"Sobering results" reported in the 2016 Hep-CORE Report - ELPA  

Berlin - First Major European Viral Hepatitis Study Reports Serious Gaps in Policies ELPA presents the stark findings of the 2016 Hep-CORE Report. Fifty-two per cent (52%) of surveyed European and Mediterranean Basin countries lack national strategies to address viral hepatitis B or C despite the WHO World Health Assembly resolution calling on all countries to have one. Only three of these countries have access to the new, highly effective medicines (direct-acting antivirals) for hepatitis C without restrictions. These are just two sobering results from the 2016 Hep-CORE Report on the state of viral hepatitis policy and practice in Europe, released by the European Liver Patients Association (ELPA). The Hep-CORE Report was conducted under the direction of Prof. Jeffrey V. Lazarus of IS Global, University of Barcelona. According to Lazarus, “2016 has been a turning point for viral hepatitis thanks to the adoption of the first-ever WHO Global health sector strategy on viral hepatitis. The European region can and should take the lead in implementing it. These Hep-CORE results serve as an unprecedented analysis of regional and national gaps, clearly showing where there are deficient policies and, by default, what action needs to be taken.” For example, despite an urgent need for broad monitoring and disease surveillance, this ground-breaking study found that 17 countries (63%) have no national hepatitis B virus (HBV) register and that 15 countries (56%) have no national hepatitis C virus (HCV) register. Basic access to testing and screening facilities is vital for patients, especially those from high-risk groups such as people who inject drugs, or prisoners. Despite this, patient groups from 10 countries (37%) reported that there are no HCV testing or screening sites outside of hospitals for the general population in their countries. Even more alarming, patient groups from 12 of the countries (44%) reported that there are no such sites outside of hospitals that provide testing or screening services for high-risk populations. With the design of the Hep-CORE Report, ELPA has looked to a unique approach. The data were collected from local specialists in each country. The research team asked one patient group in each of ELPA’s 27 member-country to complete a 39-item survey about various aspects relating to HBV and HCV: overall national response, public awareness and engagement, disease monitoring and data collection, prevention, testing and diagnosis, clinical assessment, and treatment. Another section of the survey asked a set of questions oriented towards understanding hepatitis prevention in each country. This section focused on the availability of harm reduction – services that target the reduction of negative health consequences associated with drug use, such as the spread of viral hepatitis. It was reported that clean needle and syringe programmes are available in at least one area of a patient group’s country in 22 cases (81%), that opioid substitution therapy is available in at least one area of a patient group’s country in 24 cases (89%), and that drug consumption rooms are available in only 5 cases (19%). Significant gaps in harm reduction with regards to reported coverage and availability remain. "It is completely unacceptable that hepatitis continues to be so poorly addressed in Europe. There are excellent prevention and treatment possibilities, well-thought-out strategies are available, and we have numerous international initiatives, especially from WHO," said Tatjana Reic, President of ELPA. “I expect this study to change the landscape of viral hepatitis policy surveillance on a regional, and even global, level.” Baseline data for the transmission and development of infection are prerequisites for the elimination of pandemic infectious diseases like viral hepatitis. Such data is grossly underreported and, even in best-case scenarios, poorly estimated in Europe. What we do know is that every year 171 000 people die due to viral hepatitis related causes (approximately 2% of all deaths annually). This translates to more than 400 deaths from hepatitis every day. The vast majority of these deaths are due to late effects of chronic HBV and HCV infections (which caused an estimated 56 000 and 112 500 deaths in 2013, respectively). “The reduction to zero of the incidence of hepatitis C in defined risk groups is possible in the coming years. For that we need rigorous HCV surveillance across all European countries, effective screening programmes, increased treatment uptake with high efficacy therapies, and close collaboration between stakeholders,” emphasised Prof. Massimo Colombo from the University of Milan and Chairman of the EASL International Liver Foundation. Prof. Lazarus concluded that, “the 2016 Hep-CORE Report findings are a resource that can aid the efforts of all those working to eliminate HBV and HCV as public health threats in Europe, and beyond, in line with WHO’s global strategy and the recently adopted ‘Action plan for the health sector response to viral hepatitis in the WHO European Region’. We now have a starting point from which we can systematically scale up hepatitis prevention, treatment, and care – and monitor the much-needed progress. Viral hepatitis, which affects millions of people in Europe, has to be combated on a large scale and this requires individual country and concerted pan-European action.”

For more information: http://tinyurl.com/hkhnz35

Hep C World News - Week of December 18, 2016

Hepatitis C in Irish haemophilia population 'eradicated' 

Dublin - 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: https://www.rte.ie/news/2016/1222/840646-health-haemophilia/

Hep C World News - Week of December 11, 2016

Almost half of MSM with HIV/HCV co-infection have HCV in their rectal fluid 
 

New York, NY - Almost half of HIV-positive men who have sex with men (MSM) who have co-infection with hepatitis C virus (HCV) have detectable HCV in their rectal fluid, US investigators report in the online edition of Clinical Infectious Diseases. The presence and level of HCV in rectal fluid was strongly associated with the level of HCV in blood. “This study provides the first direct evidence that HCV is shed into the rectum of HIV-infected men,” comment the authors. “We found HCV at substantial levels in the rectal fluid of almost half the HIV-infected men we studied.” The authors believe their findings support the hypothesis that rectal bleeding is not needed for the sexual transmission of HCV infection between MSM. They call for the development of health promotion interventions that reflect their findings. The first cases of sexual transmission of HCV involving HIV-positive MSM were reported in the early 2000s and there are now well-established epidemics of sexually transmitted HCV involving HIV-positive MSM in a number of European and US cities. Despite this, there is still considerable uncertainty about the body fluids involved in transmission and the precise sexual practices that carry the highest risk of infection with the virus. Investigators in New York City therefore designed an observational study involving 43 HIV-positive MSM with HCV co-infection. HCV viral load was quantified in paired samples of rectal mucus and blood. Sixty per cent of participants were white and the median age was 43 years. All were taking antiretroviral therapy, but because of poor adherence, only 49% had viral suppression. Two-thirds of participants had high-resolution anoscopy at the time rectal fluid was sampled. None of these individuals had evidence of rectal trauma or bleeding. However, blood was detected on the rectal swab from a man who did not initially undergo anoscopy. Subsequent anoscopy revealed the presence of proctitis. HCV in rectal fluid was detected in 47% of men. The median HCV viral load in rectal fluid was 2.9 log10 IU/ml. Blood viral load was significantly higher among men with HCV in their rectal fluid compared to those in whom it was not detected (6.4 log10 IU/ml vs. 4.0 log10 IU/ml, respectively, p < 0.001). The presence of HCV in rectal fluid was strongly associated with HCV viral load in blood above 5 log10 IU/ml (p = 0.001) and even more strongly with blood HCV viral load above 6 log10 IU/ml (p < 0.001). Moreover, 85% of those with a blood HCV viral load above 5 log10 IU/ml and 90% of individuals with a blood HCV viral load above 6 log10 IU/ml had HCV in their rectal fluid. There was a significant positive correlation between the level of HCV in rectal fluid and HCV viral load in blood. High-level rectal shedding of HCV – 4 to 5 log10 IU/ml – was detected in a quarter of individuals with a blood viral load above 6 log10 IU/ml. The man with the highest rectal HCV viral load (5.2 log10 IU/ml) was the person with visible blood on his rectal swab and proctitis. “These results support the accumulating epidemiological evidence that rectal bleeding is not required for transmission of HCV infection among HIV-infected MSM, and may be the explanation for the epidemiological associations found in some studies between group sex or fisting,” write the authors. “We suggest that for clinical and public health purposes, finding HCV RNA in rectal fluid should be taken as evidence of infectiousness until proven otherwise.” The authors conclude that, “semen and rectal fluid, rather than frank blood from the rectum, are likely the fluids that mediate most HCV infections in this epidemic.” They call for public health campaigns to educate MSM about these routes of HCV transmission.
 

For more information: http://tinyurl.com/j85whz4  
 

Hep C World News - Week of December 4, 2016

Canada needs 'defined model' of universal pharmacare 
 

Ottawa, ON - Canada needs a comprehensive system of universal drug coverage to eliminate variations between the provinces and territories, a citizen-driven panel looking at the idea of national pharmacare recommends. The Citizens' Reference Panel on Pharmacare in Canada — comprised of 35 volunteers randomly selected from across Canada, similar to a coroner's jury — met in Ottawa for five days and heard from 20 experts to produce a report on the issue. The report, entitled "Necessary Medicines", will be presented today to the House of Commons' Standing Committee on Health. "In public opinion research that's been conducted, Canadians routinely support some form of pharmacare," panel chair Paul MacLeod said. "But that's always been a placeholder. We haven't really had a defined model that Canadians are saying they would endorse. That's part of what this report provides." The panel's recommendations include: Creating a new national formulary of universally publicly covered medicines that accommodates the full range of individual patient needs, including rare diseases. Requiring all covered drugs to undergo a rigorous evaluation process to ensure both the efficacy and value-for‐money of funded treatments. Endorsing an ongoing role for private insurers in providing supplemental coverage. Canada is the only developed country with universal health coverage that does not also offer universal prescription drug benefits. The Organization for Economic Co-operation and Development has also found that Canada has the second-highest per capita spending on prescription drugs in the OECD. An estimated one in 10 Canadians can't fill prescriptions because of the expense. Canadians spend almost $30 billion a year on prescription medicines. Colleen Flood, director of the Centre for Health Law, Policy and Ethics at the University of Ottawa, is one of the experts who presented to the panel. She supports the idea of a Canada-wide pharmacare plan. "Essentially for pharmaceuticals needed outside the hospital, we pretty much have a U.S.-style system," Flood said. Under a national plan, Flood said Canadians could have access to pharmaceuticals without breaking the bank, just as medicare does for hospital and physician services. "Other countries show us that you can have your cake and eat it too," she said. "You can have full public medicare, covering everybody, and you are going to spend less, not more." There isn't a lot of political momentum to introduce universal pharmacare because most Canadians think they're covered, says Prof. Colleen Flood. (EvidenceNetwork.ca) While Canadians may appreciate that a national pharmacare plan would allow governments to negotiate lower drug prices, Flood said governments will also need to be able to say no if a drug doesn't pass the bar on efficacy or cost-efficiency. For its part, the panel suggests starting with a short, basic list of essential medicines comprised of frequently prescribed drugs — one that could expand once a national formulary is in place. "[Most Canadians are] fortunate enough to have coverage through [their] employer or we've enjoyed good health and we haven't had to pay a lot of pocket," MacLeod said. "We tend to assume that must be how it is for everybody. "I think the biggest surprise for the panel is really understanding the health consequences and the fiscal consequences for individuals who aren't so fortunate as to enjoy that kind of employer-provided coverage, and those people, of course, who deal with very serious health issues." Flood agrees that the current system "leaves a gap." A national pharmacare program was originally recommended in 1964 as part of the Royal Commission on Health Services, also known as the Hall Commission, as well as in later reports, such as the 2002 Romanow Commission. As for why national pharmacare hasn't yet been implemented, Flood pointed to two reasons: Most Canadians have private health insurance through employers. A lot of provinces have legislation to cover the poor and elderly. "It leaves a gap, but it also doesn't leave a lot of political momentum for people to do much about it, because most of us are OK and we think we're covered," Flood said. The panel's research was funded by the Canadian Institutes of Health Research. A committee of clinicians, senior public servants and health researchers from across Canada oversaw the process. Other speakers included doctors, nurses, pharmacists, brand name and generic manufacturers, insurers, retailers, patients, public agencies, academics and former policy-makers. A national drug plan is not officially on the federal government's agenda of priorities.
 

For more information: http://www.cbc.ca/news/health/pharmacare-citizen-panel-1.3882481
 

Hep C World News - Week of November 27, 2016
 

Shorter Hep C regimens of interest at Liver 2016 
 

Boston, Mass - Shortening the length of curative regimens for hepatitis C treatment will be one of the hot topics here at The Liver Meeting 2016. One study likely to garner significant interest examines an investigational conjugated drug (RG-101) that, used in combination with oral direct-acting antivirals, can produce high rates of sustained responses after just 4 weeks of therapy in patients with genotypes 1 and 4 hepatitis C. And in a study looking at the link between hepatitis C and cancer, investigators will present data on the incidence and pattern of de novo hepatocellular carcinoma in patients treated with oral direct-acting antiviral agents. "We've moved away from a single, one-size-fits-all program into something that's more customizable for the audience," said Keith Lindor, MD, from Arizona State University in Phoenix, who is president of the American Association for the Study of Liver Diseases (AASLD). "We've tried hard to make this a very user-friendly meeting," Dr Lindor told Medscape Medical News. "We have created convenient times for special interest groups to meet, and we've moved the posters away from Tuesday morning [the final day of the meeting], so that morning will be filled with highlights from the meeting and a late-breaking abstracts session." Two common and difficult-to-treat problems — nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) — will be the focus of several abstracts, including one with the self-explanatory title of, Not Just What, but Also When You Eat: Analyzing the Impact of Meal Timing Patterns on Non-Alcoholic Fatty Liver Disease. The troubling trend toward NASH and advanced fibrosis in adolescents with NAFLD in the United States will be examined in another presentation, and a third study will look at the increased risk for cirrhosis in first-degree relatives of patients with NAFLD cirrhosis. Investigators will also present data from a nationwide retrospective study on the impact of statins on mortality in patients with compensated or decompensated alcoholic cirrhosis. And a risk-prediction model — an especially valuable tool in orthotopic liver transplantation — will be presented for portal vein thrombosis in patients on the transplant list.
 

For more information: http://www.medscape.com/viewarticle/871472
 

Hep C World News - Week of November 20, 2016

HCV and alcoholism common
 

Houston, TX - The question of whether and when to treat patients with hepatitis C who also have uncontrolled alcohol use disorder has plagued clinicians for nearly 30 years. There are a number of arguments for and against. For example, those in favor of treating immediately might suggest, simply, that if a patient has a disease, and if there is an available cure for that disease, it should be cured. Conversely, other clinicians might argue that even if a patient is cured of HCV, excessive alcohol use may lead to high-risk behaviors that predispose the patient to reinfection. One of the central arguments is whether a period of abstinence from alcohol should be required before initiating therapy. In the interferon era, with mediocre response rates and a host of adverse events — including mental health effects that could exacerbate addiction — there was ample reason to demand control of alcohol intake before therapy. But with the overwhelming efficacy and safety of direct-acting antivirals, many believe that there is no need to wait. Hashem B. El-Serag, MD, MPH, professor of Medicine and Chief of Gastroenterology and Hepatology at the Michael E. DeBakey VA Medical Center and Baylor College of Medicine in Houston Tex., commented on this aspect of the discussion. “The availability of highly efficacious treatments with minimum side effects has infused a lot of enthusiasm to providers as well as patients who are active alcoholics to overcome the obstacles delaying treatment,” he said. “Therefore, the discussion of adverse effects of drinking, including the discussion of withholding treatment and rehabilitation, at least temporarily, is happening more frequently and more vigorously.” He acknowledged that the idea of a set period of abstinence before initiating therapy — an approach that is declining in popularity — is still a reasonable option to consider. However, there is flexibility. “There are more methods and avenues to stop drinking than there were previously,” he said. “Some providers, including me, are more compromising about the duration or strictness of non-drinking. Full completed rehab is ideal, but a considerable reduction in alcohol intake or active enrollment in rehab are acceptable alternatives.” A unique by-product of the efficacy and safety of DAAs is that patients are more willing than ever to get their drinking under control.
 

For more information: http://tinyurl.com/z58l8p6
 

Hep C World News - Week of November 13, 2016

HCC incidence stable in DAA-treated patients with HCV, cirrhosis
 

Boston, MA - Patients with hepatitis C infection cirrhosis treated with oral direct-acting antiviral agents were not at increased risk for developing hepatocellular carcinoma, according to study findings presented here. “However, a subset of patients may go on to develop an aggressive tumor during or directly following treatment,” Alfredo Alberti, MD, from the University of Padova in Italy, said during a press briefing. “This suggests that the immunological and molecular changes in the liver microenvironment could support the growth and spread of microscopic, and initially invisible, HCC. Further studies are needed to clarify these issues and identify predictive markers. Meanwhile, patients treated with direct-acting antiviral agents with advanced liver disease should continue to be closely monitored for HCC.” Recent conflicting data suggest a possible association between HCC risk and antiviral therapy, with some reports suggesting a significant recurrence of HCC or de novo incidence during or after DAA therapy, according to Alberti. For this reason, the researchers sought to assess the incidence of HCC in patients with HCV and advanced liver disease who underwent DAA therapy and did not have previous HCC. Patients with fibrosis F3 or cirrhosis (n = 3,381) were prospectively enrolled between January 2015 and June 2016. They were assessed for the timing and pattern of HCC diagnosis and the factors associated with tumor occurrence. According to study results, patients with fibrosis F3 had an SVR of 97%. This was followed by 92% in those with cirrhosis Child Pugh A and 80% in those with cirrhosis Child Pugh B. The overall incidence for de novo HCC was 1.64%, with a stable 2.5% increase in cumulative incidence during the 18-month follow-up period. When the researchers further analyzed HCC incidence during different liver disease stages, incidence was 0.23% PPY in patients with fibrosis F3; 1.64% PPY in those with cirrhosis and cirrhosis Child Pugh A; and 2.92% PPY in those with cirrhosis Child Pugh B. Results of Kaplan Meier analysis indicated a difference in cumulative incidence during follow-up, however, this did not reach statistical significance at the Mantel test, according to Alberti.
 

For more information: http://tinyurl.com/gp8l8wp
 

Hep C World News - Week of November 6, 2016

Australia Changes Hep C Prescribing To GPs  
 

Queensland, AU - ASHM welcomes changes to the Pharmaceutical Benefits Scheme (PBS) which will allow skilled and experienced clinicians to initiate hepatitis C treatment using direct-acting antivirals (DAAs) for their patient without the need for costly consultation with specialist services. "This will allow the relatively small number of community based clinicians: GP, sexual health physicians and drug and alcohol and addiction medicine service providers for example who have done training or developed experience in this area to initiate treatment without having to consult a third party." "This adds to the available access points for people with hepatitis C seeking care. All clinicians, irrespective of their experience will still be able refer patients or start them on treatment if this is recommended following consultation with a specialist. So all Australians continue to have access." "This just simplifies the process and reduces the delays for patients and their clinicians wanting to start. It also reduces the unpaid burden on specialists who are reviewing many hundreds of requests to start patients on therapy. Many of these coming from doctors who have the experience and skills to make that decision themselves." "This is another example of Health Minister Ley's commitment to making care accessible. It recognizes the commitment of the clinical community and is another step to eradicating hepatitis C in Australia", said Levinia Crooks Chief Executive Officer of the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine which led the call to have these clinicians able to initiate therapy independently. "This is not another cost to the healthcare purse, it allows more Australians to take up treatment under the cost arrangements negotiated by the government. If anything it will reduce costs," said Crooks, "as people will be able to start treatment in one visit, rather than having to wait for a review by a specialist. It will also strip hours of work out of the specialists busy week, with specialists not having to unnecessarily review the work of doctors they know have the skills to manage these patients. This will free those specialists up to provide assistance to clinicians who have no experience in hepatitis C and who may really need help to assess their hepatitis C patient's treatment needs." "Over time, as more clinicians treat hepatitis C, we hope more will get skilled up in this area and increase the number of people working independently in this area."
 

For more information: http://tinyurl.com/zxg9lxr
 

Hep C World News - Week of October 30, 2016

Study Explores Marijuana Use and Fibrosis in Women with HIV and Hepatitis C  
 

Ottawa, ON - A study in women coinfected with hepatitis C and HIV found that use of marijuana was not associated with progression to advanced liver fibrosis. University researchers studied long-term effects of tetrahydrocannabinol (THC) from marijuana on fibrosis progression in women enrolled in the Women’s Interagency HIV Study. Results were published recently in the Oxford Journal of Clinical Infectious Diseases. The hepatitis C virus (HCV) is a blood-borne disease that, left unchecked, can lead to fibrosis, cirrhosis, liver cancer, or the need for a liver transplant. The authors note that marijuana use has been associated with progression of liver fibrosis in retrospective analyses of patients with chronic hepatitis C and that other studies on the impact of THC use and liver fibrosis progression have reported conflicting results. “Currently, marijuana has been legalized for medicinal and/or recreational use in 23 US states, as well as the District of Columbia, and its use in HIV/HCV-coinfected patients is common,” the authors stated in the article. “Given that it is becoming more widely available and more regularly consumed, it is critical to assess its clinical effects, including any negative impact of THC use on liver fibrosis progression.” In this longitudinal analysis, researchers measured marijuana and alcohol use, quantifying it as average exposure per week. Liver fibrosis was categorized according to FIB-4 scores, as none, moderate or significant. The study followed women who were coinfected with hepatitis C and HIV for an average of 11 years. Out of 575 women, 25% reported less than weekly THC use, 12% reported weekly use and 7% said that they used daily; just over half reported no THC use at all. There were not many women who were heavy users of THC, but the study’s long follow-up period and study size enabled researchers to conclude that occasional THC is unlikely to contribute to fibrosis progression, according to the article. “We found no evidence that THC accelerated fibrosis progression in women with HIV-HCV coinfection,” lead author Erin Kelly, MD, assistant professor at the University of Ottawa in Canada, said in an email. “Importantly, daily users were less prevalent in this cohort, therefore our results should not be extrapolated to this group.” The possibility of underreported THC and alcohol use by the women in the study was noted as a limitation. In addition, liver biopsy was not conducted and fibrosis stage was instead determined using non-invasive tests. Much like findings from other published studies, predictors of progression of significant fibrosis involving women in the WIHS study included the presence of baseline fibrosis, as well as entry CD4 count and HCV RNA level and ongoing alcohol consumption, according to the article. “Fibrosis progression was associated with poor HIV control and alcohol use,” the authors concluded. “Clinicians should therefore counsel patients on limiting or excluding alcohol intake, in addition to optimizing medical treatment for HIV and HCV, as these factors are more important than THC use in modulating liver disease,” they advised.
 

For more information: http://tinyurl.com/zsw9jop
 

Hep C World News - Week of October 23, 2016
 

Only 35% of baby boomers diagnosed with HCV in ED linked to care 
 

Birmingham, Alabama - Only one out of three baby boomers diagnosed with hepatitis C virus infection in the ED was successfully linked to care for the virus, according to a retrospective cohort study published in “Here, we characterized the ‘no show phenomenon’ to HCV care and the potential role played by demographic and clinical factors, similarly to what has been described in HIV care,” James W. Galbraith, MD, associate professor of emergency medicine at the University of Alabama at Birmingham, and colleagues wrote. An estimated 50% of individuals with HCV are unaware of their infection and more than 60% of those aware of their infection are not receiving medical care. EDs are high-yield settings for detecting HCV infection, the researchers said, but data on subsequent linkage to care are limited. Galbraith and colleagues assessed failure rates of linkage to HCV care among baby boomers after their ED diagnosis. They also aimed to describe the clinical and demographic characteristics of baby boomers infected with HCV and identify the factors associated with failures in linking them to care. From September 2013 to June 2014, opt-out HCV screening was conducted on 4,371 persons born from 1945 to 1964 who presented at the University of Alabama at Birmingham ED. 
 

For more information: http://tinyurl.com/gwnnl7y 
 

Hep C World News - Week of October 16, 2016
 

Coffee, Genetics May Block Hepatitis in Heavy Drinkers 
 

Las Vegas, NV - Among heavy drinkers, those who also reported drinking coffee regularly were less than half as likely as coffee nondrinkers to develop alcoholic hepatitis, a researcher said here. Additionally, those with the PNPLA3 C/C genotype also showed a markedly reduced risk of alcoholic hepatitis in the case-control study of 340 heavy drinkers, according to Naga P. Chalasani, MD, of the Indiana University School of Medicine in Indianapolis. Just over 25% of participants who had the C/C genotype and drank coffee regularly had alcoholic hepatitis, versus 86% of those with the G/G genotype who didn't drink coffee, Chalasani told attendees at the American College of Gastroenterology's annual meeting. The study examined a host of factors in 190 heavy drinkers -- men consuming an average of at least 60 g of ethanol daily and women at least 40 g for the past 5 years plus acknowledging current active drinking -- diagnosed with alcoholic hepatitis and 150 equally heavy drinkers without the condition. These individuals were part of an ongoing prospective study of heavy drinkers called TREAT 001, Chalasani told attendees. Alcoholic hepatitis was diagnosed with "appropriate clinical and laboratory criteria," he said, with ambiguous cases confirmed with liver biopsy. Non-hepatitis controls were matched to hepatitis cases by gender, age, and race. Participants were mostly in their mid-30s to mid-50s, predominantly white, and about 60% were male. Chalasani and colleagues sought to identify baseline differences between cases and controls, other than those directly related to hepatitis (such as liver enzyme levels). The PNPLA3 genotype and self-reported coffee drinking jumped out as the most prominent, he said. The latter, he was, "was a big surprise to us."Notably, Chalasani said, there appeared to be an interaction between PNPLA3 genotype and coffee habits. As indicated above, the lowest likelihood of hepatitis was in those with both the C/C genotype and regular coffee drinking, whereas the highest risk was among those with the G/G genotype and no coffee drinking. In between were those with other genotype combinations and coffee drinking. Limitations to the study included reliance on self-reported data on alcohol and coffee drinking histories.
 

For more information: http://tinyurl.com/gu4xem5
 

Hep C World News - Week of October 9, 2016
 

Hepatitis C is Killing Americans in Record Numbers  
 

Atlanta, GA - As part of the Centers for Disease Control and Prevention’s (CDC) National Notifiable Diseases Surveillance System, viral hepatitis case-reports are received electronically from U.S. state and territorial health departments via CDC’s National Electronic Telecommunications System for Surveillance, a computerized public health surveillance system that provides CDC with data on a weekly basis. After receiving reports of cases of acute hepatitis C ranging from 781-877 during the years 2006–2010, reported cases of acute HCV infection increased more than 2.5 times from 2010–2014. Cases of acute HCV infection rose annually, from 850 in 2010 to 1,232 in 2011, 1,778 in 2012, 2,138 in 2013, and 2,194 in 2014. The increase from 2010–2014 is thought to reflect both true increases in incidence and, to a lesser extent, improved case ascertainment. Based on new epidemiologic studies, at least 4.6 million persons are HCV-antibody positive and approximately 3.5 million are currently infected with HCV. New cases of HCV infection are predominately among young persons who are white, live in non-urban areas (particularly in Eastern and Midwestern states), have a history of injection-drug use, and previously used opioid agonists such as oxycodone. Mortality among HCV-infected persons—primarily adults aged 55–64 years—is increasing. For the first time in the United States. In 2007 the number of HCV-related deaths (n=15,106) exceeded the number of HIV/AIDS-related deaths (n=12,734) and has since continued to increase. The number of HCV-related deaths rose to 19,659 in 2014 and more than one-half of deaths occurred among persons aged 55-64 years. A key public health challenge is to increase the proportion of persons tested, and of those who are currently infected, increase the proportion referred for care and treatment. To address this challenge, the USPSTF joined with CDC in 2013 to recommend one-time testing for HCV infection among adults born during 1945–1965. HCV is transmitted primarily through percutaneous (parenteral) exposure that can result from injection-drug use, needle stick injuries, and inadequate infection control in health-care settings. Much less often, HCV transmission occurs among HIV-positive persons, especially MSM, as a result of sexual contact with an HCV-infected partner. Among persons who receive tattoos in unregulated settings, and among infants born to HCV-infected mothers. After adjustment for populations not sampled in the NHANES household surveys, such as incarcerated and homeless populations, an estimated 3.5 million persons are living with HCV infection in the United States. HCV guidance is continuously updated to incorporate new information regarding HCV testing, linkage to care, and treatment.
 

For more information: http://www.hcvguidelines.org
 

Hep C World News - Week of October 2, 2016

DAA’s may reactivate Hep B  
 

Silver Spring, Maryland - FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. As a result, we are requiring a Boxed Warning, our most prominent warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment. This warning will also be included in the patient information leaflet or Medication Guides for these medicines. Direct-acting antiviral medicines are used to treat chronic hepatitis C virus (HCV) infection, an infection that can last a lifetime. These medicines reduce the amount of HCV in the body by preventing HCV from multiplying, and in most cases, they cure HCV. Without treatment, HCV can lead to serious liver problems including cirrhosis, liver cancer, and death (see List of Direct-Acting Antivirals). Patients should tell your health care professional if you have a history of hepatitis B infection or other liver problems before being treated for hepatitis C. Do not stop taking your DAA medicine without first talking to your health care professional. Stopping treatment early could result in your virus becoming less responsive to certain hepatitis C medicines. Read the patient information leaflet or Medication Guide that comes with each new prescription because the information may have changed. Contact your health care professional immediately if you develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of serious liver problems. We identified 24 cases of HBV reactivation reported to FDA1 and from the published literature in HCV/HBV co-infected patients treated with DAAs during the 31 months from November 22, 2013 to July 18, 2016.2-7 This number includes only cases submitted to FDA, so there are likely additional cases about which we are unaware. Of the cases reported, two patients died and one required a liver transplant. HBV reactivation was not reported as an adverse event in the clinical trials submitted for the DAA approvals because patients with HBV co-infection were excluded from the trials. The trials excluded these patients in order to specifically evaluate the safety of DAAs, including their effects on the liver, in patients infected with only HCV and without the presence of another virus which affects the liver (see Data Summary). We urge health care professionals and patients to report side effects involving DAAs and other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.
New Guidance: Test for HBV Before Starting DAAs for HCV
It is important that all patients beginning hepatitis C (HCV) treatment using direct acting antiviral (DAA) therapies should be assessed for hepatitis B (HBV), according to the AASLD/Infectious Diseases Society of America (IDSA) Guidance Panel. The AASLD/IDSA Recommendations for Testing, Managing and Treating Hepatitis C have been updated to include this new practice guidance.
In addition to testing, the Guidance Panel recommends:
• HBV vaccination for all susceptible individuals.
• Obtaining a test for HBV DNA prior to DAA therapy in patients who could be actively replicating.
• Starting patients who meet criteria for treatment of active HBV infection on therapy at the same time — or before — HCV DAA therapy is started.
• Monitoring patients with low or undetectable HBV DNA levels at regular intervals as recommended by the AASLD’s HBV treatment guidelines.
Visit HCVguidelines.org for more information about the newest recommendations and to view the full report and to read the entire FDA Safety Communication on hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C.
 

For more information: http://tinyurl.com/m3pt5zw
 

Hep C World News - Week of September 25, 2016

More options to be made available to treat hepatitis C 
 

London, UK - Another ‘potential curative’ drug for people with chronic hepatitis C will be made available on the NHS. New draft guidance published today from NICE recommends elbasvir-grazoprevir - one of the newer hepatitis C antiviral drugs that can offer patients more effective treatment. In clinical trials, elbasvir-grazoprevir showed cure rates above 90% for people with genotypes 1 and 4. The cure rate is dependent on the genotype, treatment history and presence of liver damage. Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “Treating chronic hepatitis C had previously been a major challenge with patients having to experience long and unpleasant courses of treatment. “Elbasvir-grazoprevir, like other newer direct acting anti-viral treatments, is a drug that provides considerable health benefits to patients without some of the adverse side effects associated with earlier anti-viral treatments, such as peginterferon alpha with ribavirin.” A 12-week course of treatment with elbasvir-grazoprevir usually costs £36,500 per patient, but the NHS will pay less than this as the company has offered a confidential discount. Taken once daily, the tablet could treat around 4,000 patients in the first year, alongside other options already available for hepatitis C. Professor Longson continued: “Our positive recommendation for elbasvir-grazoprevir means that more treatment options will become available to patients with hepatitis C. And as these types of anti-viral drugs are more effective, the spread of the virus can be reduced.” Hepatitis C is a virus spread through blood which causes infection of the liver, and often leads to liver disease. The virus is spread through the blood, often from contaminated syringes and needles but also through the sharing of razors or toothbrushes, unprotected sex and from an infected mother to her child during pregnancy. The draft guidance recommends that decisions to treat patients with elbasvir-grazoprevir are made by the multidisciplinary teams in the operational delivery networks put in place by NHS England, and to prioritize treatment for people with the highest unmet clinical need. Final guidance is expected to publish in October, when the NHS will have a three-month period to make the drug available to patients.
 

For more information: http://tinyurl.com/gw4gh42
 

Hep C World News - Week of September 18, 2016
 

Clinical frailty scale better detects death in outpatients with cirrhosis 
 

Calgary, AB - The clinical frailty scale — a 1-minute bedside screening test — appeared to better detect unplanned hospitalization or death in outpatients with cirrhosis, according to recent findings published in the American Journal of Gastroenterology. “There are three key findings from our study,” Puneeta Tandon, MD, at the Zeidler Ledcor Center of the University of Alberta, and colleagues wrote. “First, unplanned hospitalizations are common in outpatients with cirrhosis. Second, frailty … is a robust predictor of unplanned hospitalization or death. Third, … the [clinical frailty scale] performed as well, if not better than the [Fried frailty criteria] and [short physical performance battery].” According to Tandon and colleagues, there are not enough screening tools to determine which outpatients with cirrhosis are at highest risk for unplanned hospitalization. Since the clinical frailty scale previously appeared to be a good prognostic indicator, the researchers evaluated the test in 300 outpatients with cirrhosis. Mean age of the patients was 57 years, 35% were women, 81% were white and 66% had hepatitis C or an alcohol-related liver disease. Researchers defined frailty as a clinical frailty score (CFS) greater than 4. The primary outcome was unplanned hospitalization or death within 6 months. Eighteen percent of patients were frail and 30% had an unplanned hospitalization or death within 6 months.  A CFS greater than 4 was associated with an increased risk for unplanned hospitalization or death with a dose-dependent response. Further, a CFS greater than 4 had a greater discrimination than Fried frailty criteria or short physical performance battery (c-statistic = 0.84). The researchers concluded this score could be easily adopted in live clinics. “In outpatients with cirrhosis, frailty defined using the CFS is a robust, easy-to-use and independent predictor of unplanned hospitalizations or death within 6 months,” they wrote. “Validation of this finding in an independent cohort is needed before incorporating into clinical practice, but it is clear that measuring frailty is important.”
 

For more information: http://tinyurl.com/jugolb2
 

Hep C World News - Week of September 11, 2016

AASLD/IDSA update HCV guidance
 

Alexandria, Virginia - The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America have released updated guidelines on their website for the treatment of hepatitis C virus infection, according to a press release. Multiple sections of the guidance — posted on HCVguidelines.org — have been revised to reflect the FDA’s approval of Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) for all chronic HCV genotypes in adults. The combination drug was approved in June for patients with HCV regardless of cirrhosis status. “We believe that the updated recommendations will help caregivers with regimen choice, not only in common treatment scenarios, but will also importantly provide guidance in cases where randomized trial data or specific FDA labeling may be lacking,” Raymond Chung, MD, co-chair of the HCV Guidance panel, said in the release. The guidelines include the recommendation of a daily, fixed-dose combination of 400 mg sofosbuvir and 100 mg velpatasvir for 12 weeks for treatment-naive patients with HCV genotypes 1 through 4 with or without compensated cirrhosis. For patients with genotypes 5 and 6, the same combination is recommended for treatment-naive patients regardless of cirrhosis status. For patients with moderate to severe cirrhosis, the combination is approved with ribavirin. The update also includes clinical trial data for other combination regimens of direct-acting antivirals to treat unique or harder-to-treat patient populations, including those with impaired kidney function, HIV coinfection or those who have undergone liver transplantation, according to the release. “The latest update bring a trusted document up to date with the latest therapeutic options,” Hugo Vargas, MD, chair of the division of hepatology and professor of medicine at Mayo Clinic College of Medicine, and HCV Guidance panel co-chair, said. “The guidance now offers more than one front-line regimen for each viral genotype and updates recommendations for patients of high complexity. Most treating clinicians will find workable treatment options for the majority of their patients.” HCV Next Editorial Board member Arthur Kim, MD, FIDSA, assistant professor of medicine at Harvard Medical School, and guidance panel co-chair, said the updated guidance will enable more providers to “join the fight against this deadly disease” and epidemic.
 

For more information: http://tinyurl.com/hc2l5tt
 

Hep C World News - Week of September 4, 2016
 

Treating elderly HCV patients
 

Frankfurt, Germany - Until recently, treatment options in elderly patients with chronic HCV infection were limited, mainly due to contraindications and side effects associated with IFN-based therapies. Moreover, lower SVR rates and higher rates of treatment discontinuation were reported. The recent approval of highly effective IFN-free regimens has led to a paradigm change with improved options for difficult-to-cure patients, including those of older age. Interestingly, despite improved safety profiles of all-oral DAA treatments, elderly patients were once again excluded from most clinical trials. Despite this, a recent retrospective analysis of the LDV/SOF approval trials showed high SVR rates in patients ≥65 years of age. However, older patients represented a mere 12% of the total study population and the proportion of patients aged 75 years and older was only 1%. In their retrospective study (Vermehren, K.-H. Peiffer, C. Welsch, G. Grammatikos, M.-W. Welker, N. Weiler, S. Zeuzem, T. M. Welzel, C. Sarrazin), they included a large proportion of elderly patients (25%). The different combinations of all-oral DAA therapies showed comparable efficacy in patients aged ≥65 years and younger patients. Moreover, when specifically looking at genotype 1 patients treated with the currently most widely used regimens (LDV/SOF ±RBV or PTV/OBV +DSV ±RBV), SVR rates exceeded 95% in both age cohorts, and this was also true in the subgroup of patients ≥75 years of age. While DAA treatment seems to be feasible in virtually all patients regardless of age and comorbidities, the question arises whether old patients should always be considered for antiviral therapy. On the one hand, progression to cirrhosis has been shown to be an age-dependent process. However, given the high costs of current DAA regimens, treatment priority should clearly be given to patients with advanced liver disease whereas treatment is not recommended in patients with limited life expectancy. Obviously, the decision to treat elderly patients or not is greatly influenced by local guidelines and/or reimbursement policies as well as societal considerations. On the other hand, if cirrhosis is not present in elderly patients despite a long history of HCV infection, progression to cirrhosis may never occur. In our study, 41% of patients aged 75 and older had no cirrhosis at the time of DAA treatment. Thus, prevention of fibrosis progression was not the main driver for treatment initiation in these patients. Indeed, only a mild disease progression has been observed in several studies, particularly in women, despite a long history of HCV infection. However, despite this favourable course of disease, high levels of psychological distress and impaired quality of life due to debilitating fatigue may still be present in many of these patients. Presence of such factors and other extrahepatic manifestations which have been shown to increase with age may justify the decision to treat older patients, even in case advanced liver disease is not present. This is supported by recent data that suggest that DAA therapies are associated with significantly improved patient-reported outcomes and even favourable short-term health economic outcomes.
 

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

Hep C World News Week of August 28, 2016

England's NHS waged tense behind-the-scenes fight against pricey hep C drugs
 

London, UK - When England’s cost-effectiveness gatekeepers gave their blessing to Gilead Sciences’ pricey hepatitis C drugs last year, some of the country’s sickest patients were already being treated under a special access program. But as the National Institute for Health and Care Excellence (NICE) was weighing Gilead’s evidence and pricing on Sovaldi and Harvoni, the country’s National Health Service was maneuvering behind the scenes to delay or block the agency’s approvals, according to a BMJ investigation to be published Thursday. The NHS inflated the number of patients it expected to treat, the BMJ says, to argue that the pricey drugs were too expensive to be broadly used. And when NICE issued its cost-effectiveness blessing anyway, the NHS resorted to setting treatment quotas to restrict the number of patients receiving the meds. “NHS England, unable to budget for broad access to these drugs, tried to alter the outcome of the NICE process and, when it failed, defied NICE’s authority by rationing access to the drugs,” the BMJ article states. The journal worked on its investigation with researchers from the University of Cambridge and the University of Bath. The BMJ investigation highlights the tension between patient access and drug pricing and illustrates how treatments deemed cost-effective aren’t necessarily affordable. And it shows that single-payer healthcare systems--theoretically able to take a more long-term view of expensive drugs that prevent future healthcare costs--can still be overwhelmed by drugs that promise a cure but impose a heavy up-front cost burden. That’s all been under debate since Gilead was preparing to roll out its highly effective, yet highly expensive, hepatitis C drugs in 2014. When the drugs hit the market, U.S. payers began a complicated dance: Caught between patients needing treatment and price tags of $84,000 per year for Sovaldi and later, $94,500 for Harvoni, insurers and PBMs raised coverage hurdles to limit their spending. After a new cocktail from AbbVie hit the scene, U.S. payers quickly struck discounts, and more rebates are expected to follow as Merck negotiates formulary deals on its new entrant Zepatier. Some insurers are still restricting access despite those discounts--and some Medicaid programs are said to be limiting access severely--but top payers, such as the pharmacy benefits manager Express Scripts, promised to open up access once they inked discount deals. But in England and other single-payer countries, prices have been much lower from the beginning. France, for instance, strong-armed Gilead into a big discount, complete with refunds on patients who didn’t respond. The BMJ quoted prices of €41,000 in France and £35,000 in England. Even so, the NHS pushed back as NICE was reviewing the meds, arguing that the drugs couldn’t be cost-effective if the health service couldn’t afford them. Some experts took issue with the NHS’s calculations--“The figure they quoted in the NICE submission was something like £2bn, which was clearly fantasy,” a Queen’s Medical Centre hepatologist, Steve Ryder, told the BMJ. “The assumption to come up with that figure was that you had no discounts on any of the drugs at all and that every single person with hepatitis C in England would come forward that year for treatment, so it was a completely ridiculous standpoint to take.” But it wasn’t all about numbers, or so some say. One set of patient groups saw the hep C battle as a power struggle between the NHS and NICE. And a former NHS clinical advisor, who quit in the midst of the hep C battle, figures that the NHS was using the hep C drugs as part of that fight. “I think some people in NHS England would love to clip NICE’s wings and turn it into a kind of recommendatory rather than mandatory body,” said Andrew Ustianowski, a consultant in infectious diseases at Pennine Acute Hospitals NHS Trust (as quoted by the BMJ). “And if you are going to choose a fight then choosing this battlefield is quite a sensible thing to do,” he added, particularly because the NHS had arranged for the sickest hep C patients to be treated already. With fewer truly sick patients needing treatment, dragging its feet would be less of a PR hazard for the NHS. “People don’t have symptoms for years or cirrhosis for decades. So once you’ve treated the obviously sick and those with cirrhosis, who do you treat next?” Ustianowski said. “I think they’ve chosen this fight quite well."
 

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

Hep C World News Week of August 21, 2016
 

Statin use may reduce cirrhosis and HCC in HepC patients
 

Boston, MA - In patients with hepatitis C, both atorvastatin and fluvastatin use were associated with a dose-dependent reduction in both cirrhosis and hepatocellular carcinoma, according to recent findings published in Hepatology. “This was the first study of patients with chronic HCV to be associated with a clear, dose-dependent reduction in rates of both incident cirrhosis and HCC with statins, independent of fibrosis stage or attainment of sustained viral response,” Raymond T. Chung, PhD, director of Hepatology and Liver Center at Massachusetts General Hospital, told Healio.com/Hepatology. “We also observed a difference in effect according to statin type, with the greatest antifibrotic benefits seen in users of atorvastatin and fluvastatin, a finding we hope to validate in future studies.” Previously, researchers associated statin use with a reduction in both cirrhosis and HCC in patients with HCV. In 2015, Yang et al. observed that statin use was associated with a dose-dependent reduction in cirrhosis. However, the patients in this population-based cohort did not have laboratory-confirmed diagnoses of HCV. Further, the study did not adjust for statin type, baseline disease activity or fibrosis severity. To provide a more conclusive answer to Yang et al.’s study, Chung and colleagues assessed a well-established cohort of U.S. veterans. They aimed to determine the impact of statin type and dose on fibrosis progression and HCC in patients with HCV. The researchers identified 9,135 patients in the Electronically Retrieved Cohort of HCV Infected Veterans (ERCHIVES) database who were initiated on HCV antibody therapy between 2001 and 2014, 1,649 of whom developed cirrhosis and 239 of whom developed HCC. The researchers measured statin use with cumulative defined daily dose, which is the assumed average maintenance dose per day for a drug when used in its main indication as defined by the WHO. They found that statin use was associated with a 44% reduction in cirrhosis and a 49% reduction in HCC. “Whether statins can be recommended as antifibrotic or chemopreventive agents to reduce liver disease progression remains to be seen,” Tracey G. Simon, MD, fellow of gastroenterology at Massachusetts General Hospital told Healio.com/Hepatology. The findings of statins in reducing HCC and cirrhosis is not new, but there are other novel findings, according to an editorial by Juan G. Abraldes, MD, in the division of gastroenterology at the University of Alberta, and Kelly W. Burak, MD, FRCPC, BSc, MSc (Epid) of Calgary Liver Unit, division of gastroenterology and hepatology at University of Calgary, Canada, and colleagues. On the choice of statin, and the potential relevance of dosing, the current study provides some hints, Abraldes and colleagues wrote. But not definitive answers.
 

For more information: http://tinyurl.com/j8ox8ny
 

Hep C World News Week of August 14, 2016

Victims of Canada’s tainted blood scandal to share $207M

Toronto, ON - Victims of the hepatitis C tainted blood scandal of the 1990s will be compensated from a surplus of more than $200 million, now that an Ontario court has rejected Canada’s efforts to claw it back. The excess money is part of a $1-billion trust created to settle a class action launched in 1998 against the Canadian Red Cross, which then administered blood banks, and the federal government and provinces. It is meant to compensate people infected between 1986 and 1990, when there was a lab test that could have prevented it. The year before the lawsuit began, a Royal Commission led to the creation of Canadian Blood Services and Héma-Québec, at arm’s-length from government. The new decision from Judge Paul Perell of Ontario Superior Court followed an unusual hearing in June in Toronto, with live links to courtrooms in Vancouver and Quebec and a steady stream of anguished stories from people infected with the liver disease by tainted blood transfusions. At issue was the court’s discretionary power to pay out the excess money, return it to the government, or leave it sitting in the 80-year trust. Many victims spoke of the inadequacy of the compensation so far, in which individual payouts ranged between $10,000 and $250,000. An estimated 50,000 were expected to apply when the fund was set up but only 22,000 actually did. Other mistakes were made in how the money was allocated, court heard. “The existence of excess capital provides an opportunity for Class Members to correct what, with the benefit of hindsight, were unfortunate decisions that their fellow Class Members were unfortunately called on to make,” Judge Perell wrote. He agreed to the recommendations by victim representatives that the amount of excess capital be revised down from $236 million to $207 million to account for the possibility that some victims might be reclassified because of the degenerating nature of hepatitis C. As a result, there remains more than $40 million in excess capital in the trust. Most of the remaining surplus is to be paid out to class members who missed a deadline, or to increase fixed payments already being made, or to increase payments to family class members, or for support to dependents of deceased class members. 
 

For more information: http://tinyurl.com/z4u9jm5
 

Hep C World News Week of August 7, 2016

Why government must negotiate a better deal for publicly funded research  
 

London, UK - The investigation by The BMJ and Cambridge and Bath universities into the availability of breakthrough hepatitis C drugs raises important questions for NHS England about access to lifesaving drugs.1 However, the main question is why medicines are so expensive in the first place. The pricing strategy of Gilead for sofosbuvir (Sovaldi) and ledipasvir-sofosbuvir (Harvoni) raises questions that go well beyond the UK. The BMJ’s investigation is just an example of a more general problem. What is the right price to pay for a particular drug, and how should this be determined? Pharmaceutical innovation should be structured so that it focuses on unmet health needs globally and delivers therapeutic advances that are affordable and accessible to all, not just profitable for manufacturers. This requires an approach that directs effort towards therapeutic innovations rather than “me too” drugs, and a financing and pricing structure which is transparent, focused on access, and reflects the collective investment and risk taking involved. Drug companies have often ignored the collective element of innovation and argued that their research and development investment justifies the extraordinarily high prices for some medicines, even though they refuse to provide transparency on their costs. The Drugs for Neglected Diseases initiative has documented much lower drug development costs, and several authors have shown the extent to which taxpayer funded investments subsidises those costs. In the US alone, tax payers fund $32bn a year of research and development expenditure channelled through the National Institutes of Health (NIH). Sofosbuvir and ledipasvir, the two drugs on which The BMJ investigation is based, relied on early stage funding from the NIH and the Veterans Administration. Sales of the two drugs were around $12bn in 2014, far in excess of the $880.3m which Gilead reported for sofosbuvir related trials from 2012 to 2014 showing a complete disconnection between price and development costs. As high prices are hard to justify based on research and development costs, drug companies have been turning to a different line of defence: they argue that their prices are proportionate to the intrinsic value of the drugs—that is, the costs to society if a disease was not treated, or if treated with the second best therapy available. “Price is the wrong discussion,” declared Gilead’s executive vice president, Gregg Alton, responding to criticism over the price of sofosbuvir, “value should be the subject”. But there is no consistent link between a drug’s price and the associated medical benefit. A study published in 2015 in the Journal of Economic Perspectives examining a sample of 58 cancer drugs approved in the US between 1995 and 2013, shows that the increasing trend in the price of these medicines is not explained by the survival benefits they provide to patients. Over two thirds of new medicines reaching the market do not represent any therapeutic advance for patients, with many patents based on a reshuffling of old combinations or on additional uses for existing ones.
An effective pricing system should ensure accessibility but also reflect the public contribution so taxpayers don’t pay twice, through publicly subsidised research and high priced medicines. In such a system, drug prices do not need to be so much higher than manufacturing costs. We could, for example, limit patents on new medicines (the current source of company profits) and instead establish a competitive prize system that rewards well targeted pharmaceutical innovation. This would allow widespread access to drugs at competitive prices through generics, while pushing drug companies to focus their energy on delivering innovations that fulfil real medical need. In any case, patents should not be so upstream to affect scientific research, and should remain relatively narrow so as not to close off future discoveries around a therapeutic area. In other words, they should foster innovation, not stifle it. Importantly, drug pricing must be completely transparent, so that governments can negotiate for better value on behalf of their populations. Public funders could, for example, retain the lion’s share of intellectual property rights (patents) produced by public research so that spillovers through licensing can be better managed to foster diffusion, and governments could ensure that the prices of new drugs reflect the burden of financial risk borne by the tax payer. In the US, the 1980 Bayh-Dole Act that allowed publicly funded research to be patented includes a clause enabling the government to cap the prices of drugs that are largely publicly funded. The US government has never exercised this right, despite repeated petitioning. The international debate about unsustainable drug prices, including those for hepatitis C drugs, presents us with an opportunity to rethink the therapeutic innovation ecosystem—the direction and the accessibility of the drugs that result. Realising that government has power to actively shape and create markets, and not just remain on the sidelines fixing broken ones, especially in the area of health that is heavily subsidised by the public, is the first important step to reaching a better deal.
 

For more information: http://www.bmj.com/content/354/bmj.i4136
 

Hep C World News Week of July 31, 2016

Fibrosis in HCV genotype 3 progresses with age  
 

London, UK - Evidence of fibrosis was common in older patients with hepatitis C virus genotype 3 infection, indicating fibrosis progresses with age and this patient population should be treated as often and with the same medications as other severe HCV patient populations, according to data presented at the British Society of Gastroenterology Annual Meeting. According to Keeley Fairbrass, of the Digestive Disease Centre, Bradford Teaching Hospitals NHS Foundation Trust, U.K., and colleagues, The National Institute for Health and Care Excellence (NICE) previously issued a guidance that recommended only patients with moderate to severe HCV be treated. More recently, NICE advised that patients with HCV genotype 3 be treated with pegylated interferon plus ribavirin, and not direct-acting antivirals. The researchers sought to determine the rate of fibrosis in this patient population, due to the fact the current recommended treatment indicates a longer treatment duration with lower sustained virologic response and more adverse events. They analyzed data from a single center database to measure demographics, age of liver biopsy, fibrosis stage and SVR in patients with HCV genotype 3. Between 1998 and 2015, 477 patients underwent biopsy. “We aimed to plot the rate of progression of fibrosis in HCV [genotype 3] patients to ensure NICE guidance isn’t disadvantageous to this group,” the researchers wrote. Among those with HCV genotype 1 (n = 112; 81 men, average age 40 years; 31 women, average age 42 years), 48% achieved SVR. In the HCV genotype 2 group (n = 16; 10 men, average age 39 years; 6 women, average age 43 years), 75% achieved SVR. For HCV genotype 3 (n = 337; 194 men, average age 39 years; 143 women, average age 40 years), 68% achieved SVR. In the HCV genotype 4 group (n = 12; 10 men, average age 38 years; 2 women, average age 45 years), 42% achieved SVR. In patients with F0 to F2 fibrosis, SVR was 80%; in patients with F3 to F4 fibrosis, SVR was 70%; and in patients with F5 to F6, SVR was 65%. “The point prevalence of fibrosis in HCV [genotype 3] at the time of liver biopsy confirms that fibrosis progresses with age, but not in an exponential way and also recognizes the well-described fall in SVR with increasing fibrosis,” the researchers wrote. The researchers concluded: “Our SVR data strongly suggests that we should provide all of our HCV [genotype 3] patients with the new potent DAAs to prevent progression of disease and subsequent consequences. We urge for a change in the current guidance.”
 

For more information: http://tinyurl.com/gnc9ro4
 

Hep C World News Week of July 24, 2016

Unrestricted Access to Novel Hep C Therapies May Reduce Overall Costs 
 

Pittsburgh, PA - The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) announced the publication of an empirical study demonstrating that current Medicaid policies restricting hepatitis C treatment to patients with advanced disease are more costly and less effective than unrestricted, full-access strategies. The results of this novel research, “Economic and Public Health Impacts of Policies Restricting Access to Hepatitis C Treatment for Medicaid Patients,” were published in the June 2016 issue of Value in Health. The authors used a Markov model to compare two strategies for 45-55 year old Medicaid beneficiaries: (1) Current Practice—only advanced disease is treated before Medicare eligibility; and (2) Full Access—both early-stage and advanced disease are treated before Medicare eligibility. Full Access was less costly and more effective than Current Practice for all cohorts and perspectives, with differences in cost ranging from $5,369 to $11,960 and in effectiveness from 0.82 to 3.01 quality-adjusted life-years. Compared with Current Practice, Full Access averted 5,994 hepatocellular carcinoma cases and 121 liver transplants per 100,000 patients. “Two recently approved interferon-free drug regimens for patients with hepatitis C genotype 1 disease—sofosbuvir/ledipasvir (or ombitasvir, paritaprevir) and ritonavir with dasabuvir—are more than 94 percent effective in as few as eight weeks for many patient subgroups, but most state Medicaid programs restrict their use due to cost,” said corresponding author Alexis P. Chidi, PhD, MSPH, of the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. “And while such restrictive treatment policies are likely to reduce short-term costs to state Medicaid programs,” she added, “our cost-effectiveness analysis revealed that for current Medicaid beneficiaries, the increased short-term costs of unrestricted access to care can be offset by savings from reduced complications in 9-16 years, depending on the treatment strategy and age of the cohort.”
For more information: http://tinyurl.com/zk336s5
 

Hep C World News Week of July 17, 2016
 

Vaccination could help control of HCV epidemic
 

London, UK - A vaccine, even with low efficacy, could lead to meaningful reductions in the incidence and prevalence of hepatitis C virus (HCV) among people who inject drugs (PWID), a modelling study published in PLOS One shows. An international team of investigators analysed the potential impact of three different vaccination scenarios – low, moderate and high efficacy – on the HCV epidemic among PWID in the UK over 20 and 40 years. A low efficacy vaccine (50% protection for five years) would halve prevalence over 20 years if large numbers of PWID were vaccinated each year. Vaccination rates needed to reduce incidence were lower than those required for falls in prevalence, regardless of the potency of the vaccine. Researchers also compared the impact of vaccination with HCV treatment on the UK epidemic, calculating the number of vaccinations needed per case of treatment with new direct acting agents (DAAs) to achieve the same effect. “Our analysis suggests that even low efficacy HCV vaccines could have considerable impact; potentially halving HCV prevalence and incidence among PWID in 40 years for vaccine coverage levels comparable to what has been achieved for HBV [hepatitis B virus] among PWID in the UK, 72% in 2013,” comment the investigators. “Our modelling suggests that similar reductions in HCV prevalence or incidence could be achieved with 4-16 or 2-11 times fewer treatments. Nonetheless, at current HCV drug costs and even reduced costs, these ratios suggest that vaccination could be a much cheaper strategy for reducing HCV transmission than scaling up-treatment.” Globally, 60% of PWID have antibodies to HCV. This population is therefore a priority for HCV prevention efforts. Research has suggested that therapy with new highly effective anti-HCV direct acting agents could have a significant impact on new infections among high-risk populations. However, these treatments are very expensive. The results of the study are consistent with other research that modelled the potential impact of a vaccine on the dynamics of the HCV epidemic among PWID in San Francisco. The authors note that the infrastructure for HCV vaccination is in place in the UK because of HBV immunization campaigns and that high-levels of HBV vaccination coverage have been achieved among PWID in some UK settings. An attraction of HCV vaccination would be its likely cost, which could be approximately $500 per PWID, at least 50 times less than the current cost of HCV DAA therapy in high-income settings. “It is possible that treatment and vaccination could act in unison,” conclude the authors, “with HCV uninfected PWID receiving vaccination and HCV infected PWID receiving treatment, and possibly then vaccination.”
 

For more information: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4880220/
 

Hep C World News Week of July 10, 2016

Pan-genotypic, once-daily HepC drug approved in Canada
 

Mississauga, ON - Gilead Sciences Canada, Inc. (Gilead Canada) has received a Notice of Compliance (NOC) from Health Canada for EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg), the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. EPCLUSA - for 12 weeks - is for use in patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin (RBV) for patients with decompensated cirrhosis. EPCLUSA is the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Health Canada had previously granted EPCLUSA a Priority Review, which is given to a medication that offers a significant advance in treatment over existing options for a serious, life-threatening or severely debilitating condition. "This newly-approved treatment represents an important step forward in how we treat HCV," said Dr. Jordan Feld, Hepatologist and Research Director, Francis Family Liver Clinic, Toronto Centre for Liver Disease, Toronto General Hospital. "We can now cure the majority of HCV-infected patients with a simple, safe and effective 12-week treatment, regardless of genotype or treatment history." The approval of EPCLUSA is supported by data from four international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. "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. "Having a therapy that works for all genotypes will make treatment easier for both patients and physicians to manage, but it must be accessible regardless of where someone lives or their ability to pay." "At Gilead, we continue to be motivated by the urgent need to develop medicines and transform and simplify care for people living with HCV," said Ed Gudaitis, General Manager, Gilead Canada. "We are committed to working with drug plans across the country to help ensure EPCLUSA is accessible to patients who need treatment for this life-threatening disease." The Canadian Product Monograph for EPCLUSA describes safety information including the complete warnings and precautions, adverse reactions and drug-drug interactions.
 

For more information: http://bit.ly/2a0jvXt
 

Testosterone therapy increases muscle mass in men with cirrhosis
 

Melbourne, Australia - Administering testosterone to men with cirrhosis and low testosterone safely and effectively increased muscle and bone mass, suggesting testosterone may increase survival for this patient population, according to results of a placebo-controlled trial. “This trial demonstrates for the first time that testosterone therapy can safely increase muscle mass in men with cirrhosis who have low baseline testosterone levels and thus represents the first evidence-based therapy for sarcopenia in cirrhosis,” Marie Sinclair, MD, of the Liver Transplant Unit, Austin Health, Melbourne, Australia, and colleagues wrote. The researchers at a single tertiary center randomly assigned 101 men with established cirrhosis and low serum testosterone either placebo or testosterone for 1 year. Body composition was measured at baseline, 6 and 12 months in each patient using dual-energy X-ray absorptiometry. After 1 year, appendicular lean mass was higher in men treated with testosterone. Men treated with testosterone also had a higher total lean mass matched by reduced fat mass. Neither group experienced cardiovascular events, infection or bleeding at injection site, nor was there any increase in adverse events in the patients treated with testosterone. Mortality was lower in men treated with testosterone. However, the researchers note that it was insignificantly lower compared with men treated with placebo. The researchers concluded: “Both low testosterone and muscle wasting are associated with increased risk of death in men with severe liver disease. … Testosterone has non-muscle beneficial effects which may be able to increase survival in this population."  

For more information: http://tinyurl.com/jszhp8x
 

Hep C World News Week of July 3, 2016

Race does not impact early mortality among patients with HepC

Detroit, Michigan - Recent findings published in the Journal of Viral Hepatitis showed that race was a non-factor in the early mortality of patients with hepatitis C virus infection. African-American patients with “All patients with chronic HCV regardless of race died at an earlier age (53-65 years) than predicted for the overall population (75-79 years),” Paul H. Naylor, PhD, assistant professor of internal medicine - gastroenterology at Wayne State University School of Medicine, and colleagues wrote. This is the first study to report racial disparity in co-morbidities and that the increased HCV mortality in African-Americans has as a significant risk factor chronic kidney disease. In the United States, 3.2 million people are infected with HCV and are at risk for cirrhosis, liver failure and hepatocellular carcinoma, the researchers wrote. Many studies have demonstrated these poor outcomes for patients with HCV, but few studies have assessed the influence of race. To determine whether race is a factor in HCV mortality, the researchers performed a retrospective study of 3,724 patients with HCV who were initially seen between 1995 and 2008. Patients with chronic HCV included 2,879 African-Americans, 758 whites and 87 who belonged to another race. The average time to death from first visit was 5 years, and the mean age at death was 55 years. Naylor and colleagues determined that African-Americans (23%) were just as likely to have died from HCV as whites (22%). Increased mortality was associated with cirrhosis, fibrosis, low albumin, diabetes, renal impairment and cardiac symptoms. Both African-American and white patients who were treated and cleared the virus, however, had a mortality of 5% compared with 26% of treatment-naive African-American patients and 24% of untreated white patients. The investigators noted that African-American patients with kidney disease and low albumin were at greater early mortality risk than whites with those characteristics. “The data also suggest patients with cirrhosis must receive treatment as rapidly as possible,” Naylor and colleagues wrote. “Given that a significant number of individuals in the United States are just now being identified by screening protocols, rapid treatment as soon as possible before patients reach significant fibrosis is critical for preventing an early death due to their HCV infection.”
 

For more information: http://tinyurl.com/hkwya3g
 

HepC World News Week of June 26, 2016

FDA approves Gilead’s Epclusa® for the treatment of all Hep C genotypes

Foster City, CA - Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). “The approval of Epclusa represents an important step forward in the global effort to control and potentially eliminate HCV as it provides a safe, simple and effective cure for the majority of HCV-infected patients, regardless of genotype,” said Ira Jacobson, MD, Chairman of the Department of Medicine at Mount Sinai Beth Israel, New York City and a principal investigator in the Epclusa clinical trials. “Building on the established backbone of sofosbuvir, Epclusa demonstrated consistently high cure rates across all genotypes, including among patients with genotype 2 and 3, who traditionally have required ribavirin or other multi-pill regimens.” The FDA granted Epclusa a Priority Review and Breakthrough Therapy designation, which is given to investigational medicines that may offer major advances in treatment over existing options. Epclusa’s approval is supported by data from four international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotype 1-6 chronic HCV infection, without cirrhosis or with compensated cirrhosis received 12 weeks of Epclusa. “Today’s approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens,” said John Milligan, Ph.D., President and Chief Executive Officer of Gilead. “As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings. We look forward to making Epclusa available to patients around the world as quickly as possible.” 
 

For more information: http://www.businesswire.com/news/home/20160628006005/en/
 

HepC World News Week of June 19, 2016

Race does not impact early mortality among patients with HepC 
 

 Detroit, Michigan - Recent findings published in the Journal of Viral Hepatitis showed that race was a nonfactor in the early mortality of patients with hepatitis C virus infection. African-American patients with “All patients with chronic HCV regardless of race died at an earlier age (53-65 years) than predicted for the overall population (75-79 years),” Paul H. Naylor, PhD, assistant professor of internal medicine - gastroenterology at Wayne State University School of Medicine, and colleagues wrote. This is the first study to report racial disparity in comorbidities and that the increased HCV mortality in African-Americans has as a significant risk factor chronic kidney disease. In the United States, 3.2 million people are infected with HCV and are at risk for cirrhosis, liver failure and hepatocellular carcinoma, the researchers wrote. Many studies have demonstrated these poor outcomes for patients with HCV, but few studies have assessed the influence of race. To determine whether race is a factor in HCV mortality, the researchers performed a retrospective study of 3,724 patients with HCV who were initially seen between 1995 and 2008. Patients with chronic HCV included 2,879 African-Americans, 758 whites and 87 who belonged to another race. The average time to death from first visit was 5 years, and the mean age at death was 55 years. Naylor and colleagues determined that African-Americans (23%) were just as likely to have died from HCV as whites (22%). Increased mortality was associated with cirrhosis, fibrosis, low albumin, diabetes, renal impairment and cardiac symptoms. Both African-American and white patients who were treated and cleared the virus, however, had a mortality of 5% compared with 26% of treatment-naive African-American patients and 24% of untreated white patients. The investigators noted that African-American patients with kidney disease and low albumin were at greater early mortality risk than whites with those characteristics. “The data also suggest patients with cirrhosis must receive treatment as rapidly as possible,” Naylor and colleagues wrote. “Given that a significant number of individuals in the United States are just now being identified by screening protocols, rapid treatment as soon as possible before patients reach significant fibrosis is critical for preventing an early death due to their HCV infection.”
 

For more information: http://tinyurl.com/hkwya3g
 

HepC World News Week of June 12, 2016

UMMS study suggests hepatitis C patients face barriers to new drug treatments 
 

Boston, MA - A UMass Medical School study suggests some patients with hepatitis C face barriers to receiving the newest medications to treat the virus. The research, led by Karen M. Clements, ScD, MPH, assistant professor of quantitative health sciences and a senior project director in Commonwealth Medicine, was published in the June edition of the Journal of Managed Care & Specialty Pharmacy. “In order to reduce future health care costs and premature mortality associated with HCV [chronic hepatitis C virus], the number of patients receiving these potentially curative antiviral treatments must be increased,” the authors said. “This study suggests that there are barriers to treatment access in addition to the high cost of these medications that will have to be addressed in order to achieve this goal.” The paper examined the use of sofosbuvir and simeprevir, medications that have been very effective in treating HCV, among members of MassHealth, Massachusetts’ Medicaid program. Chronic hepatitis C can cause severe liver disease and affects 3 to 6 million people, roughly 1 to 2 percent of the U.S. population. It occurs most often in individuals with substance use disorder and more than half are intravenous drug users. The study found use of the medications did not increase as quickly as expected considering MassHealth has few restrictions on treatment access, and treatment referral was varied. People with substance use disorders, who comprise a large portion of those with HCV, were less likely to have treatment requested than MassHealth members with more advanced liver disease, according to the authors. Several barriers to treatment were outlined by the authors, including: Payers being concerned about having enough resources for all who request treatment; Nearly all state Medicaid programs require prior authorization for sofosbuvir and simeprevir because of limited budgets; Some patients may have difficulty adhering to treatment regimens; and Physicians may not want to treat patients they consider poor risks. Despite the high cost of the drugs, the authors said, they may be a good value because they can reduce complications and health care costs, and improve the quality of life for people with HCV.
 

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

HepC World News Week of June 5, 2016

Colistin resistance detected in US patient for first time

Bethesda, Maryland - Colistin resistance has been detected in a patient in the United States for the first time, further magnifying fears over antibiotic resistance. The discovery was made by Defense Department researchers who recently began looking for resistance to the last-resort antibiotic in specimens submitted to the clinical microbiology laboratory at Walter Reed National Military Medical Center. They detected the colistin-resistant mcr-1 gene in an Escherichia coli culture taken from a female patient with a urinary tract infection. CDC Director Thomas R. Frieden, MD, MPH, announced the finding during an address at the National Press Club and warned that better stewardship was needed to fight antibiotic resistance. “The medicine cabinet is empty for some patients,” Frieden said. “It is the end of the road for antibiotics unless we act urgently.” The specimen came from a woman who sought treatment at a Pennsylvania clinic in April. The woman, aged 49 years, reported no travel within the previous 5 months, according to Patrick McGann, PhD, microbiologist at Walter Reed, and colleagues, who published their findings in Antimicrobial Agents and Chemotherapy. “To the best of our knowledge,” they wrote, “this is the first report of mcr-1 in the United States.” The E. coli cultured from the woman’s urine, MRSN 388634, was forwarded to the lab at Walter Reed, where researchers began testing for resistance to colistin in response to the discovery of mcr-1, which they called a “truly pan-drug resistant bacteria.” MRSN 388634 belongs to a rare E. coli sequence type that was first identified in 2008 from a urine culture in the United Kingdom and later identified from a bloodstream culture in Italy, McGann and colleagues wrote. They warned that they were in the early stages of testing and that continued surveillance was needed to determine the true prevalence of mcr-1 in the population. “The more we look, the more we’ll find,” Frieden said. “The more we look at drug resistance, the more concerned we are. We need to do a very comprehensive job so we can have [antibiotics] and our children can have them. We can make new ones, but without better stewardship and identification of outbreaks, we’ll lose these miracle drugs.” 
 

For more information: http://tinyurl.com/ht9258t
 

HepC World News Week of May 29, 2016

WHO Issues Updated HCV Guidelines for Treatment

Barcelona, Spain - Due to the rapid development and evolution of direct-acting viral treatments, WHO issued updated guidelines for the screening, care and treatment of individuals with chronic hepatitis C virus infection at the International Liver Congress. WHO first issued recommendations in 2014, and since then, multiple direct-acting antivirals have been developed or are currently in the pipeline. The objective of the updated guidelines is to provide evidence-based recommendations for treating HCV using DAA-only combinations. The recommended guidelines are geared toward policy-makers in low- and middle-income countries who formulate country-specific treatment guidelines and who plan infectious disease treatment programs and services, as well as clinicians responsible for providing treatment, according to the guidelines. They are intended to promote the “scale-up of HCV treatment”, more specifically among people in low- and middle-income countries, where very few have access to these new treatments. As of October 2015, eight separate DAAs have been approved for the treatment of HCV: asunaprevir (Bristol-Myers Squibb), Daklinza (daclatasvir, Bristol-Myers Squibb), dasabuvir (AbbVie), ledipasvir (Gilead Sciences), Olysio (simeprevir, Janssen Pharmaceuticals), ombitasvir (AbbVie), paritaprevir (AbbVie) and Sovaldi (sofosbuvir, Gilead Sciences). Taking these into consideration, WHO recommends: DAA regimens be used for treating HCV instead of regimens with pegylated interferon and ribavirin. However, for patients with HCV genotype 3 with cirrhosis and patients with HCV genotypes 5 and 6 with and without cirrhosis, an interferon-based regimen [sofosbuvir/pegylated interferon plus ribavirin] is still recommended as an alternative treatment option, according to the guidelines. Regimens containing Incivek (telaprevir, Vertex Pharmaceuticals) or Victrelis (boceprevir, Merck) are no longer recommended for treating HCV. The organization notes that “implementation of the recommendations may not be immediate,” since new treatments are expensive and may not have gained regulatory approval in certain countries yet. For the full list of recommendations, use link below.
 

For more information: http://www.who.int/hiv/pub/hepatitis/hepatitis-c-guidelines/en/
 

HepC World News Week of May 22, 2016

France announces universal access to new Hep C treatments

Paris, France - France’s Health Minister announces the end to a public health aberration. Today May 25, 2016, on the occasion of the national day against hepatitis, Health Minister Marisol Touraine announced the gradual implementation by September of universal access to new treatments against the hepatitis C virus. The first stage will take effect immediately with the inclusion of new beneficiaries, especially the most vulnerable groups, before a generalization to all patients in September. This announcement follows two years of intensive mobilization of associations, and offers healing opportunities for hundreds of thousands of people living with hepatitis C in France. AIDES welcomes this decision and will be particularly vigilant about its effective implementation. It was one of the few black spots of public policies to fight against hepatitis C. While courageous steps have been taken in recent months in the field of prevention, risk reduction and screening, access to new treatments was still not guaranteed for the vast majority of those affected. "We are two years into a totally absurd situation," explains Aurélien Beaucamp, president of AIDES. "So we finally have all the necessary tools to prevent, detect and effectively treat hepatitis C. Most of those affected are still denied access to new treatments. This announcement takes us out of the impasse. Establishing universal access is a way to to end definitively the hepatitis C epidemic." 
 

For more information: http://tinyurl.com/hzkqy7a
 

HepC World News Week of May 15, 2016

Community-based HCV treatment lessens burden on specialists

Barcelona, Spain - Moving treatment for hepatitis C virus infection into community practices may lighten the load currently felt by HCV specialists without sacrificing health of the patients, according to a study presented in a Late Breaker poster at the International Liver Congress 2016. “With such a large patient cohort, ensuring that patients can access safe, effective and appropriate treatment is essential,” Sarah Kattakuzhy, MD, assistant professor at the University of Maryland School of Medicine, said in a press release. “Currently, the limited availability of experienced specialists restricts rapid expansion of hepatitis C treatment, compromising the goal of global eradication. As such, care models which bypass this therapeutic bottleneck must be explored.” This multi-center, open label, phase 4 study sponsored by the National Institutes of Health, included patients receiving non-randomized treatment from a specialist in infectious disease or hepatology, a primary care physician or a nurse practitioner, all of whom participated in a 3-hour training on the HCV Guidelines. Patients, in turn, received the same treatment with Harvoni (ledipasvir/sofosbuvir). Of the 304 patients with available results, 285 patients achieved sustained virologic response at 12 weeks. Broken down by treatment provider, specialists achieved SVR12 in 92.1% of patients (152/165), primary care physicians did so in 96.7% (58/60) and nurse practitioners in 94.9% (75/79). “The data presented here is extremely welcome and shows great potential to escalate treatment options and protocols for hepatitis C. We have the therapies, we now need to make sure we can effectively roll them out to patients,” Tom Hemming-Karisen, MD, PhD, EASL Vice-Secretary, said in a press release. “We know we have too few experienced specialists treating HCV and this is severely hampering our ability to eradicate this disease once and for all. This research has the potential to be a genuine game changer in the way we look at HCV treatment across the board, and could provide the opportunity to increase access to care and treatment to many regions of the world”
 

For more information: http://tinyurl.com/jbzx2b6 
 

HepC World News Week of May 8, 2016

Hepatitis C Therapy May Reduce Need for Liver Transplants
 

Barcelona, Spain - Treatment with antiviral drugs may reduce the need for a liver transplant for people with severe liver damage and hepatitis C, a new study suggests. This study included 103 liver transplant candidates in Europe with severe liver damage and hepatitis C. They were treated with direct-acting antiviral drug combinations used to treat and cure people with hepatitis C. Thirty-five percent of the patients improved to the point where they were no longer in urgent need of a liver transplant. And 20 percent got so much better that they no longer needed a transplant, researchers found. Currently, more than 15,000 people in the United States are on the liver transplant waiting list. About 16 percent will die before receiving a new liver. And roughly 30 percent of adults on the liver transplant waiting list have severe liver damage and hepatitis C, the researchers said. "The results of the study are very encouraging, but a word of caution is to be mentioned since it is presently unknown how long the clinical improvement will last," study author Dr. Luca Belli said in an International Liver Congress news release. Belli is from the gastroenterology and hepatology liver unit at Niguarda Hospital in Milan, Italy. Belli said international studies need to be done to see how patients taken off the transplant list fare. He said it's critical to assess the long-term risk of death, development of liver cancer and further deterioration of the liver. "These results show notable improvements in the outlook for some of these patients," Laurent Castera, secretary general of the European Association for the Study of the Liver, said in the news release. "Treating these patients with direct-acting antiviral therapy could result in those with a more pressing need for a liver transplant receiving the donation they need, potentially reducing the number of deaths that occur in patients on the waiting list," Castera added.
 

For more information: https://www.nlm.nih.gov/medlineplus/news/fullstory_158321.html
 

Japan's PMDA reviews hep B risk link to hep C therapies

Tokyo, Japan - Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing approved hepatitis C drugs in the country for links to a possible reactivation of the hepatitis B virus, which could result in label changes. In a notice last week, PMDA said that the review covers Gilead Sciences' Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) as well as AbbVie's Viekirax (ombitasvir and paritaprevir and ritonavir), Bristol-Myers Squibb's Daklinza (daclatasvir) and Sunvepra (asunaprevir), Mitsubishi Tanabe's Telavic (telaprevir), Janssen Pharmaceutical K.K.'s Sovriad (simeprevir), and Merck's Vanihep (vaniprevir). Related to the review, PMDA posted a notice from BMS warning that a suspected reactivation of hepatitis B virus following the use of Daklinza and Sunvepra caused hepatic dysfunction, including one death. On the PMDA notice, BMS called on doctors to send patients for hepatitis B virus marker tests prior to treatment. A similar review is being conducted by the EMA, which began back in March. The agency has recently extended its review to also look at the risk of liver cancer (hepatocellular carcinoma) coming back in patients who were treated with direct-acting antivirals for hepatitis C, after a study published in April suggested this may be the case. In a statement to FiercePharmaAsia, Janssen said: “[We] are aware of the recently initiated review of Direct Acting Antivirals (DAAs) as a treatment for hepatitis C being conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Simeprevir is one of the treatments currently undergoing the review procedure by the EMA and PMDA. We believe that the safety of our medicines is paramount and we remain fully cooperative with both of these reviews.” 
 

For more information: http://tinyurl.com/zdwzq5j
 

HepC World News Week of May 1, 2016

Study says that hep C treatment reduces later risk of liver cancer
 

Washington, DC - Researchers found that successful antiviral treatment for hepatitis C is associated with a significant reduction in risk of cirrhosis, HCC and overall mortality, regardless of age. Therefore, delaying treatment should not be advised. Patients with hepatitis C aged 65 to 85 years who received less antiviral treatment than younger patients were more likely to develop cirrhosis and liver cancer than patients with hepatitis C aged 20 to 49 years. A new study by researchers at Baylor College of Medicine found that treatment and cure of chronic hepatitis C reduce the risk of hepatocellular carcinoma (HCC), especially if given early, before cirrhosis develops, and while patients are still young. The report appears in the journal Hepatology. Chronic hepatitis C is a common and progressive liver infection caused by the hepatitis C virus, a strong risk factor for HCC, the most common type of primary liver cancer. “With the advent of new highly effective medications for treating hepatitis C, we expect to see a lot of people cured of the disease,” said Dr. Hashem El-Serag, chief of gastroenterology and hepatology at Baylor and at the Michael E. DeBakey Veterans Affairs Medical Center and lead author of the study. “However, we did not have good information about what happens to these people in terms of their future risks of developing HCC after cure.” This large and definitive study involved 33,005 individuals infected with the hepatitis C virus who received treatment in Veterans Health Administration hospitals throughout the United States, and of whom 10,817 patients achieved cure. Researchers tracked their risk of developing HCC liver cancer over several years of follow-up and examined the association between several demographic and clinical features at the time of the cure with the future risk of liver cancer. Researchers found that successful antiviral treatment for hepatitis C is associated with a significant reduction in risk of cirrhosis, HCC and overall mortality, regardless of age. Therefore, delaying treatment should not be advised. Patients with hepatitis C aged 65 to 85 years who received less antiviral treatment than younger patients were more likely to develop cirrhosis and liver cancer than patients with hepatitis C aged 20 to 49 years. “Patients with cirrhosis or diabetes or those who are older than 55 who get cured of hepatitis C need continued surveillance according to current guidelines,” said El-Serag. The time of cure is essential for determining prognosis. High emphasis should be given to increasing screening and diagnosis of hepatitis C before those infected develop cirrhosis, through assessment of degree of liver fibrosis, said El-Serag. 
 

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

HepC World News Week of April 24, 2016

Head and Neck Cancers May Be Linked to Hepatitis C

Houston, TX - Hepatitis C may increase the risk for certain types of head and neck cancers, researchers say. Hepatitis C is a serious liver infection caused by a virus. It's the most common blood-borne infection in the United States, affecting as many as 3.5 million people, according to the U.S. Centers for Disease Control and Prevention. Many are unaware they have the infection. "What we are trying to make all understand is that this is an infection that has consequences -- and it's an infection we can cure," said study leader Dr. Harrys Torres, an associate professor of infectious diseases at the University of Texas MD Anderson Cancer Center. It's already known that people with hepatitis C have a significantly higher risk of liver cancers and non-Hodgkin's lymphoma, according to the researchers. Antiviral drugs cure more than 90 percent of hepatitis C cases, and screening and treatment could prevent cancer from developing, Torres said in a center news release. He and his colleagues analyzed data from more than 34,500 patients tested at the medical center. The researchers found that those with hepatitis C seemed to have more than twice the risk for cancers in the mouth and throat and a nearly fivefold higher risk for larynx cancers than those without hepatitis C. The researchers also found that head and neck cancer patients with hepatitis C were more likely to have human papillomavirus (HPV), which is linked with a number of cancers. The study, published April 13 in the Journal of the National Cancer Institute, could prove important in the screening of hepatitis C patients and the treatment of those with head and neck cancers, the authors said. Hepatitis C can also affect how cancer patients respond to treatment, Torres added. Doctors need to understand that hepatitis C affects not only the liver, but is a body-wide infection, he said.
 

For more information: https://www.nlm.nih.gov/medlineplus/news/fullstory_158294.html
 

HepC World News Week of April 17, 2016

Hepatitis C Tourism From China

Shanghai, China - Chinese people in the past have gone to the U.S. to for cancer treatment and have snatched up cold medicine and painkillers on trips to Japan. Chinese now go overseas for another medical purpose: curing their liver diseases. Although treatment of the virus has gone through revolutionary development in the last few years, none of the direct-acting antiviral agents which have shown to cure more than 90% of patients within a few months, have yet been approved by the Chinese regulator. China still uses old-generation therapies including injections of interferon, which has harsh side effects such as headache and hair loss. Even after a year of being treated with weekly interferon injections, 46-year-old Sun Wei from Shenyang in China’s northeast wasn’t cured. Instead she had lost 42 kilos, or 92 pounds, and developed severe joint pain. “I barely had the appetite to eat anything, or energy to do housework,” she said. “I looked older than 60.” In October, Ms. Sun boarded a plane to New Delhi with the help of a Shanghai-based company. It was a first trip outside China. She came back with three months’ worth of Gilead Sciences’ blockbuster drug Sovaldi, which is still in the testing stage in China. She says she now tests negative for hepatitis C. A number of Chinese companies are tapping into the growing population – now estimated at around 10 million – of Chinese infected with hepatitis C with especially designed trips to countries such as India, where Sovaldi and Gilead’s Harvoni are sold at a much cheaper price than the U.S. price tag of $84,000 and $98,000 per regimen, respectively, and to Laos and Bangladesh, where generic versions are available. For example, a 35,000 yuan ($5,323) four-day package to India offered by Kangantu, a Shanghai-based company, includes medicines, consultations with doctors, round-trip flights, a four-star hotel and a half-day tour of New Delhi. Patients who sign up for the trip will be taken to a hospital where the all-oral drugs are prescribed by the doctors.A similar package offered by Beijing-based Medihorizon to Bangladesh cost 30,000 yuan ($4,600).

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

HepC World News Week of April 10, 2016

Ridding U.S. of Hepatitis B, C Possible
 

Washington, DC - Experts say there's real hope in someday ridding the United States of the "public health problem" of hepatitis B and C infection. The two viral strains cause serious, often fatal, liver disease for tens of thousands of Americans each year. The comprehensive new report is from a panel of experts at the U.S. National Academies of Sciences, Engineering, and Medicine. They believe that the advent of a powerful new vaccine and medicines could help drastically lower hepatitis B and C rates across the country. Still, to reach that goal will take time and considerable resources, the report said. "Ending illness and deaths from hepatitis C depends on both stopping the disease's progression in its early stages and reversing the course of advanced disease," the committee said in a news release. According to the report, between 700,000 and 1.4 million Americans have chronic hepatitis B, and between 2.5 million and 4.7 million have chronic hepatitis C. Between them, the two viruses kill about 20,000 people a year in the United States. Eliminating hepatitis B and C as a public health problem is not the same as completely eliminating them from the country, the panel stressed. Instead, it means stopping their transmission in the United States and preventing signs and symptoms of the disease in people who are still infected. Hepatitis B can be transmitted from an infected mother to child, through contact with infected blood and through unprotected sex with an infected person. Transmission in the United States can be halted with universal immunization of children and adults, according to the report. The three-dose vaccine provides long-lasting, 95 percent immunity. And while current treatments do not cure hepatitis B infection, they do prevent disease progression and deaths from cirrhosis and liver cancer. Hepatitis C is transmitted through contact with infected blood (for example, through needle-sharing) and less often through unprotected sex or from an infected mother to child. There is no vaccine for hepatitis C, so preventing transmission is vital, the experts said. People born between 1945 and 1965 account for the majority of Americans with chronic hepatitis C, but most new infections are occurring among injection drug users. Hepatitis C can be cured, however, and curing infected injection drug users could reduce transmission and lower disease rates between 20 and 80 percent. However, outreach and intervention involving injection drug users is challenging, the report acknowledged. Some research suggests that programs such as needle exchanges might help reduce hepatitis C transmission among injection drug users. Efforts to curb drug addiction rates could also lower hepatitis C rates, the report said. The report is the first of two. The second, scheduled for release in early 2017, will outline ways to achieve the goals listed in this report, which also outlined a number of barriers to eliminating this public health problem. One barrier is that most state and local health offices can't identify hepatitis B and C infections, the report's authors said. Another barrier is that about two-thirds of Americans with chronic hepatitis B and half of those with chronic hepatitis C do not know they are infected because both diseases do not cause symptoms until the later stages. Stigma about the hepatitis-linked diseases can also prevent people from getting testing and receiving care. Also, the report notes that most new cases of chronic hepatitis B in the United States occur in foreign-born people, who may face language or social problems in seeking care.

For more information: https://www.nlm.nih.gov/medlineplus/news/fullstory_158249.html
 

HepC World News Week of April 3, 2016

Failed Hep C therapy increases risk for HCC
 

Detroit, Michigan - Patients with hepatitis C virus infection who failed interferon-free therapy have an increased risk for hepatocellular carcinoma compared with patients who achieved sustained virologic response, according to recently published data. Mei Lu, PhD, of the department of public health sciences, Henry Ford Health System, Michigan, and colleagues evaluated the electronic medical records of 10,091 patients enrolled in the Chronic Hepatitis Cohort Study, an observational study comprising four different U.S. health systems that follows patients for 7 years. The goal was to determine how treatment failure compared with lack of treatment. "Although interferon-free regimens — including highly effective and well-tolerated direct-acting oral agents — are transforming the landscape of HCV antiviral treatment, understand the long-term impact of interferon therapy in the ‘real world’ will improve care for patients in the future,” the researchers wrote. Thirty-six percent of the patients received treatment (n = 3,681), of which 57% experienced treatment failure (n = 2,099) and 43% achieved SVR (n = 1,582). After inverse probability treatment weighting on multivariate and univariates analyses, patients who failed treatment showed nearly twice the risk for HCC compared with patients who did not receive treatment (adjusted HR = 1.95, 95% CI, 1.5–2.53). The risk for increased HCC among this population remained across all stages of fibrosis, according to the research. Patients who achieved SVR had lower risk for HCC compared with patients who failed treatment (aHR = 0.48, CI 0.31–0.73). Overall treatment — regardless of outcome — reduced all-cause mortality for patients who achieved SVR (aHR = 0.45, CI 0.34–0.6) and patients who failed treatment (aHR = 0.78, CI 0.65–0.93). The researchers concluded that patients who fail interferon-based therapy demonstrate a higher risk of HCC than untreated patients, possibly due to interferon-related acceleration of fibrosis in the absence of successful viral eradication. They suggestted that such treatment failure patients may represent a cohort of individuals for whom re-treatment with new, highly effective direct-acting all-oral antiviral therapies should become a priority.
 

For more information: http://tinyurl.com/gpb72ze

HepC World News Week of March 27, 2016

HepC Epidemic Peaked 15 Years Earlier than Previous Estimates
Vancouver, BC - A study by the BC Centre for Excellence in HIV/AIDS (BC-CfE), in partnership with the US Centers for Disease Control and Prevention (US CDC), published in The Lancet Infectious Diseases, found the peak growth of the hepatitis C virus (HCV) epidemic in North America among individuals born between 1945 and 1964 (“baby boomers”) occurred when they were young children. Historically, stigma has surrounded the HCV epidemic among baby boomers because of the presumed link to risky behaviors, such as injection drug use experimentation, high-risk sexual practices or unsafe tattooing. Moreover, while North America does face a more recent HCV epidemic among people who inject drugs, the majority of those living with HCV are baby boomers – many of whom were infected through medical procedures or accidental exposures in hospitals decades earlier. The BC-CfE study revises by 15 years previous estimates of the exponential growth phase of the North American HCV genotype 1a epidemic, the region’s most dominant form of HCV. The oldest members of the baby boomer cohort were roughly five years of age at the peak of the epidemic in 1950. The peak exponential growth of HCV corresponds to an overall increase in medical procedures following World War II—much earlier than the peak in injection drug use that occurred in North America around 1969. A plateau in the spread of HCV was observed between 1960 and 1990, consistent with the hypothesis that changes in injection technology were a driving factor. These findings suggest HCV spread among baby boomers was not associated with risky behaviour, but rather reuse of needles and syringes in health care settings before disposables became the uniform standard of practice. The results of the study strongly support routine HCV screening for all people born between 1945 and 1964, in line with recent US CDC recommendations. “Hepatitis C among baby boomers has been previously linked to sex and drugs. As such, HCV testing has long carried a substantial stigma. Our results should go a long way to remove this persistent barrier to testing among HCV infected baby boomers,” said Dr. Jeff Joy, a Research Scientist with the BC-CfE and the study’s lead author. “Reduced stigma will facilitate widespread testing and timely access to life saving HCV treatment. Any baby boomer could be living with HCV even in the absence of symptoms or any history of high risk behaviours, and as such they should be encouraged to proactively seek HCV testing,” said Dr. Julio Montaner, Director of the BC-CfE. These findings are consistent with previous research from other parts of the world—including France, Italy, Japan and Russia—where reusable syringes and needles are recognized to have played a key role in the spread of HCV among baby boomers. “The vast majority of North Americans with hepatitis C are baby boomers – and most are unaware that they have this infection,” said John Ward, M.D., Director of the Division of Viral Hepatitis at CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. “Over time, hepatitis C infection can lead to cirrhosis, liver cancer and other life-threatening conditions. All baby boomers need to be tested for hepatitis C so that those who are infected can receive life-saving care and treatment. This study demonstrates the importance of offering a test to all baby boomers rather than relying on risk based testing alone.

For more information: http://tinyurl.com/jzo8b2r

Many inmates won’t get new HepC treatment
Ottawa, ON - Correctional Service of Canada (CSC) has decided to limit the number of patients to its current target of 240 in treatment annually it was reported in the CMAJ this week. Outside analysts say that could exclude as many as 1700 eligible patients from treatment. Each region within CSC manages demand for access to HCV medications in the context of funding all other health services at the same time. Some of the new direct-acting antiviral therapies cost up to $60 000 for the full treatment. Hepatitis specialists describe CSC’s decision to exclude large numbers of patients as a public health setback. “Many of these folk will only come into contact with health care when they are in prison,” says Dr. Peter Ford, a specialist in HIV and HCV care in federal prisons. “CSC is in a unique position of potentially being able to treat the people that otherwise will slip through the net.” Ford says “CSC needs to be making a pitch for extra funding on this basis.” Adam Cook, a hepatitis policy researcher with the Toronto-based Canadian Treatment Action Council is encouraged by the increase in treatment, but says it is “still just a drop in the bucket. We’re not even getting ahead of new infections with this approach.” He says the CSC lacks leadership and is “late to the game.” Some experts contend that if CSC implemented national treatment guidelines, the number of eligible inmates could be as high as 2000. CSC’s director general of clinical services and public health, Henry De Souza, acknowledges that the number of patients eligible for treatment is far larger than the 290 who will receive it. But he says that “not every individual who has the antibody requires treatment. Of those who require treatment, not all of them require treatment immediately, so there is a process in terms of individuals and the decision by their physicians to treat them.” “Our estimate is that by the end of 2013, there were about 668 inmates in Ontario who had antibodies to HCV, but not all of these would have active HCV infections or meet the criteria for treatment,” De Souza said. 

For more information: http://tinyurl.com/hm3cky2

HepC World News Week of March 20, 2016

Quebec government extends coverage for Harvoni
Quebec City, QC - INESSS (Institut national d’excellence en santé et en services sociaux) has updated the reimbursement criteria for Harvoni™ in accordance with their July 2015 recommendations for the second year following listing of the medication. The expanded reimbursement criteria for Harvoni can be found at the respective links below on the RAMQ (Régie de l'assurance maladie du Québec) website. This expanded access is an integral stage of the province’s comprehensive approach to treatment access for hepatitis C patients over a 6 year period. This is a public health policy approach to management of HCV and an important step towards elimination of Hepatitis C. Ledipasvir/Sofosbuvir is approved for use as monotherapy, for treatment of persons suffering from chronic hepatitis C genotype 1 with mild hepatic fibrosis (Metavir score of F1) and at least one poor prognostic factor, moderate hepatic cirrhosis, severe hepatic fibrosis or compensated cirrhosis (Metavir score of F2, F3 or F4) and who have never received an anti-HCV treatment. Authorization is granted for a maximum period of eight weeks for persons without cirrhosis whose viral load (HC V-RNA) is less than 2,2 million UI/ml (measured with the Abbott RealTime HCV assay) or 6 million UI/ml (measured with Roche’s COBAS TaqM an HCV Test version 2.0) before treatment. Authorization is granted for a maximum period of 12 weeks for other persons. Poor prognostic factors are defined as: severe extra-hepatic manifestations of hepatitis C (e.g. type II or III mixed cryoglobulinemia with damage to the organs, vasculitis, nephropathy , B-cell non-Hodgkin's lymphoma); HIV or HBV co-infection; other liver disease (e.g. nonalcoholic steatohepatitis); type-2 diabetes; or porphyria cutanea tarda.

For the complete list of approved uses and conditions see the INNESS March 24, 2016 update:
For English version of the update, see page 72 > http://tinyurl.com/hdw76w2
For French version of the update see page 77 > http://tinyurl.com/jtwgay2

Pan Canadian strategy should not be delayed by fear of costs
Ottawa, ON - Action Hepatitis Canada (AHC), which includes the Canadian AIDS Society and the Canadian Liver Foundation, wants Ottawa to act now on a 2014 World Health Organization resolution urging member states to adopt national hepatitis plans similar to those already implemented by Australia, France, the United Kingdom and the United States. “National strategies in these countries promote prevention and screening, as well as price controls for HCV [hepatitis C virus] medicines,” says Patricia Bacon, chair of the AHC’s steering and executive committees. A national hepatitis strategy would result in higher treatment rates, improved prevention strategies, higher treatment retention, fewer treatment disparities and new pharmaceutical treatments moving faster to market, she says. Hepatitis is not a small problem, Bacon emphasizes. According to the Canadian Liver Foundation, more than 500 000 Canadians are likely chronically infected with hepatitis B or hepatitis C. In a Jan. 25 statement, AHC also asked the federal government to take steps to curb the expense of new hepatitis medicines, some of which cost up to $60 000 for the complete treatment. The coalition wants the federal government to force down prices through measures such as bulk buying. “Manufacturers of new HCV treatments are profiting at rates that are vastly disproportionate to their investment or to any reasonable expectation of commercial gain,” the AHC charged. “In the case of new HCV drugs, the prices have been set so high that governments and private payers cannot afford to treat all those who would benefit.” Many provincial formularies list HCV drugs, but severely curtail access due to the cost. The coalition would also like to see a national strategy to promote testing for everyone born between 1945 and 1975. “Nearly half of the Canadians who are living with HCV are unaware of their infection, and of those who are aware of their infection, too few are being treated to cure the disease,” Bacon says. “At these low rates of diagnosis and treatment, HCV rates will continue to rise as will health care costs, due to expensive treatment for liver failure and liver cancer, such as liver transplantation.” Hepatologist Dr. Morris Sherman, chair of the Canadian Liver Foundation, agrees a national strategy is urgently needed. “The Canadian government needs to understand that if not tackled today, both hepatitis B and C will be major burdens on the health care system in the next 20 years, as today’s patients will suffer complications, develop liver cancer or require liver transplants.” Sherman says liver cancer is most frequently a result of hepatitis B and C and its incidence is increasing more rapidly than any other cancer.

For more information: http://tinyurl.com/gkptqk5

HepC World News Week of March 13, 2016

Patients will get free HepC treatment in Georgia, Russia
Georgia, Russia - Twenty thousand people suffering from Hepatitis C in Georgia will receive free treatment this year and potentially enjoy 100 percent recovery thanks to an offer from American pharmaceutical firm Gilead to provide a new medicine to Georgia for free. Prime Minister Giorgi Kvirikashvili addressed patients taking part in the country’s Hepatitis C Elimination Program to tell them about the next stage of the package. Since the program launched in April 2015, more than 7,000 people suffering from Hepatitis C received free treatment and 3,000 had completed their course of treatment, said Kvirikashvili. Ninety percent of the 3,000 were totally cured,” the PM stressed. Georgia has one of the highest estimated virus prevalence rates in the world, affecting 6.7 percent of the population. But through the public-private partnership between the US and Georgian Governments, along with Gilead, Georgia was on its way to making history and completely eliminate Hepatitis C from the country. Kvirikashvili thanked Georgia’s Ministry of Health, Labour and Social Affairs, doctors, Gilead and the United States (US) Embassy to Georgia for their assistance to eliminate the virus in Georgia. The Prime Minister also thanked the patients involved in the special program and sharing their experiences with new patients. Harvoni, the new Hepatitis C medicine, has already been imported to Georgia. Gilead gave the medicine to Georgia free of charge following a memorandum signed between the company and Georgia’s Health Ministry. Typically Harvoni cost €110,000 per person for one course of treatment. During the first stage of the Hepatitis C Elimination Program in 2015 Georgia used Gilead’s medicine Sofosbuvir, also free of charge. Harvoni is a new Hepatitis C medication combining Sofosbuvir and Ledipasvir, providing nearly a 100 percent cure, said Georgia’s Health Minister Davit Sergeenko. The Hepatitis C virus infected an estimated 130–150 million people globally and resulted in an estimated 700,000 deaths annually.

For more information: http://agenda.ge/news/53559/eng

VA to offer HepC Drugs to all infected
Washington, DC - The Veterans Affairs Department says it will provide hepatitis C treatments to all veterans in its health system who have the virus, regardless of their disease stage, the Military Times reports. It says the VA last year got a budget boost to cover the cost of hep C meds for the estimated 174,000 veterans enrolled in the VA health system who have the disease. The publication says the VA projects it will spend $1 billion this year for Gilead Sciences' hep C meds, which cure the disease in about 99% of cases. The VA had been criticized for limiting availability because of the cost while presidential candidate Sen. Barrie Sanders has urged the agency to pull the patent on the drugs so cheaper generics could be substituted. AbbVie makes competing Viekira Pak.

For more information: http://tinyurl.com/jnero9p

HepC World News Week of March 6, 2016

Liver damage caused by heavy drinking or hepatitis could be reversed
Baltimore, Maryland - A protein has been found that halts liver fibrosis and cirrhosis in rats, bringing a potential cure a step closer for the thousands of patients living with the devastating diseases. Liver damage caused by heavy drinking or hepatitis could be reversed - offering hope of an alternative to a transplant. A protein has been found that halts liver fibrosis and cirrhosis in rats, bringing a potential cure a step closer for the thousands of patients living with the devastating diseases. At present, there is little effective treatment and no cure other than liver transplantation, which carries its own risks and often fails. Human trials could start in the next two years and the breakthrough may also offer hope for sufferers of other fibrotic diseases such as pancreatic or lung fibrosis. Professor Justin Hanes, of Johns Hopkins University, Baltimore, said: "This approach has tremendous potential to help people with this devastating condition and may also be helpful to the millions of patients with other diseases where fibrosis plays an important role." Heavy alcohol use and hepatitis can lead to a process called fibrosis in the liver, which involves the formation of excessive scar tissue. Cirrhosis happens when this scarring becomes too severe, interfering with the way the liver works. Currently doctors can do little more than try to prevent more damage by changing the patient's lifestyle or treating the virus which caused it. In the study published in Hepatology the protein was modified to increase the amount of time it circulates in the bloodstream. Prof Hanes said: "Our findings demonstrate that the damaging effects of liver cirrhosis in laboratory rats can be effectively treated, and perhaps even reversed." Liver fibrosis and its more severe form, cirrhosis, are usually induced by chronic alcohol abuse, infections and autoimmune diseases. The progressive stiffening of the liver, a hallmark of the disorders, occurs when a type of liver cell known as the hepatic stellate cell is "activated" and overproduces the stringy network of proteins called the extracellular matrix that binds cells together.

For more information: http://tinyurl.com/jbd8to5

HepC World News Week of February 28, 2016

Ottawa seeks to join provinces to cut cost of prescription drugs
Ottawa, ON - The federal government is set to join the provinces in lowering the cost of prescription drugs by co-ordinating their purchases, a move that could signal a new era of co-operation between Ottawa and provincial leaders. The collaboration is expected to come as early as this week when Federal Health Minister Jane Philpott joins her provincial and territorial counterparts for a meeting in Vancouver. The meeting is the first in what will be a critical year as Ottawa works to hammer out a new deal on health that will set national standards and deliver the stable funding promised by the Liberals during the election. The new federal minister, herself a family doctor, said she expects this week’s meeting to be the beginning of a “year-long project” to reach a new health accord and lay the groundwork for transforming Canada’s health system. Even before the two days of meetings begin Wednesday, a number of provincial health ministers are staking out their positions on future federal health transfers. Some, such as B.C. Health Minister Terry Lake, want extra per-capita funding for seniors, while Manitoba Health Minister Sharon Blady said the same consideration should be given to First Nations populations. Alberta Health Minister Sarah Hoffman, whose province stands to lose if transfers are adjusted based on age, is opposed to such changes. Dr. Philpott, who will join the meeting on the second day, wants to steer the talk away from dollars. “My hope is that we won’t allow ourselves to be inappropriately distracted by conversations about details of the transfer at this stage of the conversation,” she said. Dr. Philpott said reducing the cost of prescription drugs is one of her top priorities. “Canadians pay some of the highest costs for prescription drugs. That is an area that I am quite determined to address,” she said. Joining the Pan-Canadian Pharmaceutical Alliance, an initiative started in 2010 by the provinces and territories to drive down costs of publicly funded drug programs through bulk buying, is the first step, she said. Federal drug programs that cover the military, First Nations and inmates make Ottawa the fifth-largest spender on pharmaceuticals in Canada, Dr. Philpott said. “We will be a major buyer that will be coming to the table and participating in the bulk purchasing, which I think obviously will help our purchasing power,” she said. The new federal government is looking at other ways to reduce drug costs, she said, including changes to the Patented Medicine Prices Review Board, the quasi-judicial body that regulates the prices of patented drugs. A study this fall by the Organization for Economic Co-operation and Development ranked Canada as the fourth-highest spender on pharmaceuticals among 29 countries when measured by population. Pharmaceutical spending in Canada worked out to $713 (U.S.) a person in 2013, well above the OECD average of $515. Steve Morgan, a professor of health policy at the University of British Columbia, said the federal move to join the Pan-Canadian Pharmaceutical Alliance is a sign of “good will and good faith,” but pointed out the majority of Canadians pay for prescriptions out of pocket or through private drug plans. Home care is another priority for the federal Health Minister, following on the Liberal party’s $3-billion campaign pledge. Dr. Philpott wants to tie new federal money to performance targets, but said it’s too soon to say what they will be. Mr. Lake, B.C.’s Health Minister, who will lead the provincial-territorial talks, said the issue of physician-assisted death also must be a top priority, given last week’s Supreme Court ruling. “We really need to have some serious discussions with the federal government over how they’re going to move forward,” he said. “I would prefer to see a consistent approach across Canada so that we don’t develop different regulatory regimes in every province. That will be a topic of intense discussion.”

For more information: http://tinyurl.com/hs4xm24

HepC World News Week of February 21, 2016

FDA approves supplemental indications for Harvoni
San Francisco, CA - Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni® (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. Harvoni in combination with ribavirin (RBV) for 12 weeks was approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation. Harvoni is now approved for use in a broader range of patient populations, including HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis. “Hepatitis C-infected patients who have decompensated cirrhosis and those who have previously received a liver transplant have an urgent need for treatment, but historically their options have been limited,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “We are pleased that health care providers now have the information needed to offer these patients an all-oral, 12-week duration therapy with high cure rates and a tolerable side effect profile.” The supplemental new drug application (sNDA) approval for genotype 1 or 4 HCV liver transplant recipients without cirrhosis or with compensated cirrhosis, and for genotype 1 HCV patients with decompensated cirrhosis, was supported by data from the Phase 2 SOLAR-1 and SOLAR-2 trials. These open-label studies evaluated 12 and 24 weeks of treatment with Harvoni in combination with RBV in HCV treatment-naïve and treatment-experienced patients with genotype 1 and 4 infection who had undergone liver transplantation and/or who had decompensated liver disease. SVR12 rates among genotype 4 HCV post-transplant patients without cirrhosis or with compensated cirrhosis (n=12) were similar to the reported genotype 1 SVR12 rates; no subjects relapsed. Available data in subjects with genotype 4 HCV who had decompensated cirrhosis (pre- and post-liver transplantation) were insufficient for dosing recommendations. A total of seven patients in the 12-week treatment arms of SOLAR-1 and SOLAR-2 had fibrosing cholestatic hepatitis (FCH), and all achieved SVR12. FCH is a rare and severe form of recurrent hepatitis that occurs following liver transplantation and is associated with high morbidity and mortality. Previously, there were no approved treatment options for FCH. Adverse events observed in the two SOLAR studies were consistent with the expected clinical sequelae of liver transplantation and/or decompensated liver disease, or the known safety profile of Harvoni and/or RBV. Among liver transplant and decompensated liver disease patients, 1 percent and 2 percent of patients discontinued Harvoni with RBV due to an adverse event, respectively. The most common adverse reactions (≥10 percent, all grades) observed with treatment with Harvoni in combination with RBV for 12 weeks were asthenia, headache and cough.

For more information: http://tinyurl.com/zz52ak4

HepC World News Week of February 14, 2016

Pharmacare plans in Canada shifting burden onto patients
Ottawa, ON - Nova Scotia's move to a seniors' pharmacare program based on income is a shift toward a British Columbia and Manitoba model where rich subsidize poor, and away from the flatter fees typically charged in Atlantic Canada. Canada has an fragmented approach to pharmacare for seniors. Details are complicated and vary between provinces. But Nova Scotia's latest move to increase premiums for its richest registrants is part of a general trend to deal with an ever-more expensive drug system, Carleton University public policy associate professor Marc-André Gagnon said in an interview. "One of the trends we're seeing in all provinces is this cost-shifting onto the shoulders of patients, first and foremost," Gagnon said. "What we're seeing is increased premiums, increased co-pays or deductibles." As of April, individual Nova Scotia seniors making more than $75,000 will pay annual premiums of up to $1,200, nearly three times the current cap of $424. Couples making $100,000 or more will pay $2,400. "For anyone it's problematic if you ask them to pay more for the same type of coverage," Gagnon said. Nova Scotia's changes bring the province closer to income-based plans in British Columbia and Manitoba, where drug coverage is for all ages and annual fees are similar to Nova Scotia's premiums. Manitoba bases its payments on income and a deductible rate, taking into account pension splitting and how many dependants there are in a family. For instance, a couple that makes $24,000 annually and has no children under 18 pays $1,065 per year. After that, all prescriptions costs are covered. By comparison, a couple that makes $100,000 a year pays $6,730. It drops to $6,326.20 if they have two children. In British Columbia, there is a slight discount for seniors born in 1939 or earlier. Annual fees are slightly less than in Manitoba; around $500 per year for families making $24,000 and around $3,000 for families making $100,000 or more. Quebec has a premium similar to Nova Scotia that can go up to $640 for the highest income bracket. How much seniors pay for their drugs depends on which province they live in. Marc-André Gagnon, a Carleton University associate professor of public policy, says costs of public drug plans are shifting onto patient shoulders Gagnon and others say a Canada-wide system — a national pharmacare plan — would be more consistent and help the country negotiate for cheaper drug prices as a single unit. It may also help people rely less on private drug coverage to make up the gap, Gagnon said, which also contributes to diluting provincial power to negotiate on drug costs. "That would make things more sustainable," Gagnon said. "In the end the problem is the same. We have a very inefficient system in terms of drug coverage that's costing way too much. Somebody have to pay for that and, yes, we end up making richer people pay."

For more information: http://tinyurl.com/hl4aatq

HepC World News Week of February 7, 2016

Zepatier approved for sale in Canada
Kirkland, QC –Merck, known as MSD outside Canada and the United States, announced today that ZEPATIER (elbasvir/grazoprevir) is now available in Canada. It is indicated for the treatment of chronic hepatitis C (CHC) genotypes 1, 3 or 4 infections in adults; see the About ZEPATIER section below for full indication details.1 “We value this accelerated approval of ZEPATIER in Canada which allows us to offer an effective, simple and well tolerated treatment not only for Canadians with the hepatitis C virus with genotype 1 infection, but also for genotype 3 and 4 infected patients for whom options were limited until now,” says Chirfi Guindo, President and Managing Director, Merck Canada Inc. “With this new product, we now have the opportunity to help a broad range of patients overcome hepatitis C using a simple regimen of 1 pill daily, with most patients cured with an 8 to 12-week therapy.” “Chronic hepatitis C is a serious liver disease which, if left untreated, can lead to reduced liver function, liver failure or liver cancer, and is responsible for almost half of all liver transplants in Canada,” added Billie Potkonjak, National Director of Health Promotion and Patient Services for the Canadian Liver Foundation (CLF). “ZEPATIER is indicated for patients with CHC genotype 1, 3 and 4 infection and genotype-1 infected patients with renal failure. The CLF welcomes this additional treatment option for hepatitis C, which broadens the patients that can be treated. We urge the provinces to take us another step closer to the elimination of hepatitis C in Canada by making this therapy financially accessible to patients across the country.” “Although I am Chairman of the Canadian Liver Foundation,” explained Dr. Morris Sherman, Gastroenterologist, Toronto General Hospital Liver Clinic, “I am also a practicing hepatologist and it is as a liver doctor that I make this comment. Hepatitis C treatment has undergone a revolution in the last two years, and with the approval of this new product, we now have another agent to add to our armamentarium for a broad range of hepatitis C patients. In addition, this treatment is particularly indicated for patients with renal failure and with patients with genotype 4 infection, a group that continues to have difficulty in accessing treatment in Canada. We hope that the funding agencies quickly approve reimbursement for ZEPATIER. There are patients who have been waiting a long time for this to be available.” “It is important that Canadians address hepatitis C now,” emphasized Lesley Gallagher, Hepatitis C Nurse Clinician, Vancouver Coastal Health. “People are dying from this disease. The hepatitis C treatment community is setting a high bar for the elimination of hepatitis C in Canada, and advances like this one raise awareness with the public, health care professionals and patients. We are moving towards a time when Canadians can surpass the stigma of hepatitis C, and be empowered to deal with this disease sooner rather than later.”

For more information: http://www.merck.ca/english/pages/home.aspx

HepC World News Week of January 31, 2016

Report supports prison needle program to reduce Hep C and HIV
Toronto, ON - In a newly released report researchers in Toronto provide a framework for the introduction of what they call “prison-based needle and syringe programs” in Canada — programs that the authors argue are sorely needed in provincial and federal jails to address levels of HIV and hepatitis C infections that are “astronomically” high compared with those in the general population. As reported in the Toronto Star, this new research is meant to show that needle and syringe programs can be effective. According to Sandra Ka Hon Chu, director of research and advocacy for the Canadian HIV/AIDS Legal Network, who contributed to the report, “We involved a broad range of stakeholders, including former prisoners and people who work in prison health care, to demonstrate how it might actually work.” Researchers held a conference with experts, interviewed health workers, inmates and prison workers, and pored over existing studies to draft a series of recommendations for a future safe injection regime in Canadian jails. These include ensuring prisoners can easily access sterile needles and syringes in a way that’s confidential and devoid of disciplinary consequences. It also argues prisoners should have access to drug education and addiction support from trained personnel, and that the justice system should generally move away from treating drug use as a crime and look at it as a health and social issue. Critics of the programs have argued they could lead to increased drug use, or that prisoners could use syringes as weapons. The report counters that several studies — including reports from federal government agencies — found no evidence that prison needle programs lead to more drug use, and that there are no reported cases of needles being used as weapons from 60 existing clean-needles programs in prisons in other countries.

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

HepC World News Week of January 24, 2016

The MPP signs first sub-licences for Hep C medicine Daclatasvir
Geneva, Switzerland - The Medicines Patent Pool (MPP) announced its first round of sub-licences for the generic production of Bristol-Myers Squibb's daclatasvir, a novel direct-acting antiviral that is proven to help cure multiple genotypes of the hepatitis C virus. The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, viral hepatitis C and tuberculosis treatments in low- and middle-income countries. Generic companies Cipla, Emcure, Hetero and Natco have signed non-exclusive, royalty free agreements with Bristol-Myers Squibb and the MPP to produce and sell daclatasvir in 112 low- and middle-income countries. These generic companies are India-based pharmaceutical manufacturers. The sub-licences follow MPP's announcement of its first hepatitis C licensing agreement, signed with Bristol-Myers Squibb in November 2015, and mark the first time that generic manufacturers have worked through a non-profit, public health organisation to increase access to new hepatitis C medicines for developing world patients. Between 130 and 150 million people worldwide are estimated to have hepatitis C. The vast majority lives in low- and middle-income countries. "Given the burden of hepatitis C, MPP worked quickly to forge agreements with generic companies," said Greg Perry, Executive Director of the MPP. "Cipla, Hetero and Emcure are long-term partners working with us to develop generic HIV anti-retrovirals. We welcome Natco, a new collaborator, to the MPP and hope to have other companies on board as well." MPP is assessing applications from several other companies and expects to grant further sub-licences soon. The MPP licence allows generic manufacturers to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of hepatitis C (HCV). Daclatasvir, in combination with sofosbuvir, for example, produces high cure rates after 12 weeks of treatment, with recent Phase III studies demonstrating that the regimen could cure up to 100% of HCV patients depending on genotype and stage of liver disease.
For more information: http://tinyurl.com/justrd3

HepC World News Week of January 17, 2016

Scientists in Barcelona discover a potential treatment for cirrhosis
Barcelona, Spain - Scientists headed by Raúl Méndez, ICREA research professor at the Institute for Research in Biomedicine (IRB Barcelona), and Mercedes Fernández, at IDIBAPS in Barcelona, reveal that the inhibition of CPEB4 protein may prevent the development of the abnormal blood vessels associated with cirrhosis. Pathological angiogenesis is one of the most serious complications in patients with cirrhosis and a key factor in the development and worsening of the disease. Consequently, many research efforts focus on identifying treatments for this condition. The results of the study have been published in the most recent issue of Gastroenterology. In Western countries, cirrhosis is among the 10 leading causes of death among adults. It is a very common disease in Spain and the leading cause of liver transplantation in this country. It is responsible for a high rate of hospital admissions and use of health resources due to complications that occur in advanced stages of the disease. Cirrhosis is a chronic lesion characterised by the accumulation of scar tissue (fibrous nodules), which alters the normal structure and function of the organ. Chronic hepatic lesions are caused mainly by alcoholism, hepatitis C, and increasingly by obesity. The accumulation of scar tissue impedes blood circulation in the liver, thus leading to portal hypertension (the portal vein). To relieve the pressure in the vein, collateral blood vessels develop outside the liver. The problem is then two-fold, first because the liver receives even less blood, thereby causing greater damage to the organ, and second because the blood vessels are of poor quality (pathological angiogenesis). "Hepatic cells try to repair liver lesions, but the way by which they do this turns out to be fatal for the organ. This is a loop that gets bigger and finally threatens the patient's life. Also, the collateral blood vessels form varicose veins in the oesophagus and stomach of patients with cirrhosis; these veins are fragile and have a high tendency to burst, causing heavy bleeding that is difficult to stop," explains Mercedes Fernández, from IDIBAPS and co-leader of the study. "This is why a treatment that regresses and/or prevents pathological veins--which is not currently available--would be efficient," she adds. VEGF (vascular endothelial growth factor) is the main effector protein in the development of blood vessels. "All current drugs that aim to prevent neovascularisation are based on inhibiting VEGF or VEGF receptors, but the problem is that indiscriminate attack of this protein impairs the normal development of blood vessels, thus causing unbearable adverse effects."

For more information: http://www.medicalnewstoday.com/releases/304008.php

HepC World News Week of January 10, 2016

AbbVie nabs quick FDA review for Viekira Pak in genotype 1b patients
Chicago, IL - AbbVie knows that expanding to untapped niches is key to its hep C success, targeting small populations of patients to increase market share for its blockbuster-in-the-making, Viekira Pak. Now, with the help of a quick FDA review, the med is set to gain more ground this year. The agency gave its priority review designation to Viekira Pak without ribavirin to treat individuals with chronic genotype 1b hep C and cirrhosis. The move comes months after AbbVie revealed some promising data for the drug from a trial with genotype 1b patients, showing that its combo med boasted a 100% cure rate. That trial, dubbed TURQUOISE-III, is just one part of AbbVie's plan to demonstrate Viekira Pak's promise in treating different subtypes of hep C. About 2.7 million people in the U.S. have chronic hep C, and genotype 1 is the most common type. Of those patients, about 77% are genotype 1a and 23% have genotype 1b, the company said in a statement, presenting an opportunity for drug makers like AbbVie that are trying to carve out a niche in a competitive market. "We are pleased that the FDA has granted priority review for Viekira Pak without ribavirin as a therapy for treating GT1b chronic hepatitis C patients who have compensated cirrhosis," AbbVie CSO Dr. Michael Severino said in a statement. "The filing of this sNDA further underscores AbbVie's commitment to patients living with chronic HCV infection." But AbbVie is far from alone in its quest for hep C dominance. The company competes head-to-head in genotype 1 with Gilead Sciences, whose Sovaldi and Harvoni continue to gobble up market share. AbbVie gave Gilead a run for its money last year by striking an exclusive deal with Express Scripts for Viekira Pak, but Gilead bounced back with a few deals of its own to hold on to its top-dog status in the market. And Gilead is already charging ahead this year, planning to roll out a new hep C combo pill that treats genotypes 1-6 of the virus. The company got a boost earlier this week when the FDA granted the med a speedy review. Regulators are expected to hand down a final decision on the drug by the end of June. Meanwhile, Bristol-Myers Squibb and Merck are developing their own hep C combo treatments. Merck, for one, seems confident about its prospects. The company knows "the players, and we know the managed care organizations very, very well," Adam Schechter, Merck's president of global human health, said last year. That attitude, combined with Merck's plan for tapping smaller patient pools, could mean competition for AbbVie in the year ahead.

For more information: http://tinyurl.com/zb97h8f

HepC World News Week of January 3, 2016

India's hep C market sets a global pace on cost, access
Hyderabad, India - Two Indian companies are set to roil the global market for hepatitis C drugs further, calling into question spending and approval paces by Japan, Australia and the United States among others, while China, the potential top market, slowly grinds through clinical and regulatory processes. Hyderabad based Natco Pharma said in late December that it will market generic daclatasvir in a fixed-dose combination with Gilead Sciences' sofosbuvir for the treatment of patients with genotype 3. The product, according to the company website, will go under the brand name Natdac at INR6,000 ($90.46) for 28 tablets, according to a company release. The cost places it light-years away from the $84,000 price tag for a 12-week full-scale treatment of Sovaldi in the U.S., though the treatments are not directly comparable. The announcement by Natco came on the heels of a similar one from Hetero Drugs, also based in Hyderabad, of approval from the Drug Controller General of India to sell a fixed-dose combination of ledipasvir-sofosbuvir, a generic version of Gilead's Harvoni. The company did not provide pricing. The move to combination drug formulae was noted that companies in India were taking a page out of a playbook used to make cheap HIV drugs in fixed-dose combinations and applying it to hep C. In this particular case, both companies are among nearly a dozen licensed by Gilead to manufacture and/or market its existing hep C treatments at sharply lower prices in India and nearly 100 developing countries, but not China or Russia. That's in sharp contrast to China, where hepatitis C patients must rely on imports in a country with 10% of the world's cases. What's more, the standard treatment in China, interferon/ribavirin, is a poor second cousin to cutting-edge antivirals that can cure 95% of hep C cases.

For more information: http://tinyurl.com/zltw6ed