also saving money, which is not common. That gives us a lot of impetus to implement such a program.”
 

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Hep C World News - Week of April 2, 2023

Drug use, homelessness double HCV reinfection risk

Boston, MA - Hepatitis C reinfection rates were high among a population of people who had experienced homelessness but increased even more among those experiencing homelessness at the time of treatment, researchers found. “The primary care-based hepatitis C treatment program at Boston Health Care for the Homeless Program works to share its experience and outcomes,” Marguerite Beiser, ANP-BC, director of Hepatitis C Virus (HCV) Services at the Boston Health Care for the Homeless Program, told Healio. “We believe that describing the unique successes and challenges we encounter caring for this highly vulnerable population can help us devise better systems to meet their unique needs.” She added, “Anecdotally, we knew our patients were experiencing reinfection, and we wanted to explore this outcome.” Beiser and colleagues conducted a time-to-event analysis to understand reinfection risk over time among what she said is the “biggest homeless-experienced community-based cohort in published literature.” According to the study, the researchers assessed people receiving HCV direct-acting antiviral treatment through the Boston Health Care for the Homeless Program between 2014 and 2020 with post-treatment follow-up assessments. HCV reinfection was identified based on recurrent HCV RNA following SVR. Overall, 535 people were included in the study — 70% of whom were facing homelessness or unstable housing at treatment initiation. A total of 74 HCV reinfections were detected, including five second reinfections. According to the study, HCV reinfection rate was 12/100 person-years (95% CI, 9.5-15.1) overall, 18.9/100 person-years (95% CI, 13.3-26.7) among individuals with unstable housing, and 14.6/100 person-years (95% CI, 10-21.3) among those experiencing homelessness. Beiser added that the risk of reinfection increased to 25/100 person-years among people experiencing homelessness or unstable housing and reporting recent drug use before their HCV treatment. An adjusted analysis showed that experiencing homelessness vs. stable housing (adjusted HR = 2.14; 95% CI, 1.09-4.2) and drug use within 6 months before treatment (aHR = 5.23; 95% CI, 2.25-12.13) were associated with increased reinfection risk. “In the near-term, expansion and reinforcement of HCV care, including post-treatment care that is closely integrated within routine care structure in which people are already engaged is urgently needed,” Beiser said, adding that individual-level social determinants of health and the systems-level factors that contribute to community transmission need to be addressed. “Ultimately, housing, particularly permanent supportive housing, should be recognized as a primary intervention for HCV elimination,” she said.
 

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Hep C World News - Week of March 26, 2023

UN launches Group of Friends to eliminate hepatitis
 

New York, NY - At a side event to the 77th UN General Assembly in New York (NY, USA), representatives from Ministries of Health of nine countries (Egypt, Georgia, Sierra Leone, Nigeria, Tanzania, Ghana, Chile, Ukraine, and Mongolia) and six UN permanent missions (Egypt, Malaysia, Tanzania, Brazil, Chile, and Portugal) joined together to form a Group of Friends to eliminate hepatitis. They were accompanied by WHO, Africa Centres for Disease Control and Prevention, the World Hepatitis Alliance, and other international institutes and global non-governmental organisations. All representatives spoke of the urgency of the moment and shared their support for the Group of Friends initiative. Egypt's Minister of Health and Population (KAG), pledged Egypt's leadership in bringing together UN member states in a call for formation of a UN Group of Friends to support health diplomacy around viral hepatitis elimination. The Minister expressed Egypt's willingness to lead the group's international efforts to accelerate the elimination of hepatitis by 2030, in line with the achievement of the UN Sustainable Development Goals and the goals of WHO. The UN Group of Friends to eliminate hepatitis will create a forum for member states to exchange information on progress, innovations, and lessons learned with other member states, organisations within the UN system, technical experts, civil society organisations, and other stakeholders. By raising awareness at the diplomatic level, the UN Group of Friends aims to bring high-level attention of donor agencies, development banks, philanthropic organisations, and national governments, helping low-income and middle-income countries to eliminate viral hepatitis. On Dec 20, 2022, Ambassador Abdelkhalek, the UN Permanent Representative of Egypt in New York, invited all member states to join the Group of Friends to eliminate hepatitis. He stated: “As we engage in three UN General Assembly health-related high-level meetings in 2023, I believe the formation of this Group can lead to the promotion of our efforts towards attaining the international goal of hepatitis elimination by 2030.” In consultation with WHO, The Task Force for Global Health's Coalition for Global Hepatitis Elimination serves as the group's secretariat. The Group of Friends will hold periodic meetings to exchange information, best practices, and lessons learned.
 

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Hep C World News - Week of March 19, 2023

Cleveland Clinic surpassed 1,000 organ transplant milestone in 2022

Cleveland, OH - The Cleveland Clinic reached an institutional milestone in 2022, with 1,050 heart, kidney, liver, intestine and lung transplants, surpassing its previous record high set in 2021, according to a press release. “We want to thank organ donors and their families who make the gift of life possible,” Charles Miller, MD, enterprise director of transplantation at Cleveland Clinic, said in the release. As the second largest transplant program in the U.S., Cleveland Clinic performed 726 transplants in 2022, including 215 liver transplants and 320 kidney transplants, the highest numbers in the history of its program. Additionally, Cleveland Clinic is one of the few hospitals worldwide that offer laparoscopic living-donor surgeries for liver transplants. Among its notable accomplishments in 2022, Cleveland Clinic successfully performed a first-in-the-world full multi-organ transplant to treat a patient with pseudomyxoma peritonei, during which the patient received a liver, stomach, pancreas, duodenum and small intestine. Cleveland Clinic’s milestone organ transplant numbers contributed to another record-setting announcement from the Organ Procurement and Transplantation Network: As of September 9, 2022, 1 million solid organ transplants have been performed in the United States.
 

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Hep C World News - Week of March 12, 2023

Pill for skin disease also curbs excessive drinking, new study shows

Seattle, OR - Researchers from Oregon Health & Science University and institutions across the country have identified a pill used to treat a common skin disease as an "incredibly promising" treatment for alcohol use disorder. Their study was recently published in the Journal of Clinical Investigation. On average, the people who received the medication, called apremilast, reduced their alcohol intake by more than half—from five drinks per day to two. "I've never seen anything like that before," said co-senior author Angela Ozburn, Ph.D., associate professor of behavioral neuroscience in the OHSU School of Medicine and a research biologist with the Portland VA Health Care System. The lead author is Kolter Grigsby, Ph.D., a postdoctoral fellow in the Ozburn laboratory at OHSU. Beginning in 2015, Ozburn and collaborators searched a genetic database looking for compounds likely to counteract the expression of genes known to be linked to heavy alcohol use. Apremilast, an FDA-approved anti-inflammatory medication used to treat psoriasis and psoriatic arthritis, appeared to be a promising candidate. They then tested it in two unique animal models that had a genetic of risk for excessive drinking, as well as in other strains of mice at laboratories across the country. In each case, apremilast reduced drinking among a variety of models predisposed to mild to heavy alcohol use. The researchers found that apremilast triggered an increase in activity in the nucleus accumbens, the region of the brain involved in controlling alcohol intake. Researchers at the Scripps Research Institute in La Jolla, California, then tested apremilast in people. The Scripps team conducted a double-blind, placebo-controlled clinical proof-of-concept study involving 51 people who were assessed over 11 days of treatment. "Apremilast's large effect size on reducing drinking, combined with its good tolerability in our participants, suggests it is an excellent candidate for further evaluation as a novel treatment for people with alcohol use disorder," said co-senior author Barbara Mason, Ph.D., Pearson Family professor in the Department of Molecular Medicine at Scripps. The clinical study involved people with alcohol use disorder who weren't seeking any form of treatment, and Mason predicts that apremilast may be even more effective among people who are motivated to reduce their alcohol consumption. "It's imperative for more clinical trials to be done on people seeking treatment," Ozburn said. "In this study, we saw that apremilast worked in mice. It worked in different labs, and it worked in people. This is incredibly promising for treatment of addiction in general." An estimated 95,000 people in the United States die every year from alcohol-related deaths, according to the National Institute on Alcohol Abuse and Alcoholism. Currently, there are three medications approved for alcohol use disorder in the United States: Antabuse, which produces an acute sensitivity akin to a hangover when alcohol is consumed; acamprosate, a medication thought to stabilize chemical signaling in the brain that is associated with relapse; and naltrexone, a medication that blocks the euphoric effects of both alcohol and opioids.
 

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Hep C World News - Week of March 5, 2023

Is the brain wired differently in people with addiction?

Montreal, PQ - Some 10% to 15% of people will have a substance abuse problem at some point in their life, making it one of the most common psychiatric disorders. Risks associated with substance abuse include dangerous driving, missed work, problems with depression, anxiety, health and money problems. Yet people with addictions seem to experience a sort of myopia, getting in deeper and deeper to cope with unpleasant emotions and to feel good, regardless of the cost. Research has clearly established that psychosocial and environmental factors play a role in the development of substance abuse disorders. But there is more to the story, and now functional magnetic resonance imaging (MRI) studies are highlighting the importance of biological factors, in particular how the brain functions. "The influence of such factors can be as much as 50%—this astonishingly high figure is why we're so interested in what's going on in the brains of substance abusers," explained Stéphane Potvin, a professor in Université de Montréal's Department of Psychiatry and Addiction whose research focuses primarily on the harmful effects of cannabis and alcohol on the brain structures of people with schizophrenia. Zeroing in on markers. Potvin, who coordinates the Neurobiology and Mental Health division of the Centre de recherche de l'Institut universitaire en santé mentale de Montréal, wanted to zero in on the neurobiological markers associated with addiction. With his student Jules R. Dugré, a Ph.D. candidate in biomedical sciences, he conducted a meta-analysis of 96 studies involving a total of 5,757 subjects with some form of substance dependence—alcohol, nicotine, cannabis, psychostimulants or another drug. Rather than focusing on brain activity as a whole, in his analysis Potvin and Dugré looked at what is known as "functional connectivity," in other words, how well different parts of the brain communicate with each other. This is the first time an analysis of this type has been done. Published in November in Addiction Biology, the study reveals a number of anomalies in the brain's reward, decision-making and habit formation systems:

1. Reward: "The brains of substance abusers tend to show hyperconnectivity between the ventromedial prefrontal cortex and ventral striatum, two key areas of the reward system," said Potvin. "This could explain the tendency to choose immediate gratification and why the substance's motivational value increases over time despite the negative impact on other spheres of life."

2. Decision-making: "We also see reduced connectivity in certain brain areas involved in decision-making, such as the prefrontal cortex and amygdala," added Potvin. "This is consistent with the fact that substance abusers can seem indifferent to the harmful consequences of their choices."

3. Habit formation: The most original finding is the presence of anomalies in the brain regions associated with habit formation, including the dorsal striatum and premotor cortex. "This hyperconnectivity could explain the compulsive nature of substance abuse," Potvin noted.

The meta-analysis did not, however, show changes in the brain regions and networks associated with impulse control. This contrasts with previous studies, which showed abnormalities in these regions using other neuroimaging approaches. Potvin is quick to point out the limitations of his study. "In our analysis, we included all relevant studies of substance abusers, whatever the substance. But are brain systems equally affected by different substances? We really don't know." Ultimately, these findings will help guide the development of neuromodulation-based interventions in the field of addiction. "First we need a better understanding of the brain systems involved in substance abuse," said Potvin. "This will allow us to pinpoint the areas to stimulate or inhibit in order to rebalance the brain and change behavior. The more solid evidence we have, the more treatment centers will be motivated to invest in the equipment needed to carry out this type of intervention."

For more information: https://tinyurl.com/yckmjssh

Hep C World News - Week of February 26, 2023

About three in ten adults with chronic pain use medical cannabis

Ann Arbor, MI - About three in 10 adults with chronic pain who live in states with medical cannabis laws reported using cannabis to manage their pain, according to researchers, highlighting the need for more research on the subject. Although most states have laws that allow people to use cannabis for chronic pain treatment, accurate estimates of cannabis use or its substitution of treatments for chronic pain are unavailable, Mark C. Bicket, MD, PhD, an assistant professor in the department of anesthesiology at the University of Michigan School of Medicine, and colleagues wrote in JAMA Network Open. “Evidence is mixed about whether medical cannabis serves as a substitute for prescription opioids or other pain treatments,” they added. Bicket and colleagues conducted a cross-sectional study, surveying a representative sample of people aged 18 years or older who have chronic pain residing in the 36 states and Washington, D.C., with active medical cannabis programs from March 3, 2022, to April 11, 2022. They fielded the survey with the National Opinion Research Center AmeriSpeak panel, a probability-based panel that includes roughly 54,000 people and is sourced from a sample covering 96% of United States households. The final analysis included 1,661 people with chronic pain, 57.1% of whom were women. Of the participants, 31% reported ever having used cannabis to manage their pain (95% CI, 28.2-34.1). More specifically, 25.9% (95% CI, 23.2-28.8) reported cannabis use to manage their pain in the last year and 23.2% (95% CI, 20.6-26) reported use in the past 30 days. “Our results suggest that state cannabis laws have enabled access to cannabis as an analgesic treatment despite knowledge gaps in use as a medical treatment for pain,” the researchers wrote. Additionally, most of those who used cannabis to manage chronic pain also reported using at least one nonpharmacologic pain treatment or pharmacologic treatment — 70.6% (95% CI, 64.8-75.7) and 94.7% (95% CI, 91.3-96.8), respectively. Fewer than half of the participants said cannabis use altered their nonpharmacologic pain treatments, the researchers wrote. But 38.7% reported that their cannabis use led to decreased physical therapy use (5.9% reported increased use); 26% reported it led to decreased cognitive behavioral therapy use (17.1% reported increased use); and 19.1% reported that it led to decreased meditation use (23.7% reported increased use). More than 50% of those who used cannabis said it led them to decrease the use of prescription nonopioid and opioids and over the counter pain medications. Fewer than 1% reported increased use. “Most persons who used cannabis as a treatment for chronic pain reported substituting cannabis in place of other pain medications including prescription opioids,” Bicket and colleagues wrote. “The high degree of substitution of cannabis with both opioid and nonopioid treatment emphasizes the importance of research to clarify the effectiveness and potential adverse consequences of cannabis for chronic pain.”

For more information: https://tinyurl.com/bdekth7b

Hep C World News - Week of February 19, 2023

FDA panel backs moving opioid antidote Narcan over the counter
 

Washington, DC - The overdose-reversing drug naloxone should be made available over the counter to aid the national response to the opioid crisis, U.S. health advisers said Wednesday. The panel of Food and Drug Administration experts voted unanimously in favor of the switch after a full day of presentations and discussions centered on whether untrained users would be able to safely and effectively use the nasal spray in emergency situations. The positive vote, which is not binding, came despite concerns from some panel members about the drug’s instructions and packaging, which caused confusion among some people in a company study. The manufacturer, Emergent Biosolutions, said it would revise the packaging and labeling to address those concerns. The FDA will make a final decision on the drug in coming weeks. Panel members urged the FDA to move swiftly rather than waiting for Emergent to conduct a follow-up study with the easier-to-understand label. “There’s perhaps a far greater risk of delaying the availability of the product given the climate of this crisis and its devastating consequences,” said Maria Coyle, a pharmacy professor from Ohio State University, who chaired the panel. The prefilled nasal device, Narcan, is the leading version of the drug in the U.S., which is also available as an injection. If FDA approves, Narcan would be the first opioid treatment to make the regulatory switch to a non-prescription drug. The potential move represents the latest government effort to increase use of a medication that has been a key tool in the battle against the U.S. overdose epidemic that kills more than 100,000 people annually. The decades-old drug can counteract the effects of an opioid overdose in minutes. Narcan is already available without a prescription in all 50 states, where state leaders have issued standing orders for pharmacists to sell the drug to anyone who asks for it. But not all pharmacies carry it and those that do must keep it behind the counter. Also, the stigma of opioids can discourage people from asking for the drug. “We believe that nonprescription naloxone may help address these barriers,” said FDA’s Dr. Jody Green, noting the switch would allow the drug to be sold in vending machines, convenience stores and supermarkets. Emergent presented results from a 70-person study designed to show that people of various ages and backgrounds could quickly and correctly understand how to use the device in an emergency. About a third of people in the study had low reading ability, a group that FDA said should have been larger. FDA staffers also cautioned that a number of participants had trouble following the directions, in part because of the way the multi-step instructions were laid out across two sides of the carton, FDA noted.  “Where is step one?” one participant asked, according to interview transcripts from the study presented by the FDA. Emergent said it plans to move all the directions to a single panel and add pictograms, per FDA’s suggestion. Despite flaws in the original packaging, the panel of 19 pain and medical education experts expressed confidence that the product could be used effectively by most adults and adolescents. “Perfect should not be the enemy of the good and the evidence we saw today provides clear indication that the drug can be used without the direction of a health care provider,” said Dr. Brian Bateman of Stanford University. Government officials hope that moving naloxone beyond the pharmacy counter will boost sales, with the potential to lower costs. Currently the drug can cost $50 for a two-pack, when not covered by insurance. Community advocates and organizations that favor distributing the drug welcomed the potential approval of an over-the-counter version. “It’s going to make a tremendous impact on how people view the medication,” said Sheila Vakharia, deputy director of research and academic engagement at the Drug Policy Alliance. “It will help to destigmatize it and make people know it’s safe and easy to use.” But Maya Doe-Simkins, a co-director of Remedy Alliance/For The People, worried that an over-the-counter version of Narcan could also lead to a perception that it’s better than other forms of naloxone. “We have some trepidation about how companies that have ‘over-the-counter’ products may misrepresent injectable products,” said Doe-Simkins, who has long advocated for an over-the-counter version. U.S. overdose death rates began steadily climbing in the 1990s, driven by painkillers. Waves of deaths followed, led by other opioids like heroin and — most recently — illicit fentanyl. Nearly 107,000 Americans died of drug overdoses in 2021, an all-time high, though recent data suggests deaths may be plateauing. Gaithersburg, Maryland-based Emergent Biosolutions makes most of its money from medical products purchased by the federal government for the Strategic National Stockpile, including drugs and vaccines against anthrax. In 2021, the company came to the public’s attention for its disastrous handling of COVID-19 vaccine production for Johnson & Johnson and AstraZeneca. Contamination problems at the company’s Baltimore plant ultimately forced the drugmakers to discard the equivalent of hundreds of millions of vaccine doses.
 

For more information: https://tinyurl.com/yckpvtkp

Hep C World News - Week of February 12, 2023

HIV incidence in sub-Saharan Africa ‘appears low,’ but rates remain ‘staggering’

Chapel Hill, NC - Despite some progress being made, sub-Saharan Africa remained a hot spot for new HIV infections, with approximately 689,000 new infections annually among HIV-negative adults between 2015 and 2019, according to data pooled from 15 countries. “We were surprised that there [were] no empirical data characterizing HIV incidence in sub-Saharan Africa,” Nora E. Rosenberg, PhD, MSP, associate professor in the Gillings School of Global Public Health’s department of health behavior at the University of North Carolina at Chapel Hill, told Healio. “These 15 nationally representative datasets provided an opportunity to characterize HIV incidence across much of the continent,” she said. For the study, Rosenberg and colleagues analyzed data from 13 Population-based HIV Impact Assessment surveys, as well as two additional population-based surveys conducted between 2015 and 2019 in 15 sub-Saharan African countries. HIV-seropositive samples collected from adults aged 15 to 59 years and older were tested for recent infection using an algorithm consisting of the HIV-1-limiting antigen avidity enzyme immunoassay, HIV-1 viral load and qualitative detection of antiretroviral agents. Data were then pooled across countries, and sampling weights were incorporated to represent all adults in the 15 national populations. Among 445,979 adults sampled, 382 had recent HIV-1 infection, generating an estimated HIV-1 incidence rate of 3.3 per 1,000 person-years (95% CI, 2.6-4) among women and 2 per 1,000 person-years (95% CI, 1.2-2.7) among men (incidence rate difference: 1.3 per 1,000 person-years; 95% CI, 0.3-2.3). In an age-adjusted analysis, the study demonstrated that the incidence rate was higher among women aged 15 to 24 years (3.5 per 1,000 person-years) than among men (3.5 vs. 1.2 per 1,000 person-years; difference of 2.3, 95% CI, 0.8-3.8), although infection rates were similar between sexes in all other age groups. When broken down by location, the study showed that the HIV-1 incidence rate was 7.4 per 1,000 person-years (95% CI, 5-9.7) in southern sub-Saharan Africa, 2.3 per 1,000 person-years (95% CI, 1.7-2.9) in the eastern subregion and 0.9 per 1,000 person-years (95% CI, 0.6-1.2) in the western and central subregion. Rosenberg said that although these rates “may appear low,” they translate to approximately 689,000 adult infections each year, which she said is a “staggering number.”
 

For more information: https://tinyurl.com/2p86tzc2

Hep C World News - Week of February 5, 2023

Australia to allow prescription of MDMA and psilocybin for treatment-resistant mental illnesses

Sydney, Australia – According to a report published in the Guardian, authorised psychiatrists in Australia will soon be able to prescribe the drugs for post-traumatic stress disorder and severe depression. Experts say the decision will make Australia the first country in the world to officially recognise MDMA and psilocybin as medicines. After decades of “demonisation”, psychiatrists will be able to prescribe MDMA and psilocybin in Australia from July this year. The Therapeutic Goods Administration made the surprise announcement on Friday afternoon. The drugs will only be allowed to be used in a very limited way, and remain otherwise prohibited, but the move was described as a “very welcome step away from what has been decades of demonisation” by Dr David Caldicott, a clinical senior lecturer in emergency medicine at Australian National University. 3,4-methylenedioxy-methamphetamine (MDMA) is commonly known as ecstasy, while psilocybin is a psychedelic commonly found in so-called magic mushrooms. Both drugs were used experimentally and therapeutically decades ago, before being criminalised. Specifically authorised psychiatrists will be able to prescribe MDMA for post-traumatic stress disorder, and psilocybin for treatment-resistant depression. Ecstasy was developed as an appetite suppressant in 1912, but in the 1970s it started being used in therapy sessions in the US. It entered Australia in the 1980s as a party drug, and was criminalised in 1987. Many species of magic mushrooms grow wild in Australia, but it is illegal to possess or supply psilocybin. Caldicott said it had become “abundantly clear” that a controlled supply of both MDMA and psilocybin “can have dramatic effects on conditions often considered refractory to contemporary treatment” and would particularly benefit returned service men and women from the Australian defence force. “The safe ‘re-medicalisation’ of certain historically illicit drugs is a very welcome step away from what has been decades of demonisation,” he said. “In addition to a clear and evolving therapeutic benefit, it also offers the chance to catch up on the decades of lost opportunity [of] delving into the inner workings of the human mind, abandoned for so long as part of an ill-conceived, ideological ‘war on drugs’.” Cognitive neuropsychologist Prof Susan Rossell, from Swinburne’s Centre for Mental Health, said she still had “a significant degree of caution” about the decision, and that further research was needed. Rossell is the lead researcher on Australia’s biggest research trial of psilocybin’s effectiveness for treatment-resistant depression. “We’ve got no data on long-term outcomes at all, so that worries me a lot, which is one of the reasons why I’m doing my very large study,” she said. Dr. Stephen Bright, a senior lecturer and director of Psychedelic Research in Science and Medicine at Edith Cowan University, said the decision made Australia “the first country in the world to officially recognise MDMA and psilocybin as medicines”. It is an “important step in drug policy reform”, he said, but added that extensive training was needed for the approved psychiatrists. He said the announcement could also lead to more people accessing the drugs illegally, “through desperation”. In a statement, the TGA said the decision acknowledged “the current lack of options for patients with specific treatment-resistant mental illnesses”. “It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting,” the TGA said. “However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.”
 

For more information: https://tinyurl.com/ynvrw3w3

Hep C World News - Week of January 29, 2023

Stricter rules for tattoos and piercings in Wales

Cardiff, Wales - Wales is set to become the first UK nation to introduce mandatory licensing for tattoo artists, body piercers and cosmetic clinics. The tougher controls aim to reduce infections and poor working practices by creating a public register of licence holders. About 3,500 practitioners will need to be licensed and 1,868 business premises will require approval. A 12-week consultation has been launched by the Welsh government. The new rules are the final phase of changes introduced under the Public Health (Wales) Act 2017 to improve standards of infection prevention and control in the industry. The legislative work was due to be brought in during 2020 but the scheme was delayed by Brexit and the Covid pandemic. Ashley Davies, who has been running Stronghold Tattoo in Cardiff for eight years and has been working with the Welsh government on the new qualification, said: "The increase in quality of tattoos in the last decade has been exponential so the hygiene needs to be raised. "This is all positive for the industry and helps shake the image of it being dark and shady. It's reassuring for those getting tattooed as well." The pass rate for those practitioners who have already undertaken the level 2 award in infection prevention and control voluntarily is 95%. But there are still concerns about many without licences, including self-taught tattooists, known in the industry as "scratchers". Health experts have warned of the dangers of contracting blood-borne viruses - such as hepatitis B, hepatitis C or HIV - from unlicensed tattoo artists, and warn how blood poisoning caused by dirty needles can kill. Ffion Hughes, a paramedic tattooist who helps mastectomy patients with scarring and areola loss, told BBC Radio Wales Breakfast that her clinic in Caernarfon, Gwynedd, often sees distressed patients after "having bad work, infections, viruses… a bad image on their body that they can't get rid of". "Anybody can pick up a tattoo gun and become a tattooist which is absolutely shocking," she said, "because that's actually on your body for the rest of your life." She said the new regulations bring medical tattoo practitioners and tattoo artist to the same level. "It's going to be a huge shock for the [tattoo parlour] industry," she said, but she believes the general public will be "more accepting of it and respect it a bit better now that there's better work out there". Shaun Newman, manager at Stronghold Tattoo, said tattoos had become a lot more popular because of heavily tattooed celebrities such as David Beckham and exposure through social media, but that has brought extra issues. "There can be a real problem of people going to unlicensed tattooists at their homes because they're cheap," he said. "People think it doesn't matter if it's cheap, but it really matters that these people have no idea how to use the machinery properly or take care of the tattoo during and after the process, which is critical." Wales' chief medical officer Frank Atherton said extra regulation was needed following an outbreak of skin infection pseudomonas at a Newport tattoo and body piercing establishment in 2014. "This specific incident in 2014 highlighted the problem of unlicensed body art practitioners and body piercers and led to very difficult consequences for a number of people in south Wales," he said. "Some very young people were affected, even as young as 13 and they had significant hospital treatment and reconstructive surgery. It cost the NHS nearly £250 000. "Good standards of hygiene and infection control by all special procedures practitioners and businesses is essential as these procedures are capable of causing harm if not carried out properly."

For more information: https://www.bbc.com/news/uk-wales-64372294

Hep C World News - Week of January 22, 2023

Another HIV vaccine fails to provide protection in discontinued trial

Leiden, Netherlands - Janssen recently announced that it has stopped the phase 3 Mosaico trial because the investigational HIV vaccine regimen it was testing was not effective in preventing HIV infection compared with placebo. No safety issues were identified, but the study’s independent data and safety monitoring board determined the study would not reach its primary endpoint of preventing HIV. “We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable and affected by HIV,” Penny Heaton, MD, global therapeutic area head for vaccines in Janssen’s research and development unit, said in a press release. It was the latest HIV vaccine trial to be stopped because the experimental regimen being tested did not work. Janssen discontinued the phase 2 Imbokodo trial — which tested a similar vaccine regimen as Mosaico — in 2021, and the National Institute of Allergy and Infectious Diseases halted a phase 2b/3 clinical trial in early 2020 that was testing a regimen based on the only investigational HIV vaccine combination ever to demonstrate efficacy in a large clinical study. Stephaun E. Wallace, PhD, MS, director of external relations at the HIV Vaccine Trials Network (HVTN), which conducted the study, told Healio that the organization “does not have any HIV vaccine efficacy trials currently in the field that are recruiting.” Both the Mosaico and Imbokodo studies are in follow-up, Wallace said. “In the coming weeks, (Mosaico) study participants will have a final study visit, at which they will learn which study arm they were assigned to, have blood specimens taken for HIV diagnostic testing, receive information regarding vaccine-induced seropositivity and seroreactivity, and again receive counseling regarding HIV prevention options and [be] provided with appropriate referrals,” Wallace said. The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men, transgender people or both at more than 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the United States. Beginning in 2019, and with vaccinations complete in October 2022, participants received either placebo or a vaccine regimen containing a mosaic-based adenovirus serotype 26 vector administered in four doses over 1 year, with the second two doses including a mix of soluble proteins. Since completion of the study vaccine series, “the number of HIV infections were equivalent between the vaccine and placebo arms of the study,” the NIAID said in a statement, adding that “the Mosaico findings track with developments in the phase 2b Imbokodo clinical trial.” In the Imbokodo study, which enrolled 2,637 women aged 18 to 35 years from Malawi, Mozambique, South Africa, Zambia and Zimbabwe, the vaccine being tested was estimated to be 25.2% efficacious. “We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine,” Heaton said.
 

For more information: https://tinyurl.com/268nanr2

Hep C World News - Week of January 15, 2023

Roche’s Tecentriq touts industry-first liver cancer win

Basel, Switzerland - The study is the first phase 3 for an immunotherapy combo to show tumor recurrence benefits in early-stage liver cancer, Roche’s chief medical officer Levi Garraway, M.D., Ph.D., noted (Roche) For Roche’s immunotherapy Tecentriq, 2023 is expected to be a prolific year filled with clinical trial readouts in early-stage cancers. In the first trial in the series, Tecentriq has delivered a win. Nearly three years after snatching a first-in-class FDA approval in metastatic liver cancer, a combination of Roche’s Tecentriq and Avastin posted a first-in-class win in early-stage disease. The combo significantly reduced the risk of tumor recurrence compared with simple surveillance when used as adjuvant treatment following surgery in people with hepatocellular carcinoma at a high risk of rebound, Roche said. Roche plans to discuss the results from the phase 3 IMbrave050 study with drug regulators, including the U.S. FDA and the European Medicines Agency. The study is the first phase 3 trial for an immunotherapy combo to show tumor recurrence benefits in early-stage liver cancer, Roche’s chief medical officer Levi Garraway, M.D., Ph.D., noted in a statement. More than 70% of early-stage liver cancer patients may see their cancer return after surgery, and recurrence is linked with shorter survival, he noted. Before the adjuvant liver cancer readout, the Tecentriq-Avastin combo in 2020 became the first immunotherapy regimen approved in newly diagnosed metastatic liver cancer. That came after the combo showed it could extend patients’ lives compared with Bayer’s Nexavar. As expected for an early-stage cancer trial, IMbrave050’s data on patients’ life expectancy remained immature at the interim analysis. Roche said the study will continue to allow for further follow-up. Investigators plan to share detailed data at an upcoming medical meeting, Roche said. Industry watchers will look for the magnitude of the recurrence-free survival benefit, as well as subgroup data, especially by PD-L1 expression levels. Recurrence-free survival in PD-L1-positive disease is a secondary endpoint of IMbrave050.
 

For more information: https://tinyurl.com/2zz32wr3

Hep C World News - Week of January 8, 2023

HIV, HBV, HCV testing up among Medicaid enrollees, although missed opportunities remain

Portland, ME - Testing for HIV, hepatitis B, and hepatitis C increased among U.S. Medicaid enrollees initiating treatment for opioid use disorder. However, a recent study showed approximately three-quarters of enrollees were not tested for each condition. “Limited information exists about testing for HIV, hepatitis B virus, and hepatitis C virus among persons enrolled in Medicaid who are starting medication treatment for their opioid use disorder, despite guidelines recommending such testing,” Katherine Ahrens, PhD, epidemiologist and assistant research professor in the Public Health Program at the University of Southern Maine Muskie School of Public Service, told Healio. “Testing for these conditions is recommended because past or current injection drug use is common among persons starting medication treatment for opioid use disorder (MOUD), and highly effective treatments exist for all three diseases that lower the risk of subsequent morbidity, prevent disease transmission, and are cost-saving.” Because of this, Ahrens and colleagues assessed 2016-2019 Medicaid data from 11 states using a distributed research network called MODRN. According to the study, the researchers looked at testing within 90 days of starting MOUD among 361,537 Medicaid enrollees aged 12 to 64 years. Measures of MOUD initiation, as well as HIV, HBV, and HCV testing, comorbidities and demographics were based on enrollment and claims data. Between 2016 and 2019, testing for HIV increased from 20% to 25%, whereas testing for HBV and HCV increased from 22% to 25% and 24% to 27%, respectively. Additionally, testing for all three conditions increased from 15% to 19%. The researchers determined that rates of testing for all three conditions were lower among enrollees who were male compared with nonpregnant females, those living in a rural area compared with an urban area, and those initiating methadone or naltrexone compared with those initiating treatment with buprenorphine. “Using a distributed research network in 11 states, we found 90-day testing for HIV, HBV, HCV, and all three conditions increased from 2016 to 2019 among enrollees initiating medication treatment for their opioid use disorder,” Ahrens said. “However, approximately three-quarters of enrollees were not tested within 90 days, highlighting room for improvement in meeting testing recommendations and missed opportunities for curing HCV, managing HBV and HIV, and reducing transmission of these viruses.”
 

For more information: https://tinyurl.com/mr2v6nxh

Hep C World News - Week of January 1, 2023

Sustained alcohol abstinence benefits even advanced cases of alcohol-related cirrhosis
 

Vienna, Austria - Abstinence from alcohol was associated with reduced risk for hepatic decompensation and mortality among patients with alcohol-related cirrhosis, regardless of disease stage, according to results in Clinical Gastroenterology and Hepatology. “Our results clearly show that all patients with alcohol-related liver cirrhosis who maintain sustained abstinence from alcohol not only suffer complications of liver cirrhosis significantly less frequently, but also live considerably longer — even in the case of pronounced portal hypertension," Benedikt Silvester Hofer, MD, of the division of gastroenterology and hepatology at the Medical University of Vienna, said in a related press release. In an observational, single-center study, Hofer and colleagues investigated the clinical implications of abstinence among 320 patients (median age, 57 years; 75.6% men) with alcohol-related cirrhosis and clinically significant portal hypertension, defined as hepatic venous pressure gradient (HVPG) of at least 10 mm Hg. At enrollment, 87.5% of patients had decompensated cirrhosis and the median HVPG was 20 mm Hg, with 53.8% of patients exceeding 20 mm Hg. During a median follow-up of 36 months, 75.3% of patients remained abstinent and 24.7% continued drinking alcohol. Researchers reported that abstinence correlated with a “significantly reduced” risk for hepatic decompensation (adjusted HR = 0.391; 95% CI, 0.276-0.555), liver-related mortality (aHR = 0.428; 95% CI, 0.263-0.697) and all-cause mortality (aHR = 0.453; 95% CI, 0.3-0.686). Further, abstaining from alcohol also reduced the cumulative incidence of hepatic decompensation among those with an HVPG of 10 mmHg to 19 mmHg and an HVPG of 20 mmHg or greater. MELD score (aHR = 1.049; 95% CI, 1.004-1.096) was also a “significant independent predictor” of decompensation. Researchers estimated a lower probability of 3-year decompensation among those who abstained from alcohol for both HVPG measurement groups (32.4% vs. 60% and 57.5% vs. 82.6%, respectively). “Our new data provide important evidence for the daily counseling of our patients and show that it is never too late to strive for complete abstinence from alcohol,” Thomas Reiberger, MD, lead study author and associate professor of hepatology at the Medical University of Vienna, said in the release. “However, the study also showed that even patients with sustained abstinence from alcohol are at risk of developing complications, especially if the extent of portal hypertension remains very pronounced. Therefore, all those affected need regular medical check-ups.”
 

For more information: https://tinyurl.com/y4svk2d