Virtual touch quantification (VTQ) for staging liver fibrosis   
 

Kumamoto, Japan - Assessing liver fibrosis in patients with hepatitis C is important to predict carcinogenesis. In a recent study, researchers evaluated the usefulness of virtual touch quantification (VTQ) for staging liver fibrosis, and investigated factors causing the discrepancy between the estimated fibrosis stage using VTQ and the pathological fibrosis stage. Virtual touch quantification provided a noninvasive method for fibrosis staging and was more accurate than Fibrosis-4 index and aminotransferase-to-platelet ratio index in patients with hepatitis C. However, skin liver capsule distance longer than 17.5 mm may result in measurement failures. “Liver biopsy (LB) remains the gold standard for liver fibrosis staging, but it is invasive, has sampling errors, and there is variation in diagnosis among pathologists,” the researchers wrote. “[Virtual touch quantification (VTQ)] is easily performed using conventional [ultrasound] probes during abdominal ultrasonography. VTQ can be used in patients with ascites, whereas [transient elastography] cannot be used in these patients.” The study comprised 302 patients with HCV. All patients underwent liver biopsy and liver stiffness measurement with VTQ, FIB-4 index and APRI. Biopsy results showed that 108 patients had fibrosis stage 1, 93 patients had stage 2, 62 patients had stage 3 and 39 patients had stage 4.  “The accuracy of [acoustic radiation force impulse (ARFI)] seems to be lower in patients with a long SCD, although steatosis, hepatic inflammation, and hepatocyte ballooning have little effect on ARFI measurement failures,” the researchers wrote. “Because we can measure the SCD easily at the same time as performing the usual ultrasonography, it is beneficial to set the cut-off value of SCD as an indicator of reliability.

For more information: https://tinyurl.com/y7kb4tt3
 

Hep C World News - Week of December 24, 2017

Opioids now kill more people than breast cancer
 
Atlanta, GA - More than 63,600 lives were lost to drug overdose in 2016, the most lethal year yet of the drug overdose epidemic, according to a new report from the National Center for Health Statistics, part of the US Centers for Disease Control and Prevention. Most of those deaths involved opioids, a family of painkillers including illicit heroin and fentanyl as well as legally prescribed medications such as oxycodone and hydrocodone. In 2016 alone, 42,249 US drug fatalities -- 66% of the total -- involved opioids, the report says. That's over a thousand more than the 41,070 Americans who die from breast cancer every year. Much of the increase was driven by the rise in illicit synthetic opioids like fentanyl and tramadol. The rate of deadly overdoses from synthetic opioids other than methadone has skyrocketed an average of 88% each year since 2013; it more than doubled in 2016 to 19,413, from 9,580 in 2015. Heroin also continues to be a problem, the report says. Since 2014, the rate of heroin overdose deaths has jumped an average of 19% each year. The opioid crisis has raised significant awareness of prescription painkillers. Between 1999 and 2009, the rate of overdoses from such drugs rose 13% annually, but the increase has since slowed to 3% per year. In 2009, prescription narcotics were involved in 26% of all fatal drug overdoses, while heroin was involved in 9% and synthetics were involved in just 8%. By comparison, in 2016, prescription drugs were involved in 23% of all deadly overdoses. But heroin is now implicated in about a quarter of all drug fatalities, and synthetic opioids play a role in nearly a third. These increases have contributed to a shortening of the US life expectancy for a second year in a row. The states with the highest rates of overdose in 2016 were West Virginia, Ohio and New Hampshire, the report said. The rate of overdose in West Virginia was over 2.5 times the national average of 19.8 overdose deaths for every 100,000 people. While the outlook nationwide is fairly bleak, it's particularly bad in some states. Twenty-two states and the District of Columbia had overdose rates significantly higher than the national average. While overdose rates increased in all age groups, rises were most significant in those between the ages of 25 and 54.

For more information: https://tinyurl.com/yc78rnh9
 

Hep C World News - Week of December 17, 2017

Screening people at low risk for HCV   
 

Ottawa, ON - In April 2017, the Canadian Task Force on Preventive Health Care recommended against hepatitis C screening among patients with a low risk for infection. Among the reasons for its recommendation, the group cited low HCV incidence among low-risk Canadian populations and the potential harms of treating infected patients who would not have developed disease. “Given the lack of direct evidence that mass screening is beneficial and that patients identified by screening will either never develop symptoms of hepatitis C, or will remain well for decades after infection, we have recommended against screening for HCV in adults who are not at elevated risk,” task force member Roland Grad, MD, MSc, an associate professor in the department of family medicine at McGill University in Montreal, said at the time. Infectious Disease News asked Jordan Feld, MD, MPH, a scientist with the Toronto General Hospital Research Institute and an associate professor of medicine at the University of Toronto, for his opinion on the matter. With all the progress in HCV, the biggest challenge in the past few years has been trying to obtain these very effective therapies for our patients. It was very exciting in Canada to see recent negotiations with the federal government loosen restrictions and allow us to start treating more people with a promise to have universal access for the country in the next 2 years or even less. This was fantastic news for patients but was followed shortly by less optimistic news. We now have a guideline from the Canadian Task Force on Preventive Health Care for screening recommendations for HCV in Canada. I must admit that I and many of my colleagues were disappointed to see the conclusions of the task force. They reviewed literature on screening and treatment, and concluded that screening should not be done in people at low risk. That, in itself, is somewhat of a self-evident statement and unfortunately not very helpful. The Canadian Liver Foundation previously advocated for baby boomer screening similar to that in the United States but with a slightly different birth cohort of 1945 to 1975. That is based on very solid data in Canada showing this is not only effective in identifying HCV, but it is also cost-effective. If the prices on new treatments come down — and they may already be there — this could even be cost-saving for our health care system. Screening makes a lot of sense. How the task force could look at the data and conclude that we should not be screening, and we should simply stick to our old paradigm of screening high-risk individuals is disconcerting. We know that does not work. It has failed in every country in which it has been attempted and every disease in which it has been implemented. This antiquated recommendation is rather disappointing. It is hoped that clinicians and academics in Canada will look beyond these guidelines and recognize the evidence supporting broader screening. With this recognition, we can move to include risk-based screening but also to advocate for population-based screening likely based on the birth cohort of 1945 to 1975 so we can identify those with HCV. With improved access to treatment, we can get them cured and reduce the public health burden from this illness.
 

For more information: https://tinyurl.com/ybhcxfb5
 

Hep C World News - Week of December 10, 2017

Shaming people about their lifestyle does nothing to improve their health   
 

San Diego, CA - Going to the doctor usually involves exposing the body with all its faults and flaws. In a culture that increasingly values self control and bodily perfection, being sick or even merely old can lead to feelings of shame and inadequacy. Any defects or difficulties can feel like personal failings, especially if they are linked to lifestyle, such as problems related to weight, sexual behaviour, smoking, addiction, alcohol or other substance use. People with these issues face being shamed for “unnecessarily” using health or disability services, or welfare benefits. This is all part of the contemporary political dogma of “personal responsibility”, which is reinforced by doctors who are now supposed to use every consultation – regardless of its original purpose – to talk to a patient about how to take responsibility for a healthier lifestyle. What’s wrong with a bit of shaming? For centuries, religions and laws have thrived on the fact that shame can be used to change or control people’s behaviour. And we know from reality TV series that being shamed can motivate some people to change their life or behaviour to something healthier. But, for the most part, shame makes people want to withdraw and hide. Research shows that experiencing shame in medical settings can be harmful. In a study conducted by the University of California, San Diego (UCSD), about 50% of patients experienced one or more encounters with a doctor that left them ashamed. And feeling shame is deeply unpleasant, to the point that people will seek to avoid it even if doing so is bad for them. For example, some people will avoid seeing their doctor. Others will lie about the state of their mental or physical health, or lie about their lifestyle. Shame may even make them hide a diagnosis from family or friends. In the UCSD study, not all patients felt that being shamed had been a bad thing, but even those who thought the experience was valuable were likely to lie to their doctor in a subsequent visit. None of this is likely to benefit a person who is unwell, and it can lead to ineffective or incorrect treatments being prescribed. While health-related shame matters to most people, its impact is even worse for those who are part of a stigmatised or marginalised group.
 

For more information: https://tinyurl.com/y8sleah5
 

Hep C World News - Week of December 3, 2017

Health-care wait times longest in two decades of tracking  
 

Vancouver, BC - Canadian patients face a median wait time of 21.2 weeks for medically necessary treatment -- the longest ever recorded in more than two decades of tracking, according to an annual report. The Vancouver-based Fraser Institute surveyed specialist physicians to measure the time between a referral from a general practitioner and a patient’s treatment. The median wait time was 21.2 weeks in 2017, which is 1.2 weeks longer than the previous year. When the group first began tracking wait times in 1993, it was just 9.3 weeks. Report on wait times in Canadian hospitals The problem appears to be focused on the Atlantic provinces. New Brunswick had the longest median wait times in Canada, at 41.7 weeks, followed by Nova Scotia (37.7 weeks) and P.E.I. (32.4 weeks). Ontario recorded the shortest wait times, at 15.6 weeks, which is a slight improvement from last year. The only other province that saw wait times reduced was Newfoundland and Labrador, which dropped to 21.5 weeks from 26 weeks. Waiting too long for important procedures can have serious consequences for patients, the report warns, including lost wages, pain and worsened medical outcomes. “The simple answer of why these wait times have increased and why nothing’s really changed is because we haven’t seen any significant shift in policy to address the situation,” Bacchus Barua, associate director of health policy studies at the Fraser Institute, told CTV News Channel on Thursday. He said other countries with universal health-care systems have been able to manage wait times more effectively by partnering with private medical facilities, among other solutions. Barua said wait times not only prolong illness and pain for patients, but also have an economic impact since some people are unable to work while waiting for medical care. The survey also analyzed different types of procedures and found that orthopaedic surgery (41.7 weeks) and neurosurgery (32.9 weeks) had the longest times. Medical oncology had the shortest wait times, at 3.2 weeks. For diagnostic procedures, the report found that this year Canadians waited about 4.1 weeks for a CT scan, 10.8 weeks for an MRI and 3.9 weeks for an ultrasound.  
 

For more information: https://www.fraserinstitute.org/sites/default/files/waiting-your-turn-2017.pdf
 

Hep C World News - Week of November 26, 2017

Low skeletal muscle mass improves after successful HCV treatment

Mie Tsu, Japan - Skeletal muscle mass increased significantly among patients with hepatitis C and low skeletal muscle mass after achieving sustained virologic response with direct-acting antiviral therapy, according to recently published data. “Changes in body composition, such as the accumulation of visceral fat or thinness, are known to effect patients with chronic HCV including liver cirrhosis,” Ryosuke Sugimoto, MD, PhD, from the Mie University Graduate School of Medicine, Japan, and colleagues wrote. “An understanding of the various measurements of body composition, such as the amount of body fat and skeletal muscle mass, is required to properly examine liver disease patients.” The researchers enrolled 30 patients who achieved sustained virologic response after treatment with direct-acting antiviral therapy and had available body composition measurements. At the start of DAA therapy, 14 patients had chronic HCV, 16 had compensated cirrhosis, three had visceral obesity and nine had low skeletal muscle mass. Those with low skeletal muscle mass (LSM) had significantly lower BMI compared with the other patients. The patients had received nutritional counseling to address chronic liver disease for more than 6 months prior to DAA therapy. Researchers advised patients to engage in 20 minutes of aerobic exercise two to three times per week, though they did not confirm adherence.
 

For more information: https://tinyurl.com/yatkch96
 

Hep C World News - Week of November 19, 2017

Liver cancer risk reduced by 70% after HCV clearance   
 

Washington, DC - “Our results show that DAA-induced SVR is associated with a 71% reduction in HCC,” George N. Ioannou, MD, from the Veterans Affairs Puget Sound Healthcare System and the University of Washington, said in his presentation at The Liver Meeting 2017. “Eradication of HCV is associated with a similar reduction in HCC irrespective of the regimen that is used to achieve that eradication.” Ioannou presented data from the Veterans Affairs health care system, conducting a retrospective cohort study on patients who started antiviral therapies from 1999 through 2015 (n = 62,354). Of these, 58% (n = 35,871) received interferon only; 7% (n = 4,535) received interferon plus a DAA; and 35% (n = 21,948) received only DAAs. “We used data from the national VA health care system,” he said. “It’s the largest integrated health care system in the United States and also contains the largest number of patients with hepatitis C infection and the largest number of patients with hepatocellular carcinoma and cirrhosis.” The researchers followed these patients through June 15, 2017, with follow-up ranging from 2 to 18 years (mean follow-up = 6.1 years) and found 3,271incident cases of HCC. Ioannou defined incident HCC as an HCC diagnosis at least 180 days after initiation of HCV treatment. He said they did not include any within those 180 days because “these cancers most likely were present at the beginning of antiviral treatment and were clinically occult and there was no way the antiviral treatment could have influenced their incidence one way or the other.” He showed that the incidence of HCC was highest in patients with cirrhosis who also failed treatment (3.25 per 100 patient-years) Ioannou said their study “clearly shows that patients with SVR had a lower incidence of hepatocellular carcinoma, both among cirrhotic patients ... and among non-cirrhotic patients.” Additionally, he said this difference is only more obvious as follow-up continues. “The difference between the SVR and the no-SVR group, if anything, keeps increasing over time. The more years that accrue, the greater the difference in incidence of hepatocellular carcinoma between the SVR and the no-SVR group, both in the cirrhotic and the non-cirrhotic patients,” he said.
 

For more information: http://tinyurl.com/yd94rvtm
 

Hep C World News - Week of November 12, 2017

This is how to eliminate Hep C 
 

Cairo, Egypt – An estimated 600,000 Egyptians will be treated with DAAs to eliminate chronic hepatitis C this year using locally manufactured generic medicines, according to Waheed Dous, director of the National Institute of Endemic and Liver Diseases. His comments were made recently at a conference at Menoufia University. Two million people infected with HCV in Egypt were cured in recent years, Dous said. “The National Committee for the Control of Viral Hepatitis originally planned to treat 300,000 patients with hepatitis C virus every year, but currently we manage to treat 600,000 patients yearly,” he said. Locally  manufactured drugs are used to cure up to 98 percent of cases. Egypt does not need other new drugs, except in rare cases of Hep C. On September 16, 2017 the Minister of Health and Population Ahmed Rady said, "Egypt will become free of HCV this year, and the cost of treatment is less than the American price by one in a thousand. Now we are searching for patients in villages and towns to give them free treatment.” Since 2014, Egypt has increased the services provided to eliminate HCV following President Abdel Fatah al-Sisi’s initiative to treat 1 million HCV-infected patients annually. In 2014, a number of Egyptian companies started manufacturing local medications similar to Sovaldi to increase the chances of survival among infected patients by 90 percent. Although some 399,000 people die each year from HCV, according to the World Health Organization (WHO), more than 95 percent of patients can be cured by anti-viral medicines.
 

For more information: http://tinyurl.com/yd6ydxcq
 

Hep C World News - Week of November 5, 2017

UK elimination of hepatitis C in jeopardy unless more patients found 
 

Sao Paulo, Brazil - Just one in three people with hepatitis C in the United Kingdom has been diagnosed according to the latest estimates released at this year’s World Hepatitis Summit in São Paulo, Brazil (1-3 November). The estimate comes from a global synthesis of data on hepatitis C prevalence and diagnosis carried out by the Polaris Observatory, led by Dr Homie Razavi. The Polaris Observatory study shows that out of an estimated 162,000 people living with hepatitis C in the UK, only 62,200 (38%) are diagnosed. “Even these numbers overestimate how many people are available for treatment because the majority of the ‘diagnosed’ are not in touch with services for a variety of reasons”, says Charles Gore, CEO of the national hepatitis C charity, The Hepatitis C Trust, and also President of the World Hepatitis Alliance. “Many were diagnosed years ago. They were never informed how deadly hepatitis C can be and they do not know about the new drugs and how extraordinarily effective and easy to take they are.” The poor rates of diagnosis in the United Kingdom call into question the possibility of achieving the World Health Organization target of hepatitis C elimination by 2030, according to Dr Razavi. “To make the 2030 elimination target, at least 10,000 patients need to be treated each year, and there are already signs that it is becoming harder to find diagnosed patients to treat,” said Dr Razavi. “Although in 2016 some 10,000 people were treated and in 2017 this could reach 12,500, the projections suggest the annual total will drop to an estimated 5,000 patients treated per year by 2020 without better diagnosis and linkage to care.” When direct-acting antivirals were introduced in the United Kingdom treatment was tightly rationed in order to contain costs. As a result of large price reductions negotiated with pharmaceutical companies it has been possible to expand the number of people treated, but according to the World Hepatitis Alliance, some areas are already running out of patients to treat. Having vetoed two years ago a Hepatitis C Improvement Framework designed to improve diagnosis and linkage to care, the NHS is now scrabbling to put in place initiatives to do just that. According to Public Health England’s most recent report on hepatitis C, the number of tests carried out for hepatitis increased by around 20 to 25% between 2011 and 2015. Public Health England suggests that the World Health Organization’s European target of diagnosing 50% of people with hepatitis C by 2020 has already been met in England and Wales, and points to a high rate of testing among people who have ever injected drugs, the group with the highest hepatitis C virus prevalence in England and Wales. But, although hepatitis C virus prevalence is high among people who have injected drugs, anyone exposed to blood in the past could be infected. People who received blood transfusions or blood products prior to the introduction of screening in the United Kingdom in 1992, and people who have received blood or undergone medical procedures in countries with lower infection control standards, could be living with undiagnosed hepatitis C. “We have at least 100,000 people to find,” says Charles Gore. “If we don’t find them, not only will we never reach the goal of elimination, but significant numbers will die. To be honest, with these new drugs available, if anyone dies of hepatitis C, it should be viewed as an appalling failure of the system.”
 

For more information: http://www.infohep.org/page/3187129/
 

Hep C World News - Week of October 29, 2017

HCV-positive liver transplants possible  
 

Boston, MA - Results of a virtual trial showed that transplantation with hepatitis C-positive livers with preemptive direct-active antiviral therapy may be a viable option for improving patient survival on the liver transplant wait-list, according to Jagpreet Chhatwal, PhD, from the Massachusetts General Hospital and Harvard Medical School. Donor liver availability continues to be limiting factor in increasing the number of liver transplants. Under current guidelines, hep C-positive livers are not transplanted into hep C-negative recipients because of adverse post-transplant outcomes as observed during interferon-based therapies. Several things have changed in the last few years that prompted researchers to revisit this question. The researchers designed a simulated virtual trial to compare long-term outcomes of patients without HCV on the liver transplant wait-list who were willing to receive an HCV-positive liver with those only willing to accept HCV-negative livers. The trial model included data from published studies and the United Network for Organ Sharing. Model patients who received HCV-positive livers were treated preemptively with 12 weeks of DAA therapy. “Efficacy of preemptive treatment was based on data in hep C-positive recipients because we do not know any well-connected studies that show outcomes in hep C-negative recipients,” Chhatwal said at the recent 2017 Liver Meeting. “I should emphasize that our study is not based on any specific drug regimen, it’s only based on the [sustained virologic response] rate that matters in being offered the transplant.” Patients who were willing to accept livers that were either positive or negative for HCV had an increased life expectancy when their MELD score was at 20 or higher (range, 18-20, depending on UNOS region), compared with those who would only accept an HCV-negative liver. The clinical benefit was greatest in UNOS regions with the highest HCV-positive liver donor rates. According to Chhatwal, the model outcomes had robust results based on sensitivity analysis with a wide range of parameters. “Clinical trials are needed to confirm the efficacy of the results in this setting,” Chhatwal concluded. “In fact, our analysis can help inform future trials and minimize patient harm".

For more information: http://tinyurl.com/y8j284rb
 

Hep C World News - Week of October 22, 2017

New Hep C infections nearly tripled over five years  
 

Atlanta, GA - Over just five years, the number of new hepatitis C virus infections reported to CDC has nearly tripled, reaching a 15-year high, according to new preliminary surveillance data released today by the Centers for Disease Control and Prevention (CDC). Because hepatitis C has few symptoms, nearly half of people living with the virus don’t know they are infected and the vast majority of new infections go undiagnosed. Further, limited surveillance resources have led to underreporting, meaning the annual number of hepatitis C virus cases reported to CDC (850 cases in 2010 and 2,436 cases in 2015) does not reflect the true scale of the epidemic. CDC estimates about 34,000 new hepatitis C infections actually occurred in the U.S. in 2015. Hepatitis C kills more Americans than any other infectious disease reported to CDC. The data released today indicate that nearly 20,000 Americans died from hepatitis C-related causes in 2015, and the majority of deaths were people age 55 and older. “By testing, curing, and preventing hepatitis C, we can protect generations of Americans from needless suffering and death,” said Jonathan Mermin, M.D., director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. “We must reach the hardest-hit communities with a range of prevention and treatment services that can diagnose people with hepatitis C and link them to treatment. This wide range of services can also prevent the misuse of prescription drugs and ultimately stop drug use – which can also prevent others from getting hepatitis C in the first place.” New hepatitis C virus infections are increasing most rapidly among young people, with the highest overall number of new infections among 20- to 29-year-olds. This is primarily a result of increasing injection drug use associated with America’s growing opioid epidemic. However, the majority (three-quarters) of the 3.5 million Americans already living with hepatitis C are baby boomers born from 1945 to 1965. Baby boomers are six times more likely to be infected with hepatitis C than those in other age groups and are at much greater risk for death from the virus. While surveillance data do not accurately capture hepatitis C infection rates among infants, other recent CDC studies indicate that hepatitis C virus infections are growing among women of childbearing age – putting the youngest generation of Americans at risk. Hepatitis C treatment not only cures the vast majority of people living with the virus, but also prevents transmission to their partners and children. Comprehensive approaches are needed to combat the dual epidemics of opioid addiction and injection-related infectious diseases.
 

For more information: http://tinyurl.com/ycnglylh
 

Hep C World News - Week of October 15, 2017

Efficacy of Ravidasvir plus Sofosbuvir for Chronic Hep C Genotype 4 
 

Cairo, Egypt - Patients with chronic hepatitis C virus-genotype-4 (HCV-GT4) in countries with limited resources may have a new treatment option with the combination of ravidasvir (an NS5A inhibitor) plus sofosbuvir, with or without ribavirin, according to a phase 3 study published in the Journal of Hepatology. In one of the largest studies of interferon-free direct-acting antiviral treatment conducted in patients with HCV-GT4, 300 patients were randomly assigned to one of three groups according to their previous use of interferon and whether they had cirrhosis. Two of the groups received ravidasvir 200 mg daily plus sofosbuvir 400 mg daily and were randomly assigned 1:1 to treatment with or without weight-based ribavirin for 12 weeks. The third group received ravidasvir plus sofosbuvir with ribavirin and were randomly assigned 1:1 to a treatment duration of 12 weeks or 16 weeks. Overall, 95.3% of patients achieved the primary end point of sustained virologic response at 12 weeks posttreatment, including 98% of patients without cirrhosis and 91% of patients with cirrhosis, regardless of their history of interferon treatment. Concomitant treatment with ribavirin and previous interferon use did not affect the response rates. Combination treatment with ravidasvir and sofosbuvir was well tolerated, and most adverse events were mild and similar to those of other direct antiviral combination therapies. This was the first clinical trial evaluating the combination of ravidasvir plus sofosbuvir, with or without ribavirin, and the authors concluded that “RDV plus SOF is a promising new once-daily oral treatment that was well tolerated in a large group of HCV-G4 patients, with high rates of sustained virologic response in patients with and without cirrhosis.”
 

For more information: https://www.ncbi.nlm.nih.gov/pubmed/28935432
 

Hep C World News - Week of October 8, 2017

Universal drug plan could cut more than $4-billion a year  
 

Ottawa, ON - A national, universal pharmacare program that all but eliminates all out-of-pocket expenses for Canadians who need to fill their prescriptions could slash the overall price tag for drugs in this country by more than $4-billion a year. The parliamentary budget officer came up with that number in an analysis of the potential impact of a universal pharmacare program. The savings would come largely from the impact of bulk purchases of drugs, allowing Health Canada to negotiate better prices for most pharmaceuticals, as well as an increase in the use of generic drugs. However, the plan – which would replace all provincial and private drug plans – would still carry a price tag of more than $19-billion, and the federal government isn't exactly jumping up and down with excitement to do it. The government will analyze the report, but the current system needs work as it is before anything can be done about moving to a universal program, Bill Blair, the parliamentary secretary to the minister of health, said in question period. NDP health critic Don Davies said Canada is the only country that has a universal health-care program without an accompanying universal pharmacare system. Canada has some of the highest prescription drug costs in the world, outstripped among industrialized countries only by the United States and Mexico. "The high cost of pharmaceuticals is forcing too many Canadians to choose between filling their fridge and filling their prescriptions," Davies said in the House of Commons. In 2015, an Angus Reid poll found almost one in four Canadians chose not to fill or renew prescriptions, or skipped doses, because of the high cost of buying medicine. The PBO analysis found in 2015-16, about $28.5-billion was spent on pharmaceuticals in Canada, not including medicines provided to patients in hospitals. Provinces and the federal government paid for $13.1-billion of that, private insurance companies covered $10.7-billion and individual Canadians were on the hook for $4.7-billion. Using lists of drugs covered by provincial health plans, the PBO decided about $24.6-billion would be eligible for coverage by a national pharmacare program. The rest was spent on drugs that are not currently covered. Every province has its own list of drugs which are covered by provincial pharmacare programs and the PBO used Quebec's list for this analysis. Looking at the various options for cost savings, the PBO believes a national pharmacare program could have cut the annual costs of those drugs to $20.4-billion. Under the universal pharmacare program, Ottawa would be on the hook for $20-billion of that, while individual Canadians would pay about $400-million. The PBO says Ottawa already spent about $645-million in 2015-16 on drugs for people it has responsibility for, including First Nations, veterans, RCMP officers, members of the military, refugees and federal prisoners. So the net increased cost to Ottawa would have been $19.3-billion. By 2021, that net increased cost would rise to $22.6-billion. The PBO looked at the costs of a plan that would be universal for all Canadians, replace provincial and private drug plans, and significantly cut out-of-pocket drug expenses. Under such a plan, seniors, kids, pregnant women, people with disabilities and those receiving employment insurance or welfare would have no out-of-pocket expenses. Everyone else would pay a maximum of $5 for a prescription of a brand name drug. Generic drugs would be free for everyone. Provinces, for whom prescriptions have become the second most costly part of the health budget, have been pushing Ottawa for a national pharmacare program. Prime Minister Justin Trudeau has not committed to the idea. He has directed his health minister only to work with the provinces to increase bulk buying of drugs in order to cut costs. "Let me make it clear," Blair said. "We need to make sure Canada's existing prescription drug system is more efficient and responsive before we can begin to discuss universal drug coverage."
 

For more information: http://tinyurl.com/y935qh3g
 

Hep C World News - Week of October 1, 2017

The 8-week cure for Hepatitis C   
 

Silver Spring, Maryland - In less than a month, the FDA approved a second medication for hepatitis C virus (HCV) infection. The newer entry into the treatment arena is the first drug capable of suppressing viral load to undetectable levels in only 8 weeks. Marketed as Mavyret, the recently approved medication is a combination of glecaprevir and pibrentasvir. Clinical trials involving about 2300 adults with any of the 6 HCV genotypes showed that 92% or more who received the combination for 8, 12, or 16 weeks had no detectable virus in their blood 12 weeks after treatment ended, suggesting their infections were cured.
 

For more information: http://tinyurl.com/y9bayeoa
 

Hep C World News - Week of September 24, 2017

Women injecting drugs at higher risk for HCV than men  
 

Albuquerque, New Mexico - Women who inject drugs are about 39% more likely to become infected with hepatitis C virus than men who inject drugs, research suggests. A range of factors could account for the disparity, the researchers wrote in Clinical Infectious Diseases. “Our findings provide important evidence that sex disparities in HCV acquisition exist independent of selected behavioral risk and demographic factors,” researcher Kimberly Page, PhD, MPH, division chief of the department of internal medicine at the University of New Mexico Health Sciences Center, and colleagues wrote. “When considering HCV risk differential among women, multiple factors including biological, social and network factors — as well as differential access to prevention services — need to be considered.” The researchers assessed data from seven of the 10 InC3 Collaborative studies of HIV and HCV among people who inject drugs (PWID), which included locations in the United States, Europe and Australia. Page and colleagues included data from 1,868 PWID, 590 (31.58%) of whom were women. No data from participants who reported being transgender were assessed. In all, the researchers found 511 PWID with incident HCV during follow-up. Of those, 182 (31.5%) were female. The unadjusted female-to-male HR for HCV infection was 1.38 (95% CI, 1.15-1.65). The disparity remained significant after adjustment for behavioral and demographic risk factors, the researchers said, slightly rising to 1.39 (95% CI, 1.12-1.72). Page and colleagues cited previous studies suggesting biological and social factors that may help to explain the difference. “All of these factors should be studied further to better understand sex-related differences in risk and to maximize prevention effects of drug treatment programs and their potential to reduce acquisition of blood-borne viruses, including HCV and HIV,” they wrote.
 

For more information: http://tinyurl.com/y6u3tz6j
 

Hep C World News - Week of September 17, 2017

Gilead receives approval in Canada for expanded indication of EPCLUSA®   
 

Mississauga, ON - Gilead Sciences Canada, Inc. announced that Health Canada has granted a Notice of Compliance (NOC) for updated labeling of EPCLUSA® (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV-1. Health Canada granted EPCLUSA an NOC in July 2016, for the treatment of adults with genotype 1-6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin. "HCV co-infection remains a major cause of morbidity in HIV-infected individuals. With this expanded indication, EPCLUSA provides co-infected patients with a much-needed one-pill-a-day regimen that works across all HCV genotypes and at all stages of disease. Being compatible with most widely-used antiretroviral regimens adds to its convenience," said Dr. Brian Conway, President and Medical Director, Vancouver Infectious Diseases Centre. "With EPCLUSA, physicians have an important new treatment option for their HCV/HIV co-infected patients." The supplemental new drug submission was supported by data from the open-label, Phase 3 ASTRAL-5 study, which evaluated 12 weeks of treatment with EPCLUSA in 106 subjects with genotype 1-4 HCV infection who were co-infected with HIV and on stable antiretroviral therapy. In the study, 95 per cent (101/106) of patients achieved the primary endpoint of SVR12, defined as an undetectable viral load 12 weeks after completing therapy. The study also included patients with compensated cirrhosis. The safety profile of EPCLUSA in HCV/HIV co-infected patients was similar to that observed in HCV mono-infected patients. The most common adverse events (in at least 10 per cent of subjects) were fatigue (22 per cent) and headache (10 per cent). "Canada has committed to eliminating hepatitis C by 2030. To accomplish this goal, it is imperative that steps be taken to increase treatment rates in Canada, including treatment for people who are co-infected with hepatitis C and HIV," said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and Hepatologist at Toronto General Hospital. "Hepatitis C progresses faster in individuals who are co-infected with HIV, often increasing and speeding up the onset of liver damage. Today, with pan-genotypic curative hepatitis C therapies approved for treatment in hepatitis C and HIV co-infected patients, it is an important time for patients to discuss treatment options with their health care providers." "EPCLUSA has already helped further simplify HCV treatment among mono-infected patients, and we are pleased that HCV/HIV co-infected patients can benefit from this pan-genotypic single tablet regimen," said Kennet Brysting, General Manager, Gilead Canada. "This approval advances the commitment we've made to the HCV and HIV communities to deliver innovative new treatments that address their unmet medical needs."
 

For more information: http://tinyurl.com/y9yn2525
 

Hep C World News - Week of September 10, 2017

Health minister says Ontario to invest $222M over 3 years on opioid crisis  
 

Toronto, ON - There were 865 opioid deaths in the province in 2016, a 19% increase, Ontario's chief coroner says Ontario Health Minister Eric Hoskins says the provincial government will invest $222 million over three years to improve access to harm reduction services and addiction treatment amid an opioid crisis in the province. "This is a public health crisis, provincially and nationally," added Hoskins. "This is a national crisis comprised of literally thousands of individual tragedies. Each life lost represents a valued individual, individuals that I view with decency, with respect, with dignity and with worth." There were a total of 865 opioid deaths in the province in 2016, a 19 per cent increase from the previous year, Ontario's chief coroner Dr. Dirk Huyer said Tuesday. The funding will be used to hire more front-line harm-reduction workers, expand the supply of naloxone, and create new rapid access addiction clinics. Naxolone is medication used to block the effects of opioids. Zoe Dodd, a harm reduction worker, told reporters on Monday: 'We cannot afford to lose any more people and we are losing people at an alarming rate.' Hoskins said he, along with The announcement comes a day after more than 700 health care workers called on the province to declare an emergency due to a "disturbing" increase in overdose deaths. Hoskins said he decided not to declare a provincial emergency because the Ontario government already has the tools it needs to fight the opioid crisis, but has "answered that call with a highly substantial increase in funding." Funding will go towards hiring more front-line harm-reduction workers, expanding the supply of naloxone, and creating new rapid access addiction clinics.  A provincial emergency is typically short-term and short-lived and has a beginning and an end, he explained. "This is a long term crisis and it's one that we need to fight and fight vigorously. But it is not finite." Many of the deaths due to opioid use disorder involve young people, according to Huyer.  "There's a horrible number of deaths and many young people dying," he said. Dr. David Williams, Ontario's chief medical officer of health and provincial overdose co-ordinator, told reporters that the crisis is "complex and multi-faceted. One of the best things we can do to help those struggling with addiction is ensure that when the people reach out for help, it's there for them," Williams said. The funding includes: More than $15 million to support health-care providers on appropriate pain management and opioid prescribing; More than $7.6 million to increase addictions treatment in primary care; $70 million in long-term support for people who have addiction disorders; $9 million to add more front-line harm-reduction outreach workers in communities across the province; And, beginning in 2018-19, $20 million over two years for specialized support for Indigenous communities and appropriate care for youth. Hoskins said the government will continue to consult health care workers in the coming months if more action is needed. "The lives of drug users and people living with addiction matter," he said.
 

For more information: http://tinyurl.com/yb6q8n32
 

Hep C World News - Week of September 3, 2017

Ottawa rejects expert calls to decriminalize illegal opioids   
 

Ottawa, ON - Ottawa says it has no plans to consider decriminalizing hard drugs, such as heroin, despite calls from local politicians, health officials and experts who argue such radical action is needed to combat the overdose epidemic that first hit British Columbia and is now a national crisis. Vancouver’s mayor became the latest person to advocate for this shift in drug policy after new statistics showed his city had already surpassed last year’s overdose death toll of 231 people. But a spokesperson for federal Health Minister Jane Philpott says Canada is focused on legalizing cannabis not decriminalizing other, more deadly illicit drugs. “Our government is currently working on the legalization, strict regulation, and restriction of access to cannabis, in order to keep it out of the hands of youth, and profits out of the hands of criminals,” spokesperson Andrew MacKendrick said in an e-mailed statement late last week. “We are not looking to decriminalize or legalize other illicit substances at this time.” Ms. Philpott, who was unavailable for an interview last week, told the annual general meeting of the Canadian Medical Association on Monday that the federal response to the “unprecedented national public-health emergency” of increasing opioid deaths includes a commitment to harm reduction, facilitating access to supervised consumption sites and making naloxone available without prescription. Late last month, Ms. Philpott and Justice Minister Jody Wilson-Raybould travelled to Portugal, along with Canada’s chief public health officer, to learn more about how that country drastically improved its addiction and overdose rates after it decriminalized personal possession of all drugs in 2001. Ottawa could make a similar shift, but should first strike a new federal commission to study regulating all illicit drugs, according to a key recommendation from the final report of Canada’s Drug Futures Forum, a two-day meeting in April of more than 200 scientific experts, front-line workers, politicians and people who use drugs. That report, written to create a long-term vision for drug policy in Canada, states that the federal government should establish an independent body to: “conduct a cost-benefit analysis of current drug-control policies; explore potential steps toward decriminalization, legalization and regulation of each class of currently illegal drugs; and consider formal acknowledgment and redress for harms of drug-prohibition policies.” Dan Werb, co-organizer of the forum and director of the Toronto-based International Centre for Science in Drug Policy, said it is hypocritical for the Prime Minister to argue that marijuana must be legalized so that the government can better control its danger to public health and safety when deadly opioids are being deliberately kept in the black market. Plus, he argued, Ottawa has already begun the de facto regulation of heroin by bolstering a program to prescribe pharmaceutical-grade doses of the drug to severe addicts. “What we’re going to see in Canada within a year is what is widely understood to be the most dangerous drug – heroin – and the most benign drug cannabis both the subject of regulation,” Dr. Werb said. “So then the question is what about the drugs in the middle?”
For now, Ottawa is not interested in forming an arm’s-length body to study the controversial question of decriminalizing or legalizing more drugs, the Health Minister’s spokesperson said in an e-mailed statement.
 

For more information: http://tinyurl.com/ycaaaqsf
 

Hep C World News - Week of August 27, 2017

Women who inject drugs may be at greater risk of HCV than men  
 

Washington, DC - There is a clear body of research assessing sex and gender differences in risk behaviors among people who inject drugs, however little or no research has investigated sex differences in hepatitis C (HCV) susceptibility. A newly published analysis examining data from more than 1800 people suggests that women who inject drugs have a 38% higher risk of contracting HCV than their male counterparts. Interestingly, while sharing of syringes and other injection equipment is a significant risk factor for HCV, differences in these behaviors did not account for the higher risk among women. The research was funded by the National Institute on Drug Abuse (NIDA), part of the National institutes of Health. The analysis used data from the International Collaboration of Incident HIV and HCV in Injecting Cohorts, a project of pooled biological and behavioral data from ten prospective cohorts of people who inject drugs, including the United States, Australia, Canada and the Netherlands. This study includes data from seven of the 10 cohorts. The results underscore the need for research to better understand the behavioral, social and biological factors that contribute to higher HCV susceptibility in women. For example, it is unclear why enrollment in medication assisted treatment programs for opioid addiction reduced the risk for contracting HCV to a greater extent in men than in women. In addition, studies are needed to determine if differences in hormonal activity or immune cell composition between the sexes contribute to these findings. Understanding the reasons behind the difference in risk can help with future, more tailored HCV prevention approaches by the public health community.
 

For more information: http://tinyurl.com/y782ba36
 

Hep C World News - Week of August 20, 2017

Post DAA therapy HCV liver transplant survival improves  
 

Stanford, CA - Researchers found that survival rates improved among patients who underwent liver transplant for chronic hepatitis C after direct-acting antiviral therapy. “In the past, pre-emptive treatment of recurrent HCV infection in LT recipients with interferon-based regimens was not pragmatic due to sub-optimal sustained virological response (SVR) rates and poor adverse effects profile,” George Cholankeril, MD, from Stanford University School of Medicine, and colleagues wrote. “In contrast, the second generation direct-acting antiviral (DAA) agents are highly efficacious and well-tolerated by HCV-infected LT recipients.” The researchers reviewed the outcomes of liver transplant for chronic HCV as reported in the United Network for Organ Sharing database from 2011 to 2012 – the pre-DAA era – and from the DAA era of 2014 to 2015. They excluded 2013 as a 1-year overlap of follow-up. The study comprised 3,672 patients from the pre-DAA era and 3,855 from the DAA era and excluded patients with hepatocellular carcinoma. Both 1-year post-transplant survival and graft survival were significantly higher among patients from the DAA era (91.9% vs. 89.9%; P < .001). Further, researchers observed an association between the DAA era and a 34% reduction in 1-year post-transplant mortality (HR = 0.66; 95% CI, 0.6-0.72). The data showed no significant difference in either 1-year patient or graft survival between eras among non-HCV liver transplant patients. Compared with patients undergoing liver transplant for HCV, patients who underwent liver transplant for non-HCV indications in 2011 (91.2% vs. 88.6%; P < .001) and 2012 (92.5% vs. 89.4%; P < .001) had greater 1-year survival, whereas after 2013 there was no significant difference in the rates. “The reduction in HCV-related post-LT mortality and graft failure may be a result of efficacious peri-transplant therapeutic options available to prevent and treat complications including fibrosing cholestatic hepatitis (FCH). FCH is noted in up to 10% of HCV LT recipients presenting as rapidly progressive cholestatic liver disease leading to rapid graft loss and increased mortality,” the researchers wrote. “DAA-based regimens have proven to be effective in preventing post-LT complications of recurrent HCV infection”.
 

For more information: http://tinyurl.com/ydfhd4uj
 

Hep C World News - Week of August 13, 2017

Gilead receives approval in Canada for VOSEVI™   
 

Mississauga, ON - Gilead Sciences Canada, Inc. announced that Health Canada has granted a Notice of Compliance for VOSEVI (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets for re-treatment of certain patients with Hep C. VOSEVI is a pan-genotypic single-tablet regimen for adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1, 2, 3 or 4 previously treated with sofosbuvir-containing regimen without an NS5A inhibitor. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies that evaluated 12 weeks of VOSEVI in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis. "HCV treatment has been transformed by effective direct-acting antiviral regimens, allowing health care providers the opportunity to cure many patients. However, for those patients who have failed with prior therapy, there remains an unmet clinical need for an effective and well-tolerated option," said Dr. Stephen Shafran, Professor of Medicine, Division of Infectious Diseases, University of Alberta. "VOSEVI Phase 3 clinical studies have resulted in high cure rates among patients who were not previously cured with several widely-prescribed DAA regimens, providing physicians with an important new therapeutic option that could offer hope for their hardest-to-cure patients." VOSEVI is the latest single-tablet regimen in Gilead's portfolio of sofosbuvir-based DAA treatments that offer people living with HCV a short course of therapy to cure their HCV infection, with the convenience associated with once-daily single-tablet regimens. Since 2013, Gilead has brought to market four HCV treatments, including three single-tablet regimens. To date, more than an estimated 1.5 million patients worldwide have been prescribed sofosbuvir-based regimens. "The evolution of Gilead's portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible," said Kennet Brysting, General Manager, Gilead Canada. "The approval of VOSEVI in Canada completes our HCV portfolio and this will enable the company to commit to collaborative partnerships that will help drive progress towards the goal of eliminating HCV in Canada by 2030."
 

For more information: http://tinyurl.com/y94rem3x
 

Hep C World News - Week of August 6, 2017

Research shows indigenous peoples have higher rates of hep C  
 

Lafayette, CO - A new meta-analysis of global hepatitis data -- presented at this year's World Indigenous Peoples' Conference on Viral Hepatitis in Anchorage, Alaska, USA (8-9 August) -- shows that Indigenous Peoples are up to 10 times more likely to be infected by viral hepatitis than the general population in their respective countries. The analysis is presented by Dr Homie Razavi and Devin Razavi-Shearer, The Polaris Observatory*, Lafayette, CO, USA. Both hepatitis B and hepatitis C are viral infections, which, if left untreated, can cause serious liver damage, liver cancer, and ultimately death. Both can be transmitted through contact with the blood of an infected person, sexual transmission, injection drug use, unsafe medical procedures and tattooing where equipment has not been sterilized. Hepatitis B is also commonly sexually transmitted. For hepatitis C, people who received a blood transfusion before 1992 when universal blood screening practices were introduced in most high-income countries, are also at risk. An estimated 71 million people worldwide have chronic hepatitis C infection; for hepatitis B the numbers are higher at 257 million. Most people with hepatitis B virus are adults infected before the hepatitis B vaccine became widely available. In this new research, the authors reviewed prevalence of both viruses in the Indigenous Peoples and general populations of North America, South America, Australia, and New Zealand. For hepatitis C, data that could be extrapolated to the general population was found for 11 countries and included 23 specific Indigenous Peoples and nations as well as 12 more broad groupings, covering the period from 1991 onwards. In Canada hepatitis C rates among the Inuit and Métis are 3 times higher than the general population. "The higher prevalence of anti-HCV observed in Indigenous Peoples and nations can be the result of disproportionately high rates of poverty, injection drug use, and incarceration. This, in combination with the lack of access to healthcare and prevention measures, greatly increases the risk and thus prevalence of hepatitis C," said the authors.
 

For more information: http://tinyurl.com/ycv6qtym
 

Hep C World News - Week of July 30, 2017

HCV eradicated in patients of infected kidney transplants  
 

Philadelphia, PA - In September 2016, researchers at Penn Medicine reported on the results of a clinical trial in which kidneys from hepatitis C virus (HCV)-positive donors were transplanted into 10 patients on the kidney waiting list. All 10 of the patients were cured of HCV following the transplants, and the trial was extended, with 10 more patients being enrolled in a similar trial at Johns Hopkins University. In April of this year, the researchers announced that an additional 10 kidney transplant recipients had been cured of HCV. There are more than 97,000 patients in the United States waiting for kidney transplants. “We estimate that as many as 1,000 additional kidney transplants could happen each year if transplant centers and organ procurement organizations aggressively pursued the use of every viable HCV-infected kidney from a deceased donor,” Peter Reese, MD, assistant professor of medicine and epidemiology at Penn and the chair of the ethics committee for the United Network of Organ Sharing (UNOS), said.  In the pilot study, the researchers recruited patients who were on dialysis due to the extensive damage to their kidneys. The participants were educated about the risks associated with the trial before beginning the process of enrollment. All of the participants had been on the waiting list for a transplant for a minimum of 18 months, and were between the 40 and 65 years old. The average wait for study participants to receive a kidney was 58 days. Once the transplant was complete, the patients began a standard, 12-week course of elbasvir/grazoprevir (Zepatier). Zepatier is a direct acting antiviral (DAA) approved by the US Food and Drug Administration (FDA) to treat HCV genotypes 1 — the most common form of the virus in the US — and 4 in January 2016. It is often used to treat non-transplant patients, Reese said. David S. Goldberg, MD, assistant professor of medicine and epidemiology in the Perelman School of Medicine at the University of Pennsylvania, and trial co-leader, presented early data from the study at the 2017 American Transplant Congress in Chicago. Simultaneously, the team published a letter describing the trial in the New England Journal of Medicine. Reese said the team anticipated submitting results, "including outcomes for the second group of kidney transplant recipients, for publication in winter 2017.” The next step for the researchers is two-fold: larger trials of kidney transplants and a trial for heart transplants. In the future trials of HCV-positive kidney transplants, the researchers may modify the inclusion criteria in order to increase the the number of participants, such as making consider to whether or not the patients should be required to already be on dialysis.
 

For more information: http://tinyurl.com/y9nqzg5u
 

Hep C World News - Week of July 23, 2017

Primary care providers can treat Hep C  
 

Boston, MA - Primary care physicians and nurse practitioners can achieve cure rates matching those of liver disease specialists Primary care providers can successfully manage direct-acting antiviral (DAA) treatment for hepatitis C, though some complicated cases should still be referred to specialists, experts say. Recent studies have shows that hepatitis C treatment by primary care physicians and nurse practitioners can result in cure rates similar to those achieved by hepatologists and infectious disease specialists. Increasing the number of providers is key to expanding access to effective new therapies. "There is no reason that a primary care provider cannot successfully treat the uncomplicated patient with chronic hepatitis C," said Raymond Chung, MD, chief of hepatology at Massachusetts General Hospital in Boston. However, it is important that prospective treaters receive proper education and training first." The advent of DAAs has made treatment of chronic hepatitis C shorter, easier, and much more effective compared with the old interferon-based therapy. Because of its complexity and poor tolerability, interferon treatment was typically handled by hepatologists, gastroenterologists, or infectious disease specialists. Treatment was usually deferred until patients were found to have advanced liver fibrosis or cirrhosis, which required liver biopsies. Viral load was monitored frequently to determine which patients were responding to therapy and which ones could stop treatment that was unlikely to work. In addition to interferon and ribavirin, various adjunct therapies -- ranging from antidepressants to blood transfusions -- were often needed to manage side effects. Today, using interferon-free DAA regimens, treatment duration has fallen from a year to 8 or 12 weeks, and sustained virological response (SVR) rates exceed 95% even for hard-to-treat patients. A growing number of experts maintain that all hepatitis C patients should be treated, and that biopsies are no longer necessary. "The short duration of therapy and the few serious adverse events related to the new hepatitis C medications present an opportunity to expand the number of mid-level practitioners and primary care physicians in the management and treatment of HCV infection," according to HCV guidelines developed by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA). Some people may find it difficult to follow-up on referrals to specialists after a hepatitis C diagnosis. Seeing additional providers can involve extra time, effort, and expense. But this may not be necessary if patients can be treated by their regular care provider -- if they have one -- or in locations where they receive other health and social services, such as in methadone clinics or homeless shelters. "We have seen a sizable number of patients diagnosed with HCV who fail to follow through with visits to specialists who might otherwise benefit from HCV care centered in their primary care provider's office," Chung said. The influx of patients seeking these new therapies has led to a backlog. Access to treatment has been limited not only by the high price of DAAs and the restrictions imposed by some private insurers and public payers, but also by the lack of enough specialists to treat everyone. This shortage is expected to only worsen with stepped-up efforts to encourage all baby boomers and others at risk to get tested for HCV. "Hepatologists and infectious disease specialists alone cannot carry the burden of treating the estimated 3.5-plus million people living with HCV in the United States," said Emalie Huriaux of Project Inform, an HIV and hepatitis C treatment advocacy group. "Advocates must demand that health insurers currently imposing prescriber restrictions, by only allowing specialists to prescribe treatments that cure HCV, remove these restrictions immediately." Studies show that many, or even most, hepatitis C patients do not need to be treated by specialists in the DAA era.
 

For more information: http://tinyurl.com/yc5cqm2g
 

Hep C World News - Week of July 16, 2017

FDA approves Vosevi for Hepatitis C   
 

Silver Spring, Maryland - The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A. “Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV. Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. According to the Centers for Disease Control and Prevention, an estimated 2.7 to 3.9 million people in the United States have chronic HCV. Some patients who suffer from chronic HCV infection over many years may have jaundice (yellowish eyes or skin) and develop complications, such as bleeding, fluid accumulation in the abdomen, infections, liver cancer and death. There are at least six distinct HCV genotypes, or strains, which are genetically distinct groups of the virus. Knowing the strain of the virus can help inform treatment recommendations. Approximately 75 percent of Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small number of patients are infected with genotypes 4, 5 or 6. The safety and efficacy of Vosevi was evaluated in two Phase 3 clinical trials that enrolled approximately 750 adults without cirrhosis or with mild cirrhosis. The first trial compared 12 weeks of Vosevi treatment with placebo in adults with genotype 1 who had previously failed treatment with an NS5A inhibitor drug. Patients with genotypes 2, 3, 4, 5 or 6 all received Vosevi. The second trial compared 12 weeks of Vosevi with the previously approved drugs sofosbuvir and velpatasvir in adults with genotypes 1, 2 or 3 who had previously failed treatment with sofosbuvir but not an NS5A inhibitor drug. Results of both trials demonstrated that 96-97 percent of patients who received Vosevi had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured. Treatment recommendations for Vosevi are different depending on viral genotype and prior treatment history.
The most common adverse reactions in patients taking Vosevi were headache, fatigue, diarrhea and nausea. Vosevi is contraindicated in patients taking the drug rifampin. Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. HBV reactivation in patients treated with direct-acting antiviral medicines can result in serious liver problems or death in some patients. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with Vosevi. The FDA granted this application Priority Review and Breakthrough Therapy designations. The FDA granted approval of Vosevi to Gilead Sciences Inc. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 

For more information: http://tinyurl.com/ycwm657b
 

Hep C World News - Week of July 9, 2017

Hep C patients not covered for treatment putting others at risk

Halifax, NS - Canada's pledge to eliminate hepatitis C by 2030 could be undermined by Nova Scotia's model of coverage for treatment, says an advocate for those with the virus. Roughly 5,000 Nova Scotians are living with hepatitis C, a virus that infects the liver and can cause liver damage and cancer. In May, a new treatment that researchers have hailed as a cure was added to Nova Scotia's pharmacare program. But Alexandra MacDonnell, executive director of the Hepatitis Outreach Society of Nova Scotia, said not everyone infected with the virus is eligible for treatment under the program. "There's a whole group of people that we're missing who are still able to transmit the virus, so it's hard to eliminate the virus when we're not treating everybody," MacDonnell told CBC's Information Morning. 'They're just not being cured' In Nova Scotia, those with stage two fibrosis from hepatitis C — which means the infection has caused some liver damage, possibly resulting in flu-like symptoms — as well as more advanced stages of the virus, are eligible for coverage. Patients in the earlier stages of the virus are not eligible except in certain circumstances, even though they can still transmit hepatitis C. Infection can be spread through tattoo needles, intravenous drug use, unprotected sex and other forms of blood-to blood contact. MacDonnell said the eligibility requirements may be motivated by cost but are counterproductive from the standpoint of public health. "No other illness really waits until you're more sick [before offering treatment]," she said. "You're missing a group of people when it comes to clearing the virus, so these people are still able to transmit the virus, but they're just not being cured right now." The Department of Health and Wellness has not commented. MacDonnell said treatment for hepatitis C can cost between $60,000 and $110,000 for a 12-week course of medication. Coverage is an important advancement in public health, she said. "The World Health Organization states that by 2030 they want to eliminate hepatitis, so it's a great first step towards that," she said.

For more information: http://tinyurl.com/y94z8vqv
 

Hep C World News - Week of July 2, 2017

Financial incentives increase adherence in HIV patients 
 

New York, NY - Gift cards used as financial incentives significantly increased viral suppression and continuity in care among patients with HIV, according to a recent study published in JAMA Internal Medicine. The study, HPTN 065, is the largest to date that examines the effect of financial incentives on HIV–related care outcomes, according to Wafaa El-Sadr, MD, MPH, of the Mailman School of Public Health at Columbia University, and colleagues. For the study, the researchers randomly designated 37 HIV test centers and 39 HIV care centers in the Bronx, New York, and Washington D.C. — two areas in the U.S. severely affected by HIV — as sites offering financial incentives or standard of care. The financial incentives included coupons redeemable for two cash-equivalent gift cards — one totaling $25 for getting blood drawn for HIV–related tests, and another totaling $100 for meeting with a clinician to develop a care plan — for patients who tested positive at a financial incentive site. Meanwhile, those with viral suppression on ART were eligible for a $70 gift card once every 3 months. The incentives were offered from April 2011 to December 2012 at the HIV test sites and from February 2011 to January 2013 at the HIV care sites. Over the study period, 1,061 coupons were distributed for linkage to care at 18 financial incentive sites, and 39,359 gift cards were awarded to 9,641 eligible patients at 17 financial incentive sites. Although the overall percentage of patients with viral suppression increased during the study period at both financial incentive and standard-of-care sites, the proportion of patients with viral suppression was 3.8% higher at the financial incentive care sites. “While seemingly modest, an increase of 4% in viral suppression with financial incentives may potentially have considerable clinical and preventive implications on a population level, particularly in settings and among patients with less robust viral suppression,” the researchers wrote. El-Sadr and colleagues noted that the use of financial incentives to motivate behavior is controversial; however, they took measures to avoid “untoward consequences.” They added that additional analyses are needed to determine the cost-effectiveness of offering financial incentives to patients.
 

For more information: http://tinyurl.com/yab8swkz
 

Hep C World News - Week of June 25, 2017

People who use drugs have same treatment adherence as non users   
 

Dublin, Ireland - Outcomes from a large 10 year hepatitis C treatment programme in people who inject drugs found no effect of recent or former injecting drug use on treatment adherence or therapeutic response People who inject drugs (PWID) are historically viewed as having “difficult to treat” hepatitis C disease, with perceived inferior treatment adherence and outcomes, and concerns regarding reinfection risk. We evaluated for differences in treatment adherence and response to Peginterferon-alfa-2a/Ribavirin (Peg-IFNα/RBV) in a large urban cohort with and without a history of remote or recent injection drug use. Patient data was retrospectively reviewed for 1000 consecutive patients—608 former (no injecting drug use for 6 months of therapy), 85 recent (injecting drug use within 6 months) PWID, and 307 non-drug users who were treated for chronic hepatitis C with Peg-IFNα/RBV. The groups were compared for baseline characteristics, treatment adherence, and outcome. There was no significant difference in treatment non-adherence between the groups (8.4% in PWID vs 6.8% in non-PWIDs; RR = 1.23, CI 0.76–1.99). The overall SVR rate in PWID (64.2%) was not different from non-PWIDs (60.9%) [RR = 1.05, 95% CI 0.95–1.17]. There was no significant difference in SVR rates between the groups controlling for genotype (48.4% vs 48.4% for genotype 1; 74.9 vs 73.3% for genotype 3). Former and recent PWID had similar adherence rates. People who inject drugs have comparable treatment adherence and SVR rates when compared to non-drug users treated with Peg-IFNα/RBV. These data support a public health strategy of HCV treatment and eradication in PWID in the DAA era.
 

For more information: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0178398
 

Hep C World News - Week of June 18, 2017

More Work Needed to Diagnose, Treat Viral Hepatitis Worldwide  
 

Geneva,Switzerland - Just 20% of people with hepatitis C have been diagnosed, and only 7% have been treated. An estimated 71 million people worldwide were living with hepatitis C and 257 million with hepatitis B, in 2015, but only a small fraction have been tested and treated, according to a new report from the World Health Organization (WHO). Viral hepatitis was responsible for 134 million deaths in 2015 -- more than the mortality due to HIV and comparable to that for tuberculosis, according to the "Global Hepatitis Report, 2017." And while HIV and TB deaths are on the decline globally, viral hepatitis deaths continue to rise. Hepatitis B can be prevented with a vaccine, and effective new therapies can now cure most patients with hepatitis C. Widespread vaccination, treatment, and harm-reduction efforts could potentially eliminate viral hepatitis as a public health crisis, but these are not yet reaching enough people, experts said. "We're moving toward elimination, but we still have a long way to go," Gottfried Hirnschall, MD, director of WHO's Global Hepatitis Programme, told reporters at the recent International Liver Congress in Amsterdam, the annual meeting of the European Association for the Study of the Liver (EASL). "There are still millions who do not know they are infected. There are good [hepatitis C] treatments out there, but they're not getting to everyone who needs them," he said. The report -- which provides the first global and regional viral hepatitis estimates -- focuses on hepatitis B and C, which are mainly transmitted by contact with blood, often through sharing syringes used to inject drugs. The hepatitis B and C viruses (HBV and HCV) can also be transmitted from mother to child during pregnancy, and less often through sex. Over years or decades, chronic hepatitis B or C can cause serious liver damage, including cirrhosis and liver cancer. Most viral hepatitis-related mortality is attributable to liver cirrhosis (720,000 deaths in 2015) or hepatocellular carcinoma (470,000 deaths), the report says. Hepatitis A, which is spread through contaminated food and water, resolves on its own and is rarely fatal. "Today, 325 million men, women, and children are living with a cancer-causing illness despite the availability of preventative vaccines for hepatitis B and curative treatments for hepatitis C," said World Hepatitis Alliance CEO Raquel Peck. "We need to use this report to advocate for a public health approach, so that testing and treatment are rolled out at the scale necessary to ensure that every person has the opportunity to live a healthy life." Both hepatitis A and B can be prevented with vaccines, which are now routinely recommended for infants in many countries, including the United States. Globally, 84% of children born in 2015 received all three hepatitis B vaccine doses, although less than 40% got the recommended birth dose that can prevent perinatal transmission. Widespread vaccination has reduced the proportion of children newly infected with HBV from 4.7% to 1.3%, according to the report. WHO estimates that 9% of people with hepatitis B (22 million) had been diagnosed in 2015, and 8% of those diagnosed (1.7 million) had received treatment. Hepatitis B can be controlled with antiviral drugs such as tenofovir (Viread), but these seldom lead to a cure and typically require long-term treatment. There is currently no vaccine for hepatitis C, but it can be prevented by avoiding re-use of medical equipment and through harm-reduction services that provide sterile syringes and other equipment to people who inject drugs. However, prevention coverage is inadequate, as indicated by the approximately 1.75 million new HCV infections in 2015, the report said. The new hepatitis C prevalence estimate of 71 million is about half the previous estimate of 130 million to 150 million. The decline is primarily attributable to the use of HCV RNA or viral load testing, which gives a better indication of current active infection than do HCV antibody tests, which reveal past exposure. Some people naturally clear the infection and others clear it with treatment, and so are no longer chronically infected. Hepatitis C prevalence estimates range from 0.5% (10 million cases) in Southeast Asia to 2.3% (15 million cases) in the Mediterranean region, the report says. WHO estimates that seven million people in the Americas, 11 million people in Africa, and 14 million people in Europe are living with hepatitis C. The CDC estimates that up to 3.9 million people in the United States have chronic hepatitis C. New direct-acting antiviral drugs used in interferon-free regimens can produce sustained virological response, considered a cure, in more than 90% of people with hepatitis C. Treatment is well tolerated and lasts 3 months for a majority of patients -- a big improvement over the old interferon-based therapy, which lasted 6 to 12 months and caused difficult side effects. Getting rid of HCV not only improves the health of the individual patient, but also prevents onward transmission, leading some experts to believe hepatitis C epidemics can be halted.
 

For more information: http://www.who.int/mediacentre/news/releases/2017/global-hepatitis-report/en/
 

Hep C World News - Week of June 11, 2017

Liver Cancer Rates Rising Rapidly in U.S.

Atlanta, GA - The incidence of liver cancer in the U.S. has doubled since the 1970s and is expected to continue increasing until at least 2030, with the overall prognosis remaining poor and with substantial disparities in death rates by sex, race/ethnicity, and state, according to a new report from the American Cancer Society (ACS). Major differences in risk factors and inequalities in access to healthcare are the primary drivers of these disparities, an ACS research team led by Farhad Islami, MD, PhD, reported online in the journal CA: A Cancer Journal for Clinicians. Between 2010 and 2014, liver cancer death rates were 5.5 per 100,000 for non-Hispanic whites, 8.4 per 100,000 for non-Hispanic blacks, and 11.9 per 100,000 for American Indian/Alaska Natives, according to their analysis of data from the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) program. Death rates also varied by state. In North Dakota, for instance, liver cancer deaths occurred in 3.8 per 100,000 people whereas in the District Columbia, there were 9.6 deaths per 100,000. Paradoxically, liver cancer stage distribution at the time of diagnosis was very similar between patients of different races and ethnicities, leading the authors to conclude that the increased death rates in non-Hispanic blacks and Native Americans is driven by inequalities in access to care. "I think this is a really important point and something [for] state-level decision-makers to consider that when they're looking at liver cancer control programs," co-author Kimberly Miller, MPH, of the ACS, said in an interview. Despite some survival gains in the last two decades, only 1 in 5 patients survive 5 years after diagnosis, the authors noted, adding that since most liver cancers are potentially preventable, many of these deaths could be avoided. It is estimated that in 2017, liver cancer will account for about 41,000 new cancer cases and 29,000 cancer deaths in the U.S.

For more information: https://www.medpagetoday.com/HematologyOncology/OtherCancers/65947
 

Hep C World News - Week of June 4, 2017

Increased stroke risk tied to cirrhosis
 

New York, NY - Patients with cirrhosis have a significantly increased risk of stroke, particularly hemorrhagic stroke, a retrospective cohort study of Medicare beneficiaries showed. In a nationally representative sample of 1,618,059 patients, the incidence of stroke was 2.17% per year in patients with cirrhosis and 1.11% annually in patients without cirrhosis, according to Neal S. Parikh, MD, of Weill Cornell Medicine and New York-Presbyterian Hospital in New York City, and colleagues. Although patients with cirrhosis had a higher risk of any kind of stroke (HR 1.4) than those without cirrhosis, the association between cirrhosis and stroke appeared to be much stronger for subarachnoid hemorrhage (HR 2.4) and intracerebral hemorrhage (HR 1.9) than for ischemic stroke (HR 1.3), the study authors reported online in JAMA Neurology. Similar associations were seen regardless of cirrhosis type in the 5% sample of Medicare inpatient and outpatient claims submitted from Jan. 1, 2008, through Dec. 31, 2014. However, the strongest association with stroke was seen in decompensated cirrhosis, Parikh and colleagues said. "Additional investigation into the epidemiology and pathophysiology of this association may yield opportunities for stroke risk reduction and prevention," they said, noting that their findings could potentially be explained by the mixed coagulopathy seen in cirrhosis. "The increased risk of ischemic and hemorrhagic stroke observed in our study may reflect these complex coagulation system aberrations, particularly for patients with more advanced, decompensated cirrhosis because these patients appeared to have a higher risk of all stroke types." The study did not show any association between mild, non-cirrhotic liver disease and stroke. These data "challenge the prevailing notion that cirrhosis is protective against stroke, an idea which can be traced to autopsy studies decades old," said Parikh. "In the context of recent data demonstrating that patients with cirrhosis are not protected against venous thromboembolism, our results suggest that clinicians caring for patients with cirrhosis should perhaps remain vigilant of risk factors for both thrombotic and hemorrhagic complications," he wrote.  This study was funded by the National Institute of Neurological Disorders and Stroke and the Florence Gould Endowment for Discovery in Stroke.
 

For more information: https://www.medpagetoday.com/Neurology/Strokes/65811
 

Hep C World News - Week of May 28, 2017

Triple-DAA Pill Offers HCV Retreatment Option

Marseilles, France. A pill that contains three powerful antiviral drugs might offer a cure for many hepatitis C patients who have failed other treatments, researchers report. The pill -- which contains the antiviral drugs sofosbuvir (Sovaldi), velpatasvir and voxilaprevir -- was nearly 100 percent effective in curing hepatitis C in patients whose disease returned after treatment with other antiviral drugs, the researchers said. "Currently, we have very good treatments for hepatitis C, and we are able to achieve a cure in over 90 percent of patients. So globally, although only a few patients relapse, it still is a significant number," said lead researcher Dr. Marc Bourliere, from the Hospital Saint Joseph in Marseilles, France. This new pill is being developed as a rescue treatment for patients who have failed other therapy, he said. When it was used as an initial treatment in another study, the combination pill fared no better than the usual treatment, he added. Adverse events associated with the combination were mild and similar to those seen among patients getting a placebo or the approved combination of sofosbuvir and velpatasvir (Epclusa), Bourlière and colleagues reported in the June 1 issue of the New England Journal of Medicine. While retreatment options are available for patients with chronic HCV who have failed previous treatment with an interferon-containing regimen, there is no approved treatment for those whose treatment with direct-acting antiviral agents (DAAs) was unsuccessful. Although the DAA regimens are highly effective, with cure rates in many cases of more than 95%, the sheer number of people with chronic HCV -- estimated to be some 150 million around the world -- means that a substantial number will fail therapy and need retreatment. To help fill the gap, Bourlière and colleagues tested the three-drug combination in two trials -- dubbed POLARIS-1 and POLARIS-4 -- whose central difference was that patients in POLARIS-1 had failed therapy with an NS5A inhibitor, while those in POLARIS-4 had unsuccessful treatment with DAAs attacking other viral targets.
The investigators cautioned that there were only small numbers of patients with some of the less common HCV genotypes, so that the results might not apply broadly. As well, some patients had unsuccessful therapy with DAA regimens that are not commercially available. And the result can't be applied to people co-infected with hepatitis B or HIV and those with decompensated cirrhosis, who were excluded from the studies.
 

For more information: http://tinyurl.com/ycnx7vca
 

Hep C World News - Week of May 21, 2017

Gilead warns against Hep C drugs from buyers clubs

Foster City, CA - California-headquartered Gilead Sciences has warned against the use of generic versions of its blockbuster Hepatitis C drugs procured by patients directly through “buyers clubs.” A disruptive phenomenon, dozens of buyers clubs have mushroomed in recent years that enable supply of generic lifesaving medicines to thousands of patients afflicted with the fatal liver ailment. In its latest May 9 regulatory filings in Form 10K at the US Securities Exchange Commission, Gilead said it is aware of the existence of various “buyers clubs” around the world, adding that through personal importation of such medicines, patients may be at risk of taking unapproved medications which may not be what they purport to be, may not have the potency they claim to have or may contain harmful substances. Gilead warned that those (generic versions) medicines have not been approved for use in the countries into which they are imported. “To the extent patients take unapproved generic versions of one or more of our medications and are injured or not cured by these products, our brand or the commercial or scientific reputation of our HCV products could be harmed,” it said in the filings made last week. In the US, Gilead’s Hepatitis C treatment came with a listed price of USD 84000 and that has drawn wide criticism. According to news reports, Gilead has cited that the price level is comparable to the earlier treatment options. It also argued that the price to patients come with a significant discount. Gilead’s official spokesperson told CNBC TV18, “With regard to buyers Clubs, the source and quality of Hepatitis C medicines secured through medical tourism and buyers’ clubs are unknown. Patients cannot be sure that they are receiving effective or safe medicine.” The company avoided questions on whether it will launch an investigation into such supplies from any of its Indian partners. As part of a 2014 agreement, Gilead, amid outcry from health activists on issues such as data privacy, had incorporated several safeguards like monitoring of medicine prescriptions for patients. However, things seem to have moved as per plans with its Indian partners. Gilead expressed satisfaction with the progress made through its voluntary licensing arrangements for HCV (Hepatitis C virus) drugs with over a dozen drug makers that include Zydus Cadila, Cipla, Biocon, Hetero, Laurus, Strides Shasun and Natco, among others. Gilead informed CNBC TV18 the voluntary licence partners have proven their ability to rapidly scale up the manufacture of high-quality, low-cost medicines and enable broad distribution to where the need is great. “As of the end of 2016, we estimate that 50 percent of patients living in developing countries being treated with one of Gilead’s Hepatitis C medicines, received or are receiving a licensed generic version,” the company said in its statement. The arrangement with the Indian partners included supplies to over a hundred countries but clearly came with binding provisions to prevent supplies to developed markets like US and Europe, where the company directly markets its medicines. Gilead revolutionized treatment of HCV through a range of single ingredient and combination therapies like Sovaldi and Harvoni nearly wiping out interferon-based treatments. Apart from taking issue with buyers clubs, Gilead noted as part of its filings that third parties may illegally distribute and sell counterfeit versions of its products, which do not meet the rigorous quality standards of our manufacturing and supply chain. “For example, in the first quarter of 2017, bottles of counterfeit drugs labelled under the Harvoni brand name were discovered at a retail pharmacy chain and pharmaceutical wholesalers in Japan,” Gilead said, adding it is taking steps to accelerate planned changes in packaging standards to make counterfeits more difficult. James Freeman, Founder at FixHepC, a buyers club based in Australia, countered the claims made by Gilead about the safety issues. Freeman agreed that supply chain integrity is vital in ensuring patients received correct medicines. “As an additional safety check, we provide a tablet testing service using qNMR (Quantitative Nuclear Magnetic Resonance analysis). This is available to any patient who has sourced generic medications from any source. To date, none of the samples tested has been found deficient,” Freeman added. Freeman, who came into spotlight for helping several Australian patients get Hep C medicines, said, "Looking at India specifically what the licence says is that the product is licensed to be sold within the territory - it is a point of sale licence, rather than an end-user licence of the type found in say arms sales." "If an Indian doctor sees a patient by video conference, and writes in Indian script, and there is an Indian invoice, paid in India would that not be a sale in the licensed territory," Freeman countered.
Terming Gilead’s approach to market as “predatory pricing,” Freeman further clarified that he would accept that (what buyers club does) is a breach of the spirit of the law, it is not a breach of the letter of the law. Gilead uses one set of laws to price these medications at unaffordable prices. We use another set of laws to help provide affordable access….FixHepC uses the law to correct that problem, at least for those fortunate enough to be able to afford generic prices. It is an imperfect solution for an imperfect world.”

For more information: http://tinyurl.com/motwflg
 

Hep C World News - Week of May 14, 2017

New Hepatitis C Infections Reach 15-Year High  
 

Atlanta, GA - Preliminary surveillance data recently released by the Centers for Disease Control and Prevention (CDC) shows that the number of reported hepatitis C virus (HCV) cases has almost tripled in number from 2011-2015, “reaching a 15-year high.” The CDC attributes the rising numbers amoung younger individuals primarily to injection drug use related to the ongoing opioid epidemic in the United States. However, younger individuals aren’t the only ones affected by HCV; it turns out that baby boomers are the ones with the biggest burden. According to the CDC, half of the individuals who are living with the virus are not even aware that they are infected. This is because the vast majority of individuals infected with the virus do not present with many symptoms, and therefore, new infections remain undiagnosed. In addition, the CDC notes that because surveillance resources are limited, the number of cases may be underreported. For example, a total of 850 cases were reported to the CDC in 2010 and 2436 cases were reported in 2015, but these numbers do not necessarily “reflect the true scale of the epidemic.” In fact, the CDC estimates that the number of cases that actually occurred in the United States in 2015 is significantly more than that: 34,000, to be exact. HCV is the leading cause of death from infectious disease for Americans, according to the CDC. In 2015, a staggering 20,000 individuals died because of HCV-related causes. Most of these individuals were 55 years of age or older, according to the new data. “By testing, curing, and preventing hepatitis C, we can protect generations of Americans from needless suffering and death,” Jonathan Mermin, MD, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention said in the press release. “We must reach the hardest-hit communities with a range of prevention and treatment services that can diagnose people with hepatitis C and link them to treatment. This wide range of services can also prevent the misuse of prescription drugs and ultimately stop drug use—which can also prevent others from getting hepatitis C in the first place.”
 

For more information: http://www.contagionlive.com/news/new-hepatitis-c-infections-reach-15-year-high
 

Hep C World News - Week of May 7, 2017

Genetic marker predicts SVR failure in patients with HCV, cirrhosis    
 

Chicago, IL - A research team identified genetic markers that predict which patients with hepatitis C and cirrhosis will most likely improve with DAAs and those who will fail to improve or possibly worsen, according to a report published in Healio.com. “The current generation of direct-acting antiviral agents provides virological cure for 90% to 95% of patients with hepatitis C cirrhosis. Unfortunately, about 5% of hepatitis C patients with cirrhosis failed to clinically improve or even worsened after achieving virological response SVR,” Winston Dunn, MD, associate professor of gastroenterology at the University of Kansas Medical Center, said during a pre-conference press program. “It is important that we figure out a way to identify, in advance, the people with decompensated cirrhosis who may respond best to treatment and those who may not. The information will help us minimize the need for liver transplantations.” The researchers analyzed the PNPLA3 gene, the most important genetic factor for both alcoholic liver disease and nonalcoholic fatty liver disease, according to Dunn, and specifically focused on the rs738409 polymorphism, a variation in a single base pair of DNA in the PNPLA3 gene. Patients will have either CC, CG or GG genotypes. The study comprised 32 patients with decompensated cirrhosis who initially achieved SVR. The researchers tracked changes in MELD and Child-Pugh scores in the patients at 12, 24 and 48 weeks after SVR. Child-Pugh scores improved by at least one point in 81% of the patients with CC genotype and by 56% of patients with either CG or GG genotypes. Child-Pugh scores worsened by at least one point in 6% of CC genotype patients and 13% of CG or GG genotype patients. MELD scores improved by at least one point in 50% of CC genotype patients and by 38% in CG or GG genotype patients. MELD scores worsened by at least one point in 6% of CC genotype patients and by 19% in CG or GG genotype patients. Mean difference in change in distribution of Child-Pugh scores and MELD scores from baseline to after SVR were 1.67 points and 1.7 points, respectively. “These data suggest that a patient’s genotype in the PNPLA3 gene should be a factor when deciding which patient with decompensated cirrhosis should be evaluated for liver transplant. Identifying this genetic marker continues to move toward precision medicine that we are seeing today, where health care providers can develop specific treatment plans based on the individual needs of patients,” Dunn said in the press program. “As the next step, our team will be conducting research to possibly explain the underlying mechanism behind these findings.”
 

For more information: http://tinyurl.com/mqlopbu
 

Hep C World News - Week of April 30, 2017

Nova Scotia lists Epclusa on public drug plan    
 

Mississauga, ON - Gilead Sciences Canada, Inc. announced that Nova Scotia will provide public access to EPCLUSA™ (sofosbuvir/velpatasvir) tablets, the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. This listing will support patients to access curative therapy, and will advance Canada's efforts to achieving its World Health Organization commitment to eliminate hepatitis C by 2030. Epclusa, one tablet taken daily for 12 weeks, is for use in adult patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin (RBV) for those with decompensated cirrhosis. It is also the first single tablet regimen approved for the treatment of patients with genotypes 2 and 3, without the need for RBV. The listing in Nova Scotia follows the completion of a recent agreement between the pan-Canadian Pharmaceutical Alliance (pCPA) with member provincial, territorial and federal drug plans to fund this innovative therapy for patients. In addition, aligned with the pCPA agreement, Nova Scotia will expand access to include patients with less advanced liver disease (fibrosis scores of F0 or F1) if they have been diagnosed with certain co-existing factors. All HCV patients with fibrosis scores of F2 or higher also remain eligible for reimbursement. In Nova Scotia, the Public Health Agency of Canada estimates that more than 4,252 people are living with chronic HCV. In Canada, it is estimated that 250,000 Canadians are living with chronic HCV, with thousands of new cases diagnosed each year. There are six genotypes of hepatitis C. Genotype 1 infection is the most prevalent genotype in Canada representing 64.1 per cent of infected individuals. Genotypes 2 and 3 account for approximately 14.1 per cent and 20.2 per cent of infections in Canada, whereas genotypes 4, 5, and 6 are less prevalent in Canada (0.3 per cent). "Gilead Canada is pleased that the pCPA and Nova Scotia are recognizing the innovation and clinical value of EPCLUSA for the treatment of all genotypes of hepatitis C in a single tablet regimen," said Kennet Brysting, General Manager, Gilead Canada. "Broader treatment access for patients will potentially have a profound impact on disease elimination efforts in Canada, and supporting such efforts is a key priority for our company. We will continue to work closely with all jurisdictions to bring this simple and cost-effective curative treatment to all eligible patients, regardless of their genotype or stage of fibrosis."
 

For more information: http://tinyurl.com/kefxlk5
 

Hep C World News - Week of April 23, 2017

Canadian guidelines recommend against HCV screening in low-risk adults
 

Ottawa, ON - The Canadian Task Force on Preventive Health Care recommends against screening for hepatitis C virus in low-risk patients, including baby boomers. The task force said its first-ever guidance for HCV screening, published in the Canadian Medical Association Journal, was based on several factors, including the low prevalence (between 0.64% and 0.71%) of HCV in the Canadian population not at an elevated risk for chronic infection and the lack of direct evidence on the benefits and harms of screening. “Given the lack of direct evidence that mass screening is beneficial and that patients identified by screening will either never develop symptoms of hepatitis C, or will remain well for decades after infection, we have recommended against screening for HCV in adults who are not at elevated risk,” Roland Grad, MD, CM, MSc, FCFP, associate professor in the department of family medicine at McGill University in Montreal and member of the task force, said in a news release. According to the release, Grad and colleagues also based their guidance on the expected lack of access to antiviral treatment for many chronic HCV patients identified through screening; the potential harms associated with screening, including stigma and difficulties with insurance; the low risk for household and sexual transmission or transmission through routinely screened blood products; and the anticipated increase in harm associated with diagnosing and treating patients who were identified through routine screening but would not have developed HCV–related disease. The task force’s recommendation not to test asymptomatic baby boomers is contrary to guidance issued by some other groups, including the Canadian Liver Foundation, which says all adults born between 1945 and 1975 should be tested once for HCV. Likewise, the CDC and U.S. Preventive Services Task Force (USPSTF) recommend one-time HCV testing for patients born between 1945 and 1965. Grad and colleagues said their reasons for developing the recommendations included the availability of new treatments for chronic HCV infection and the lack of Canadian guidelines for screening. Their guidance was based on two independent reviews into the effectiveness of screening patients for HCV. The guidance is meant for patients who are not at an increased risk for HCV infection and does not apply to pregnant women or patients at an increased risk, including those with a history of using injection drugs; those who have been in jail; who were born, traveled or lived in a country where HCV is endemic; or who received a blood transfusion, blood products or organ transplant before 1992 in Canada. According to a related commentary by Geneviève Cadieux, MD, PhD, and Herveen Sachdeva, MD, MHSc, of the University of Toronto, up to 44% of Canadians with chronic HCV are unaware of their infection. Cadieux and Sachdeva said the high cost of treatment for HCV infection and limited access to publicly funded treatment have been barriers to population-based screening in Canada but that such screening should be reconsidered in light of negotiations to reduce the price of direct-acting antivirals and emerging evidence on HCV transmission and the long-term benefits of treatment. “Similar to strategies for HIV testing in North America, it is likely that a combination of risk-based testing and population-based screening will be needed in the future,” they concluded.
 

For more information: http://tinyurl.com/l5p7fac
 

Hep C World News - Week of April 16, 2017

Dedicated treatment program for homeless achieves SVR 
 

Boston, MA – Healio News on-line recently reported that a community-based treatment with a dedicated primary care program led to sustained virologic response in most homeless and marginally housed patients with hepatitis C. “Historically, homeless and marginally housed adults have faced barriers to HCV treatment,” the researchers wrote. “New, interferon-free therapies have excellent cure rates and improved tolerability, reducing barriers for treatment.” A dedicated HCV treatment team of primary care clinicians and physicians at the Boston Health Care for the Homeless Program treated 64 patients with oral antiviral agents between February 2014 and 2015. Either Medicare or Medicaid covered treatment for all but one patient. Sixty-two patients achieved SVR. Mean age of these patients was 55.5 years, 77% were men and 47% were white. Overall, 49 patients had genotype 1, three patients had genotype 2, three patients had genotype 4 and seven patients had mixed genotypes. Of the two patients who did not achieve SVR, one was diagnosed with genotype 2 with cirrhosis, treatment naive, HCV-monoinfected, treated with Sovaldi (sofosbuvir, Gilead) plus ribavirin for 12 weeks, and reported no missed doses. While this patient had an undetectable viral load at the end of treatment, there was detectable viral load at 12 weeks follow-up. The second patient was diagnosed with genotype 1 with cirrhosis, treatment naive, HCV-monoinfected, treated with Harvoni (ledipasvir-sofosbuvir, Gilead) for 12 weeks, and missed one dose. The patient had a detectable viral load at end of treatment. Resistance testing demonstrated H58P and L31V mutations. “These findings demonstrate that with a dedicated program for treating HCV in [homeless and marginally housed] adults in the primary care setting, it is possible to achieve outcomes similar to those of clinical trials and other cohorts despite significant additional barriers and competing priorities to health care faced by this population,” the researchers concluded.
 

For more information: http://tinyurl.com/kwww2n2 
 

Hep C World News - Week of April 9, 2017

Hep C treatment denial increasing
 

Boston, MA - Recent data released by Trio Health show that the prevalence of hepatitis C drug patients diagnosed with Hepatitis C but not started on curative drugs, such as Harvoni and Zepatier, more than tripled between 2014 and 2016—signaling that payers continue to deny coverage despite increased marketplace competition and availability of discounts. “There are no other disease states that I’m aware of where curative therapies are increasingly withheld from patients who are covered by commercial insurance plans, Medicaid or Medicare,” Nezam Afdhal, MD, professor of medicine, Harvard University, and chairman of Trio Health’s Scientific Steering Committee, said in a press release. According to the data, although the number of treated patients continually decreases, the total number of patients seeking treatment for their condition continues to grow each year. On average, as of last September, 37% of patients who showed little-to-moderate traces of the disease were denied—a steady increase from 27% in October 2015. Likewise, 24% of those with advanced forms of hepatitis C were also denied—an increase from 15% during 2015. Overall, non-starts increased from 8% in 2014 to over 30% in 2016. The data included evaluation of treatment patterns for use of all direct acting antiviral agents, including Harvoni, Sovaldi, Epclusa, Viekira Pak, Zepatier, and Daklinza. “What is most surprising is that this trend is growing even though treatment cure rates are now above 90 percent, duration of therapy has been reduced to as little as eight weeks for the majority of patients, and real treatment costs are one-third lower than just a few years ago,” Dr Afdhal said. “In almost any other commercial setting, this would result in a significant expansion of market access, but with Hepatitis C, we’re seeing fewer patients receive care even though the number of patients seeking treatment continues to grow.” It was reported that among commercial health plans 39% of patients with moderate disease activity did not start treatment after being prescribed therapy, and 36% of patients with severe disease activity also did not start.
 

For more information: http://tinyurl.com/mh8pkns
 

Hep C World News - Week of April 2, 2017

Alberta and Saskatchewan list EPCLUSA™ on Public Drug Plans
 

Mississauga, ON - Gilead Sciences Canada, Inc. has announced that Alberta and Saskatchewan will provide public access to Epclusa (sofosbuvir/velpatasvir) tablets, the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. This listing will support patients to access curative therapy, and will advance Canada's efforts to achieving its World Health Organization commitment to eliminate hepatitis C by 2030. Epclusa, one tablet taken daily for 12 weeks, is for use in adult patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin (RBV) for those with decompensated cirrhosis. It is also the first single tablet regimen approved for the treatment of patients with genotypes 2 and 3, without the need for RBV. The listing in Alberta follows the completion of a recent agreement between the pan-Canadian Pharmaceutical Alliance (pCPA) with member provincial, territorial and federal drug plans to fund this innovative therapy for patients. In addition, aligned with the pCPA agreement, Alberta will expand access to include patients with less advanced disease (fibrosis scores of F0 or F1) if they have been diagnosed with certain co-existing factors. All HCV patients with fibrosis scores of F2 or higher also remain eligible for reimbursement. 

For more information: http://bit.ly/2oBtPs2
 

AbbVie receives priority review for new 8-week DAA in Japan
 

Tokyo, Japan - The Japanese Ministry of Health, Labour and Welfare has granted priority review to AbbVie’s direct-acting antiviral glecaprevir/pibrentasvir for the treatment of all major genotypes of chronic hepatitis C, according to a press release. Glecaprevir/pibrentasvir (G/P) is an investigational ribavirin-free regimen under evaluation as a potential 8-week cure for patients with HCV genotypes 1 through 6 with cirrhosis who are new to treatment with DAAs. G/P is also under evaluation for treatment of patients with special conditions, such as patients with genotype 3 who were not cured with previous DAA treatment and patients with chronic kidney disease, including those on dialysis. To date, AbbVie’s G/P global clinical development program combined with its phase 3 CERTAIN studies in Japan have evaluated more than 2,300 patients in 27 countries with major HCV genotypes and special conditions. “We will work closely with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) as part of our commitment to provide a potential cure for as many people living with HCV as possible,” Michael Severino, MD, executive vice president of research and development and chief scientific officer of AbbVie, said in the release. “We are pleased that G/P has now been recognized as a potential important therapy for people living with HCV through the receipt of priority review designations by regulatory authorities in Japan, the EU and the U.S.”
 

For more information: http://tinyurl.com/lag3w6n
 

Hep C World News - Week of March 26, 2017

MSF joins Europe-wide action challenging patent on key hepatitis C drug
 

Rome/Geneva – Médecins Sans Frontières (MSF) has today filed a patent challenge on the hepatitis C drug sofosbuvir with the European Patient Office (EPO) in an effort to increase access to affordable hepatitis C treatment. MSF has joined Médecins du Monde (MdM) and other civil society organisations from 17 countries in simultaneously filing patent challenges on the pharmaceutical corporation Gilead’s monopoly on sofosbuvir, in a bid to remove the barriers that prevent millions of people receiving treatment. “With an estimated 80 million people worldwide living with hepatitis C, treatment should be available to everyone who needs it, no matter where they live – including in Europe,” said Dr Isaac Chikwanha, hepatitis C medical advisor for MSF’s Access Campaign. “The price of sofosbuvir is keeping treatment out of reach for millions of people who need it, and treatment is being rationed or is just unavailable across the globe, including in many of the countries where MSF works, such as Russia, and many other middle-income countries including Thailand and Brazil. A drug that cures doesn’t do any good if the people who need it can’t afford it.” Sofosbuvir forms the backbone of most hepatitis C combination treatments for people, one of a range of oral ‘direct-acting antivirals’ to come to market within the last four years that has caused cure rates to skyrocket. In Europe, Gilead charges as much as US$59,000 per 12-week sofosbuvir treatment (€55,000) – in the United States, Gilead initially set the price at $84,000, or a staggering $1,000 per pill. Meanwhile, studies have shown that it costs less than $1 per pill to produce the drug. “Gilead’s patent monopolies on sofosbuvir are blocking access to affordable hepatitis C treatment, including generic versions, in many countries including those in Europe,” said Aliénor Devalière, EU policy advisor for MSF’s Access Campaign. “The patents on some of these drugs can – and should – be challenged; the science behind sofosbuvir isn’t new.” "People all over the world, and in the projects where MSF works, need affordable access to life-saving medicines." Access to affordable medicines has become a global challenge. Countries where Gilead retains monopoly control over sofosbuvir cannot import or produce generic versions; for many people living in some middle-income countries, Gilead’s restrictive voluntary licensing agreements still keep sofosbuvir out of reach for people and their governments. Patent challenges – or patent oppositions – can remove or shorten the length of a patent and enable the robust generic competition needed to dramatically reduce prices. Key patents on sofosbuvir have already been revoked in China and Ukraine, and decisions are pending in other countries, including Argentina, India, Brazil, Russia and Thailand. “Successful patent oppositions have created access to life-saving drugs for millions of people in the past, and are now being employed as a legal measure to improve access to hepatitis C treatment,” said Yuanquiong Hu, legal advisor for MSF’s Access Campaign. “MSF has filed or supported patent challenges in many countries. People all over the world, and in the projects where MSF works, need affordable access to life-saving medicines.” If the patent challenge is successful, it could accelerate the availability of affordable generic versions of sofosbuvir in Europe. It would also encourage all countries to take measures to open up access to affordable generic versions of sofosbuvir by either negotiating better deals with Gilead right now, and/or taking actions including issuing compulsory licences to import or manufacture more affordable generics.
 

For more information: http://tinyurl.com/lefcqj4
 

Liver inflammation remains in some Hep C patients after SVR
 

Frankfurt, Germany - According to a German study published in PLOS One about one-third of patients who were successfully treated to eliminate the hepatitis C virus continued to exhibit liver inflammation. The findings include people who took direct-acting antiviral (DAA) drugs, the current preferred therapy for the virus. “This is the first comprehensive study on a large patient cohort investigating the prevalence and risk factors for ongoing liver inflammation after eradication of hepatitis C,” wrote Christoph Welsch, MD, and colleagues at the J. W. Goethe-University Hospital in Frankfurt am Main, Germany. The team set out to investigate whether a patient with chronic hepatitis C would experience continued liver irritation after reaching sustained virological response (SVR), or undetectable levels of serum hepatitis C virus RNA 12 to 24 weeks after therapy ended. SVR, which signals the successful eradication of the virus, is achieved for most patients with novel treatment regimens, according to the study. SVR is typically accompanied by a return to normal levels of an enzyme called aminotransferase (ALT). While the blood commonly contains low levels of ALT, a diseased liver releases additional amounts into the bloodstream, providing a clue about the organ’s health. The German researchers collected data from 834 patients with hepatitis C in two separate groups. An “unexpected” high number of patients exhibited liver inflammation after SVR. Up to 10% had persistently elevated levels of ALT and another 25% showed amounts that “require further surveillance.’’ The remaining 65% had healthy ALT levels after the virus was extinguished, the researchers reported. “The major finding from our study is the high prevalence of post-SVR elevated ALT levels despite viral eradication, including patients that have been treated with novel IFN-free direct-acting antiviral-based therapy,” the team wrote. “This observation supports our notion that ongoing aminotransferase elevation upon SVR is not a rare clinical event.” Men who had achieved SVR were more likely to have elevated ALT, reinforcing previous observations on the course of the infection. Patients with advanced liver disease and steatosis were also strongly predictive for persistent ALT elevation.
 

For more information: http://tinyurl.com/l4npfk3
 

Hep C World News - Week of March 19, 2017

Epclusa™ added to Quebec formulary

Mississauga, ON - Epclusa (sofosbuvir/velpatasvir) tablets will be listed on the Quebec formulary effective on March 22, 2017. The drug is the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. This listing will support patients to access curative therapy in Quebec, and is a significant contribution to advancing Canada's efforts to achieving its World Health Organization commitment to eliminate hepatitis C by 2030. Epclusa, one tablet taken daily for 12 weeks, is for use in adult patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin (RBV) for those with decompensated cirrhosis. It is also the first single tablet regimen approved for the treatment of patients with genotypes 2 and 3, without the need for RBV. The approval of Epclusa was supported by data from four international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. Of the 1,035 patients without cirrhosis or with compensated cirrhosis treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 per cent) achieved SVR12 (sustained virologic response 12 weeks after the end of treatment). In ASTRAL-4, patients with decompensated cirrhosis who received Epclusa with RBV for 12 weeks achieved a high SVR12 rate (94 per cent) compared to those who received Epclusa for 12 weeks or 24 weeks without RBV (83 % and 86 %, respectively). The most common adverse events in the four ASTRAL studies were headache and fatigue, and were comparable in incidence to the placebo group included in ASTRAL-1. New médicament d'exception criteria for Sovaldi® (sofosbuvir), Harvoni® (ledipasvir/sofosbuvir) and Epclusa will increase access to patients with a lower stage of disease and poor prognosis. "We now have the ability to cure almost all patients with chronic HCV with a simple, safe and effective 12-week treatment, regardless of genotype or patient history," said Dr. Peter Ghali, Hepatologist, and Program Director, Hepatology training, McGill University Health Centre. "Broader access to Epclusa, particularly at the earlier stage of the disease, means that we can move more quickly to help patients achieve a cure and improve their quality of life, while saving valuable funds associated with the significant long-term burden of illness and costs to the healthcare system." The Institut national de la santé publique du Québec (INSPQ) estimates that between 40,000 to 75,000 people in the province could have chronic hepatitis C infection. Between 1990 and 2014, 39,700 individuals were identified with hepatitis C. In 2015, an additional 1,073 cases were identified, thus supporting the importance of access to treatment to prevent the future complications of the disease. "Gilead Canada is pleased that INESSS (Institut national d'excellence en santé et services sociaux) and the Ministry of Health and Social Services are recognizing the innovation and clinical value of Epclusa for the treatment of all genotypes of hepatitis C in a single tablet regimen," said Kennet Brysting, General Manager, Gilead Canada. "Broader treatment access for patients will potentially have a profound impact on disease elimination efforts in Canada, and supporting such efforts is a key priority for our company. We will continue to work closely with all jurisdictions to bring this simple and cost-effective curative treatment to all eligible patients, regardless of their genotype or stage of fibrosis."
 

For more information: http://tinyurl.com/n8esluj
 

British Columbia also lists Epclusa™ on their public drug plan

Mississauga, ON - Gilead Sciences Canada, Inc. (Gilead Canada) today announced, effective March 21, 2017, British Columbia will provide public access to Epclusa (sofosbuvir/velpatasvir) tablets, the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. This listing will support patients to access curative therapy, and will advance Canada's efforts to achieving its World Health Organization commitment to eliminate hepatitis C by 2030. The listing in British Columbia follows the completion of a recent agreement between the pan-Canadian Pharmaceutical Alliance (pCPA) with member provincial, territorial and federal drug plans to fund this innovative therapy for patients. In addition, aligned with the pCPA agreement, BC PharmaCare will expand access to include patients with less advanced disease (fibrosis scores of F0 or F1) if they have been diagnosed with certain co-existing factors. All HCV patients with fibrosis scores of F2 or higher also remain eligible for reimbursement. In 2018-19, PharmaCare plans to provide coverage for any resident of the province living with chronic hepatitis C, regardless of the type or severity of their disease.

For more information on BC's expanded access criteria: http://tinyurl.com/lrycwpp

HCV infection and cancers in elderly

Rockville, Maryland - Hepatitis C virus (HCV) infection is associated with a range of non-liver-related cancers, investigators from the United States report in the journal, Cancer. The study population comprised over 1.6m elderly people with cancer and 200,000 closely matched cancer-free controls. Overall, cancer incidence was higher among people with HCV antibodies, as was incidence of several specific malignancies including cancers of the liver, bile ducts, pancreas, certain skin cancers, myelodysplastic syndrome, and diffuse large B-cell lymphoma. The investigators estimated that elimination of HCV infection would have only a modest effect on the risk of many of these cancers. “Our analyses of a large, population-based data set of elderly individuals demonstrate that, along with HCC [hepatocellular carcinoma], several additional cancers are associated with HCV infection,” comment the investigators. “Although the introduction of direct-acting antivirals has dramatically improved cure rates, HCC risk still remains relatively high in infected individuals who have cleared the virus – particularly elderly individuals.” An estimated 3m individuals in the United States have HCV infection. Many of these infections involve individuals born between 1945 and 1965, the “Baby Boomer” generation. This age group has been prioritised for HCV screening. HCV infection is known to increase the risk of HCC and non-Hodgkin lymphoma. Some data suggest that the infection also increases the risk of other cancers. However, few studies have examined the association between HCV infection and non-liver-related cancers. A team of US investigators therefore analysed data collection via the Surveillance, Epidemiology and End Results (SEER) surveillance programme to determine the association between HCV and the risk on people aged 66 years and older. Elderly people receiving care between 1993 and 2011 were eligible for inclusion. The authors identified 1,623,538 people with cancer. These individuals were matched with cancer-free individuals of the same age, sex, race and calendar year of follow-up. Prevalence of HCV and hepatitis B virus (HBV) was higher among people with cancer compared to the controls. The investigators estimated that eliminating HCV would reduce the risk of liver cancer by 16%. However, elimination would only have a modest impact on the risk of cancers of the bile ducts, pancreas, MDS and DLBCL (1.15%-0.28%). “We observed significant associations between HCV infection and several cancers other than liver cancer, notably intrahepatic and extrahepatic cholangiocarcinomas and DLBCL,” conclude the authors. “Studies are needed to strengthen the evidence linking HCV infection to these cancers and to further elucidate biological mechanisms.”
 

For more information: http://tinyurl.com/n58449q

Hep C World News - Week of March 12, 2017

Coffee consumption associated with reduced risk for chronic liver disease
 

Los Angeles, CA - A recent study reported in the journal Healio revealed an association between coffee consumption and a reduced risk for developing chronic liver disease, particularly in non-alcoholic fatty liver disease, alcoholic liver disease and chronic hepatitis C. “Coffee consumption has been inversely associated with [chronic liver disease (CLD)] severity, but studies were mainly conducted in chronic hepatitis C (CHC)] while fewer studies have been done in other etiologies,” Veronica Wendy Setiawan, PhD, of the department of preventive medicine and the Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, and colleagues wrote. “Our findings support data from studies showing the effect of coffee on liver enzyme reduction and the association of increased coffee consumption with reduced histological activity, in particular fibrosis in CHC.” The study comprised 5,385 patients from the Multiethnic Cohort study.
 

For more information: http://tinyurl.com/jm2u9l8   
 

Hep C World News - Week of March 5, 2017

Boomer HCV testing not significantly increasing
 

Atlanta, GA - More baby boomers had been tested for hepatitis C (HCV) two years after a recommendation for universal one-time testing but not many more than before the recommendation, researchers reported. The prevalence of HCV testing among people born between 1945 and 1965 was just 12.3% in 2013, when the U.S. Preventive Services Task Force (USPSTF) urged the testing program, according to Ahmedin Jemal, DVM, PhD, and Stacey Fedewa, PhD, both of the American Cancer Society in Atlanta. Two years later, the prevalence of testing stood at just 13.8%, Jemal and Fedewa reported online in the American Journal of Preventive Medicine. Testing "did not increase substantially" -- only 10.5 million of 76.2 million baby boomers report ever being tested -- although the difference between 2013 and 2015 reached statistical significance, Jemal and Fedewa concluded. "These findings underscore the need for increased awareness for HCV testing among healthcare providers and baby boomers and other innovative strategies such as state-mandated HCV testing," they argued. An estimated 3.5 million people are chronically infected with HCV in the U.S. and 75% of them are baby boomers, according to the CDC. Importantly, because HCV can be without symptoms for years, many of those infected are not aware of the fact. Chronic HCV can lead to cirrhosis and hepatocellular carcinoma; the disease is the leading indication for liver transplant in the U.S., the CDC says. The advent of new direct-acting agents against the virus -- drugs that have increased cure rates or shortened the treatment period -- suggests that if more people with chronic HCV were aware of the fact, they might be able to be cured, preventing a host of other liver diseases. On the other hand, people with chronic HCV face barriers as they try to access the novel therapies, investigators said last summer -- barriers that include cost and restrictions on who can get treatment.
 

For more information: https://www.medpagetoday.com/Gastroenterology/Hepatitis/63649
 

Hep C World News - Week of February 26, 2017

Hep C Care in Rural/Remote BC 
 

Prince George, BC - Does care for hepatitis C in rural/remote areas differ from that in urban parts of our province, and if so, how? On March 6 (11 am – noon), researchers from the BC Centre for Disease Control (BCCDC) will try to answer these questions. Núria Chapinal, PhD, an epidemiologist in BCCDC’s Clinical Prevention Services, will share some new calculations made using data from over a million individuals collected by BCCDC since 1990. Her presentation will be shared remotely at a gathering at Positive Living North offices, 1563 Second Ave. in Prince George. The public is invited to view this presentation and partake in a short question period following. The presentation will also be recorded and made available online. Provincial hepatitis C patient advocacy group, HepCBC Hepatitis C Education and Prevention Society (www.hepcbc.ca/) requested that BCCDC do these calculations to improve understanding of any gaps in access and engagement in care and treatment. It will show the estimated % of BC’s rural/remote population that is infected with hepatitis C (prevalence), has developed chronic infection, has been screened, has received follow-up testing, has been “genotyped” (type of hepatitis C determined), has started treatment, and has been cured. Greatly improved new treatments will soon be covered by PharmaCare for all infected people in BC. These “Direct-Acting Antivirals” (DAAs) have made it possible to cure this often “silent” killer which is responsible for increasing rates of cirrhosis, liver cancer, liver failure, liver transplant, hepatic encephalopathy, and other serious complications of hepatitis C. Provincially, the BCCDC has determined approximately 73,000 individuals have hepatitis C, 55,000 of those have been diagnosed, 41,000 of those had follow-up testing, 26,000 of those were genotyped, 8500 of those started treatment, and 5,000 have actually been cured. The new study will attempt to divide up those figures into urban and rural/remote components. The public is welcome to attend this event. For more information, call Positive Living North at 250-562-1172. The Canadian Liver Foundation, HepCBC and Positive Living North urge everyone born between the years 1945 and 1975 to ask their doctor for a simple, one-time test for hepatitis C. Both Positive Living North and HepCBC will also have information tables at the March 5th Wellness North Expo at Prince George’s Conference and Convention Centre. Anyone interested in more information about this study or event, please contact Cheryl Reitz, Volunteer with HepCBC Hepatitis C Education and Prevention Society. creitz@hepcbc.ca 250-882-6024
 

For more information: http://tinyurl.com/gst5yck
 

Hep C World News - Week of February 19, 2017

Coverage for new pan-genotypic Hep C drug, Epclusa, approved in Ontario
 

Mississauga, ON - Gilead Sciences Canada announced that effective February 28th, 2017, Ontario will provide public access to EPCLUSA™ (sofosbuvir/velpatasvir) tablets, the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. This listing will support patients to access curative therapy, and will advance Canada's efforts to achieving its World Health Organization commitment to eliminate hepatitis C by 2030. EPCLUSA, one tablet taken daily for 12 weeks, is for use in adult patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin (RBV) for those with decompensated cirrhosis. It is also the first single tablet regimen approved for the treatment of patients with genotypes 2 and 3, without the need for RBV. The Ontario listing follows the completion of a recent agreement between the pan-Canadian Pharmaceutical Alliance (pCPA) with member provincial, territorial and federal drug plans to fund this innovative therapy for patients. In addition, aligned with the pCPA agreement, Ontario will expand access to include patients with less advanced disease (fibrosis scores of F0 or F1) if they have been diagnosed with certain co-existing factors. All HCV patients with fibrosis scores of F2 or higher also remain eligible for reimbursement. "We now have the ability to cure the majority of patients with chronic HCV with a simple, safe and effective 12-week treatment, regardless of genotype or patient history," said Dr. Curtis Cooper, Associate Professor of Medicine, University of Ottawa, and Director, The Ottawa Hospital and Regional Hepatitis Program. "Broader access to EPCLUSA, particularly at the earlier stage of the disease, means that we can move more quickly to help patients achieve a cure and improve their quality of life, while saving valuable funds associated with the significant long-term burden of illness and costs to the healthcare system." In Ontario, the Public Health Agency of Canada estimates that more than 102,000 people are living with chronic HCV. In Canada, it is estimated that 250,000 Canadians are living with chronic HCV, with thousands of new cases diagnosed each year. There are six genotypes of hepatitis C. Genotype 1 infection is the most prevalent genotype in Canada representing 64.1 per cent of infected individuals. Genotypes 2 and 3 account for approximately 14.1 per cent and 20.2 per cent of infections in Canada, whereas genotypes 4, 5, and 6 are less prevalent in Canada (0.3 per cent). "Canada, and other countries, have committed to eliminating hepatitis C by 2030, and to accomplish this goal we need to significantly increase treatment rates," said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and hepatologist at Toronto General Hospital. "Treatment regimens are getting shorter, simpler and more widely effective across genotypes meaning that treatment is now easier for both patients and physicians to manage.
 

For more information: http://tinyurl.com/jv6hr2h
 

More Patients to Benefit from Hepatitis C Treatments      
 

Vancouver, BC - Thousands of British Columbians living with hepatitis C will have better access to treatment as a result of successful negotiations brokered by the pan-Canadian Pharmaceutical Alliance (pCPA). “This agreement changes the landscape for hepatitis C patients living in B.C.,” said Health Minister Terry Lake. “Not only are there four new treatment options for what is now a curable virus, but the savings that were negotiated will allow us to cover treatment options for all hepatitis C patients – rather than just those in more advanced stages of the disease.” British Columbia and Ontario co-led the negotiations with the drug manufacturers on behalf of the pCPA. The alliance helps provinces and territories leverage their collective buying power and negotiate better prices for new drugs. The collaborative effort resulted in a significant cost savings to drug plans for participating provinces and territories. The agreement also allows access to treatment for all eligible patients in a fiscally sustainable manner. Prices and terms for this negotiation are confidential. The list cost to the health system for hepatitis C treatment has ranged from $45,000 to over $100,000 per patient, depending on the drug and disease progression. Agreements with the pCPA were reached with Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada to provide several hepatitis C drugs at an improved cost:

Daklinza (daclatasvir) – new
Epclusa (sofosbuvir/velpatasvir) – new
Harvoni (ledipasvir/sofosbuvir)
Sovaldi (sofosbuvir)
Sunvepra (asunaprevir) – new
Zepatier (elbasvir/grazoprevir) – new

PharmaCare is expanding the criteria in March 2017 to provide coverage to more patients living with hepatitis C. Physicians can apply for coverage of the new drugs on behalf of their patients on or around March 21, 2017. Starting in 2018-19, PharmaCare will provide coverage for any British Columbian living with chronic hepatitis C, regardless of the type or severity of their disease. Up to 75,000 British Columbians are estimated to be living with hepatitis C. Approximately 24% of those exposed to the virus are able to clear it on their own. However, when left untreated, it can cause serious complications such as liver failure and liver cancer. The new modern hepatitis C therapies are highly effective, with the ability to clear the virus at rates over 95%. If untreated, hepatitis C virus infection can be a life-threatening communicable disease. Risk and harm reduction practices are strongly encouraged for those who may be at higher risk for re-acquiring the virus after successful treatment, including people who inject drugs, men who have sex with men, and commercial sex workers. Hepatitis C is the most-frequent cause of premature death among reportable infectious diseases in North America, and has become the most-frequent cause of premature death among people living with both hepatitis C and HIV.
 

For more information: https://news.gov.bc.ca/releases/2017HLTH0037-000374
 

Hep C World News - Week of  February 12, 2017

B.C. sees spike in organ donors who died of drug overdose      
 

Vancouver, BC - According to a report published in the Toronto Star, there has been a spike in the proportion of organs coming from donors who have died of drug overdoses in British Columbia. Transplant specialist, Dr. David Landsberg, head of the province’s renal transplant program, said 25 per cent of the deceased donors that have come into the program so far in 2017 were the result of overdoses. “Unfortunately, always when there is a donation there’s been a tragedy,” Landsberg said. “But for patients who have been in desperate need of transplants, it’s been a blessing.” B.C. illicit drug overdose deaths hit a record high of 914 in 2016 Federal government announces $65 million to address opioid crisis as B.C., Ottawa sign health deal. B.C.’s chief medical officer declared a state of emergency 10 months ago over the number of overdose deaths. The crisis saw 914 people die in the province last year from illicit drugs, a significant portion of which were linked to the deadly opioid fentanyl. Figures released by the coroner’s office on Friday showed 116 people died in January from illicit drug overdoses. The crisis has played a role the number of organs donated for transplant, Landsberg said, though part of that growth can also be attributed to improvements in transplant co-ordination and outreach. All organs are tested for diseases but recipients are still advised when an organ comes from someone who engaged in “high-risk” behaviour, he added. “Previously we would have shied away from accepting that type of donor because of concerns about disease transmission,” Landsberg said. “We are equally as concerned today as we were a couple years ago, but we have better systems in place to make sure that there is no active disease, and then to be able to offer it to people in a way which is safe.” James Breckenridge, head of the Canadian Transplant Society, said it makes no difference to transplant recipients if an organ comes from someone killed by a drug overdose. “If you were dying and you were told you had 48 hours to live and here’s a guy who smoked crack, would you take his liver, as long as they told you it was healthy? Of course, you would,” he said. Between 2013 and 2016, donors who tested positive for drugs when they died grew from about seven per cent to 22 per cent. These included all drugs, not just fentanyl, and do not mean the donor died from a drug overdose. A similar trend has been taking place in recent years in the United States, most notably in New England. Research conducted by the U.S. Health Department shows that between 2012 and 2016, the number of transplants coming from donors who died due to “drug intoxication” more than doubled, from five per cent to 12 per cent. More than 25 per cent of all deceased donors died from drug intoxication in the northeastern region in 2016, compared to 12 per cent in 2012. The area encompasses Maine, New Hampshire, Massachusetts, Connecticut and Rhode Island. The Canadian Institute of Health Information says 2,580 transplants were performed across the country in 2015. More than 4,700 patients waited for a transplant that year, while 21 either withdrew or died while on the wait-list.   
 

For more information: http://tinyurl.com/gnkaet7
 

Hep C World News - Week of February 5, 2017

Toronto is a liver cancer hot spot 
 

Toronto, ON – An article published in the Toronto Star recently speaks to the fact that survival rates are rising but more than 1,000 people die every year in Ontario from liver cancer. And, most of these deaths occur in the Greater Toronto Area. In fact, the epidemic level of liver cancer in this city often goes unrecognized, as it’s diluted by provincial and national statistics. So what is it about Toronto that makes it such a hot spot for this type of cancer? Most of the cases occur in patients with chronic liver disease, typically due to chronic blood-borne infections with the hepatitis B or C viruses. The transmission of hepatitis B occurs mainly from mother to child and is prevalent in several regions of the world. Immigrants from East Asian and African communities are at an especially elevated risk of carrying hepatitis B, and of developing liver cancer. Hepatitis C is found throughout the world and mainly spread through sharing and inadequate sterilization of needles and syringes. Those who’ve been exposed to infected blood are also at a higher risk — and adults born between 1945 and 1975 are much more likely to have been exposed to hepatitis C. Both infections are silent, with no symptoms until it is too late. And it’s a big issue: liver cancer is among the most fatal cancers in the province — now the fifth most common cause of cancer death among men in Ontario. This is new for North America, where it has traditionally been uncommon (globally it’s the second most common cause of death from cancer). But with the undetected spread of hepatitis C and a growing immigrant population, Ontario has seen a staggering 4.5 per cent increase every year for the past 30 years. Today, the province’s rate of new cases is similar to regions with moderately high incidence, such as Western Africa. But because of the concentration of immigrants in Toronto the rate is even higher. If you live in this city, there is a real chance you may be at risk. The survival rate from liver cancer has tripled over the past 30 years but it remains quite low. According to provincial statistics, only 24 per cent of patients will survive five years or longer. But when caught early, there is a high chance of cure.
 

For more information: http://tinyurl.com/hlws9wc
 

Hep C World News - Week of January 29, 2017

Breakthrough hep C meds may carry severe risks    
 

Horsham, PA - A  new report highlighted safety concerns for two of Gilead's stalwart hepatitis C meds—Harvoni and Sovaldi—along with other rivals in the class. The new DAAs, which have been lauded for their ability to cure hep C, could be associated with severe side effects such as liver failure, according to an analysis by the Institute for Safe Medication Practices. Aside from the Gilead drugs, the ISMP report included other direct-acting antivirals from AbbVie, Merck & Co., Bristol-Myers Squibb and Johnson & Johnson. By looking at FDA adverse event data for the 12 months ending on June 30, 2016, ISMP found 524 cases of liver failure around the world associated with the drug class and 1,058 reports of severe liver injury. In another 761 cases, the antivirals failed to work. More than 30% of the patients who experienced liver failure died. Gilead said in a statement that its meds were approved for patients already experiencing liver problems, adding that it's “seen no evidence of a causal relationship between sofosbuvir-based regimens and liver failure.” Drug failures aren't "unexpected" given the numbers of patients treated, a Gilead spokesperson added. Based on the company's experience and published articles, virologic failure "occurs as relapse in a small proportion of patients after treatment completion." Speaking to ISMP, J&J's Janssen unit noted that it considers its med's adverse event profile as "consistent with those seen in clinical trials and reflected in the prescribing information," according to the report authors. However, the authors said “90% of cases were reported by healthcare professionals as a drug-related adverse event and not the natural progression of hepatitis C.” While not definitive, the report said the data “show the need for further investigation into the negative consequences of these expensive and important new drugs." The findings come on the heels of an FDA decision last fall to slap a black-box warning on the class, alerting patients and docs of the potential for a return of hep B infection in current or previous hep B patients. That represented the first major safety issue for the drugs, ISMP noted, and couldn’t have been “detected in clinical testing because such patients were excluded.”
 

For more information: http://tinyurl.com/zh8odrc
 

Hep C World News - Week of January 22, 2017

Drug industry unveils massive new campaign to counter criticism    
 

Washington, DC - Under withering public criticism, the drug industry is doubling down on its arguments that the debate over drug prices is distorted, rolling out a multimillion-dollar ad campaign to repair its reputation and defend the value its medications provide. The industry’s major lobbying group here, the Pharmaceutical Research and Manufacturers of America, unveiled the campaign on Monday. Officials said they would spend in the “high” tens of millions of dollars every year for the next four to five years, rehabilitating their image in the wake of former industry executive Martin Shkreli and the political backlash to rising prices. “Less hoodie, more lab coats” is how PhRMA President and CEO Stephen Ubl described the advertising campaign in a briefing with reporters. (Shkreli, not missing an opportunity for publicity, responded with a hastily produced website detailing how double-digit price increases are hardly unique to companies outside PhRMA’s membership.) The campaign, branded “Go Boldly,” sounds like a more aggressive version of the industry’s previous image-making campaign, “From Hopes to Cures.” It will emphasize that biopharmaceutical companies develop breakthrough medications that save lives and that they can be the answer to the problem of health care costs, rather than the cause. The first television ad being released as part of the new campaign is being called “Do Not Go Gentle.” It blends Dylan Thomas’s famous poem with images of goggled scientists peering through microscopes and patients heading into treatment. The PR campaign will be paired with a series of events intended to remake the public debate, from one about drug prices to one about medical breakthroughs and the value that novel medications provide by saving costs in the long run. The industry believes its preferred policies — value-based contracts and a modernized Food and Drug Administration — can fix the cost problem better than more direct price controls that drug makers view as their greatest threat. “We have a great story to tell and we’re going to do a better job telling it,” Ubl said. That is a promise, though, that industry officials have been making for more than a year. What Monday’s announcement made clear is that they are prepared to spend huge sums of money to fulfill it. Since Shkreli, the “pharma bro,” first became a national news story, the industry has said it would work to distinguish itself from such bad actors by focusing on the unprecedented scientific progress its companies are making. As Americans continue to name drug affordability one of their top health care concerns, drug makers have argued that their products, by better treating or even curing diseases, can actually help keep costs down. Nonetheless, President Trump — without any prompting — declared war on drug companies in a press conference earlier this month and pledged to rebuff their considerable political influence. The new PhRMA campaign will notably be attributed to “America’s Biopharmaceutical Companies,” not the trade group. The campaign rolled out Monday represents a major gamble and investment to turn the tide of public opinion. It seeks to redefine drug companies as bold risk-takers in the same vein as world-famous explorers; print and digital ads evoke Columbus and Magellan. “I think there’s a national narrative about the industry that doesn’t reflect the reality of what’s happening in our labs,” said Robert Zirkelbach, PhRMA’s executive vice president of public affairs. Ubl referred repeatedly to the new treatments for hepatitis C as a quintessential example of this misinformed public debate. The drugs actually cure the disease, he pointed out, yet much of the conversation has been around the high costs. While the ad campaign hits the airwaves, screens, and pages, the industry is taking its policy agenda on a road tour. The first event will be in Boston in late February. The goal will be to bring together drug makers, doctors, and patients to discuss ideas for addressing drug costs.
 

For more information: http://tinyurl.com/zm9nw4b
 

Hep C World News - Week of January 15, 2017

Vending machines with clean pipes, needles for drug addicts coming to Ottawa    
 

Ottawa, ON - According to a report published by the CBC, Ottawa Public Health is hoping to install vending machines throughout the city that would dispense clean needles and pipes to drug users. As part of a pilot project the secured machines would be placed outside existing downtown health centres, such as the Sandy Hill Community Health Centre and the Somerset West Community Health Centre. Those facilities would give drug users tokens, which they would use to access the supplies inside the machines. Right now, drug users in Ottawa can access clean inhalation and injection supplies at various community health centres, but they're not open around the clock, which is leaving some people at an increased risk for infections such as HIV and hepatitis C, according to Dr. Vera Etches, Ottawa's deputy medical officer of health. "There's a major gap. There's a gap overnight and on weekends in terms of people being able to access those supplies," Etches said. Ottawa Public Health has heard concerns during initial consultations that the machines might diminish face-to-face interaction between drug users and counsellors, since people wouldn't have to go inside a facility to get clean supplies, Etches said. "This is a complementary service. It's not meant to replace a connection with people who are using drugs. We always want to see … can we offer them other supports? Can we link them to treatment, potentially?" Etches added. The dispensing machines may encourage new connections between drug users and support workers, according to Joanna Binch, a nurse practitioner at the Somerset West Community Health Centre. "We recognize there's a large percentage of people that aren't using our services yet. And this is a first point of contact for them, that maybe by trusting us, and showing that we're supporting new technologies and new ideas, that they will then move into our centre," said Binch. Ottawa Public Health said it hopes to also include information about preventing overdoses inside the dispensing machines. For now, there isn't a start date for the pilot project, since the health agency has yet to secure a supplier to build the vending machines.
 

For more information: http://tinyurl.com/hwasmgq
 

Hep C World News - Week of January 8, 2017

Hep C patients go abroad for drugs
 

London, UK - The BBC recently reported that patients with hepatitis C are buying medication online from abroad to treat their disease to avoid long waits on the NHS. NHS watchdog NICE has approved the use of new drugs that cure more than 90% of some strains, but there are calls for them to be made more widely available. NHS England said 10,000 were being treated this year and that will rise. An estimated 215,000 people in the UK have hepatitis C, which can cause liver damage and cancer. The BBC has seen confidential documents, which suggest the cost to the NHS of some medications has dropped by nearly three-quarters. One of the patients profiled in the report is thought to have developed the illness after having treatment for polio as a child. She was told she would have to wait for medication on the NHS and said: "Treatment was withheld from me - people who were much worse than me had to be treated first." She decided to take matters "into her own hands" and paid £1,200 for medication from India, using a website called FixHepC. The treatment was successful. Dr. James Freeman, the founder of the site, told You & Yours they had helped 400 people in the UK to access medications from abroad in the last year, but estimates the total number of people receiving it is likely to be three times as high. In England, 22 operational delivery networks, consisting of multidisciplinary teams, decide who should be treated based on clinical need, as NICE suggests. Each area has a set number of patients to treat, allocated by NHS England based on estimated prevalence of hepatitis C. Dr. Ashley Brown, from Imperial College Healthcare NHS Trust, said: It is particularly frustrating, I have patients who I know are eligible for treatment, the treatment has been approved by NICE but I can't treat them due to budgetary restrictions. "We all accept the fact the NHS pot is limited, but if that is the case, that pot of money should pay for treatment for as many patients as possible. "We have long waiting lists here in west London; in other parts of the country there are short waiting lists or no waiting lists at all." Dr. Brown said he had to prioritise those patients with the most severe disease – but elsewhere people with more mild disease were getting treated sooner. He added that he had patients who were buying medications from abroad. Baroness Randerson, co-chair of the All-Party Parliamentary Group on Liver Health, said buying medication from abroad posed an unacceptable risk to patients. Charles Gore, the chief executive of the Hepatitis C Trust, said "if the price of drugs is falling, we want those savings to be used to expand the number of people that can be treated". In a statement, NHS England said that an extra £200m a year had been made available to fund treatment with new drugs and had helped to cut deaths by 10% in one year. The number of patients receiving the drugs would rise to 15,000 in 2021. "As prices come down, we hope to be able to expand treatments even further in future years within the funding available and the industry is now engaging in the discussions with us about how best to do this." Public Health Wales told the programme there are no waiting times in Wales to access these new hepatitis C treatments. The Scottish government said there is no limit on the number of people who can be treated in Scotland. Dr. Faye Kirkland is a GP working in the NHS.
 

For more information: http://www.bbc.com/news/health-38319799?platform=hootsuite
 

Hep C World News - Week of January 1, 2017

Hep C in Irish haemophilia population 'eradicated'
 

Dublin, Ireland - The Irish Haemophilia Society has announced the effective eradication of Hepatitis C in people with haemophilia in Ireland. All people with haemophilia who required treatment for Hepatitis C have now been offered treatment, with excellent success rates. A small number of people in the country decided not to take treatment because of their age or for other reasons. From the 1970s to 1991, a total of 240 people with haemophilia were infected with Hepatitis C by blood products, used for the treatment of haemophilia. Of these individuals 105 were also infected with HIV. To date, 112 people have died of either HIV or Hepatitis C. "This was the largest medical disaster in the history of the State and it devastated the entire haemophilia community", said Brian O'Mahony, Chief Executive of the Irish Haemophilia Society. He said that thousands of people in the country still suffer from the disease and there is a plan to eradicate Hepatitis C in the country over the next number of years. "The effective eradication of this virus, which has brought so much death and despair to our community, is a milestone in the history of haemophilia in Ireland." This led to the establishment of the Lindsay Tribunal of Inquiry in 2001. People with haemophilia who were infected with Hepatitis C were supported by the society, as they sought and underwent treatment over the past number of years. Treatment uptake among people with haemophilia was strong, despite the harsh side effects and long duration of previous treatments. By 2015, all but 37 people had successfully cleared the virus through treatment. The availability of the new generation of direct acting antivirals in 2015 provided an opportunity for successfully treating the virus with a less harsh regime and a much shorter duration of treatment. The society advocated strongly for the availability of these treatments for people with haemophilia and in July 2015. It received an assurance from the Department of Health that all State infected patients, including people with haemophilia, would be treated no later than the end of 2017. That target has now been exceeded. All people with haemophilia have now been offered treatment. The majority have now completed treatment with a small number currently undergoing treatment. The success rates to date have been in excess of 90%. For those who have cleared this virus, their future risk of serious liver disease or liver cancer has been very significantly reduced.
 

For more information: http://www.rte.ie/news/2016/1222/840646-health-haemophilia/