Women's utilization of housing-based overdose prevention sites in Vancouver

Vancouver, BC - In response to a fentanyl-driven overdose crisis, low-threshold supervised consumption sites, termed overdose prevention sites (OPS), have been rapidly implemented in Vancouver, Canada. Since approximately 88% of fatal overdoses in the province occur indoors, OPS have been integrated into select non-profit-operated single room accommodations (SRA) housing. Researchers here, led by Alexandra B. Collins, examined the social-structural features of these housing-based OPS (HOPS) on women's overdose risk. Ethnographic research was conducted from May 2017 to December 2018 in Vancouver. Data included 35 in-depth interviews with women who use drugs living in SRAs and approximately 100 h of observational fieldwork in SRAs and surrounding areas. Data were analyzed using an intersectional risk environment approach, with attention to equity and violence. Findings demonstrate that the social and structural environments of HOPS created barriers for women to access these interventions, resulting in an increased overdose risk. Primary barriers included uncertainty as to who else was accessing HOPS, rules prohibiting smoking, and a lack of trust in staff's abilities to effectively respond to an overdose. Most participants considered HOPS to be unsafe environments, and expressed fear of violence from residents and/or guests. The perceived risk of violence was informed by previous experiences of assault and the witnessing of violence. Many participants thus consumed drugs alone in their rooms to better control their safety, despite heightened overdose risk. Further, most participants did not perceive themselves to be at risk of an overdose due to drug use practices and tolerance levels, and viewed using alone as a safer option than HOPS. Findings highlight how the low-barrier design and operation of HOPS can undermine women's engagement with HOPS. Overdose prevention strategies in SRAs should also include gender-specific models (e.g. women-only HOPS, women peer workers) to help mitigate barriers to these services within the context of the current overdose crisis.

For more information: https://tinyurl.com/tuzm8u5

Hep C World News - Week of December 22, 2019

New US guidelines recommend screening of all adults for hepatitis C

Arlington, Virginia - All adults in the United States should be screened for hepatitis C by healthcare providers as part of routine medical care, updated guidelines from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend. The testing is recommended as a one-time, opt-out routine test.  In addition, the new guidelines recommend repeat testing for people with behaviours, exposures or conditions associated with an increased risk of hepatitis C, and annual testing for people who inject drugs and for men who have condomless sex with men. The new US guidelines also follow guidance issued in France earlier this year, recommending a simplified treatment protocol for people with hepatitis C who do not have cirrhosis. The new recommendation is designed to encourage primary care physicians to initiate treatment in previously untreated non-complicated patients. People with cirrhosis, chronic kidney disease, HIV or hepatitis B co-infection and pregnant women should be treated by a liver specialist, as should people with a previous history of hepatitis C treatment. The guidelines recommend two regimens, either glecaprevir/pibrentasvir (Maviret) or sofosbuvir/velpatasvir (Epclusa), as suitable for all people. For people with compensated cirrhosis (Child-Pugh A, FIB-4 score > 3.25) and no complicating factors (such as HIV, pregnancy, chronic kidney disease or a previous history of hepatitis C treatment), an eight-week course of treatment with glecaprevir/pibrentasvir (Maviret) can be initiated by any physician. No genotyping is needed before starting treatment with glecaprevir/pibrentasvir. For people who have recently acquired hepatitis C – acute infection – the guidelines have been updated to recommend immediate treatment. Previous guidance counselled physicians to wait and see whether patients cleared the virus spontaneously. The new guidance recommends immediate treatment to avoid further hepatitis C transmission.
 

For more information: https://tinyurl.com/vcfvb7b

Hep C World News - Week of December 15, 2019

Trudeau says that legalizing hard drugs not a ‘panacea’ to opioids crisis

 Ottawa, ON - Prime Minister Justin Trudeau says he’s unconvinced that decriminalizing hard drugs is a “panacea” to the country’s ongoing opioids crisis, and other options need a chance before considering such a major policy shift. But Trudeau once felt the same way about marijuana — conceding it during an interview this week published in the Toronto Star — before changing his mind. During the wide-ranging interview with The Canadian Press, Trudeau said the epidemic requires a complex set of answers and not simply decriminalizing opioids to undercut a tainted black-market supply, as some jurisdictions have suggested. The prime minister said his government plans to focus on solutions such as giving doctors more authority to prescribe alternatives to street drugs and creating more supervised consumption sites across the country. However, opening supervised sites is more difficult in places where people are leery of supplying sterile drug paraphernalia and workers who can respond quickly to overdoses, he said, particularly in provinces headed by “capital-C conservative” governments. The most recent figures from the Public Health Agency of Canada showed that nearly 14,000 Canadians have been killed by opioids since 2016. Nearly all of those deaths are due to accidental overdoses. The composition of street drugs is practically impossible for users to tell, and the advent of powdered fentanyl — a super-potent opioid, easily hidden and transported, and often cut and then passed off as a less powerful drug — has been a major factor. Besides the thousands who have died, thousands more have been hospitalized or treated by paramedics. Some have suffered permanent harm. Trudeau said possible government responses “haven’t yet been fully deployed.” They will make a difference without having to “immediately jump to the biggest, perhaps biggest, lever in our arsenal,” he said, in reference to decriminalization. Though he didn’t rule out that something could change his mind.

For more information: https://tinyurl.com/wmhkc69

Hep C World News - Week of December 8, 2019

Retreatment for HCV may require switching DAA inhibitor classes

Frankfurt, Germany - Patients who failed to achieve sustained virologic response after initial treatment for hepatitis C achieved high cure rates during retreatment after switching from an NS5A inhibitor direct-acting antiviral to a protease inhibitor. “The management of DAA failure patients remains a challenge,” Julia Dietz, MD, from the Goethe University Hospital in Frankfurt, Germany, and colleagues wrote. They highlighted the fact that many patients develop resistance associated substitutions (RASs), particularly NS5A RASs, and there remains limited data on retreatment success. To analyze the efficacy of retreatment with first generation DAAs, Dietz and colleagues reviewed data from 631 patients, 262 of whom completed retreatment. Patients with genotype 1 initially received a combination of Sovaldi (sofosbuvir, Gilead Sciences) and an NS5A inhibitor, and those with genotype 3 underwent treatment with combination Daklinza (daclatasvir, Bristol-Myers Squibb) and sofosbuvir. The SVR rates at follow-up were overall 84% among patients with genotype 1, 91% for those who received a regimen with sofosbuvir and a protease inhibitor, and 90% among those with RASs. Retreatment with a protease inhibitor without sofosbuvir was less effective with an SVR rate of 82%. Repetition of treatment with sofosbuvir and an NS5A inhibitor without a protease inhibitor was comparatively ineffective with an SVR of 68%. All patients with genotype 3 underwent retreatment with an NS5A inhibitor and sofosbuvir and 60% achieved SVR. Most of these patients had developed NS5A RASs (93%) and the SVR rates were higher in the absence of cirrhosis and Y93H. “Interestingly, in a recent study with inclusion of a [protease inhibitor] ... the majority of treatment failures had [genotype 3],” Dietz and colleagues wrote, referring to Vosevi (sofosbuvir/velpatasvir/voxilaprevir, Gilead Sciences). “Thus, retreatment of [genotype 3] remains a challenge.”

For more information: https://tinyurl.com/rb9fmzg

Hep C World News - Week of December 1, 2019

Where the nurse prescribes heroin

Glasgow, Scotland - A new program in Glasgow will give drug users pharmaceutical-grade heroin twice daily in a bid to reduce drug-related deaths. The program will target those with the “most severe, longstanding and complex addiction issues,” the City Council said. It aims to reduce the risk of overdoses and the spread of viruses such as H.I.V. by prescribing diamorphine — the clinical name for pharmaceutical-grade heroin — for patients to inject in a secure clinical room under the supervision of trained medics. The clinic opened in Glasgow, Scotland’s largest city, after Britain’s Home Office granted it a license, and follows a similar initiative that began in Middlesbrough, England, last month. Up to 20 patients are expected to take part in the first year of Glasgow’s program, with the number set to double in the second year. “Heroin-assisted treatment is a much more clinical service aimed at getting people stable,” Andrew McAuley, a senior research fellow on substance use at Glasgow Caledonian University, said in an interview on Wednesday. “The program is a significant step forward, albeit for a very small number of people.” The program, called the Enhanced Drug Treatment Service, is intended for those who have exhausted other treatment options such as residential rehabilitation, methadone and community addiction services. It is available only to drug users already involved with the city’s team fighting addiction among homeless people. The program is not intended to be long-term, with research suggesting that clinical benefits can be seen after six weeks of treatment. It requires patients to visit the city clinic twice a day, seven days a week, a demand that may be too much for those not used to such a routine, Mr. McAuley said. “It’s a large commitment,” he said. Glasgow has ambitious plans to support its residents with drug-addiction issues, but Scottish officials say it has been hindered by Britain’s 1971 drug law.
 

For more information: https://tinyurl.com/uuy724c

Hep C World News - Week of November 24, 2019

HCV screening of baby boomers continues to lag
 

New York, NY - Even with help, safety-net primary care clinics serving low-income and uninsured populations in the U.S. often fall short in screening baby boomers for hepatitis C virus (HCV), as recommended by the U.S. Preventive Services Task Force, according to a new study. The study evaluated the Screen, Treat, Or Prevent Hepatocellular Carcinoma (STOP HCC) program, conducted in six safety-net primary care practices serving mostly Hispanic communities with high burdens of cirrhosis and liver cancer. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model informed implementation of the multicomponent STOP HCC program. "We supported the practices to (help them) operationalize national guidelines to . . . test all adults born from 1945 through 1965 (baby boomers) for HCV infection and to treat those with chronic HCV," said coauthor Dr. Barbara Turner of the Gehr Center for Health Systems Science and Innovation, Keck School of Medicine of USC in California. Despite the offers of support, these practices "varied widely in conducting HCV screening and treatment. Most still had substantial logistical and financial barriers to performing screening and managing infection - even though they serve communities that are disproportionately affected by liver disease," Dr. Turner said by email. As reported online today in Annals of Internal Medicine, screening baby boomers for HCV in participating practices was "virtually nonexistent" prior to STOP HCC but increased to 48% of 27,700 eligible baby boomers over a period of 29 to 43 months. However, screening rates varied by practice from about 20% to 71% of eligible patients. In four participating federally qualified health centers, 174 (85%) of 205 uninsured baby boomers diagnosed with chronic HCV completed disease staging but only 74 (36%) completed HCV treatment, ranging from 28% to 60% by practice. Of the treatment-completers, 70 (95%) patients achieved a cure. Dr. Turner told Reuters Health, "If, in the United States, policymakers and the health system want to prioritize curing millions of Americans with chronic HCV in order to eradicate this serious threat to health, we must recognize that uninsured patients need to have these tests paid for and practices need to have additional financial support to be able to manage patients diagnosed with chronic HCV. Furthermore, even patients who are on Medicaid have many barriers to accessing effective HCV treatment. Moreover, these primary care practices surveying vulnerable populations must find the resources and time to manage HCV in the context of managing multiple acute and chronic diseases and delivering preventive care." Dr. Turner concludes, "Until these specific initiatives are underway, diagnosing and curing chronic HCV infection requires external funds - such as from grants or public health projects - that support the patient's and the practices to address this very common infection." Funding for the study was provided by Cancer Prevention & Research Institute of Texas and the Centers for Medicare & Medicaid Services.

 For more information:  https://bit.ly/2OGf4U8

Hep C World News - Week of November 17, 2019

Just 5 drops of blood could help fight hep C on remote B.C. reserves
 

Prince George, BC - The CBC recently reported that an Indigenous agency hopes a simple new hepatitis C test, done by a lay person drawing just five drops of blood, will eliminate the high rates of serious liver infection in several remote B.C. communities. Carrier Sekani Family Services said its 11 member communities in north-central B.C. have about twice the rate of hepatitis C as the national average. The viral liver infection, spread through contaminated blood, can be deadly if left untreated. The disease can be cured with medication in just 12 weeks, but many people never get treated because they don't know they have hepatitis C. Testing is difficult in communities without health professionals, a medical lab, or transportation for blood biohazards. But Carrier Sekani Family Services is now changing that. It's just just unveiled a simple, new test — called dried blood spot testing (DBST) —  at an elders' gathering in Prince George. "It's finally here," said Marilyn Janzen, the agency's program manager for health and wellness. "You don't have to go in to a doctor to get your blood drawn. And there are no issues with transporting blood that's dried, so this test makes it easier for our hard-to-reach communities." "The more people that can be screened, the better." Staff can administer the test after just two hours of training, so Carrier Sekani addiction workers, mental health counselors, and other lay people are now qualified. The tests they administer are similar to a diabetes blood sugar finger poke, a system that's familiar to many elders. After the fingertip is pricked with a special lancet, five drops of blood are applied to a special piece of cardboard. The cardboard is then dried, and sent away in an envelope  to be analyzed. Similar DBST tests were rolled out this year in PEI, Calgary, and northern Ontario. In those non-Indigenous communities, test results were provided on the spot. But because of confidentiality issues in Carrier Sekani's small communities, their tests will be analyzed off site, with results sent to medical staff in the area. Carrier Sekani wellness worker Lydia Thomas was the first to administer the new test, at the elders' gathering.  "They had a lot of questions about it," Thomas said. "They're just curious. They're glad the test is happening. It doesn't hurt them." Carrier Sekani says DBST testing will eventually expand, so that people can also be screened for HIV and syphilis.

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

Hep C World News - Week of November 10, 2019

Scientists develop an opioid breath test

Davis, CA - Presently, in order to check the level of opioid drugs in a person's bloodstream, a blood sample must be taken. Things may soon be getting much less invasive, however, as scientists have now developed a breath test that does the job. The system was developed by a team at the University of California-Davis, led by postdoctoral researcher Eva Borras and Prof. Cristina Davis. People who are being tested start by breathing normally, into a collection device. Droplets of their breath condense within it, and are then frozen until they can be placed in a mass spectrometer within a lab. That machine is capable of detecting both the original drug and metabolites (compounds produced by the body as it breaks down the drug) within the droplets. In a test of the technology, six chronic pain patients were initially given infusions of medications such as morphine and hydromorphone, along with oral doses of oxycodone. When their opioid metabolite levels were subsequently checked via both blood samples and the breath test, figures for the two techniques were very similar. A larger study, which will involve the bedside testing of hospital patients, is now being planned. Ultimately, it is hoped that the breath test could be used to easily check that patients are taking the correct dosage of drugs (and that the medication is being metabolized correctly), or to identify individuals who are illegally abusing opioids. The research is described in a paper that was recently published in the Journal of Breath Research

For more information: https://tinyurl.com/yxzdgy2j

Hep C World News - Week of November 3, 2019

Most people consider medical marijuana safe for pain despite limited research

Palo Alto, CA - Nearly two-thirds of respondents in a nationwide survey showed interest in using marijuana or cannabinoids for pain management, with many reporting that they believed those options were safer than opioids and had fewer side effects than other pain medications. Results from the American Society of Anesthesiologists’ survey showed that many in the United States are unaware of the potential risks linked to marijuana and cannabidiol use. “As a community of physicians, it's important for us to remember that 100 million people in this country suffer from chronic pain,” Edward R. Mariano, MD, MAS, chief of anesthesiology and perioperative care service and associate chief of staff for inpatient surgical services in the VA Palo Alto Health Care System, told Healio Primary Care. “As their physicians, we have to ask the right questions and make sure our patients are comfortable talking with us about their pain and what they are using, including cannabinoids,” he continued. Nearly two-thirds of respondents in a nationwide survey showed interest in using marijuana or cannabinoids for pain management, with many reporting that they believed those options were safer than opioids and had fewer side effects than other pain medications. Results from the survey were based on responses from 1,005 adults aged 18 years and older. Marijuana or cannabinoid use was reported by 37% of millennials, 25% of Gen Xers and 18% of baby boomers. More than two-thirds of respondents said that they would consider using marijuana or cannabinoids to treat pain. Of those, 62% said they felt marijuana and cannabinoids were safer than opioids, and 57% thought they had fewer adverse effects than other available pain medications. Among the respondents; 57% felt more research is needed; 34% believed that they do not need to discuss marijuana and cannabinoid product use with their doctors; 48% felt that they know what to expect from marijuana or cannabinoids; 13% said they have or would use marijuana because no other pain management has worked for them; and 40% thought that the FDA approved cannabidiol sold in grocery stores, truck stops, health food stores and medical marijuana dispensaries. Mariano explained that one of the biggest issues with increasing interest in marijuana or cannabinoids for pain management is that patients do not realize these products are unregulated, and many who buy their own products do not know what is in them. One study, he noted, found that among 84, only 31% were accurately labeled. Research into medical marijuana has been limited because marijuana is considered a Schedule I drug by the Drug Enforcement Administration, Mariano said. This means that although 33 states have legalized marijuana in some form, the federal government considers it to have high abuse potential and does not currently approve it for medical use.
 

For more information: https://tinyurl.com/yyuly4wc

Hep C World News - Week of October 27, 2019

Teva, J&J make multibillion-dollar settlement offers as opioid trial gets going

Cleveland, OH - After months of waiting, one drugmaker and five distributors accused of fueling the nation’s opioid addiction epidemic may finally face a courtroom this week. But with multibillion-dollar settlement talks swirling, will a bellwether trial for thousands of those lawsuits end before it begins? Teva and five distributors will begin their defense in a trial that could set the tone for either a global settlement or a landmark trial in multidistrict litigation in Cleveland. With a prospect of a courtroom looming, Teva and at least three of the distributors named as defendants are in talks to settle the suit with the two counties whose claims are up first—Summit and Cuyahoga—as well as the thousands of other state and local suits they face in Cleveland. Months after settling opioid claims with the state of Oklahoma for $85 million, Teva is now reportedly offering to give away $15 billion in generic drugs to strike a deal in the Cleveland litigation. The deal would shell out the drug over the span of 10 years and would include the drug maker’s addiction treatment nasal spray Narcan, according to Bloomberg. On the heels of Bloomberg’s report, Teva’s share price was up 4% in pre-market trading Wednesday. A Teva spokeswoman declined to comment. With Teva coming to the negotiating table, three of the distributors named in the bellwether trial—McKesson, AmerisourceBergen and Cardinal Health—are reportedly in discussions to reach a combined $18 billion settlement of their own. Under the deal, the companies would pay it out in $1 billion increments over 18 years, according to the Wall Street Journal. All three distributors were at the center of a recent push to recuse the U.S. district judge overseeing the Cleveland litigation, Dan Polster, after accusing him of favoring a settlement in the case. The other defendants in the bellwether trial include Walgreens, a retailer named as a distributor, and Henry Schein Medical, which sells medical equipment to doctors and dentists. A spokesman for AmerisourceBergen declined to comment. Spokespersons for McKesson and Cardinal could not be reached for comment by press time. With the bellwether defendants angling to reach a deal, Johnson & Johnson is also testing the waters on a global settlement of its own—this time to the tune of $4 billion. J&J was recently the unwilling recipient of a $572 million penalty in an Oklahoma opioid bench trial in August that marked the first time a drugmaker has been found directly responsible for a state’s addiction crisis. J&J vowed to appeal that Oklahoma decision and might have picked up some extra ammunition after the trial’s judge admitted he fumbled a number in the verdict. On Wednesday, Judge Thad Balkman acknowledged that he mistakenly set aside $107,683,000 in J&J’s penalty to help combat neonatal abstinence syndrome, or NAS. The actual figure was supposed to be $107,683. "That's the last time I use that calculator," Balkman said, according to CTV News. A J&J spokesman said the company was awaiting the court's final order. As settlement talks pick up steam across the board, several Democratic presidential hopefuls said opioid maker CEOs should face prison time during a CNN debate Tuesday. California Sen. Kamala Harris, a former prosecutor, called companies like Purdue and Teva “nothing more than some high-level dope dealers” and favored incarceration for execs. As Vox pointed out, that position is nothing new for a Democratic field hoping to look the toughest on opioid makers: Both Sens. Bernie Sanders, of Vermont, and Elizabeth Warren, of Massachusetts, have called for the jailing of pharma executives who have helped spur the nation’s opioid crisis.

For more information: https://tinyurl.com/y3vcqnjj

Hep C World News - Week of October 20, 2019

 FDA expands Mavyret approval for adults, children with any HCV genotype

Silver Spring, Maryland - The FDA has expanded the approval of Mavyret for a treatment duration of 8 weeks to include treatment-naive adults and children aged 12 years and older with chronic hepatitis C genotype 1 through 6 and compensated cirrhosis. The label expansion of Mavyret (glecaprevir/pibrentasvir, AbbVie) was based on data from the phase 3b EXPEDITION-8 study that included patients with any of the six HCV genotypes. Twelve weeks after treatment, 98% of the 343 enrolled patients achieved sustained virologic response. “This approval provides a treatment duration of 8 weeks for both pediatric and adult patients with compensated cirrhosis regardless of HCV genotype,” Jeffrey Murray, MD, deputy director of the division of antiviral products in the FDA’s Center for Drug Evaluation and Research, said in the FDA brief. “[Glecaprevir/pibrentasvir] is a combination of direct-acting antiviral drugs that reduce the amount of HCV in the body to undetectable levels by preventing the virus from multiplying, and in most cases, curing HCV infection.” Additional data from the EXPEDITION-8 study showed that the most common adverse events were fatigue (8%), pruritus (7%) and headache (6%). “While over 100,000 patients have been prescribed [glecaprevir/pibrentasvir] for chronic HCV in the U.S., there are still a significant number of patients that need options,” Janet Hammond, MD, PhD, vice president of the general medicine and virology therapeutic area at AbbVie, said in a press release. “This approval provides more HCV patients an option to treat their disease in as little as 8 weeks.”

For more information: https://tinyurl.com/y5x86ntu

Hep C World News - Week of October 13, 2019

Hep C vaccine flops among injection drug users in Phase I/II trial

Washington, DC - There was a silver lining to a prophylactic vaccine against hepatitis C virus (HCV) that failed to prevent chronic HCV infection: it proved that testing vaccines in a population of patients who inject drugs is possible, a researcher said here. A phase I/II randomized trial found no effect on 6-month chronic HCV outcome among participants randomized to receive HCV vaccine or placebo (vaccine efficacy -0.529, 95% CI -2.535 to 0.339), reported Andrea Cox, MD, of Johns Hopkins University in Baltimore. But the vaccine was well-tolerated, and produced an immunogenic response in 78% of vaccine recipients (who responded to vaccine peptide pools in IFN-γ ELISpot assay, which measures T cell response), she reported in a late-breaking presentation at the IDWeek meeting, with joint sponsorship by the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, the Society for Healthcare Epidemiology of America (SHEA), and the HIV Medicine Association. Cox painted a dire picture of the global HCV epidemic worldwide, saying that the chronic rate of both HCV and hepatitis B virus (HBV) infection is rising. "If the trend continues as predicted, by 2040, [it is] estimated that the mortality from HCV and HBV will exceed that of [tuberculosis], HIV, and malaria combined," she said. The World Health Organization is targeting HCV for elimination by 2030, but significant barriers remain, Cox noted. She added that there are 1.5 million new annual infections globally and the rising rate of incident infections in the U.S., whereas HBV, a vaccine-preventable illness, has not shown similar increases. This vaccine was designed to generate T cell immunity based on viral vectors, and was comprised of recombinant chimpanzee adenovirus 3 vector vaccine prime followed by a recombinant modified vaccinia Ankara boost, both encoding nonstructural proteins of HCV, the authors said. Participants included adults (ages 18-45) who inject drugs at high risk of HCV, but who were not infected with HCV at screening. They were counseled and referred to drug treatment and needle syringe programs, Cox said. Overall, 455 participants received two injections at 0 and 8 weeks of either vaccine or placebo. Their immune response was assessed and they were tested for HCV RNA to measure incident infection. They were followed for 20 months or 9 months following acquisition of infection. But the result was the same as it has been for the past 30 years for people who have been trying to develop a vaccine against HCV, said Douglas Dieterich, MD, of the Icahn School of Medicine at Mount Sinai in New York City. "The positive is they were able to prove you can do a study in this population of IV drug users at risk for hepatitis C. The bad news is they haven't figured out what would work yet. Hepatitis C is a smart virus," he said. 

For more information: https://tinyurl.com/y5lk8cmd

Hep C World News - Week of October 6, 2019

Does hepatitis C virus remain in the body after successful treatment?

Andalusia, Spain - Persitence of very low-level hepatitis C infection after a sustained virologic respose (SVR) to hepatitis C treatment is an extremely rare event and is not associated with any liver damage, Spanish researchers report in Nature Scientific Reports this month.  Although SVR is agreed by liver experts to signify that hepatitis C virus (HCV) infection has been cured, several research groups have reported persistence of HCV RNA (viral genetic material measured by viral load tests) for up to nine years without rebound, and subsequent disappearance of HCV. Other studies, following cohorts of people cured of hepatitis C, have reported isolated cases of late viral rebound up to 18 months after achieving SVR. Viral rebound after SVR is rare, but it is unclear how rare it is and whether persistence of low-level infection is associated with continuing liver damage. Furthermore, it is unclear if a compromised immune system – as in advanced HIV disease – might encourage low-level viral persistence. Spanish scientists investigated the frequency of viral persistence in people with HIV who received treatment for hepatitis C between 2015 and 2018 at hospitals in Andalusia. Among 123 people with SVR, HCV RNA was detected in only one person. The participant tested positive for HCV RNA in peripheral blood mononuclear cells (PBMCs) but not in serum at baseline. In this person, the viral levels in PBMCs steadily declined at each visit and became undetectable at the fourth visit. The investigators conclude that viral persistence after achieving SVR is a very rare event, but evaluation of people who have achieved SVR using ultrasensitive tests may be warranted before organ and blood donation, and for women who wish to have children after being cured of hep C.

For more information: https://tinyurl.com/y582rb79

Hep C World News - Week of September 29, 2019  
 

Hepatitis C Virus Associated With Higher Comorbidity and Multimorbidity

Ottawa, ON - Patients with hepatitis C virus (HCV) have a higher prevalence of comorbidities and multimorbidity compared with the general population, according to a study published in BMC Infectious Diseases. In this retrospective cohort study, researchers used a validated algorithm to determine the prevalence of HCV comorbidities using patient data from the Ottawa hospital viral hepatitis program linked to administrative data from IC/ES (formerly Institute for Clinical Evaluative Sciences) as of April 1, 2017. Adults aged ≥18 years with HCV (n=1209) were compared with age- and sex-matched Ottawa-area residents (n=6045). Comorbidities included acute myocardial infarction, asthma, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), dementia, diabetes, hypertension, HIV, and rheumatoid arthritis. In patients with HCV, the prevalence was significantly higher for asthma (prevalence ratio [PR] 1.32; 95% CI, 1.06-1.64), any cancer (PR 1.76; 95% CI, 1.22-2.55), COPD (PR 2.42; 95% CI, 1.73-3.39), diabetes (PR 1.32; 95% CI, 1.06-1.64), and renal failure (PR 2.92; 95% CI, 1.90-4.48). There was no difference in cardiac outcomes (arrhythmias, CHF, chronic coronary syndrome) between the 2 groups. All mental health conditions, including nonpsychotic mood and anxiety disorders (PR 2.22; 95% CI, 1.86-2.64), other mental health illnesses (PR 2.71; 95% CI, 2.06-3.55), and substance use (PR 26.50; 95% CI, 18.35-38.27) were significantly more prevalent in patients with HCV liver failure was significantly more prevalent in patients with HCV (PR 6.63; 95% CI, 2.72-11.81). Multimorbidity (PR 1.38; 95% CI, 1.38-1.58) and combined physical-mental health comorbidity (PR 2.71; 95% CI, 2.29-3.20) were significantly more prevalent in patients with HCV. This study is limited by the inability to ascertain treatment outcomes in patients who were lost to follow-up, estimates that are restricted only to patients who are diagnosed with HCV and receiving care, and the potential introduction of bias if multimorbidity of those lost to follow-up had significantly different morbidity from those who were retained. The findings that patients with HCV have a higher prevalence of comorbidity and multimorbidity compared with the general population points to the need for integrated, comprehensive, and community-oriented approaches to HCV care delivery, with particular emphasis on mental health and addiction care. Strategies might include involving peers in care, case management, integration of HCV care with substance use, social service delivery, primary care services, use of telehealth services, and guidance for self-management strategies.
 

For more information: https://tinyurl.com/yy5am5wq

Hep C World News - Week of September 22, 2019

Should doctors prescribe heroin to curb opioid deaths?

Ottawa, ON - Last year, the Public Health Agency of Canada says that 4,460 Canadians died from an opioid overdose. The vast majority of the deaths were accidental. A new and controversial Canadian guideline for front-line health-care workers was published Monday in the Canadian Medical Association Journal. Experts are hoping the guideline will help to stem the tide.  The guideline is a blueprint for doctors and other health-care providers who care for patients with the most severe form of opioid use disorder. It was developed by Dr. Nadia Fairbairn at the British Columbia Centre on Substance Use and the University of British Columbia plus colleagues from across Canada who are members of the Canadian Research Initiative on Substance Misuse. *The guideline's overarching goals are to help clients enter recovery or at least limit their drug use. From where I sit, the strongest aim is to reduce opioid overdose deaths where the risk is highest. The guideline's authors said opioid pills taken by mouth are the most effective method to reduce death in people with an opioid substance use disorder. Studies have shown that opioids reduce both the cravings for the user's drug of choice as well as withdrawal side-effects like tremors, sweats, flu-like symptoms and intestinal cramps. Symptoms such as these motivate people to keep using. The most controversial part of the guideline is what to do for those in whom oral opioids prescribed by an addiction physician fail to control cravings and withdrawal symptoms. In that case, the guideline states that injectable heroin or hydromorphone should be considered. The choice between heroin and hydromorphone should be based on the which drug is available. The choice also depends on the patient's impression of which drug works best and on the judgment of the prescriber. Comparative efficacy as shown in studies is another factor. The rationale for giving these patients injectable heroin or hydromorphone is so they don't buy opioids on the street. It's the emergence of street fentanyl and carfentanil that have led to an increase in opioid deaths. These illicit opioids are far more powerful and far more dangerous than heroin and morphine. The 4,460 opioid overdose deaths in 2018 represent a nine per cent increase over 2017 and a 48 per cent increase from 2016. Ninety-four per cent of the opioid overdose deaths in 2018 were unintentional. Steering users away from street fentanyl and carfentanil is an effective way to reduce opioid deaths. Another way to prevent deaths is to distribute naloxone kits that enable bystanders to reverse the effects of an overdose in time to save lives. Admonishing people to stop using opioids doesn't work. (Graeme Roy/Canadian Press) There are several challenges in implementing the new guideline. Treatment with injectable heroin is the standard of care in several countries, including Switzerland, the Netherlands and the United Kingdom. But Canada has placed restrictions on accessing heroin. For that reason, hydromorphone (sold under the brand name Dilaudid) has been used to where heroin is not available. The authors say additional research is needed to see which of the two opioids should be used, and under what circumstances. The authors also call for expanded access to heroin across Canada. Beyond that, policy-makers and health-care people in each province need to plan for the growing number of users who might benefit from harm reduction and provide adequate funding to treat them. This harm reduction approach has its share of critics; among them, activists, politicians and even some addiction health-care providers. Some say the term harm reduction is vague because it means different things to different people. For instance, in the new guideline, it means preventing overdose deaths. But sometimes, it means preventing sexually transmitted infections and HIV. A 2017 analysis found that harm reduction policies vary widely across Canada and overall are weak conceptually. Quebec and British Columbia, produced a lot of policy documents on harm reduction, while New Brunswick and Prince Edward Island had only one relevant policy and the Yukon Territory had none. Another problem is that Canada has a history of moral ambivalence to harm reduction. In 2007, the federal Conservative government excised harm reduction from federal policy. It was brought back when the Liberals regained power in 2015. With a federal election campaign underway, it's worth keeping in mind that a new government might switch things again. Admonishing people to stop using opioids doesn't work, and it doesn't prevent opioid deaths. Harm reduction saves lives. The sooner Canadians get over their moral ambivalence, the more lives that will be saved.

For more information: https://tinyurl.com/yxu7vcky

Hep C World News - Week of September 15, 2019

Canada's first vaping-related illness reported 
 

London, ON - Vaping-related illness has emerged in Canada, marking the first link to a wider outbreak in the U.S. that has prompted officials to introduce flavour bans, increase the age of purchase and bring in other restrictions on the products. At least one case of severe vaping-related lung illness has been confirmed in London, Ont., and Toronto Public Health has received reports of other possible cases in recent weeks. A spokesman for Ontario’s Health Ministry said Health Canada informed it of two possible cases of vaping-related lung illnesses that need to be investigated. It’s unclear whether one of the cases is the same as the one reported by London health officials. Health Canada would not comment. Canadian regulators have so far resisted crackdowns, despite warnings from health advocates who say delays endanger the health of young people. “I think the response of most governments across Canada reflects indifference and inertia,” said Andrew Pipe, chair of the Heart and Stroke Foundation of Canada and a professor of medicine at the University of Ottawa. “We need quick and decisive action to remediate … the negligence of governments in failing to regulate these products, despite the fact that they were warned some time ago.” On Wednesday, officials at the Middlesex-London Health Unit confirmed that a high-school student in the area had gone to hospital with a vaping-related illness in recent weeks. In response to queries from The Globe and Mail, Toronto Public Health said on Wednesday it has also received reports of some possible vaping-related illnesses in recent weeks, but did not disclose how many. The agency said in a statement it has asked the clinicians involved in those cases to seek patient permission to share information with the agency for further investigation, but the agency has “yet to receive this information.” While the London case is the first confirmed vaping lung illness reported in Canada, hundreds of people have been sickened by the severe respiratory illness in the U.S. Officials there say at least seven people have died and 380 from 36 states have fallen sick. (The U.S. Centers for Disease Control and Prevention previously said about 450 people were sick, but have revised the number to include only those cases that have a confirmed or probable link to vaping.) The Ontario student, who has since recovered and is at home, was at one point on life support in the intensive care unit at a London hospital. Officials did not release many details, including the student’s age, name, gender and what type of vaping product he or she used. They also declined to say whether the student was vaping tetrahydrocannabinol (THC), which has been implicated in many illness reports in the U.S.

For more information: https://tinyurl.com/y5tur9p8

Hep C World News - Week of September 8, 2019

NSW Health backs plan for early warning system on drugs

Perth, Australia - NSW Health has backed a nationwide initiative for an early warning system of dangerous illicit drugs circulating in Australia by blood testing overdose victims taken to intensive care units. The state government department is helping develop an "enhanced surveillance system" that would allow it to issue public messaging about harmful recreational substances, particularly when clusters of severely ill patients are presenting to emergency departments. A NSW Health spokesperson said the department was working with a range of agencies "to ensure we have the best possible information on changing patterns of drug related harm, as well as identifying new and emerging drugs that might be circulating in our community". The national scheme, named the Emerging Drug Network of Australia (EDNA) Project, is based off research from the Royal Perth Hospital in Western Australia, which was prompted by an influx of patients who believed they had consumed the party drug ecstasy on New Year's Eve 2013. In 2016 two patients were brought to the hospital's intensive care unit, with blood tests revealing the existence of the highly toxic synthetic drug NBOMe, according to a report before the NSW Coroners Court on Tuesday. WA Police then sent out a public warning, including with pictures of the capsules sold, while the drug was still in circulation. "This public health intervention may have caused some consumers to decide against using the substance, potentially avoiding critical illness or even death," the report says. The report, by Royal Perth Hospital emergency doctors David McCutcheon and Jessamine Soderstrom, was submitted as part of an inquest into the drug-related deaths of five young NSW music festival revellers between December 2017 and January this year. The inquest also heard from emergency consultant and pill testing advocate David Caldicott, who told the court on Tuesday the pill testing trial at Canberra music festival Groovin' the Moo allowed the ACT's chief health officer, hospitals and the ambulance service to be immediately notified of dangerous substances circulating. The court heard seven people binned their drugs at this year's festival after being told by clinicians they contained the deadly substance N-ethyl pentylone.
 

For more information: https://tinyurl.com/y5clkbxw

Hep C World News - Week of September 1, 2019

Certain Hep C treatments can cause liver injury or failure

Silver Springs, MD - FDA issues a warning to patients and health care professionals about rare instances of serious liver injury or failure with certain hepatitis C treatments in some patients with advanced liver disease The U.S. Food and Drug Administration has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C (HCV) in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. These medicines are not indicated for use in patients with moderate to severe liver impairment, but are safe and effective in patients with no or mild liver impairment. Through reports submitted to the FDA as well as other sources, the agency identified 63 cases of worsening liver function, called decompensation, some leading to liver failure or death, in patients using Mavyret, Zepatier and Vosevi. In many of the reported cases, liver failure occurred in patients who had signs and symptoms of moderate-to-severe liver disease or other serious liver problems and should not have been treated with these medicines. In some cases, patients were reported as having no cirrhosis, or liver scarring, or cirrhosis with mild liver impairment (compensated cirrhosis) but had indications of advanced liver disease or risk factors for liver impairment, such as decreased platelets, portal hypertension (increased pressure in the portal vein, the vein that carries blood from the digestive organs to the liver) caused by a blockage in the blood flow through the liver, alcohol abuse or other serious medical illnesses associated with significant liver problems before starting treatment. In most patients, symptoms resolved or new onset worsening liver function improved after stopping the medicine. As noted in the Drug Safety Communication, health care professionals should continue to prescribe Mavyret, Zepatier or Vosevi as indicated, but should discontinue the use of these medicines in patients with signs and symptoms of worsening liver function. Patients should understand that the risk of serious liver injury is rare and should not stop taking these medicines without first talking to a health care professional. Patients should read the patient information leaflet every time they are prescribed Mavyret, Zepatier or Vosevi because there may be important new information about these medicines. Patients with liver disease should talk with a health care professional about the benefits and risks of these medicines. The FDA will continue to monitor this safety concern and will communicate any new information to the public as it becomes available.

For more information: https://tinyurl.com/y65zxfoy

Hep C World News - Week of August 25, 2019

Seattle may have figured out how to end the War on Drugs

Seattle, WA - While other cities are jailing drug users, Seattle has found another way. On gritty streets where heroin, fentanyl and meth stride like Death Eaters, where for decades both drugs and the war on drugs have wrecked lives, the city of Seattle is pioneering a bold approach to narcotics that should be a model for America. Anyone caught here with a small amount of drugs — even heroin — isn’t typically prosecuted. Instead, that person is steered toward social services to get help. This model is becoming the consensus preference among public health experts in the U.S. and abroad. Still, it shocks many Americans to see no criminal penalty for using drugs illegally, so it takes courage and vision to adopt this approach: a partial retreat in the war on drugs coupled with a stepped-up campaign against addiction. The war on drugs has been one of America’s most grievous mistakes, resulting in as many citizens with arrest records as with college diplomas. At last count, an American was arrested for drug possession every 25 seconds, yet the mass incarceration this leads to has not turned the tide on narcotics. The number of opioid users has surged, and more Americans now die each year from overdoses than perished in the Vietnam, Afghan and Iraq wars combined. And that doesn’t account for the way drug addiction has ripped apart families and stunted children’s futures. More than two million children in America live with a parent suffering from an illicit-drug dependency. So, Seattle is undertaking what feels like the beginning of a historic course correction, with other cities discussing how to follow. This could be far more consequential than the legalization of pot: By some estimates, nearly half of Americans have a family member or close friend enmeshed in addiction, and if the experiment in Seattle succeeds, we’ll have a chance to rescue America from our own failed policies. In effect, Seattle is decriminalizing the use of hard drugs. It is relying less on the criminal justice toolbox to deal with hard drugs and more on the public health toolbox.

For more information: https://tinyurl.com/y29752vd

Hep C World News - Week of August 18, 2019

Legal heroin prescribed to hundreds of UK drug users

London, UK - Hundreds of people addicted to heroin in the UK are benefitting from a free legal supply of the drug, new figures show. The Independent can reveal that 280 people received a prescription for diamorphine – medical-grade heroin – in 2017-18, via a freedom of information request to Public Health England (PHE) by Release, a drugs charity offering legal advice and support. Under PHE guidelines, diamorphine is usually offered as a last resort after other forms of treatment, such as methadone and buprenorphine, have proven unsuccessful.  “I’ve seen firsthand how diamorphine could help people recover to the point where they were able to work, experience liberation from a cycle of repeated criminal justice involvement, be present for their families, and have hope where previously there was none,” said Dr Prun Bijral, medical director at the UK’s largest third sector drug treatment provider, Change Grow Live. But the treatment is “under threat” due to severe cuts to drug services and the planned removal of the Public Health Grant, said Niamh Eastwood, chief executive of Release, which often works with people who fear having their prescription removed. “Any decision to remove this treatment could lead to more people dying,” said Ms Eastwood, referring to drug-related deaths remained at the highest level since records began, with a 16 per cent spike in 2018. The threat of a diamorphine prescription being removed could cause “untold damage” to those reliant upon one, said Ms Eastwood. “It can create a sense of fear and insecurity and can cause significant distress to individuals in this position.” She warned the removal of an individual’s treatment could jeopardise their employment, and created a “real risk” of these previously treatment-aversive drug users returning to street heroin. The UK has provided heroin users with diamorphine since 1926. Often referred to as the British System, the practice was the country’s main form of treatment until 1967, during which period the number of known heroin users rarely rose above 1,000. “We led the world in providing diamorphine under the British System; a pragmatic and reasoned approach to a serious issue,” said Dr Bijral. “Diamorphine is just another opioid medication, used in every hospital, every day, and has been an essential medication for well over a century.” While hundreds of people have received the drug under this legal framework ever since, the British System was largely phased out in the late 1960s – a move the then Home Office drugs chief Bing Spear branded “an unmitigated disaster” in a book detailing his time in office. Critics of diamorphine-led initiatives allege they de-incentivise individuals to stop using drugs. Speaking of plans to prescribe diamorphine at a heroin-assisted treatment centres in Glasgow, Dr Neil McKeganey told the Scottish Sun: “The treatment of people who are addicted to heroin should be focused on helping them into a drug-free state, not continuing and facilitating their dependence.” Dr McKeganey, who has faced scrutiny since June after it emerged he received funding from a heroin substitute manufacturer in 2012, said: “It should be focused on enabling them to recover and I fear this will achieve the opposite.” Many experts warn against framing outright recovery as at odds with harm-reduction measures, and several told The Independent they believe this has contributed to the rise in drug-related deaths since 2012. Dr Russell Newcombe, who helped pioneer the harm reduction philosophy in the Eighties, recalled interviewing the patients of Dr John Marks, who treated around 450 drug users in Merseyside with smokeable heroin for a decade starting in 1988. There were no drug-related deaths at the clinic during this period. “Almost all the people on diamorphine scripts I spoke to said their lives had improved dramatically, and John had literally saved them from a horrible fate,” he said. 

For more information: https://tinyurl.com/y6jev2a7

Hep C World News - Week of August 11, 2019
 

Africans with unusual HCV genotypes, face lower SVR

London, UK - Most patients with hepatitis C in Africa have genotypes outside of the common and easily cured genotype 1a and genotype 1b, which has led to a suboptimal rate of sustained virologic response. “The evidence indicates that the future desired expansion of HCV treatment in Africa may risk unacceptable rates of failure if first generation NS5A inhibitors are utilized without appropriate epidemiological and viral sequence data,” Kosh Agarwal, MD, from King’s College Hospital Trust in London, England, and colleagues wrote. “Global equity of access to curative treatment is required to avoid jeopardizing the hepatitis C elimination agenda.” Agarwal and colleagues retrospectively analyzed data from 91 patients who were born in Africa and seen at the London center between 2010 and 2018. Base genotypes included genotype 1a or 1b (n = 20), genotype 2 (n = 5), genotype 3 (n = 3), genotype 4 (n = 14) and genotype 5 and 6 (n = 2). The researchers noted 35 patients with “unusual” genotype 1 subtypes, and 12 patients who had unusual genotype 4 subtypes. Among 23 patients with initially unassigned genotype 1 subtypes, they identified 15 novel subtypes after sequencing. To date, 63 patients have completed direct-acting antiviral treatment and follow-up, of whom 56 patients achieved SVR and seven failed treatment for an SVR rate of 89%. “As expected, response rates in genotypes 1a or 1b were uniformly high. Similarly, all patients infected with genotype 2, 3, 4 and 5 achieved an SVR,” the researchers wrote. However, those patients with unusual genotype 1 or genotype 4 subtypes had an SVR rate of 75%. In multivariate analysis with SVR as the outcome, unusual genotype 1 remained correlated with a higher risk for treatment failure (P = .016). Additionally, the study cohort had high frequencies of resistance-associated polymorphisms, which “demonstrates the diversity of the virus in the African region,” the researchers wrote. “We have shown that in a metropolitan United Kingdom cohort of African patients with HCV, most patients were infected with unusual and often novel African subtypes which were associated with reduced SVR rates,” Agarwal and colleagues concluded. “The reality of global migration means that these data are also relevant for clinicians in high income countries who should exercise caution in selecting regimens for African patients with unusual or un-subtypeable genotypes.”

For more information: https://tinyurl.com/y3yva8lr

Hep C World News - Week of August 4, 2019

New plan to eliminate hepatitis C in Scotland by 2024

Dundee, Scotland - Plans to effectively eliminate hepatitis C by 2024 have been unveiled by the Scottish government. An estimated 21,000 people in Scotland live with the chronic viral infection which causes progressive damage to the liver. Three years ago ministers pledged to eliminate the virus by 2030 but now say the goal can be reached sooner. Experts last year warned that not enough progress was being made in tackling the problem. In 2018/19, NHS Scotland exceeded its target to treat 2,000 people for hepatitis C and ministers plan to ramp up the number of people being treated annually. The World Health Organization (WHO) has set targets for the elimination of hepatitis C as a public health threat, including treating 80% of those who are eligible for treatment and reducing mortality from hepatitis C infection by 65%, by 2030. Public Health Minister Joe Fitzpatrick said: "Scotland has long been known as a world leader when it comes to tackling hepatitis C and this ambitious target confirms that we are still leading the way in our mission to effectively eliminate the virus by 2024 six years ahead of the WHO expectations. "Recent figures show we are exceeding our targets on the number of people we are treating for hepatitis C and it is vital that we maintain this momentum. "We must keep getting the message out that hepatitis C can be cured with a short course of pills, and that anyone who has ever been at risk should get tested." The majority of people with hepatitis C have a history of injecting drugs and many are homeless and difficult for health professionals to reach. In a report published last year, the Hepatitis C Trust said tackling the disease should be a "national priority" and said more should be done to address the problem. A plan agreed by the Scottish government and its agency Health Protection Scotland determined that having no more than 5,000 people infected with hepatitis C and new annual presentations of the virus in single figures would meet the WHO target of elimination in the Scottish context.
 

For more information: https://www.bbc.com/news/uk-scotland-49178604

Hep C World News - Week of July 28, 2019     

Syphilis cases up 70% in 7 years reach all-time high in Europe

Solna, Sweden - Syphilis rates in Europe have steadily increased over the past decade, reaching an all-time recorded high in 2017 with more than 33,000 cases, according to data reported in Helio. The spike has been seen primarily among men who have sex with men (MSM) living in urban areas. “There is a clear relationship between sexual risk behavior and the risk of syphilis and other sexually transmitted diseases,” Andrew Amato-Gauci, MD, MSc, FFPH, FRCP, head of the European CDC program on HIV, STI and viral hepatitis, said in a news release. “The increases in syphilis infections that we see across Europe, as well as other countries around the world, are a result of several factors such as people having sex without condoms and multiple sexual partners combined with a reduced fear of acquiring HIV.” Between 2007 and 2017, more than 260,000 confirmed syphilis cases were reported among 30 European Union (EU) and European Economic Area (EEA) countries, data showed. The 33,000 cases reported in 2017 marked a significant increase from 20,000 cases in 2007 and a low of 19,000 cases in 2010. According to the European CDC, the trend was revealed using notification data from 23 countries with comprehensive surveillance systems that reported data consistently between 2000 and 2017. The notification rate was 70% higher in 2017 than in 2010, marking the first time since the early 2000s that EU/EEA countries reported more syphilis cases than HIV cases, the agency said. Over the 7-year interval, rates more than doubled in five countries — Iceland (876%), Ireland (224%), the United Kingdom (153%), Germany (144%) and Malta (123%). MSM accounted for 62% of the 152,233 syphilis cases reported between 2007 and 2017 in which the sexual orientation of the patient was known, whereas heterosexual men comprised 23% of cases and women 15%. In its report, the European CDC recommended several response or control measures for syphilis outbreaks, including screening of at-risk groups, partner notification, case management with appropriate treatment following diagnosis and educational activities directed at the general population, those at-risk of infection and health care providers. “To reverse this trend, we need to encourage people to use condoms consistently with new and casual partners,” Amato-Gauci said in the release. “Regular tests for syphilis and other sexually transmitted infections should also be part of the parcel, especially if there has been a risk of infection.”
 

For more information: https://tinyurl.com/y4jlzcb4

Hep C World News - Week of July 21, 2019

Drug overdose deaths provide one-third of organs for transplant

Vancouver, BC - As the province celebrates its 5,000th British Columbian alive today thanks to a transplant, there's one group of people—a group that's often harshly stigmatized—who deserve special recognition for the milestone. As reported in the Straight, on July 19th B.C. health minister Adrian Dix convened a small celebration in a rooftop garden at St Paul’s Hospital. The group gathered commemorate the province’s 5,000th person alive today who was saved by an organ transplant. "The success of organ transplant is a transformative feat of expertise, coordination, and caring through the province," he said. The Provincial Health Services Authority’s Dr. Maureen O'Donnell joined Dix there and praised those who made it possible. "Donors are our heroes and this incredible milestone is truly their legacy of the incredible gift of life,” she said. There’s one group of British Columbians that’s contributed an especially significant number of those heroes: victims of Canada’s overdose crisis. In 2018, people who died of a drug overdose accounted for 32 percent, or roughly one-third, of all organ donors in British Columbia. The year before, that number was even higher, at 35 %, according to statistics supplied by Transplant B.C. In 2016, people who died of a drug overdose constituted 22 percent of organ donors in B.C. and, in 2015, they were 13 percent of all organ donors. “We have always had some donors who have died due to drug overdose and that number has increased over the last few years,” Elaine Yong, a spokesperson for Transplant B.C., said. The synthetic-opioid fentanyl was detected in the vast majority of the fatal overdoses that led to an organ transplant. While a majority of organ transplants in B.C. do not involve a donation by someone who died of an overdose, the number of organ transplants in the province has roughly correlated with B.C.’s increase in overdose deaths. There were 63 organ donors in B.C. in 2013, then 61 the following year, 95 in 2015, 97 the year after that, and then 121 in 2017. In 2013, there were 333 fatal overdoses in B.C., then 369 the following year, 530 in 2015, 993 the year after that, and then 1,493 in 2017. In June 2017, the Canadian Press reported that the United States was similarly seeing organ donations rise alongside the country’s number of overdose deaths.

For more information: https://tinyurl.com/y5mpg2jw

Hep C World News - Week of July 14, 2019

Liver donations successful after physician-assisted suicide

Leuven, Belgium – Doctors and public health experts sought to examine the outcomes of liver transplants following donor euthanasia in Belgium, compared with outcomes in organs donated from patients after brain or circulatory death. Their main question asked; is liver transplantation after assisted suicide as safe and effective as when livers are donated from patients with brain death or circulatory death? What are the salient issues in liver transplantation after assisted suicide, and are the results from this study from a single medical center in Belgium applicable to medical systems in other countries? A study by researchers in Belgium found that just as livers harvested after brain death and circulatory death in donors can be viable for transplant recipients, it appears that livers can also be safely transplanted from patients undergoing euthanasia researchers reported in a JAMA research letter. "Because donation after euthanasia entails a period of detrimental warm ischemia that hampers graft survival, similar to donation after circulatory death, results after transplantation of this type of graft need to be carefully evaluated," wrote Diethard Monbaliu, MD, PhD, of University Hospitals Leuven, and colleagues. To do so, they conducted a retrospective single-center review of 409 transplantations performed with 320 livers following brain death, circulatory death, and euthanasia. The team reported the following 3-year outcomes for graft and overall survival, respectively, by type of donor death: Brain death: 80.2% and 86.1%; Circulatory death: 82% and 84.6%; Euthanasia: 90.9% and 90.9% "These data support the notion that within a very strict ethicolegal and logistic framework, donation after euthanasia may represent a valuable source of donor organs," Monbaliu and associates wrote. To conduct the study, the team reviewed data for all adult solitary livers transplanted at the hospitals from 2009 through 2015. The researchers identified a total of 409 liver transplantations, more of which were in male patients. Of these, 78% were donated after brain death, 19% after circulatory death, and 2.7% after euthanasia. The median ages of donors in the three groups were 56 (interquartile range [IQR] 46-68); 53 (IQR 44-61); and 44 (IQR 33-58 years), respectively. Most of the donor-related characteristics were similar among the groups. Monbaliu and colleagues explained that since euthanasia-related donation entails a period of detrimental warm ischemia that hampers graft survival, similar to donation after circulatory death, results after this type of graft need to be carefully evaluated. But post-euthanasia donated livers had a shorter median total donor warm ischemia time of 13 minutes (IQR 12-15, P=0.001) versus 20 minutes (IQR 15-25) after circulatory death. Post-euthanasia donated livers also had a shorter median agonal-phase warm ischemia time: 3 minutes (IQR 1-9) versus 10 minutes (IQR 7-16, P=0.001). Median asystolic warm ischemia time was 8 minutes in both cases. As for cold ischemia time, the median during transplantation from euthanasia donors was similar to that from circulatory death donors: 4.84 hours (IQR 4.10-6.20) versus 5.30 hours (IQR 4.58-6.25, P=0.99). Both were shorter, however, than the 7.75 hours (IQR 6.05-9.08, P=0.002) during transplantation from brain-death donors. Median ages were similar (late 50s and early 60s) for liver recipients in the three donor-type groups, as were Model for End-stage Liver Disease scores, with medians of 15 to 17. Although time to circulatory arrest is generally longer for donation following circulatory death, the authors cautioned that livers donated after euthanasia are still exposed to a period of warm ischemia, and this increases the risk of post-transplantation complications and graft loss. "As such, livers donated after euthanasia should still be considered high-risk livers, and, similar to donation after circulatory death, precautions such as minimization of cold ischemia time should be continued," Monbaliu's group wrote.
 

For more information: https://tinyurl.com/y3f2jb52

Hep C World News - Week of July 7, 2019

Clash over how to combat fentanyl copycats

Washington, DC – According to a news release recently published by Reuters the Trump administration officials are divided over part of a proposal to crack down on illicit versions of fentanyl, the deadly synthetic painkiller that U.S. President Donald Trump targeted in declaring a national opioid abuse emergency. In an inter-agency dispute that highlights the challenges of curbing opioid abuse, the U.S. Drug Enforcement Administration (DEA) is publicly backing tighter rules for fentanyl analogues, which are slightly altered copycat versions of the powerful drug fueling an explosion in overdoses.But an office of the U.S. Department of Health and Human Services (HHS) is raising concerns outside of public hearings, sources told Reuters, about the DEA-backed legislation, offered by Senator Ron Johnson and Representative Jim Sensenbrenner, both Republicans. Normally, the DEA and the U.S. Food and Drug Administration review chemical compounds individually to assign each one a controlled substance classification, with the FDA determining if such “scheduling” decisions are scientifically valid. In this case, the bill would cut the FDA out of the time-consuming review process by letting the DEA permanently classify illicit fentanyl analogues as Schedule I drugs, like heroin, which are deemed to be addictive with no medical use. The DEA says these legal changes would help prosecutors keep pace with criminals who constantly churn out chemically tweaked fentanyl analogues to evade strict Schedule I regulations. But an expert from HHS’s National Institute on Drug Abuse (NIDA) quietly warned Senate staff at a private June 20 briefing that permanently placing all fentanyl analogues into Schedule I poses problems. The draft bill would not only put all fentanyl analogues into Schedule I before anything is known about their potential medical benefits, but would also make it harder for researchers to win approval to study the analogues to potentially develop new approaches to tackling the surge in overdoses, the NIDA expert said. An HHS spokesperson told Reuters that the department has no position on the DEA-backed bill, but confirmed that HHS does have some concerns. “These compounds can be used to develop and test new medications for preventing opioid addiction and overdose,” the spokesperson said, noting that putting fentanyl analogues into Schedule I without accommodating scientists with a streamlined approval process “could slow valuable research aimed at addressing the opioid crisis.”

For more information: https://tinyurl.com/y24hl238

Hep C World News - Week of June 30, 2019
 

Analysis of Opioid-Related Deaths in Ontario
 

Toronto, ON - The number of fatal and non-fatal opioid-related toxicity events has risen dramatically over the past decade in Ontario. Information on the characteristics of deceased persons and the circumstances surrounding their deaths is summarized in this report to inform local, provincial and national prevention and response efforts. This information was obtained by the Office of the Chief Coroner/Ontario Forensic Pathology Services (OCC/OFPS) from completed investigations of confirmed opioid-related deaths in Ontario between July 1, 2017 and June 30, 2018. Between July 2017 and June 2018, there were 1,337 confirmed opioid-related deaths in Ontario (data extracted on January 21, 2019). Investigations revealed that: The majority of opioid-related deaths were accidental (90.4%), occurred among males (72.0%) and most often occurred among individuals between the ages of 25 and 44 (50.2%). Among suicide deaths, nearly half (47.5%) occurred among females and more often occurred among individuals aged 45 to 64 (55.6%). Among accidental opioid-related deaths (N=1,209): Fentanyl and fentanyl analogues directly contributed to death for almost three-quarters (71.2%). The non-opioid substances that most often directly contributed to death were cocaine (33.9%), methamphetamine (14.6%), alcohol (13.2%) and benzodiazepines (11.0%). Almost one-third (31.8%) of deaths occurred among people who resided in neighbourhoods with the highest material deprivation (measure of inability to attain basic resources and services). 62.0% occurred among individuals who resided in large urban population centres. The highest number (n=291) occurred in Toronto with the highest population-adjusted rate occurring in Thunder Bay District Health Unit (22.7 deaths per 100,000). Nearly half (46.8%) occurred among people who were unemployed, whereas 18.1% were employed (32.9% with unknown employment status). Where employment industry information was available, nearly one-third (31.0%) of those employed worked in the construction industry. 73.6% occurred among people living in a private dwelling and 9.8% occurred among people experiencing homelessness. Nearly half (48.6%) of deceased persons were alone at the time of incident. Most incidents occurred in a private residence: 59.6% occurred in a deceased person’s own private residence and 16.8% occurred in another private residence. The proportion of deceased persons alone at the time of the incident was higher when the incident occurred in a person’s own private residence (55.7%). 47.8% involved a resuscitation attempt and 22.2% had naloxone administered by a first responder, hospital staff or bystander. The information presented in this report is intended to provide the reader with opportunities to examine circumstances surrounding opioid-related deaths to better understand and address the unique needs of Ontarians who may be exposed to opioids.
 

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Hep C World News - Week of June 23, 2019

HCV treatment with Epclusa safe in patients undergoing dialysis for ESRD
 

Brampton, ON – Helio.com recently reported that although not currently licensed for patients undergoing dialysis for severe renal impairment, researchers found that treatment with Epclusa for hepatitis C was safe and effective in patients with end-stage renal disease. “Chronic HCV infection has a significant negative impact on morbidity and mortality in patients undergoing dialysis,” Sergio M. Borgia, MD, FRCPC, from Brampton Civic Hospital in Ontario, Canada, and colleagues wrote. “HCV-infected patients with [chronic kidney disease (CKD)] have an accelerated rate of loss of kidney function, risk of progression to end-stage renal disease (ESRD), and increased risk of all-cause mortality when undergoing dialysis.” Borgia and colleagues enrolled 59 patients with HCV and ESRD to undergo 12 weeks of treatment with Epclusa (sofosbuvir/velpatasvir, Gilead Sciences). Most were treatment-naive (78%), 92% were undergoing hemodialysis for a mean duration of 7 years (range, 0-40 years), and 8% were undergoing peritoneal dialysis. Fifty-six patients achieved SVR (95% CI, 86-99), of whom 53 had study drug adherence rates of 90% or higher. Two patients experienced virologic relapse posttreatment and one patient was discontinued from the study after 11 weeks due to nonadherence. Most patients experienced a mild to moderate adverse event (80%) such as fatigue, headache, nausea, vomiting and insomnia. The researchers noted no adverse events associated with renal dysfunction among the patients and that the incidence of grade 3 and grade 4 laboratory abnormalities was consistent with patients undergoing dialysis for ESRD. Over the last few years, several HCV treatments have been approved for use in patients with HCV infection and CKD, and each regimen has limitations,” the researchers wrote. “The data collected in this study provide information to support the use of sofosbuvir/velpatasvir in HCV-infected patients with ESRD.”

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Hep C World News - Week of June 16, 2019

Potent pot a new concern for first-mover states
 

Denver, CO - The Washington Post recently reported that first two states to legalize recreational marijuana are starting to grapple with teenagers’ growing use of highly potent pot, even as both boost the industry and reap huge tax windfalls from its sales. Though the legal purchase age is 21 in Colorado and Washington, parents, educators and physicians say youths are easily getting hold of edibles infused with tetrahydrocannabinol, or THC, the psychoactive component that causes a high, and concentrates such as “shatter,” a brittle, honey-colored substance that is heated and then inhaled through a special device. Each posses serious risks to adolescents’ physical and mental health. “Underage kids have unbelievable access to nuclear-strength weed,” said Andrew Brandt, a Boulder, Colo., software executive whose son got hooked while in high school. With some marijuana products averaging 68 percent THC — exponentially greater than the pot baby boomers once smoked — calls to poison control centers and visits to emergency rooms have risen. In the Denver area, visits to Children’s Hospital Colorado facilities for treatment of cyclic vomiting, paranoia, psychosis and other acute cannabis-related symptoms jumped to 777 in 2015, from 161 in 2005. The increase was most notable in the years following legalization of medical sales in 2009 and retail use in 2014, according to a study in the Journal of Adolescent Health published in 2018. “Horrible things are happening to kids,” said psychiatrist Libby Stuyt, who treats teens in southwestern Colorado and has studied the health impacts of high-potency marijuana. “I see increased problems with psychosis, with addiction, with suicide, with depression and anxiety.” It is unclear whether all of this means years of generally stagnant pot use among children are coming to an end. Surveys finding little change with pot since 2014 “may not reliably reflect the impact of legalization on adolescent health,” the authors of that 2018 study concluded. Washington’s latest Healthy Youth Survey showed 20 percent of eighth-graders and nearly half of seniors “perceive little risk of regular marijuana use.” Many teens consider it less risky than alcohol or cigarettes. As more than a dozen states from Hawaii to New Hampshire consider legalizing marijuana, doctors warn of an urgent need for better education — not just of teens but of parents and lawmakers — about how the products being marketed can significantly affect young people’s brain development. The limited scientific research to date shows that earlier and more frequent use of high-THC cannabis puts adolescents at greater jeopardy of substance use disorders, mental health issues and poor school performance. “The brain is abnormally vulnerable during adolescence,” said Staci Gruber, an associate professor of psychiatry at Harvard Medical School who studies how marijuana affects the brain. “Policy seems to have outpaced science, and in the best of all possible worlds, science would allow us to set policy.” The critics also insist that more must be done to maintain tight regulation of the industry. That’s not been the case so far, they argue, with dispensaries opening near high schools in Seattle and with retail and medical pot shops in Denver outnumbering Starbucks and McDonald’s locations combined.
 

For more information: https://tinyurl.com/y44s54ry
 

Hep C World News - Week of June 9, 2019   
 

California Assembly approves supervised opioid injection facility
 

Sacramento, CA - The California Assembly has passed a bill allowing San Francisco to open a facility where people can use illegal drugs under supervision, one of several local efforts nationwide to curb overdose deaths that has drawn opposition from the federal government. The bill’s passage comes months after the Justice Department sued to block a Philadelphia nonprofit organization from opening what is known as a supervised injection facility. Such sites allow people to use illicit drugs, but they also allow medical professionals to closely monitor users and help them immediately in the case of overdoses. Officials in San Francisco contend that opening such a facility is necessary to help alleviate the city’s chronic drug and homelessness problem, which has led to open-air drug use and needles and other drug paraphernalia being strewn on city streets. Mayor London Breed (D) has pushed for the facility to go forward. “She’s been clear that we have a crisis, an injection crisis, on our streets,” said Jeff Cretan, a spokesman for Breed. Just as importantly, it will provide a space where people can go when they are ready to seek treatment.” San Francisco is one of several cities that have vowed to open a supervised injection site despite the federal government saying they are illegal. Mayor Libby Schaaf (D) of neighboring Oakland introduced a resolution to the city council earlier this month asking that the bill paving the way for San Francisco’s site also include Oakland. City officials in Ithaca, N.Y., Denver, Seattle and New York City have expressed interest in opening safe injection facilities, as has a legislative committee in Massachusetts. The municipalities argue that the facilities would help alleviate the nation’s opioid epidemic, which killed more than 47,000 people in 2017. Most of the deaths have been driven by fentanyl, a powerful synthetic opioid. The Trump administration argued in the Philadelphia case that opening such a facility would violate federal law under a statute used to prosecute crack houses. Government lawyers say that allowing the use of illegal drugs would exacerbate the nation’s opioid epidemic.
 

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Hep C World News - Week of June 2, 2019
 

Custom-designed needle bins to encourage safe disposal

Kitchener-Waterloo, ON - The City of Cambridge is piloting a custom-designed sharps receptacle in Galt to encourage people to safely dispose of needles. The bins were designed by the city's ambassador team, a group of city staff members that patrol the core areas and carry out regular maintenance, including picking up discarded needles. The design is modelled after the existing wrought iron garbage receptacles used downtown. "We had heard from some people that they felt conspicuous using the large yellow mailbox-sized sharps containers, so we thought we would design a smaller sharps disposal unit that was more in line with the downtown aesthetic but still safe and easy for the public to use," said Brian Geertz, who oversees the ambassador team. Injection drug use has been an ongoing issue in Cambridge over the last few years. Geertz said the ambassador team collected thousands of discarded needles in 2018. "We're trying to brainstorm as many positive things we can do to battle some of these challenges in the community and this is one of them," he said. More options for safe disposal needed The Region of Waterloo already provides two yellow sharps disposal bins in Cambridge. Similar bins from the brand Secure Sharps retail for about $1,879.95. The custom design, which features a mailbox-style flap and a biohazard label, cost $1,000. Ruth Cameron, executive director of the Aids Committee of Cambridge, Kitchener, Waterloo and area (ACCKWA), said sharps containers are an important tool for harm reduction. The safe disposal of used needles helps prevent needle stick injuries and reduces the spread of HIV and hepatitis, she said. Cameron said if people are too self-conscious to use the traditional yellow bin, that means they aren't getting used and items may be disposed of incorrectly.The Region of Waterloo public health department already supplies Cambridge with two sharps receptacles, similar to this yellow mail-box style bin. If [the custom bin] is clearly marked and distinct in terms of its labelling from the other parts of the receptacle, hopefully individuals will feel comfortable using it, and we can create a larger variety of options for safe disposal. ACCKWA currently offers a needle exchange program and accepts returned needles and sharps containers. Cameron said the organization wants to see a larger variety of needle return options in the community and plans to help spread the word about Cambridge's new bin. "It can only make the community safer for all people, both those abusing substances and for the general public as well." said Cameron.
 

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Hep C World News - Week of May 26, 2019

Zepatier effective for HCV with mild fibrosis

Kaohsiung City, Taiwan - Results from the EGALITE study, published in the Journal of Infectious Disease, showed that 12 weeks of elbasvir/grazoprevir was a highly effective regimen for treatment-naive Asian patients with hepatitis C virus genotype 1b infection and mild liver fibrosis. Those who were given 8 weeks of therapy had “substantially lower” SVR12 rates, researchers said, suggesting that only certain patients — like those with low viral loads and patients without significant resistance to NS5A inhibitor-containing regimens — can benefit from an abbreviated regimen. “The EGALITE study, to our knowledge, is the first and only randomized, active controlled trial that compared the efficacy of an abbreviated 8-week regimen with the standard 12-week [elbasvir/grazoprevir] regimen for HCV-1b patients with mild liver fibrosis,” Chung-Feng Huang, MD, from the Kaohsiung Medical University Hospital in Taiwan, and colleagues wrote. The researchers randomly assigned 82 patients aged 20 years or older in Taiwan to 100 mg elbasvir/grazoprevir daily for 8 weeks (short treatment arm) or 12 weeks (standard treatment arm). The patients all had mild liver fibrosis and HCV genotype 1b infection — “the most common subtype in East Asia,” the researchers noted. Huang and colleagues evaluated the regimen’s efficacy in a full-analysis set population, which included all patients who had received one or more doses of medication, and in a per-protocol population, which included patients who received one or more doses of medication and had SVR12 data available. For patients in the short treatment arm, 87.8% achieved SVR12 in the full-analysis population and 90% achieved SVR12 in the per-protocol population, whereas patients in the standard treatment arm achieved 100% SVR12 in both analyses (P = .055). The researchers observed significantly lower SVR12 rate among patients in the short treatment arm who had high viral loads, defined as 1,500,000 IU/mL or greater, and who had more than 15% NS5A Y93H resistance-associated substitution (RAS) frequency at baseline. All patients had undetectable HCV RNA when treatment ended. Although five patients in the short treatment group experienced virologic relapse during the 12-week post-treatment follow-up, relapse did not occur for any patients in the standard treatment group, according to the study. The researchers noted that larger studies are needed to assess the regimen for patients with high viral loads and/or RASs. “In conclusion, we confirmed that the standard 12 weeks of [elbasvir/grazoprevir] provided excellent efficacy for naive HCV-1b patients with mild fibrosis. Nevertheless, a substantially lower SVR12 rate of 8-week [elbasvir/grazoprevir] was observed in the current study, indicating 8 weeks of [elbasvir/grazoprevir] was not noninferior to 12 weeks of [elbasvir/grazoprevir],” Huang and colleagues wrote. “A truncated 8-week grazoprevir/elbasvir regimen might be applied for the subpopulation with low viral loads or without significant NS5A RAS.”

For more information: https://tinyurl.com/yxt4h959  
 

Hep C World News - Week of May 19, 2019 
 

No safe opioid says new study

Toronto, ON - There is no such thing as a safe opioid. That's the message of a study published in The BMJ this week. American researchers found that tramadol, an increasingly prescribed post-surgery painkiller that was thought to be less addictive than other opioids, is actually every bit as dangerous. Along with his team, lead author Cornelius Thiels, chief resident in general surgery at the Mayo Clinic in Rochester, Minn., combed through prescription records of more than 444,000 patients across the U.S. who had surgeries between 2009 and 2018. The team found that at least seven per cent of patients refilled their opioid prescription three to six months after surgery — and the most commonly prescribed opioid was tramadol. "What we know now is there really is no safe opioid, and tramadol is not a safe alternative," Thiels said. "Tramadol essentially has a similar risk of long-term dependence or long-term opioid use compared to other opIoids." Dr. Cornelius Thiels led the study that found tramadol is as dangerous as other opioids fuelling the addiction crisis in North America. (Mayo Clinic) The BMJ study comes on the heels of a scientific review of tramadol conducted by Health Canada. The agency noticed a risk of serious breathing problems in some patients who metabolize tramadol quickly, and is now considering tightening regulations for the drug. "Evidence showed that high doses of tramadol have the same risks of dependency and problematic use as stronger opioids, such as morphine," Health Canada spokesperson Maryse Durette said in an email. The opioid epidemic in North America took off about a decade ago with massive increases in prescriptions of narcotic painkillers such as OxyContin, fentanyl, codeine and hydrocodone. The problem was made even worse by an illicit fentanyl crisis. Opioids block pain, and can also induce euphoria. Over time, the body builds up a tolerance to the initial rush, so that ever higher doses are needed to produce the same effect. Opioids also depress breathing, causing sleepiness at low doses. During an overdose, breathing can slow down so much that it finally stops, causing death. Tramadol was first licensed internationally in the 1970s. In Canada, it is sold under brand names such as Ultram and Durela. The drug is suspected to have contributed to 18 reported deaths across the country between 2006 and 2017, according to federally compiled statistics. Health Canada says consumption of tramadol has been increasing over the past few years. Thiels said he's noticed the same trend at his hospital in the U.S., but it's time to "reverse course" and cut back on its use. The goal is to reduce how many people become dependent on opioids after surgery — a problem Thiels says should be treated as seriously as other surgical complications, such as infection. If someone stays on opioids long-term after surgery, it's not a successful surgery, he said. The risk starts to increase after five to seven days of taking the drugs. Some patients need an opioid to aid their recovery after surgery. But in the midst of North America's deadly opioid crisis, many doctors are looking for the safest way to offer pain relief. (Shutterstock) Thiels advocates not prescribing any opioids after surgery, when possible. Instead, he recommends alternatives like non-steroidal anti-inflammatories (NSAIDs), such as ibuprofen, to control pain. The focus on trying to avoid using opioids in the health-care system should have started years ago, Thiels said, but better late than never. "We are having a dramatic kind of success in reversing or preventing new addiction, but I think there's a lot more work to be done for those who are already … dependent on opioids." Dr. David Juurlink, head of clinical pharmacology at the University of Toronto, said the BMJ study shows that some doctors are "less aggressive" about getting patients off tramadol because they don't perceive it to be "as hazardous as it sometimes can be." He explained that our bodies convert tramadol into an opioid. But individuals metabolize it at different rates, and on average, seven in 100 people don't get any pain-relieving effect at all, he said. He recalled one case where a man saw a surgeon who wanted to prescribe him Percocet, which contains the opioid oxycodone, for a shoulder problem. "The patient said, 'I'd rather not go on opioids,' and the surgeon said, 'Well, here's some tramadol,' apparently not realizing that tramadol is converted to an opioid," said Juurlink, who is also a scientist at the Institute for Clinical Evaluative Sciences in Toronto. More than a year later, Juurlink said the man faced "crippling insomnia" when he tried to cut back on the drug on his own. "We just tapered him off very, very slowly and his life is much better now. But I don't know how many times that particular anecdote has played itself out in Canada over the last 10 or 15 years." That's why Juurlink has called on Health Canada to act immediately to reclassify tramadol under the Narcotic Control Regulations. "I'm not saying that tramadol should come off the market. I'm saying that it is not a drug that deserves this preferential classification that Health Canada accorded it more than a decade ago," he said. By reclassifying tramadol from a prescription drug to a narcotic, doctors would no longer be able to phone in prescription renewals for it without first seeing the patient to discuss if he or she still needs it. Juurlink also said tramadol’s marketing and federal classification makes a psychological difference to prescribers. The misleading message they receive today is that tramadol is "somehow less encumbered by risks of addiction and dependence," he said. If and when Health Canada's proposed regulations that would add tramadol to its Schedule 1 list of drugs with the highest risk of dependence are enacted, they would go into effect a year later.
 

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Hep C World News - Week of May 5, 2019

Hepatitis elimination by 2030 in doubt

Vienna, Austria - Most countries will struggle to eliminate hepatitis C by 2030 due to lack of investment and political will, missing an internationally agreed target set by the World Health Organization, The International Liver Congress in Vienna heard earlier this month. “Despite the progress we’ve seen, we’re clearly not going to make it,” said Gottfried Hirnschall, Director of HIV and Hepatitis at the World Health Organization (WHO), speaking at a symposium on elimination of viral hepatitis organised by WHO. The World Health Assembly agreed ambitious targets for elimination of viral hepatitis in 2016. Countries pledged to scale up prevention, diagnosis and treatment so that deaths caused by viral hepatitis would be cut by 65% and new infections cut by 90%. Although 124 countries now have national plans for viral hepatitis elimination, 42% of plans have no domestic funding, Mark Bulterys, head of WHO’s hepatitis team told the symposium. Furthermore, although 5 million people had been treated with direct-acting antivirals (DAAs) by the end of 2017, most of these treatments occurred in ten 'champion countries' which have scaled up treatment quickly, including Egypt, Brazil and Australia. Even in higher-income countries, hepatitis C elimination may only be achieved by a handful of countries by 2030, the Center for Disease Analysis estimates. Nine countries – Australia, France, Iceland, Italy, Japan, South Korea, Spain, Switzerland and the United Kingdom – will achieve elimination by 2030 at current rates of diagnosis and treatment. Elimination may not occur before 2050 in Canada, the United States and smaller European countries, the modelling exercise found. Two-thirds of higher-income countries are seriously off-track, the Center for Disease Analysis reported. Despite dramatic reductions in the prices of generic versions of DAAs to less than $100 per cure, some lower-income countries are still paying substantially higher prices although they are eligible for low-price drugs under voluntary licensing agreements. Sixty-two per cent of people with hepatitis C live in countries covered by these agreements, which allow generic versions of DAAs manufactured under voluntary licence from the originator company to be imported from countries such as India or Egypt. WHO has calculated how much it will cost to eliminate hepatitis C by 2030. Its model, developed by Dr Melikha Toy of Stanford University, estimates that it will cost $58.8 billion to achieve elimination of viral hepatitis by 2030, slightly higher than the estimate presented by Professor Margaret Hellard of the Burnet Institute, Melbourne, on the opening day of the conference. But Dr Toy said that the cost of elimination could be considerably lower if drug prices fall rapidly, if countries use voluntary licensing arrangements to obtain low-cost drugs, and if the cost of diagnostics falls.
 

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Hep C World News - Week of April 28, 2019

Organs from hepatitis C virus–positive donors

Boston, MA - A study recently published in the New England Journal of Medicine looked at organs that are suitable for donation. The researchers noted that more than 113,000 persons who are waiting for transplants in the United States are in short supply; in 2018, only 36,500 persons received transplants. Many potential recipients die before transplantation, and in 2018, a total of 12,225 persons were removed from the waiting list because of death or progressive illness that rendered them too sick to undergo transplantation. Given these dismal outcomes, substantial efforts have been made to find new approaches to expand the pool of donor organs that were previously considered to be unacceptable. This expansion includes the use of organs obtained from donors with hepatitis C virus (HCV) infection in candidates for transplantation who do not have HCV infection — so-called HCV-mismatched transplantation. There are several reasons why transplantation programs are more willing to consider HCV-positive donors than they were previously. The potential pool of HCV-positive donors is substantial, in large part because of the current opioid epidemic in the United States. These donors are typically younger than donors without HCV infection, and they have fewer coexisting conditions that are associated with decreased recipient and organ survival. Moreover, a sustained viral response and cure are now achievable with the increased availability of direct-acting antiviral agents, which have expanded efficacy against diverse HCV genotypes, favorable safety profiles, limited drug interactions, and pharmacokinetic properties that allow for administration of these agents irrespective of the patient’s renal function. The published results of research involving limited numbers of HCV-mismatched transplantations have been favorable and have encouraged acceptance of a broad pool of donors. Consensus guidelines of the American Society of Transplantation have provided support for further research in this area. Approximately 2.4 million persons in the United States have HCV infection, with the highest incidence among injection-drug users, and organs obtained from these persons account for nearly a third of donor organs in many areas of the country. The time has come to consider expanding the use of HCV-mismatched transplantation under controlled conditions. Increasing numbers of successful outcomes in single-center studies provide support for further research with larger-scale multicenter trials. These are exciting times for the field of transplantation, since the ability to use organs from HCV-positive donors may substantially increase the donor pool and thus increase access to organs for patients who might otherwise have died while waiting.
 

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Hep C World News - Week of April 21, 2019 
 

Most injection drug users have been infected with HCV

Atlanta, GA - More than 55% of people who inject drugs, or PWID, in eight United States cities were found to have been infected with hepatitis C virus, including almost half of young PWID, according to study findings that also showed infection was associated with risky injection practices. “Recent HCV infection outbreaks among networks of PWID have demonstrated a changing demographic of HCV-infected PWID. Outbreaks of acute HCV infection have been reported among young PWID (18-35 years), the majority of whom are non-Hispanic white and frequently report a history of prescription opioid misuse,” Winston E. Abara, MD, PhD,from the CDC’s Division of Viral Hepatitis, and colleagues wrote. “The opioid crisis has fueled the recent increases in acute HCV infection, particularly among young PWID. Most young PWID begin by misusing prescription opioids and subsequently transition to injecting heroin because it is cheaper, more potent and more widely available than prescription opioids. Because young PWID are more likely to have just started injecting compared to older PWID, the increase in injection heroin and other opioid use among young people has been associated with increases in acute HCV infections.” Abara and colleagues assessed the age-related prevalence of and factors associated with past or present HCV infection among PWID recruited in Chicago, Dallas, Denver, Los Angeles, New Orleans, New York, Seattle and Nassau-Suffolk counties in New York. According to the study, among 4,094 PWID, 55.2% were HCV antibody-positive (anti-HCV). Among young PWID, anti-HCV prevalence was 42.1%, and associated with a high school education or lower (adjusted PR = 1.17; 95%, CI = 1.03-1.32), receptive syringe sharing (aPR = 1.37; 95%, CI = 1.21-1.56) injection equipment sharing (aPR = 1.16; 95% CI = 1.01-1.35), arrest history (aPR = 1.14; 95% CI, 1.02-1.29) and injecting a heroin and cocaine mixture, or speedball (aPR = 1.37; 95%, CI = 1.16-1.61). The study found that HCV prevalence was 62.2% among older PWID and was similarly associated with education of high school level or lower (aPR = 1.08; 95%, CI = 1.02-1.15), injection equipment sharing (aPR = 1.08; 95%, CI = 1.02-1.15) and injecting speedball (aPR = 1.09; 95%, CI = 1.01-1.16), as well as high injection frequency (aPR = 1.16; 95%, CI = 1.01-1.34). “Given the current opioid crisis, it is likely that HCV infection attributable to injection drug use will continue to increase, particularly among young PWID. Education about hepatitis C risk behaviors and expanding hepatitis C testing is essential to identify HCV-infected PWID,” the authors concluded.
 

For more information: https://tinyurl.com/y6tpjl76

Hep C World News - Week of April 14, 2019  
 

Vancouver flies flag at half-mast to mark overdose emergency

Vancouver, BC - The flag atop Vancouver’s city hall was flown at half-mast on Sunday as the city marked the lives lost in the province’s ongoing overdose crisis. Sunday, April 14th marked the third anniversary of the province declaring the overdose crisis a public health emergency. The city says it will fly the flag at half-mast on April 14 every year until B.C.’s provincial health officer rescinds the state of public health emergency. “The City is committed to addressing the issues that further exacerbate the struggles around substance use. A comprehensive approach to illicit substance use including prevention, harm reduction and treatment, will save so many lives,” said Vancouver Mayor Kennedy Stewart in a statement. “We call upon health professionals, all levels of government, and the public to join us in advocating for a safe drug supply, in Vancouver and elsewhere in Canada, to protect residents and prevent any more unnecessary deaths. Stewart joined a number of other experts and stakeholders, including the BC Centre on Substance Use and B.C.’s chief medical health officer, in calling for the decriminalization of hard drugs, to ensure people with addictions are not dying from contaminated street drugs. The federal government is in charge of policy around drug legalization but the provincial government does have jurisdiction over prosecutions. Currently, B.C. is working on ways to prescribe prescription-grade heroin to drug users and provide other medications on a regular basis. Statistics from the BC Coroners Service showed the number of overdose deaths levelling off at about three people per day province-wide in January. However, they also found a concerning spike in the number of deaths related to fentanyl analogue carfentanil, which is 100 times as powerful as its cousin.

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Hep C World News - Week of April 7, 2019 
 

Opioid Stigma and Cancer

Milwaukee, WI - Many cancer patients experienced aspects of opioid stigma and this may have affected cancer pain management, a small study showed here. Nearly two-thirds of cancer center patients reported opioid stigma and one in four said stigma concerns altered their behavior, mainly to take less opioid medication than they needed, reported Hailey Bulls, PhD, of the Moffitt Cancer Center in Tampa, Florida, and colleagues, at the 2019 American Pain Society Scientific Meeting. "This research provides preliminary evidence that stigma associated with prescription opioid use is a problem in cancer patients," Bulls told MedPage Today. "Patients most commonly expressed fears of addiction, problems filling their prescriptions at the pharmacy, feeling awkward describing their opioid pain management with clinicians, and worry about appearing drug-seeking." Recent legislative and public health efforts to limit opioid prescribing may have unintended effects on cancer patients, she added. Pain has been reported in up to 55% of patients actively treated for cancer, and opioids are a mainstay of cancer pain treatment. While cancer-related pain often is explicitly excluded in opioid prescribing and dispensing regulations, cancer patients still may internalize socially undesirable ideas or negative stereotypes about opioid use. "Patients living with chronic pain, be it cancer-related or otherwise, are experiencing high levels of stigmatization at present," noted Burel Goodin, PhD, of the University of Alabama at Birmingham, who was not involved with the study. "Much of that stigma is related to the use of opioid medications for pain relief." "If a person uses opioids for pain management, others often falsely assume that he or she is destined to become an addict," Goodin told MedPage Today. "As a result, opioid therapy may be withheld by healthcare providers, even in instances where it is clinically indicated. Alternatively, patients may underutilize their prescribed opioid medications for fear of stigmatizing reactions from others." A number of patients (29%) reported engaging in stigma-related behaviors, most commonly using less opioid medication than needed (20%). Other patients hoarded opioids, avoided them altogether, didn't fill opioid prescriptions, or didn't discuss their pain with their provider or family and friends. Patients taking less opioid medication because of stigma may contribute to undertreatment of cancer pain, Bulls and colleagues noted. If patients fear stigma from their health care providers, they may avoid talking about pain management to prevent awkward conversations or to not appear as drug-seeking, they added. This pilot study provides the first known evidence of opioid stigma and its consequences in cancer patients, the researchers said. Full survey results were reported in the Journal of Pain and Symptom Management. Limitations of the study included its small sample size and lack of a validated measure to assess opioid stigma in cancer patients.

For more information: https://www.medpagetoday.com/meetingcoverage/aps/79070

Hep C World News - Week of March 31, 2019
 

Louisiana selects unique subscription-based hep C program

Baton Rouge, LA - Dubbed the "Netflix model," Louisiana's initiative flips the script on how states pay for drugs. Instead of paying per prescription, the contract will give Louisiana an unrestricted license of use at a fixed monthly cost. Gilead beat out AbbVie and Merck & Co. with its pitch. Louisiana has a particularly low treatment rate, with less than 3% of hepatitis C patients on Medicaid receiving treatment last year, according to the state's Department of Health. In 2014, Gilead's decision to price its antiviral Sovaldi (sofosbuvir) at a cost of roughly $1,000 per pill for the 12-week treatment course spurred national criticism, and is frequently pointed to as a shift in the debate over drug pricing. Yet Sovaldi, and the drugs Gilead subsequently won approval for, are essentially curative. With new competition, particularly from AbbVie's Mavyret (glecaprevir/pibrentasvir), net prices for hepatitis C medications have come down significantly, although patients can still be exposed to the higher list prices. "We were extremely pleased that three manufacturers offered proposals, with the plan submitted by Asegua offering us a clear path forward to offer a hepatitis C cure to our most vulnerable patients," Rebekah Gee, the state's health secretary, said in a statement. Medicaid is among the biggest line items for states, leading them to search for ways to lower costs, such as through managed care. Pharmas and biotechs, meanwhile, have faced intense public and political pressure over drug prices during the Trump administration. A 2017 report from the National Academies raised the subscription service idea. Released almost exactly two years ago, an expert committee said the U.S. could get rid of hepatitis B and C with better prevention, screening and creative financing of treatments. The panel concluded there was a need for new financing methods due to no antiviral agent coming off patent before 2029. Experts proposed the government buy a license and use it in market segments with limited access, specifically in Medicaid and prisons. The idea gained more steam last year, with Louisiana putting out a request for comment last July. The National Governors Association listed subscription models as a viable alternative payment option, particularly for the Medicaid and prison populations. And last November, Republican Senator Bill Cassidy of Louisiana outlined the merits of the "Netflix model" in a JAMA opinion piece with Peter Bach and Mark Trusheim, two influential health policy thinkers. The state of Washington is advancing a similar initiative. Health officials requested hepatitis C treatment proposals from manufacturers in January. The proposal submission deadline closed earlier this month, leaving Washington to choose a partner. Washington Gov. Jay Inslee, also a Democratic presidential candidate, laid out the idea as part of an ambitious directive to eliminate hepatitis C in the state by 2030. For Gilead, the subscription payment could help offset some of the revenues decline hitting its hepatitis C business. Epclusa sales were down 44% last year after posting $3.51 billion in 2017. Total sales from Gilead's hepatitis C products have gone from making up 50% of the company's total product sales in 2016 to 17% last year.

For more information: https://tinyurl.com/y3vqzyfj

Hep C World News - Week of March 24, 2019

There are millions of people across Canada who can’t afford medications

Toronto, ON – An interview recently published by the Canadian Medical Association highlighted the gap between diagnosis and treatment in Canada. As a family doctor at St. Michael’s Hospital in Toronto, Dr. Persaud details a typical scenario he sees in his practice. A patient with poorly controlled diabetes or high blood pressure comes in and he prescribes them medication, but the patient doesn’t take it because they can’t afford it. At some point, the same patient returns with the same problem. In his early years of practice, Dr. Persaud believed there was nothing he could do to fix this cycle. But once some of these same patients started having heart attacks and strokes, he felt compelled to act. “It’s unacceptable that people are being harmed unnecessarily, when there are relatively inexpensive treatments that could prevent it,” Dr. Persaud explains. “There are millions of people across Canada who can’t afford medications, so let’s do something that might inform public policy and improve the situation for everyone.” So in 2016, Dr. Persaud launched the CLEAN Meds (Carefully selected and easily accessible at no charge medications) study, a randomized controlled trial testing the effects of providing patients access to more than 125 “essential medicines” for free. Almost 800 people are now taking part in the study through seven health centres: four in Toronto and three in the Manitoulin Island area. At the time they were enrolled, all the patients had reported being unable to afford a medication during the previous 12 months. “The current system - a mishmash of private insurance, public insurance and no insurance - is a mess that leaves taxi drivers, factory workers, entrepreneurs, musicians and others in a position where often, they can’t afford to take medications, and have to make very difficult decisions.” Half of the participants were randomly placed in the control group, without any additional support for filling their prescription. The other half were assigned to the intervention group and had a pharmacist in the study mail their medications — for free — directly to their homes. A patient with diabetes, for instance, would receive metformin and insulin at no charge.  “By comparing the two groups, we can determine the effects of free and convenient access to medications,” says Dr. Persaud. “Do people take the medications as instructed, are the medications more likely to be prescribed appropriately, and do people have better control of their conditions and diseases?” The list of essential medicines created for the study is adapted from a similar list published by the World Health Organization and tailored to the Canadian market. It ranges from inexpensive medications such as acetaminophen and vitamin D to what Dr. Persaud calls “fantastically expensive” biologics such as dolutegravir, a new HIV treatment that costs roughly $10,000 a year. He says several drugs that are commonly prescribed were kept off the list because there was no evidence, they are effective. Results from the first 12 months of the CLEAN Meds study are expected to be published in early 2019, shortly before the Advisory Council on the Implementation of National Pharmacare issues its final report. The council, chaired by Dr. Eric Hoskins, is leading a national dialogue on how to implement affordable national pharmacare for Canadians and their families, employers and governments. 

For more information: https://www.cma.ca/dr-nav-persaud

Hep C World News - Week of March 17, 2019

Acute HCV decreasing in men who have sex with men with HIV
 

London, UK - The rates of hepatitis C incidence among men who have sex with men with HIV has significantly decreased in London since the epidemic peak in 2015, coinciding with wider access to direct-acting antiviral therapy, according to data presented at CROI. “The WHO aims to reduce by 90% the number of new infections of the next decade. Micro-elimination of well-defined populations has been suggested as an initial approach and, in the U.K., the British HIV Association ambitiously aims to cure all hepatitis C coinfection by 2021,” Lucy J. Garvey, MD(Res), MRCP, from the Imperial College Healthcare NHS Trust in London, said during her presentation. “If we consider the HIV-positive MSM population as a potential for micro-elimination, modeling work has predicted that significant scale-up of treatment including access for recent infection plus risk reduction work will all be important if these reductions in incidence are to be achieved.” Between the “pre-DAA” period of 2013 and post-DAA period of 2018, Garvey and colleagues found 256 acute diagnoses of HCV including 211 first infections and 45 reinfections. Incidence peaked at 17 per 1,000 acute infections among HIV-positive MSM in 2015. “The peak in 2015 most likely represents a fall-off in rates of interferon-based treatments as patients and clinicians awaited DAAs, a so-called 'warehousing effect' which may have increased HCV transmission by prolonging the duration of viremia,” Garvey said. In 2018, all acute infections in this population decreased by 68% and first infections decreased by 79%. However, reinfection rates appear to have increased in recent years representing 47% of all infections in 2018. Garvey noted that average time between acute HCV diagnosis and treatment initiation also decreased from 41 months in 2013 to 3 months in 2018, “largely driven by clinical trial availability,” she said. “We have observed a sharp decline in new acute HCV diagnoses since the peak in 2015 with no change to screening practices,” Garvey concluded. “Nevertheless, the reduction in incidence still falls short of the WHO target to reduce new infections by 90%. Reinfection remains high and may be increasing, which highlights the ongoing need to promote and improve risk reduction strategies and design appropriate screening policies in HIV-positive and -negative MSM. Without expanding access of DAAs, progress in reducing incidence may plateau and the opportunity for HCV micro-elimination in HIV-positive MSM may be lost.”
 

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

Hep C World News - Week of March 10, 2019

HCV re-Infections common among men with HIV

Seattle, WA - Men who have sex with men (MSM) with HIV who have successfully cleared co-infection with hepatitis C virus (HCV) often become re-infected with HCV, researchers reported here at the Conference on Retroviruses and Opportunistic Infections. "Overall, what we found was that the re-infection rate was 4.4 per 100 patient years, which is a solid seven times that of the primary first infection rate for HIV-infected men who have sex with men," said Daniel Fierer, MD, of the Icahn School of Medicine at Mount Sinai in New York City, at a press conference. "Reinfections by themselves are not bad and should not be stigmatized," he said. "It is really an important sign that you are treating the people who are actively transmitting disease." Reinfections in the U.S.-based study, he said, occurred at the same rate whether patients had cleared the infection spontaneously, through interferon-based therapy, or with newer direct-acting antivirals. Most re-infections occurred within the first 2 years, but infections continued to occur for more than 11 years after clearance. "These data suggest that long-term surveillance is warranted for all HIV-infected men who have sex with men after clearance of hepatitis C virus infection," Fierer said. "Further, strategies to reduce hepatitis C virus re-infections are needed to meet the goal of eliminating hepatitis C virus in these men who are at significant risk for hepatitis C virus infection." Press conference moderator Robert Schooley, MD, of the University of California, San Diego, commented that the study shows successful treatment of HCV among HIV-infected MSM is often not the end of the story. Many of these patients continue to engage in risky behaviors that lead to HCV re-infection. "Fierer's point was this population isn't one that should be treated the British way – to say you have had your round of hepatitis C virus therapy, now be done with you – but rather the group you bring in and treat intensively every time they get infected because that is where the epidemic is being driven," Schooley said. "At the same time you bring them in, you can try to address issues related to prevention, but to say that you have had your course of treatment and we are not going to treat you again is a great way to accelerate the epidemic," he said.
 

For more information: https://www.medpagetoday.com/meetingcoverage/croi/78455   
 

Hep C World News - Week of March 3, 2019

Implant to treat opioid addiction now available in Canada

Vancouver,  BC - Canadians addicted to opioids may be eligible for an implant that provides an ongoing low dose of medication for six months, with the potential for treatment for up to a year when a new implant is placed in the opposite arm. The procedure involves trained physicians inserting match-stick sized rods under the skin of the upper arm, each containing the medication buprenorphine. Health Canada approved the implant in April 2018, two years after it was granted approval in the United States. It is marketed under the brand name Probuphine and is the first such implant for the treatment of addiction to opioids. Dr. Seonaid Nolan, a clinical researcher with the BC Centre on Substance Use and an addiction medicine physician at St. Paul's Hospital in Vancouver, said the implant is another treatment option alongside medications including Suboxone, the recommended treatment for an opioid addiction, followed by methadone. "It's so important to have a number of treatment options because there's no one-size-fits-all for turning the tide on the opioid crisis," said Nolan, who is also medical director of the addiction program at Providence Health Care. The implant's main advantage is that it eliminates barriers such as patients having to remember to take daily tablets of Suboxone, which can be a particular challenge for those entrenched in addiction while battling issues such as poverty, lack of housing and unemployment, she said. The implant would also do away with the need for patients to take a drug under supervision, at least initially, in order to ensure compliance and deal with risks of it being diverted or misused. Nolan said one addiction-medicine doctor at St. Paul's Hospital has been trained on how to insert the implant, considered a viable option for people being released from correctional facilities, residential treatment programs and prolonged hospital stays because their tolerance to illicit opioids would be markedly reduced, putting them at higher risk of overdose. The Canadian Agency for Drugs and Technologies in Health, which reviews all drugs and devices approved by Health Canada, said in a statement it has recommended provincial drug plans reimburse the cost of the implant for patients who have been stabilized on no more than eight mg of buprenorphine, in conjunction with counselling. The agency's drug-expert committee says the cost of the implant should not exceed the total drug plan cost of buprenorphine at a dose not exceeding eight milligrams a day. The Health Ministry in British Columbia, the hardest-hit province in the overdose crisis, with more than 3,000 fatalities over the past two years, said the province's independent Drug Benefit Council is conducting its own review of the implant before it determines whether the cost will be covered. Montreal-based Knight Therapeutics licensed the implant from a U.S. company to commercialize and distribute it in Canada. Knight Therapeutics president Samira Sakhia said the cost would be $1,495 per implant, equivalent to six months of treatment on Suboxone. The company has trained doctors in major Canadian cities on how to insert the implant, she said. "We are early in our launch. What we're trying to do is make sure that if a physician has a patient who they feel would benefit from Probuphine what we would do is co-ordinate with that physician so that if they're not trained they have access to someone who is trained and is close enough to them and their patient." Sakhia said one patient, in the Maritimes, has so far received the implant in Canada. "It's a complicated product because of the nature of it being an implant and we are trying to do what we can to make sure that physicians are trained, knowledgeable, and we're working towards reimbursement because that will make access easier."
 

For more information: https://tinyurl.com/y665sskk

Hep C World News - Week of February 24, 2019 
 

HCV vaccine research continues to advance

Baltimore, MD - Recent advances could mean a preventative vaccine within the decade, experts say. While direct-acting antivirals (DAAs) are proving their worth in terms of curing cases of infection with hepatitis C virus (HCV), work is still ongoing to develop a preventative vaccine, with impressive advances over the past few years. "Despite development challenges, a prophylactic vaccine is necessary for global control of HCV," researchers wrote recently in Gastroenterology. An HCV vaccine would prevent transmission, regardless of the various risk factors. Few countries are on target to eliminate HCV, with nearly 60% of surveyed countries having more infections than cures in 2016, the paper said. In an interview, lead author Justin Bailey, MD, PhD, of Johns Hopkins University School of Medicine in Baltimore, told the Reading Room: "HCV treatment is still very expensive in most countries, limiting access. HCV is usually asymptomatic, so most people throughout the world with HCV are unaware of their infection. These people may develop complications of infection like cirrhosis or hepatocellular carcinoma, and they may transmit the infection to others without ever knowing that they are infected."Is an HCV vaccine possible? Bailey said he believes this could happen within 10 years. However, "HCV unfortunately disproportionately affects people who are less politically influential and who are often underserved by the health care system, so this problem in my opinion has not received the attention and research funding it deserves. With that said, I think there is very strong scientific evidence that a vaccine for HCV is feasible." According to the World Health Organization, about 71 million people globally have chronic HCV infection, with about 399,000 dying each year from complications. While DAAs can cure more than 95% of infected people, access to diagnosis and treatment is low. On top of this, diagnosis is often done at a late stage, and reinfection is possible. There have been a variety of challenges to developing a vaccine for HCV -- a key barrier being the genetic diversity of the virus (which is greater than HIV) and the fact that the virus keeps mutating, even while infecting a person.

For more information: https://www.medpagetoday.com/reading-room/aga/lower-gi/78273

Hep C World News - Week of February 17, 2019

Rates of deceased donor organs with HCV, HBV, HIV increasing in US

Atlanta, GA - Between 2010 and 2017, the number and percentage of deceased donor organs with a transmissible infectious disease — such as hepatitis C, hepatitis B or HIV — increased in the U.S., which may likely be tied to the ongoing opioid epidemic, according to a recent report from the CDC. “These findings demonstrate the continuing need for identifying viral blood-borne pathogen infection risk factors among deceased donors to reduce the risk for transmission, monitor post transplant infection in recipients, and offer treatment if infection occurs,” Winston E. Abara, MD, from the Division of Viral Hepatitis at the CDC, and colleagues wrote. Abara and colleagues analyzed deceased donor data from 2010 to 2017 for both standard risk donors (SRDs) and increased risk donors (IRDs). During this period, the proportion of IRDs increased approximately 200% (from 8.9% to 26.3%; P < .001), the proportion of drug intoxication as the cause of mortality increased by approximately 200% (from 4.3% to 13.4%; P < .001), and the proportion of donors with reported injection drug use increased by approximately 500% (from 1.3% to 8%; P < .001). Among all deceased donors, HBV surface antigen positivity remained constant (0.1%), total HBV core antibody positivity decreased slightly (5% vs. 4.7%), anti-HCV positivity increased (4.2% vs. 7.3%), and anti-HIV positivity increased slightly (0% vs. 0.1%) during the study period. The researchers observed no substantial changes in HBsAg or anti-HBc positivity among IRDs during the study period. However, anti-HCV positivity increased (15.9% vs. 21.6%).From 2014 to 2017, the percentage of IRDs tested by HCV, HBV and HIV nucleic acid amplification increased from 4.6% to more than 99.9% for all three infections. “Because universal donor NAT testing has been implemented since 2014, reduction of the 12-month period for IRD designation to a shorter interval warrants further consideration,” the researchers wrote. “Although this study does not assess the use of donor organs, modifications to current recommendations might increase their use while still protecting recipient safety. These modifications include shortening the 12-month interval to reduce the proportion of donors categorized as IRDs and reassessment of terminology that might currently be contributing to underuse of these organs.”
 

For more information: https://tinyurl.com/y3x26uae

Hep C World News - Week of February 10, 2019  
 

Liver cancer recurrence not linked to hepatitis treatment

Dallas, TX - A study published in 2016 raised concerns that patients with liver cancer related to hepatitis C virus (HCV) may have a higher risk for recurrence if they are treated with direct-acting antiviral (DAA) therapies directed against HCV. A new multicenter study allays these concerns. It found that there was no significant difference in the risk for overall or early hepatocellular carcinoma (HCC) recurrence or degree of tumor aggressiveness between patients who received DAA therapies for HCV infection and those who did not. The retrospective cohort study in 793 patients with HCV-related HCC showed that during a median follow-up of 10.4 months, 128 of 304 treated patients (42.1%) experienced tumor recurrence, as did 288 of 489 untreated patients (58.9%). Early recurrence, defined as recurrence 365 days after complete response, was observed in 52 treated and 277 untreated patients. In both DAA-treated and untreated patients, most recurrences were within the Milan criteria (74.2% vs 78.8%; P = .23), the study found. After variable adjustment, DAA therapy was not associated with HCC recurrence (hazard ratio [HR], 0.90) or early HCC recurrence (HR, 0.96), say Amit G. Singal, MD, associate professor of internal medicine and medical director of the Liver Tumor Program at the University of Texas Southwestern Medical Center in Dallas, and colleagues. The study was published online January 18 in Gastroenterology. "Our results suggest use of direct-acting antivirals is safe and likely beneficial in hepatitis C–infected patients with a history of hepatocellular carcinoma," Singal said. "We found no significant difference in the proportion of patients with recurrence or the aggressiveness of the recurrence between DAA-treated and untreated patients. Therefore, patients with a history of HCC who achieve complete response to cancer treatment should be referred for consideration of hepatitis C therapy," he said. Although the findings suggest that DAA therapy is not associated with an increased risk for HCC recurrence, Singal pointed out that HCC recurrence was experienced by a high proportion of both DAA-treated and untreated patients. "Therefore, it is critical for all patients to undergo HCC screening with CT or MRI to evaluate for recurrence before and after DAA therapy. In our center, we typically require two consecutive imaging studies to confirm the absence of HCC recurrence prior to starting DAA therapy," he said.
 

For more information: https://tinyurl.com/ycm5pj4a

Hep C World News - Week of February 3, 2019

Australia on track to achieve WHO HCV elimination targets  
 

Sydney, Australia - Subsidized direct-acting antiviral (DAA) treatment recently became available to all adults living with chronic hepatitis C virus (HCV) in Australia. Based on rapid uptake (32 600 people initiated DAA in 2016), researchers here estimated the impact on HCV epidemiology and mortality in Australia and determined if Australia can meet the WHO HCV elimination targets by 2030. Using a mathematical model, we simulated pessimistic, intermediate and optimistic DAA treatment scenarios in Australia over 2016–2030. researchers assumed treatment and testing rates were initially higher for advanced fibrosis and the same across HCV transmission risk level sub-populations. They also assumed constant testing rates after 2016. Researchers compared the results to the 2015 level and a counterfactual (IFN-based) scenario. During 2016–2030, they estimated an intermediate DAA treatment scenario (2016, 32 600 treated; 2017, 21 370 treated; 2018 17 100 treated; 2019 and beyond, 13 680 treated each year) would avert 40 420 new HCV infections, 13 260 liver-related deaths (15 320 in viraemic; −2060 in cured) and 10 730 HCC cases, equating to a 53%, 63% and 75% reduction, respectively, compared to the IFN-based scenario. The model also estimated that Australia will meet the WHO targets of incidence and treatment by 2028. Time to a 65% reduction in liver-related mortality varied considerably between HCV viraemic only cases (2026) and all cases (2047). Based on a feasible DAA treatment scenario incorporating declining uptake, Australia should meet key WHO HCV elimination targets in 10 to15 years. The pre-DAA escalation in those with advanced liver disease makes the achievement of the liver-related mortality target difficult. Globally, 71 million people are living with hepatitis C virus (HCV) infection.[1] In many countries, morbidity and mortality associated with HCV continue to rise.[2] The development of effective well-tolerated, once-daily and short duration direct-acting antiviral (DAA) therapy for the treatment of HCV infection has been revolutionary and provides an opportunity to stem rising liver disease burden. The WHO has set an ambitious goal to eliminate HCV as a major global public health threat by 2030.[3] Between 2015 and 2030, the WHO targets include increasing HCV diagnoses from 20% to 90% and the number of eligible persons receiving HCV treatment from <5% to 80%, reducing new infections by 80%, and HCV liver-related mortality by 65%. It will be critical for countries to evaluate progress against these WHO elimination targets. In March 2016, Australia was one of the first countries to introduce Government-funded broad access to DAA therapy, with no restrictions based on liver disease stage, and drug and/or alcohol use.[4] Further, all physicians, including drug and alcohol specialists and general practitioners, were able to prescribe DAA therapies. This unrestricted DAA access programme, an already high diagnosed proportion,[5] and established high-coverage harm reduction provide the foundation for HCV elimination in Australia. During the first 10 months of access to DAA therapies in 2016, 32 600 people were treated with DAAs for HCV infection (representing ~14% of the population with chronic HCV infection).[6,7] The HCV treatment numbers declined to 21 370 in 2017 (still 5–6 times the number in 2014) with an initial "warehouse" treatment effect from large patients awaiting DAA therapy. This study modelled the potential impact of different scenarios of DAA therapy uptake on HCV elimination targets over the 2016–2030 period in Australia, including identifying the number of people who need to be treated to achieve the WHO elimination targets by 2030.

For more information: https://www.medscape.com/viewarticle/907477_2

Hep C World News - Week of January 27, 2019

New hepatitis C strains could harm world eradication goals

Cambridge, UK - The recent discovery of 3 new strains of hepatitis C virus (HCV) genotype (GT) 7 in Africa, shortly after GT 8 was identified in India, pose challenges to attaining the World Health Organization (WHO) goal of eradicating HCV globally by 2030. Manjinder Sandhu, PhD, Senior Group Leader, Wellcome Sanger Institute, Hinxton, Cabridgeshire, UK and a senior author of the study uncovering the new GT 7 subtypes, noted the strains had mutations associated with resistance to some direct-acting antivirals (DAAs), and called for increased clinical research in these under-resourced areas to facilitate development of effective interventions. "Our study highlights the need for more investment on people in Africa and developing parts of the world," Sandhu said in a statement released at the time of the report. "We show there are clear differences in HCV across the world, underlining the need for understanding HCV globally." In the largest population study of HCV in Africa to date, Sandhu and colleagues identified study candidates from a population-based survey, the Medical Research Council/Uganda Virus Research Institute (MRC/UVRI) General Population Cohort, which was taken in 2011. A cohort of 7751 participants from Uganda and 2 from the Democratic Republic of Congo (DRC) were screened for HCV, with 266 determined to be seropositive. A nested case-control study was then formed with 565 participants, comprising 197 who were seropositive and a control group of 368 seronegative individuals. An additional antibody assay screen was administered, as well as HCV-RNA determination, to ascertain the accuracy and utility of the antibody assays for disease detection and to identify the diversity of the HCV genome in the region. Sandhu and colleagues noted that approximately 11 million people in sub-Saharan Africa are currently affected, and the majority suffer from genotypes “that have received little or no attention in clinical treatment or vaccine trials, and it is likely that new genotypes remain undiscovered." The HCV strains detected in the Uganda sampling included GT 4k, 4p, 4q, 4s in addition to a new, unassigned GT 7 subtype. The 2 samples from the DRC each yielded an additional unassigned GT 7 subtype. Sandhu and colleagues explained that a new, unassigned subtype strain can be declared when the open reading frames (ORFs) of the subtype differs from another by 10% to 25% at the nucleotide level, and a new GT, such as the GT 8 identified in India, when there is at least 30% difference. The investigators found that detection of HCV seropositivity differed substantially between assay methods, which they suggest indicates there is an important role for molecular techniques to improve active infection detection. The HCV sequencing detected polymorphisms in the GT 4 and 7 strains, including NS3 and NS5A mutations associated with resistance to particular DAAs. "Our work will help inform public health policy and reveals that further studies and clinical trials in sub-Saharan Africa are urgently needed if the WHO is to achieve its vision of eliminating hepatitis C by 2030," Sandhu said.

For more information: https://tinyurl.com/ycyy7ysf
 

Hep C World News - Week of January 20, 2019

Multi drug-resistant bacterial infections surge in cirrhosis   
 

Padua, Italy - More than a third of inpatients with cirrhosis had multi drug-resistant (MDR) bacterial infections. Researchers here studied the prevalence and outcomes of bacterial and fungal infections in hospitalized patients with cirrhosis. Patients with cirrhosis – the late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules – are susceptible to an array of complications and have shortened life expectancies. While the risk of death from major complications of cirrhosis, such as hepatorenal syndrome, gastrointestinal bleeding, or hepatocellular carcinoma (HCC) has declined, the risk from sepsis has increased over time. Lack of new effective antibiotics and the spread of multidrug-resistant (MDR) bacteria have likely contributed to this phenomenon. Leaders of this study saw a need to strengthen the evidence base with respect to microbial infections, particularly MDR and extensively drug resistant (XDR) bacteria in hospitalized patients with cirrhosis. From 2015 to 2016, demographic, clinical, and microbiological treatment data were collected by senior investigator Paolo Angeli, MD, PhD, of the University of Padua in Italy, and colleagues from 1,302 patients at 46 centers (15 from Asia, 15 from Europe, 11 from Southern America, and five from Northern America). The etiology of cirrhosis was different, with hepatitis B virus being more frequent in Asia than in Europe and America. Hepatitis C virus was more frequently associated with cirrhosis in the latter two regions. Patients had advanced liver disease, as evidenced by a few key criteria: mean model of end stage liver disease (MELD) score (21±8); MELD sodium (MELD-Na) score (24±8); and a 35% rate of acute-on-chronic liver failure (ACLF) at the diagnosis of infection. Just over 40% of the hospitalized patients with cirrhosis and bacterial or fungal infections were from Europe, 32% were from Asia, and 25% were from North or South America. Most of the patients were middle-age males (69%; mean age 57 years). The primary outcome of the study was the prevalence of MDR or XDR infections. MDR bacteria were defined as not susceptible to at least one agent in three or more antimicrobial categories. XDR bacteria were defined as those susceptible to agents in no more than two categories. Intrinsic resistance was not considered for these definitions (e.g., Enterococci are constitutively resistant to cephalosporins). Secondary outcomes included in-hospital mortality, 28-day mortality, development of ACLF, septic shock, transfer to the intensive care unit, and need for organ support (mechanical ventilation or renal replacement therapy) during hospitalization. The most frequent bacterial infections identified were spontaneous bacterial peritonitis (SBP, 27%), urinary tract infections (22%), and pneumonia (19%). Angeli and colleagues estimated that the global prevalence of MDR bacteria was 34% (95% CI 31%–37%). Indian and North American centers had the highest and lowest proportions of MDR and XDR bacteria, respectively (India: 73% and 33%, respectively; North America: 18% and 2%, respectively). Antibiotic use in the 3 months before hospitalization, prior health care exposure, and the site of infection were also identified as independent risk factors for MDR bacteria.
 

For more information: https://tinyurl.com/y7v8zaxn
 

Hep C World News - Week of January 13, 2019
 

Scientists seek real way to measure pain amid opioid crisis  
 

Washington, DC - Is the pain stabbing or burning? On a scale from one to 10, is it a six or an eight?
Over and over, 17-year-old Sarah Taylor struggled to make doctors understand her sometimes debilitating levels of pain, first from joint-damaging childhood arthritis and then from fibromyalgia. “It’s really hard when people can’t see how much pain you’re in, because they have to take your word on it and sometimes, they don’t quite believe you,” she said. Now scientists are peeking into Sarah’s eyes to track how her pupils react when she’s hurting and when she’s not — part of a quest to develop the first objective way to measure pain. “If we can’t measure pain, we can’t fix it,” said Dr. Julia Finkel, a pediatric anesthesiologist at Children’s National Medical Center in Washington, who invented the experimental eye-tracking device. At just about every doctor’s visit you’ll get your temperature, heart rate and blood pressure measured. But there’s no stethoscope for pain. Patients must convey how bad it is using that 10-point scale or emoji-style charts that show faces turning from smiles to frowns. That’s problematic for lots of reasons. Doctors and nurses have to guess at babies’ pain by their cries and squirms, for example. The aching that one person rates a seven might be a four to someone who’s more used to serious pain or genetically more tolerant. Patient-to-patient variability makes it hard to test if potential new painkillers really work. Nor do self-ratings determine what kind of pain someone has — one reason for trial-and-error treatment. Are opioids necessary? Or is the pain, like Sarah’s, better suited to nerve-targeting medicines? “It’s very frustrating to be in pain and you have to wait like six weeks, two months, to see if the drug’s working,” said Sarah, who uses a combination of medications, acupuncture and lots of exercise to counter her pain. The National Institutes of Health is pushing for development of what its director, Dr. Francis Collins, has called a “pain-o-meter.” Spurred by the opioid crisis, the goal isn’t just to signal how much pain someone’s in. It’s also to determine what kind it is and what drug might be the most effective. “We’re not creating a lie detector for pain,” stressed David Thomas of NIH’s National Institute on Drug Abuse, who oversees the research. “We do not want to lose the patient voice.” Around the country, NIH-funded scientists have begun studies of brain scans, pupil reactions and other possible markers of pain in hopes of finally “seeing” the ouch so they can better treat it. It’s early-stage research, and it’s not clear how soon any of the attempts might pan out. “There won’t be a single signature of pain,” Thomas predicted. “My vision is that someday we’ll pull these different metrics together for something of a fingerprint of pain.” NIH estimates 25 million people in the U.S. experience daily pain.
 

For more information: https://tinyurl.com/y8nwzmtt
 

Hep C World News - Week of January 6, 2019

FDA tentatively approves certain forms of Brixadi for opioid use disorder 
 

Silver Spring, Maryland - The FDA tentatively approved certain Brixadi injections for treatment of moderate to severe opioid use disorder, according to a press release from Braeburn, the drug manufacturer. Brixadi (buprenorphine, Braeburn) extended-release injections — 8 mg, 16 mg, 24 mg, 32 mg weekly and 64 mg, 96 mg, 128 mg monthly —are for patients who have already received buprenorphine or have already begun treatment with a single dose of a transmucosal buprenorphine product, the company stated. According to the release from Braeburn, “FDA has concluded that Brixadi has met all required quality, safety and efficacy standards necessary for approval, but is not eligible for marketing in the U.S. because of exclusivity considerations.” According to the company, this version of buprenorphine uses FluidCrystal Injection Depot Technology, a low-volume lipid-based liquid with a dissolved active ingredient. Once injected in the stomach, buttock, thigh or upper arm, the product “immediately starts transforming into a nanostructured liquid-crystalline gel, allowing for a slow release of the buprenorphine at a continuous and steady rate,” According to the release. The product does not need refrigeration, is administered only by health care providers in a health care setting and should be part of a complete treatment program that includes psychosocial support and counseling, the release stated. “Brixadi supports current treatment guidelines that recommend frequent office visits, especially early in recovery, when patients may discontinue treatment and there is a high risk of overdose,” Mike Derkacz, president and CEO of Braeburn said in the release. According to Braeburn, in a phase 3 trial among participants who either tested positive for fentanyl before the study or were using heroin and/or injectable opioids at study initiation, this version of buprenorphine met the noninferiority for responder rate (P < .001) when compared with daily sublingual buprenorphine/naloxone. The product also showed superiority to daily sublingual buprenorphine/naloxone in the percentage of negative opioid assessments from week 4 through 24 (P = .004). The company reported that the safety profile of the weekly and monthly version of its buprenorphine generally mirrored that of oral buprenorphine. The most common adverse events were constipation, headache, injection-site pain and pruritus, insomnia, nausea and urinary tract infections, and these occurred in 5% or more of patients.
 

For more information: https://tinyurl.com/y9fcvkjn