FDA approves Viekira Pak to treat hepatitis C
Silver Spring, MD - The U.S. Food and Drug Administration approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis. Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis). “The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.” Viekira Pak is the fourth drug product approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014. Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308 participants with chronic HCV infection with and without cirrhosis. In different trials, participants were randomly assigned to receive Viekira Pak or placebo (sugar pill); Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured. Results from multiple populations, including those considered difficult to treat, showed 91 to 100 percent of participants who received Viekira Pak at the recommended dosing achieved SVR. The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily. The most common side effects reported in clinical trial participants were feeling tired, itching, feeling weak or lack of energy, nausea and trouble sleeping. Viekira Pak is the eleventh new drug product with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Viekira Pak was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness. Viekira Pak is marketed by AbbVie Inc., based in North Chicago, Illinois. Olysio is marketed by Raritan, New Jersey-based Janssen Pharmaceuticals. Sovaldi and Harvoni are marketed by Gilead Sciences, based in Foster City, California.

For more information: http://tinyurl.com/l5y7u33

Hep C World News - Week of December 21, 2014

HCV-related liver cancer deaths up 125%
Washington, DC - Data from the Global Burden of Disease Study 2013 suggest that global life expectancy has increased by 5.8 years among men and 6.6 years among women from 1990 to 2013. Some causes of death, however, have seen increased rates in that time, according to the data published in The Lancet. The most significant increase is in the rate of death from liver cancer caused by hepatitis C, which has increased by 125%. Other increases in mortality rates include atrial fibrillation and flutter by 100%; drug use disorders by 63%; chronic kidney disease by 37%; sickle cell disorders by 29%; diabetes by 9% and pancreatic cancer by 7%. Also of note is the one region where life expectancy has decreased: southern sub-Saharan Africa, where deaths related to HIV/AIDS have decreased by 5 years. Worldwide, deaths from HIV/AIDS have declined every year since 2005, but it is still the greatest cause of premature death in 20 countries in sub-Saharan Africa. “The progress we are seeing against a variety of illnesses and injuries is good, even remarkable, but we can and must do even better,” Christopher Murray, MD, professor of global health at the University of Washington, said in a press release. “The huge increase in collective action and funding given to the major infectious diseases such as diarrhea, measles, tuberculosis, HIV/AIDS and malaria has had a real impact. However, this study shows that some major chronic diseases have been largely neglected but are rising in importance, particularly drug disorders, liver cirrhosis, diabetes and chronic kidney disease.” That data include the most recent estimates of the number of yearly deaths related to 240 different causes throughout 188 countries. In high-income regions, the 15% lower rate of death related to most cancers and the 22% lower rate of death due to cardiovascular diseases have contributed to the increased life expectancy. In low-income countries, there were significantly declining rates of death related to diarrhea, lower respiratory tract infections and neonatal disorders, which has led to extended life expectancy. The 10 leading causes of premature death have not changed significantly. HIV/AIDS joined the list as the sixth leading cause of death worldwide, but tuberculosis was bumped from the top 10. Ischemic heart disease is the leading cause of death worldwide, followed by lower respiratory infections, cerebrovascular disease and diarrheal diseases. Malaria is the eighth leading cause of death worldwide. There has been a significant decline in deaths among children aged 1 to 59 months: 7.6 million in 1990 to 3.7 million in 2013. However, respiratory tract infections, malaria and diarrheal disease are still in the top five causes of death for children, and are responsible for almost 2 million deaths annually. In an accompanying commentary, Igor Rudan, PhD, and Kit Yee Chan, PhD, of the Centre for Population Health Sciences and Global Health Academy at the University of Edinburgh Medical School in Scotland, said that estimates of disease and death are necessary to guide investment decisions that could help save lives. They also said the responsibility for these estimates has typically rested with WHO. “Although WHO’s team of experts have been doing fine technical work for many years, its monopoly in this field had removed incentives to invest more time and resources in continuous improvement,” they wrote. “The emergence of the Institute for Health Metrics and Evaluation, generously supported by the Bill & Melinda Gates Foundation, has changed the science of global health metrics in a similar way to Celera Genomics’ competition with the Human Genome Project. “The competition between WHO and the Global Burden of Disease study has benefited the entire global health community, leading to converging estimates of the global causes of death that everyone can trust.”

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

Hep C World News - Week of December 14, 2014

Harvoni cost-effective at $95K, but only affordable at half the price
Oakland, CA - A California cost-effectiveness panel is prepared to say this about Gilead Sciences' brand-new combination treatment for hepatitis C: It's cost-effective, even at an eye-popping price. But--and this is a big but--the state can't afford to pay it. After an exhaustive analysis of hepatitis C drugs--clinical trial data, side effects, prescription costs--and hep C-related treatment spending, the California Technology Assessment Forum (CTAF) tabbed Harvoni as one of the only new treatment cocktails worth the price. A combination of Gilead's previously approved Sovaldi and a new agent, ledipasvir, Harvoni was "very cost effective," the draft report states. Under a commonly used metric--quality-adjusted life year--Harvoni beat a $50,000 threshold suggested by the World Health Organization. In fact, in some groups of patients, the QALY calculation came in at $20,000 or less. That's at the U.S. list price of about $1,000, and compared with old-style treatment with interferon and ribavirin. Not so for Sovaldi plus simeprevir, a.k.a. Olysio, Johnson & Johnson's new hep-C-fighting protease inhibitor at 12 weeks of treatment, or Sovaldi with ribavirin, with or without interferon, the report says. But when CTAF plugged its numbers into spending calculations, the results weren't as favorable. Using Harvoni to treat the state's Medicaid patients and prison population would add $3 billion to its drug spending. Though California would save on long-term treatment costs, the offset would only be $254 million over the first 5 years after treatment. Twenty years down the road, the cost savings would be $1.2 billion, putting the cost increase at $1.8 billion. If the state only treated patients with advanced disease, as some private insurers are doing, the costs would be considerably lower, the report states: $800 million in additional spending, with $475 million in savings over 20 years. In fact, CTAF says, to meet the state's targets for value, the cost of Harvoni would have to be less than half its sticker price: $34,000 to $42,000, depending on patient group, versus $94,500 for 12 weeks of treatment at retail prices. The CTAF panel meets Thursday to talk over the draft report and solicit feedback from companies and patient groups. Part of the meeting will be a panel including execs from Gilead and Merck , as well as Express Scripts, which has been a vocal critic of hep C pricing decisions. The report is available from CTAF at its website, http://www.ctaf.org

For more information: http://tinyurl.com/l8b74kv

Hep C World News - Week of December 7, 2014

Doctor warns of hepatitis C. 'tsunami' among baby boomers
Vancouver, BC - The doctor who’s been at the forefront of B.C.’s pioneering, globally imitated battle against HIV and AIDS for the past three decades is now turning his attention to another looming heath crisis — an estimated 80,000 people in B.C. infected with hepatitis C. Vancouver’s Dr. Julio Montaner was honoured last week, on the eve of Monday’s International AIDS day, by B.C. Health Minister Terry Lake, who said no one in Canada has contributed more to HIV/AIDS research and treatment. The United Nations has also cited Montaner’s work toward achieving “an AIDS-free generation.” Meanwhile, at his cluttered office in St. Paul’s Hospital, the head of B.C.’s Centre for Excellence in HIV/AIDS has another disease in his sights. “Hepatitis C is a bigger deal today,” Montaner said. It is a virus that takes decades after exposure to manifest symptoms, and the baby-boom generation is a silent carrier of it. “We haven’t yet seen the face of it because it takes a long time to become a real disease. The tsunami is about to start. We still have a few years to sort out our business, but it’s beginning to happen. People are starting to show up with failing livers.” Montaner said his experience in treating and containing the HIV/AIDS epidemic can be brought to bear on the new threat. “HIV and AIDS is no longer the big deal that it used to be in this province,” he said, adding that 20 years ago, for example, a 20-year-old woman who came to him with HIV faced severe illness followed by death within 15 years, along with the high risk of passing on the disease to her child if she got pregnant. “It was a disaster,” he said. “Today, I have a 20-year-old woman, just diagnosed (with HIV), and I can say, ‘Don’t worry ... Your longevity will be comparable to your peers. We will expect that if you engage in treatment effectively you’re looking to have 55 years of added survival. You are going to be able to have children, your children are not going to be infected ... and the treatment most of the time is going to be one pill once a day.’” Montaner’s method of dealing with the HIV/AIDS crisis was supported by the development of anti-retroviral drugs, but he also took steps to engage with Vancouver’s at-risk populations — IV drug users and sex-trade workers among them — to encourage testing and treatment. His tactics that have since been endorsed by the UN and adopted around the world. By reaching out to at-risk populations, “we are making a smart, targeted investment on HIV today. Tomorrow, that problem will go away.” The tactic has cut B.C.’s annual rate of new HIV infections from about 850 in the mid-1990s to 238 in 2012. HIV/AIDS deaths have dropped by more than 95 per cent in that time. Earlier this year, St. Paul’s was able to shut down its AIDS ward. But Montaner said that many of the patients now living with HIV are also starting to experience the symptoms of hepatitis C, notably liver failure.

For more information: http://tinyurl.com/owgkl2j

Hep C World News - Week of November 30, 2014

Shorter treatment shows promise with investigative HCV agents
Boston, MA - A new study suggests that some subgroups of patients with hepatitis C virus infection can achieve sustained virologic responses (SVR) in as short as 4 weeks using an aggressive, investigational three-drug regimen, researchers reported here. In the 4-week duration part of a multi-arm clinical trial, Eric Lawitz, MD, vice president of the Texas Liver Institute, San Antonio, reported that all 31 noncirrhotic genotype 1 hepatitis C virus-infected patients achieved undetectable virus at follow-up week two -- but by week eight, 19 of those patients had relapsed, giving an SVR rate of 38.7%. Among the 30 patients treated for 6 weeks, all reached undetectable virus by follow-up week two, but four of those patients later relapsed, giving an 86.7% SVR at week eight, he reported in his poster presentation and at a press briefing at the annual meeting of the American Association for the Study of Liver Diseases. "This is a phase II study. This is a proof of principle that we can accomplish SVR at 8 weeks," Lawitz said. "This was the first time there was a planned 4-week duration trial. Even though there were a number of relapses, it is biologically plausible to cure a very select subset of patients at 4 weeks." The researchers conducting the C-SWIFT trial also looked at 6-week and 8-week courses of treatment for harder-to-cure cirrhotic genotype 1 hepatitis C virus-infected patients. "Cirrhotics had SVR of about 95% at 8 weeks," Lawitz said. He noted that all 102 patients in the study -- cirrhotics and noncirrhotics -- achieved undetectable virus by follow-up week two. Among the cirrhotic patients, four patients out of 20 who were treated for 6 weeks relapsed. There was one relapse among the 21 cirrhotic patients treated for 8 weeks. "There are some valuable lessons learned from this," Lawitz said. "It is encouraging to see a three-drug regimen achieve a 95% SVR at 8 weeks in the setting of cirrhosis. It shows we may be able to get to an 8-week regimen for all patient types. "Our study looks at short duration therapy," Lawitz said. The registration trial for the two investigative agents will show SVR12 results. "In the C-SWIFT trial, which is ongoing, we used a three-drug regimen of grazoprevir and elbasvir -- the investigative drugs -- and sofosbuvir, which is already on the market.” What we saw at the end of 4 weeks was that all but six patients had achieved undetectable virus, but by follow-up week two those six patients went on to be undetectable, so at follow-up week two there was 100% of patients that were undetectable. In the 6-week arm, all but one patient was negative at the end of the treatment and that patient also went on to become negative by follow-up week two. In the cirrhotic arms all patients were undetectable at either 6 or 8 weeks," he said. Lawitz said the three-drug regimen was well-tolerated with few serious adverse events occurring in any treatment regimen, possibly a factor of the short treatment duration.

For more information: http://www.medpagetoday.com/MeetingCoverage/AASLD/48575

HepC World News Week of November 23, 2014

Does Screening Baby Boomers for Hepatitis C Work?
Boston, MA - A study presented at the annual meeting of the American Association for the Study of Liver Diseases reported that the current age-based screening recommendation from the Centers for Disease Control and Prevention (CDC) is five times more effective in identifying people currently or previously infected with hepatitis C virus when compared to the previous screening strategy. The CDC currently recommends a one-time birth cohort or age-based screening for hepatitis C virus (HCV). All baby boomers -- those born between 1945 and 1965 -- should be tested for HCV. Older screening strategies relied on identifying populations at greater risk for having HCV. While the study did not evaluate the uptake of the CDC recommendation, the study authors conclude that the results demonstrate that the implementation of birth cohort testing in the primary care setting is feasible and can be effective.  A vast majority (81 percent) of Americans living with chronic HCV are baby boomers. In that group, 2.6 percent -- or 2.16 million people -- have chronic infection yet many don’t know they have it and cannot benefit from life-saving care and treatment. Researchers conducted birth cohort testing trials for 14 months (December 2012-February 2014) at three large primary care healthcare centers. Baby boomer patients were randomly assigned to a group and automatically tested based on the birth cohort screening recommendation or to a control group based on the previous screening strategies. Almost 33,000 patients were screened using the birth cohort recommendation or control group. While this is the first clinical study that provides real-world evidence that the baby boomer recommendations can be implemented in practice and will result in a significant increase in new HCV diagnoses, monitoring of the recommendations will continue to be important. The title of the abstract is: Effectiveness of hepatitis C virus (HCV) testing for persons born during 1945-1965 -- Summary results from three randomized controlled trials. AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. This year's Liver Meeting®, was held in Boston, November 7-11.  It brought together more than 9,000 researchers from 55 countries.

For more information: http://www.aasld.org/livermeeting/press/Pages/yartel.aspx

HepC World News Week of November 16, 2014

HCV Not Main Attraction Anymore
Boston - As the therapeutic picture for hepatitis C begins to settle down, the volume of abstracts on the topic is plateauing at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). That's not to say that new HCV therapies won't get a lot of play, according to Gary Davis, MD, president of MedLogician Consulting of Ponte Vedra Beach, Fla., and secretary of the liver association. But, he said "there's a big shift toward fatty liver disease ... that reflects what people are seeing in the clinics." Over the past several years, direct-acting HCV medications have stolen the show, with a host of new drugs and drug combinations working through the clinical trials process. Now, with many of those drugs approved and others in the home stretch, meeting participants will be getting mature data, he said. For instance, the meeting will get an update on the research that underpinned the recent approval of Gilead's ledipasvir/sofosbuvir combination, trade-named Harvoni. And, Davis said, they can look forward to seeing the data that AbbVie is using to support its multidrug combination -- dubbed 3D -- which is now under review at the FDA. "It's going to be pretty exciting to see where that's at," he said. Gilead famously unleashed a firestorm of debate when it priced sofosbuvir (Sovaldi) at $1 a pill and Davis said participants might take all the drug-makers to task over pricing of HCV drugs. "I'm anxious to hear the audience questions on this, what with the whole controversy over pricing," he said. The picture in fatty liver disease is less clear than in HCV, but the condition is increasingly prevalent and researchers are now turning their attention to it, looking at the basic mechanisms as well as drug therapy. It's a "hot area," he said. Davis also said that there is increased interest in possible curative options for hepatitis B, an area of research that has been "stuck in the mud for years." HBV is tricky to cure, because the virus integrates itself into host cells and -- rather like HIV -- therapy has aimed at suppressing the virus rather than getting rid of it. But several new compounds in the early stages of investigation aim to change that and the "HBV people are quite excited about it," Davis said. As well, he said, participants will get results from a major trial of terlipressin, a drug for hepatorenal syndrome that is approved in several countries but not the U.S. An initial report from the so-called REVERSE study -- of terlipressin plus albumin versus albumin alone -- will attract considerable interest, Davis said, since improvement in renal function in patients with the syndrome is correlated with improved survival.

For more information: http://www.medpagetoday.com/MeetingCoverage/AASLD/48434

BostonWorld News Week of November 9, 2014

Harvoni & Chronic HepC Patients with Advanced Liver Disease
Boston - Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from several Phase 2 and Phase 3 studies evaluating investigational uses of Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic hepatitis C virus (HCV) infection in patients with limited or no treatment options, including patients with decompensated cirrhosis, patients with HCV recurrence following a liver transplant and patients who failed previous treatment with other direct acting antivirals. These data will be presented this week at the 65th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2014) in Boston. “Chronic hepatitis C patients with advanced liver disease are among the most difficult to cure and traditionally have had limited or no treatment options,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer, Gilead Sciences. “The data presented this week demonstrate that Harvoni provides high cure rates for patients with advanced liver disease, as well as for those who failed prior treatment with other antivirals, including sofosbuvir-based regimens.” Harvoni was approved by the U.S. Food and Drug Administration and Health Canada in October 2014 and is the first once-daily single tablet regimen for the treatment of chronic HCV genotype 1 infection in adults. Applications are pending in the European Union, Japan and New Zealand.

For more information: http://tinyurl.com/qeq4gzz

Vaccine for Hepatitis C Inches Closer to Reality
Oxford, UK - An initial study suggests that a potential vaccine against hepatitis C, a liver disease that affects at least 130 million people worldwide, is safe in people. The newly released findings are good news, said study co-author Dr. Ellie Barnes, a professor of hepatology and experimental medicine at the University of Oxford in England. The results indicate the vaccine can safely boost the immune system in a way that "targets multiple parts of the hepatitis C virus," she said. "We hope it will have the capacity to prevent people from being infected, and that's something we really need." An estimated 1 percent of U.S. residents have chronic hepatitis C, which is usually transmitted through infected blood. In many people, the disease leads to scarring of the liver -- cirrhosis -- or liver cancer. A powerful new drug called Sovaldi is expected to improve treatment of hepatitis C, but it costs $1,000 per day, or $84,000 for the typical 12-week course. Also, drugs like Sovaldi are least effective in patients with advanced liver disease and don't prevent reinfection, the study authors said. Vaccines exist for two other types of hepatitis: A and B. But it's been difficult to create a vaccine to fight hepatitis C because the germs are sly when it comes to the immune system soldiers known as antibodies, Barnes said. "They can put on a disguise and prevent antibodies from seeing them. What we're trying to do is develop a T-cell vaccine, which works by inducing T cells, a totally different part of the immune system," she explained. Part of the vaccine works by sneaking into the body through a chimpanzee cold germ that human immune systems won't know to kill, Barnes said. In the new study, a so-called phase I trial, researchers tested parts of the vaccine in 15 people. The researchers reported that the participants tolerated the vaccine well overall, with some mild or moderate side effects that largely resolved within 48 hours. The study findings also suggest that the vaccine is achieving its goals on the immune system front. But two more stages of research, each in larger groups of people, are needed before the vaccine can be approved for use in the United States. The second stage of research is already in progress, Barnes said, and results are expected in 2016. She declined to speculate how long it will take for the vaccine to become available if it works.  The vaccine will be targeted at people at high-risk for hepatitis C, not the population at large in Western countries where infection isn't widespread, Barnes said. High-risk groups include users of illegal injection drugs. Countries such as Egypt, where 20 percent of the population is thought to be infected, will need different strategies, Barnes said. It's not clear how much the vaccine might cost, but Naglaa Shoukry, a hepatitis researcher and associate professor at the University of Montreal, said it shouldn't be "outrageously expensive." Shoukry, who praised the new study, said drug companies don't make money off vaccines. "That's why they are usually hesitant to develop them," she said.

For more information: http://www.nlm.nih.gov/medlineplus/news/fullstory_149295.html

HepC World News Week of November 2, 2014
 

Bristol-Myers' 91-country hep C access plan still draws fire                                  

New York, NY - Bristol-Myers Squibb is taking Gilead's lead when it comes to developing-world access for its hepatitis C drug, offering up a tiered pricing strategy and licensing agreements with generics makers. But according to some critics, that's not enough. The company has kicked off discussions with government health authorities in several countries to facilitate access to Daklinza (daclatasvir), taking into consideration factors like their economic development, burden of disease, and government commitment to hep C treatment and care when ironing out costs through its tiered pricing model, it said. It also plans to work with generics manufacturers to supply licensed copies to 90 countries around the world, including India, Cuba, South Africa and Vietnam. "We are eager to leverage our considerable experience in developing world access to our HIV medicines in order to bring daclatasvir to the developing world as soon as possible," Bristol-Myers said on its website. The move follows a similar strategy announced by Gilead--whose pricey Sovaldi, at $84,000 per 12-week treatment course, has drawn ire since its approval late last year--in September. The California biotech has joined up with generics pros like Mylan and Ranbaxy to bring cheap versions to 91 developing countries. But according to outspoken access advocate Médecins Sans Frontières, BMS' plan won't get the job done. Rohit Malpani, the director of policy and analysis for the group's access campaign, didn't hold back, accusing the pharma giant of "intentionally" blocking affordable access to Daklinza from most middle-income countries, "with BMS keen to extract as much profit as it possibly can." "Once again, people in middle-income countries--where nearly three-quarters of the world's poor, and over 70 percent of people with hepatitis C, live--are the ones left empty-handed," he said in a statement. Pricing for the new crop of hep C drugs has come under fire at home, too. Payers have had to get creative to contain soaring costs, with Express Scripts going as far as beginning to assemble a coalition to exclude Sovaldi from formularies until lower-priced rivals hit the market and force prices down. On that front, the PBM's CMO, Steve Miller, last week told Reuters Express Scripts was ready to favor a competitor from AbbVie once it won FDA approval and hit the market, assuming it was clinically equivalent--and, of course, less expensive.
 

For more information: http://tinyurl.com/oo2bnbr
 

Quebec drug formulary expands coverage of Sofosbuvir and ribavirin

Quebec City, PQ - Sofosbuvir (Sovaldi) and ribavirin have been added to the Quebec formulary for people with genotype 2 or 3 hepatitis C virus who do not have HIV and who meet the following criteria: have never been treated for Hep C before (treatment naïve), o rhave been treated before with peg-interferon and ribavirin but were not cured, or have a contraindication or serious intolerance to peg-interferon. Twelve (12) weeks of treatment is approved for people with genotype 2 hepatitis C virus. A maximum treatment of twenty-four (24) weeks is approved for people with genotype 3 hepatitis C virus. The combination of sofosbuvir, peg-interferon and ribavirin was added to the Quebec drug formulary for people with genotypes 1 and 4 hepatitis C virus earlier this year.

For more information: www.inesss.qc.ca
 

HepC World News Week of October 26, 2014

SOVRIAD (simeprevir sodium) suspected in 3 Hepatitis C deaths
Tokyo, Japan - The health ministry said Friday three people have died after taking the hepatitis C drug Sovriad, and it has ordered the distributor to revise the drug packaging to say usage should stop when indicated by a patient blood test. The ministry also ordered the maker and distributor, Janssen Pharmaceutical K.K., to notify doctors and hospitals in writing of the change. The package insert already warns of possible deterioration of liver function from use of the drug, known generically as Simeprevir Sodium. The ministry directed the packaging also say usage should be discontinued if a blood test indicates certain abnormalities. According to the Ministry of Health, Labor and Welfare, taking the drug will increase "bilirubin" by decomposing hemoglobin in the blood and may aggravate dysfunction of the liver and kidney. Three patients in their 40s to 60s who were taking the drug died in connection with such symptoms, it said. Since the drug was put on sale last December, about 19,000 people in Japan have used it by the end of September.

For more information: http://tinyurl.com/k2e5oeb

HepC World News Week of October 19, 2014

Health Canada Issues NOC for Gilead’s Harvoni
Foster City, CA - Gilead Sciences, Inc. announced that Health Canada has issued a Notice of Compliance for Harvoni™ (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single table regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, granted marketing authorization under the trade name Sovaldi® in December 2013. The efficacy of Harvoni has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL. “With Harvoni, the majority of genotype 1 patients can be cured with a once-daily pill in as little as eight or 12 weeks without the need for interferon injections or ribavirin tablets, which are associated with significant side effects.” “Chronic hepatitis C can lead to cirrhosis, liver cancer and liver transplantation and is a major cause of liver-related morbidity and mortality in Canada,” said Dr. Robert Myers, Associate Professor and Director of the University of Calgary Viral Hepatitis Clinic. “With Harvoni, the majority of genotype 1 patients can be cured with a once-daily pill in as little as eight or 12 weeks without the need for interferon injections or ribavirin tablets, which are associated with significant side effects.” Gilead filed a New Drug Submission for Harvoni in Canada on March 19, 2014 and was granted Priority Review by Health Canada. Gilead has filed private and public payer reimbursement submissions for Harvoni and was granted a Priority Review under the Common Drug Review process on October 6, 2014. Harvoni was approved in the United States on October 10, 2014 and granted a positive opinion by the Committee for Medicinal Products for Human Use in the European Union on September 25, 2014. Applications are pending in Australia and New Zealand. The marketing authorization for Harvoni is supported by data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. These studies included non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response rates. Trial participants in the ribavirin-free arms (n=863) achieved SVR12 rates of 94 to 99 percent. For full study details, see the Clinical Studies section of the Product Monograph. Harvoni was well tolerated in the ION studies. Zero percent, less than 1 percent and 1 percent of patients treated for eight, 12 and 24 weeks, respectively, discontinued treatment due to adverse events, and fewer adverse events were observed in the ribavirin-free arms compared to the ribavirin-containing arms in all ION studies. The most common adverse reactions among patients treated with Harvoni (≥ 5 percent) were fatigue, headache, nausea, diarrhea and insomnia. See below for Important Safety Information regarding warnings and precautions, adverse reactions and drug interactions. To assist eligible hepatitis C patients in Canada with access to Harvoni, Gilead Sciences Canada, Inc. has added the medicine to the Gilead Momentum Support Program™, which provides an integrated offering of support services for patients and healthcare providers. The program provides access to dedicated case managers to help patients and their providers with insurance-related needs, including identifying their coverage options through either private insurance or publicly funded programs. In addition, the program provides financial assistance for eligible patients who need help paying for out-of-pocket medication costs.

For more information: http://tinyurl.com/n72h6bo

HepC World News Week of October 12, 2014

Unique 'pay if you clear' deal for new hepatitis drug
Glasgow, Scotland - The NHS in Scotland is to be reimbursed for the cost of a new hepatitis drug if sufferers fail to clear the virus. The novel approach was revealed after the drug Olysio was cleared for use by the Scottish Medicines Consortium (SMC). The drug's manufacturer claims the move will help cut prescribing costs. It is estimated Scotland wastes up to £44m each year on medicines for all conditions that are unused, ineffective or are taken incorrectly. The 'Pay If You Clear' scheme will come into effect if patients treated with the drug do not become free of the hepatitis C virus (HCV) after 12 weeks. SMC has approved the drug, whose generic name is simeprevir, for use within NHS Scotland. Appropriate treatment It will treat patients with chronic HCV infection, including those for whom treatment has previously failed. The manufacturer, Janssen, will pay for pre-treatment blood tests for patients to predict whether the drug is likely to be effective before treatment is initiated. “We must not forget the importance of prevention, earlier diagnosis and better testing strategies” said Charles Gore, chief executive of The Hepatitis C Trust. Any patient who does not respond to treatment within four weeks will be offered alternative therapies. Dr John Dillon, consultant hepatologist and gastroenterologist at Ninewells Hospital in Dundee, welcomed the decision by SMC. "This decision provides us with another treatment option which is convenient for patients and more affordable to NHS Scotland than some other treatments," he said. "To be able to predict a person's response to treatment, prior to them embarking on the medicine, is a particularly useful factor in managing hepatitis C care. "It means we can select the most appropriate treatment option in a cost-efficient manner." Said Charles Gore. "Decisions such as this from the SMC provide us with a key milestone for our campaign to eliminate hepatitis C. "However, we must not forget the importance of prevention, earlier diagnosis and better testing strategies." Charities claim there are more than 37,000 Scots with chronic HCV, only 55% of whom have been diagnosed, because often it has no symptoms. Of those who develop hepatitis C an estimated 30% will develop cirrhosis of the liver or cancer. Hepatitis C is the most common reason for liver transplants in Europe.

For more information: http://www.bbc.com/news/uk-scotland-29569242

HepC World News Week of October 5, 2014

Quebec expands coverage for Sovaldi
Quebec City, PQ - Great news for HepC patients in Quebec who may benefit from Gilead's HepC medication, Sovaldi. Details from the government's web site indicate the following conditions and duration of treatment.

SOFOSBUVIR: in association with ribavirin and pegylated interferon alfa, for treatment of persons suffering from chronic hepatitis C genotype 1 or 4, who are not HIV-1 infected and who have never received an anti-HCV treatment; Authorization is granted for a maximum period of 12 weeks.

SOFOSBUVIR: in association with ribavirin, for treatment of persons suffering from chronic hepatitis C genotype 2 who are not HIV-1 infected and:
• who have never received an anti-HCV treatment; or
• who have a contraindication or a serious intolerance to pegylated interferon alfa; or
• who have already experienced a therapeutic failure with a combination of ribavirin / pegylated interferon alfa; Authorization is granted for a maximum period of 12 weeks

SOFOSBUVIR: in association with ribavirin, for treatment of persons suffering from chronic hepatitis C genotype 3 who are not HIV-1 infected and:
• who have a contraindication or a serious intolerance to pegylated interferon alfa; or
• who have already experienced a therapeutic failure with a combination of ribavirin / pegylated interferon alfa; Authorization is granted for a maximum period of 24 weeks.

For more information: http://tinyurl.com/mp4haxc
 
France has a new tax for costly hep C meds
Paris, France - European countries are known for wresting price cuts from drug makers. Usually, it's a straightforward cost-effectiveness argument. But France has come up with a new strategy: Arm-twisting taxes. As Reuters reports, the French government says it will tax drug makers whose pricey hepatitis C treatments pose an undue burden on its healthcare system. The idea--which it calls a "progressive contribution scheme"--would help make sure that patients get access to the latest hep C treatments, officials say. So here's how it would work: If government spending on hep C drugs tops €450 million ($567 million) this year, France will levy a tax on sales above that cap. Next year, the cap would be €700 million, or about $883 million. Like many payers, France isn't just worried about the high prices of cutting-edge hep C treatments. It's the overall burden of treating hundreds of thousands of patients. The French price tag on Gilead's Sovaldi--€56,000, or about $70,000--and the expense of its companion meds threatens to cost the healthcare system as much as €1 billion this year by some estimates, Reuters notes. The new tax will go before French lawmakers this month, with a budget vote due by year-end.
Whether the tax would be calculated company-by-company, or apply to all hep C drug makers across the board, isn't clear. If it's more individualized, companies producing the next round of new treatments, including Bristol-Myers Squibb and AbbVie, might have more incentive to compete on price in France. U.S. payers, meanwhile, are hoping that the additional competition from rival meds, with some due for FDA approval later this year, will help push prices down. Apart from that, private insurers and pharmacy benefits managers have been using a variety of tactics to limit spending on the drug, including focusing treatment on the sickest patients

For more information: http://tinyurl.com/mydvkt6

HepC World News Week of September 28, 2014

Real-world hep C patients drop off pricey Sovaldi
Woonsocket, Rhode Island - CVS Health has some hard data on Sovaldi's excursion from the Gilead Sciences clinic and into the world. It's not encouraging: More than four times as many real-world patients are dropping off the pricey hepatitis C treatment than in clinical trials. The stats add weight to concerns about the price of Sovaldi treatment: If patients start using the $1,000-per-pill therapy only to stop taking it, that's a lot of money down the drain. Or as the pharmacy company's white paper puts it, "a substantial cost to the healthcare system without the corresponding clinical benefit and value." The stats also give payers more back-up for restricting Sovaldi treatment to specific groups of patients. In the CVS study, patients who'd been treated before--and failed--were more likely to stick to their Sovaldi-based regimens. Only 5.3% of patients with previous treatment dropped off, compared with 8.7% among the treatment-naive. According to the pharmacy company's white paper, the dropout rate was highest--10.2%--with patients on a triple-drug cocktail of Sovaldi, interferon and ribavirin. That's not surprising; interferon treatment can be ugly, and that's why these new, all-oral regimens have been developed in the first place. Meanwhile, of those on a two-drug cocktail of Sovaldi plus ribavirin, 9% didn't stick to their treatment. The lowest dropout rate was seen in patients using two brand-new drugs, Sovaldi plus Johnson & Johnson's Olysio, even those who hadn't been previously treated. Only 2.6% of experienced patients on that combo discontinued treatment, and 4.6% of the never-before-treated. "These findings underscore the well-recognized fact that real world adherence to medication is often poorer than that observed in clinical trials," the CVS white paper states. It's possible that this adherence surprise is circumstantial: The Sovaldi cocktails with the most unpleasant side effects are the ones patients are abandoning. Patients who hadn't been treated before--a group less likely to be seriously ill than those who failed on prior treatment--may have slogged off the cocktails because they know more treatment options are coming. AbbVie's hep C regimen is expected to win approval later this year, and Gilead's Sovaldi combo pill could be coming even sooner. Bristol-Myers Squibb has its own combinations on their way, too. There's another set of conclusions that could give Gilead and its coming rivals a clue about justifying their pricing to payers. CVS found that patients using its pharmacies--compared with those outside its own chain--were more likely to stick to their meds. The company offers counseling and various support services designed to boost adherence.

For more information: http://tinyurl.com/oqc6fjk

HepC World News Week of September 21, 2014

New law allows nurses to test for Hepatitis C
Albany, NY - Nurses across New York will soon be able to test for hepatitis C under a bill signed by Gov. Andrew Cuomo this week. The new law will allow doctors and nurse practitioners to authorize registered nurses to administer the test. Previously, nurses could only screen for hepatitis C if a physician gave them written permission for a specific patient. "It may seem like not a big hurdle in a small, family practitioner office," said Assemblyman Ken Zebrowski, D-New City, Rockland County, who sponsored the bill. "But in large health care settings, in hospitals and things like that, there seemed to be a barrier. There was a delay." For Zebrowski, the issue is a personal one. His father, a former assembly man also named Ken, passed away in 2007 from liver complications associated with Hepatitis C. There are an estimated 200,000 people in New York living with the Hepatitis C virus, according to the state Department of Health. Nationwide, there are an estimated 2.7 million to 3.9 million cases, with as many as 75 percent unaware of their condition. The state took action last year to expand access to Hepatitis C screenings, based on a recommendation from the U.S. Centers for Disease Control. As of Jan. 1, health care providers were required to offer a one-time Hepatitis C test to any patients born between 1945 and 1965. Baby boomers are particularly susceptible to the disease, though the reason why isn't clear, according to the CDC. More than three-quarters of adults with Hepatitis C were born during the Baby Boom. The new law, which will take effect in mid-December, adds to the list of diseases nurses can test for without a patient-specific order from a doctor. State law already allows for nurses to screen for HIV, tuberculosis and certain immunizations. Cuomo signed the bill on Tuesday. It was sponsored in the Senate by Sen. Kemp Hannon, a Nassau County Republican who chairs the chamber's health committee. "This new law knocks down unnecessary barriers that reduced opportunities for testing and for people to get the help they need," Cuomo said in a statement.

For more information: http://tinyurl.com/psdelf6

HepC World News Week of September 14, 2014

NICE recommends Olysio for Hepatitis C
London, UK - In draft guidance published today healthcare guidance body NICE has recommended simeprevir (Olysio, Janssen) as a treatment option for some people with chronic hepatitis C. The draft guidance recommends simeprevir, in combination with peginterferon alfa and ribavirin as an option for treating genotype 1 chronic hepatitis C in adults. Hepatitis C is a virus that infects the liver. It is spread by contact with infected blood, for instance by using contaminated needles for injecting drugs or sharing razors or toothbrushes. The virus can cause inflammation of, and damage to the liver, preventing it from working properly. Figures from 2012 suggest that around 160,000 people are chronically infected with the hepatitis C virus in England. More than half of people with chronic hepatitis C do not know they are infected because they only have mild symptoms or no symptoms at all for a long period of time. About 1 in 3 people infected with the hepatitis C virus will eventually develop liver cirrhosis, where normal liver tissue is replaced by scar tissue. A small percentage of people with chronic hepatitis C and cirrhosis also develop liver cancer. The aims of treatment are to clear the virus from the blood to prevent progression of liver disease, and to prevent the transmission of the hepatitis C virus. Simeprevir has a marketing authorization for treating two forms of hepatitis C, genotype 1 and genotype 4. Genotype 1 hepatitis C is the most common type of chronic hepatitis C in England, accounting for around 46% of cases. Genotype 4 hepatitis C accounts for around 4% of cases. Simeprevir is administered orally and works by inhibiting the replication of the hepatitis C virus. Commenting on the draft guidance Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “Chronic hepatitis C can have a significant impact on a person’s quality of life, particularly if it progresses to the cirrhosis stages. One of the main challenges in treating hepatitis C is ensuring that people take the drugs they are prescribed. However, current treatment regimens, particularly interferon-based therapy, often have to be given over a long period of time and are associated with significant side effects that increase the likelihood that people may discontinue treatment, or not seek it in the first place." “Simeprevir, like sofosbuvir which NICE provisionally recommended last month as an option for some patients, offers the possibility of a shortened course of interferon-based therapy. This could make it more likely that people will seek treatment for their condition. In turn this could have important benefits, not just for people with chronic hepatitis, but also in reducing transmission of the virus to people without the infection.” The independent Appraisal Committee was minded not to recommend the use of simeprevir for treating genotype 4 chronic hepatitis C and has asked the company for more information on its use for this group of patients. Because there was not enough robust evidence, the Committee did not recommend simeprevir in combination with sofosbuvir (with or without ribavirin), for treating genotype 1 or 4 chronic hepatitis C in adults. Stakeholders are now able to comment on the draft recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee at the next meeting, and following this meeting the next draft guidance will be issued. The closing date for comments on the draft guidance is 9 October 2014. This is draft guidance; NICE has not yet issued final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.

For more information: http://www.firstwordpharma.com/node/1235733#axzz3DfpkQEH3

HepC World News Week of September 7, 2014

Inks Used in Certain Tattoo Kits Cause Infections
Washington, DC - Tempted to get a tattoo? Today, people from all walks of life have tattoos, which might lead you to believe that tattoos are completely safe. But beware—there may be associated health risks. Recently, the Food and Drug Administration (FDA) became aware of a problem after testing inks in home use tattoo kits marketed by White and Blue Lion, Inc. FDA has confirmed bacterial contamination in unopened bottles of the company’s inks. According to Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors, using these inks for tattoos could cause infection. “FDA has confirmed one case of skin infection involving a consumer that used this company’s tattoo products,” Katz says, “and we are aware of other reports linked to tattoo products with similar packaging.” According to Katz, “Tattooing poses a risk of infection to anyone, but the risk is particularly high for those with pre-existing heart or circulatory disease, diabetes or compromised immune systems.” She notes that injecting contaminated ink into the skin or using contaminated needles may result in infections at the site of the tattoo. Signs of localized infection include redness, swelling, weeping wounds, blemishes, or excessive pain at the site. If you experience any of these signs, seek medical care right away. Even after a localized infection has healed, the area may be permanently scarred. Further, an infection that is left untreated or inadequately treated could spread through the bloodstream (a process known as sepsis). These infections may be associated with fever, shaking chills (rigors) and sweats. If these symptoms arise, treatment with antibiotics, hospitalization and/or surgery may be required. White and Blue Lion, Inc. recalled contaminated products on July 11, 2014, but FDA is still concerned that consumers and professional tattoo artists may be purchasing or using contaminated home tattoo kits and inks from other distributors. Specifically, how can you identify kits and inks that you should not use because they may be contaminated? FDA advises you to watch out for inks intended for permanent makeup or traditional body tattoos that have no brand name, carry a dragon logo, and/or are missing the name and place of business of the manufacturer or distributor, are sold singly and in kits containing anywhere from five to 54, or perhaps more, bottles of inks of various colors, and are marked with “Lotch” [sic] and Batch numbers, and “Date produced” and “Best if used by” dates. “If you’re buying tattoo inks or getting a tattoo from a professional tattoo artist, you should first examine the products to determine whether the inks or kits meet the above descriptions,” cautions Katz. FDA’s goal is to encourage consumers and tattoo and permanent make-up artists to take certain precautions and to urge potentially infected clients to seek medical care. “Reporting an infection to FDA and the artist is important in order for FDA to investigate, and to enable the artist to take steps to prevent others from becoming infected,” says epidemiologist Katherine Hollinger, D.V.M., M.P.H., from the Office of Cosmetics and Colors.

For more information: http://tinyurl.com/oywuy4u

HepC World News Week of August 31, 2014

Bristol-Myers Squibb's hep C therapy Daklinza gains EU approval
Brussels, Belgium - Bristol-Myers Squibb said Wednesday that the European Commission approved Daklinza (daclatasvir) for use in combination with other drugs across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. The company noted that the oral medicine is the first NS5A complex inhibitor approved in Europe and will be available for use in combination with other therapies, providing treatment durations of 12 weeks or 24 weeks, versus 48 weeks for interferon- and ribavirin-based regimens. The decision, which follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in June, was supported by data from a number of studies, including a trial investigating Daklinza with Gilead Sciences' Sovaldi (sofosbuvir) in genotypes 1, 2, and 3. Bristol-Myers Squibb noted that results showed that the combination of Daklinza and Sovaldi achieved sustained virologic response 12 weeks after the end of treatment in 99 percent of treatment-naïve patients with HCV genotype 1, 100 percent of patients with genotype 1 who had failed treatment with either Vertex Pharmaceuticals' Incivek (telaprevir) or Merck & Co.'s Victrelis (boceprevir), 96 percent of those with genotype 2 and 89 percent of those with genotype 3. Emmanuel Blin, head of worldwide commercialisation at Bristol-Myers Squibb, remarked "we look forward to our continued work with EU health authorities to ensure Daklinza-based regimens are available to patients as quickly as possible." Daklinza was approved in Japan In July in combination with the NS3/4A protease inhibitor Sunvepra (asunaprevir) as the country's first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis. In February, the FDA granted breakthrough therapy status for Bristol-Myers Squibb's combination of Daklinza and asunaprevir, with a regulatory filing made in April assigned a target review date of November 30.

For more information: http://www.firstwordpharma.com/node/1231982#axzz3DaMXHEq3
 
HepC World News Week of August 24, 2014

Pricey hep C drugs create difficulties for reimbursement                                            

New York, NY - We've heard plenty from payers looking to limit access to Gilead Sciences' pricey new hepatitis C treatment Sovaldi. What's the downstream version of that story? Doctors frustrated by reimbursement rejections and patients denied access to a potential cure. As Bloomberg reports, patients who were quick on the draw when Sovaldi was first approved in December tended to get approval from their insurance companies. But by March or April, doctors were seeing no after no. "[I]t had dawned on people how expensive these regimens were going to be and the doors closed," Oregon Clinic liver specialist Ken Flora told the news service. Now, some payers are refusing to cover Sovaldi--and a companion med from Johnson & Johnson’s Olysio altogether. Texas, for instance, won't pay for either drug for its Medicaid patients, because it hasn't yet decided on criteria to determine which patients can qualify. One Texas doctor says 40 of his Medicaid patients can't get coverage--including a woman in the early stages of liver failure. That's the sort of costly hep C complication that Sovaldi, Olysio, and prospective new treatments are designed to forestall. Gilead has defended the $84,000 price for a 12-week course of Sovaldi treatment, by comparing that figure to the cost of dealing with liver failure, liver cancer, liver transplants and other expensive consequences of hep C infection. "It's not 12 weeks of benefit," EVP Gregg Alton tells Bloomberg. "It's a lifetime of benefit. That needs to be taken into account." And some experts say that Gilead--and its fellow hep C drug makers -- are entitled to the billions in sales. Their success rewards innovation, and could inspire others to greater R&D spending, they say. If so, then Gilead's results should be extremely inspiring: The company is expected to post $3 billion in Sovaldi sales for the second quarter. And that's on top of $2.3 billion in Q1, its first quarter on the market. But the sheer up-front cost of treating hep C with these expensive drugs is massive. By some estimates, that cost could be $400 billion, more than the cost of all other drug treatments in the U.S. combined. Footing the bill now to save money later isn't something that U.S. investors--accustomed to short-term, quarter-by-quarter thinking--are likely to get behind. Much less government programs like Medicaid, which are already underfunded in many states. Which takes us back to the payers' lament. For-profit insurers would see their margins slashed--if not obliterated--by across-the-board treatment with full-price hep C meds. Cue their stocks' downward spiral. And according to a new commentary in JAMA, the insurers' solution could be raising premiums across the board--by up to $200 to $300 per insured American. A broader solution to this rock-and-a-hard-place mess isn't clear. Earlier this week, CVS Caremark executives said as much in their JAMA commentary. The authors suggested insurers need to come up with new ways to limit spending on pricey specialty meds, including hep C treatments. Others point out that Sovaldi is priced much lower in markets where government gatekeepers can negotiate. It looks as if compromise--among everyone involved--is in order, but whether all might be willing to consider that sort of give-and-take remains to be seen.

For more information: http://tinyurl.com/p4spptz

HepC World News Week of August 17, 2014

Emerging Epidemic of Hep C Infections Among Young Non-Urban Persons                                  

Atlanta, GA - Reports of acute hepatitis C in young persons in the United States have increased. Researchers examined data from national surveillance and supplemental case follow-up at selected jurisdictions to describe the U.S. epidemiology of hepatitis C virus (HCV) infection among young persons (aged ≤30 years). They examined trends in incidence of acute hepatitis C among young persons reported to CDC during 2006–2012 by state, county, and urbanicity. Socio-demographic and behavioral characteristics of HCV-infected young persons newly reported from 2011–2012 were analyzed from case interviews and provider follow-up at six jurisdictions. They found that from 2006-2012, reported incidence of acute hepatitis C increased significantly in young persons—13% annually in non-urban counties versus 5% annually in urban counties. Thirty (88%) of 34 reporting states observed higher incidence in 2012 than 2006, most noticeably in non-urban counties east of the Mississippi River. Of 1,202 newly reported HCV-infected young persons, 52% were female and 85% were white. In 635 interviews, 75% of respondents reported injection drug use. Of respondents reporting drug use, 75% had abused prescription opioids, with first use on average 2.0 years before heroin. The researchers concluded that the data indicate an emerging U.S. epidemic of HCV infection among young non-urban persons of predominantly white race. Reported incidence was higher in 2012 than 2006 in at least 30 states, with largest increases in non-urban counties east of the Mississippi River. Prescription opioid abuse at an early age was commonly reported and should be a focus for medical and public health intervention.

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

HepC World News Week of August 10, 2014

Sovaldi's Cost Could Be Unacceptable In India                                             

Kolkata, India - The price of Gilead’s new hepatitis C drug, Sovaldi, has been the topic of much debate. Although Sovaldi cures hepatitis C in more than 90% of those who for whom it has been prescribed, the 12 week course of treatment in the U.S. is $84,000, which comes to $1,000 a pill. While curing hepatitis C saves lives and prevents a lot of downstream healthcare costs for patients who, without this drug, could ultimately develop liver cancer or require a liver transplant, payers and politicians are in an uproar for a variety of reasons, not the least of which is that the drug is priced much higher in the U.S. than in the rest of the world. For example, in Europe, where the government negotiates the price, Sovaldi’s price tag is on the order of $55,000/patient. While Gilead’s pricing strategy in the U.S. can be challenged, it has certainly taken a responsible approach to Sovaldi pricing in poorer countries. In Egypt and most recently in India, the cost of Sovaldi is going to be only $900/patient. Beyond pricing this drug favorably in India, once the clinical trials are concluded in India, Gilead has also agreed to work with Indian generic manufacturers to produce the drug locally and perhaps drive the cost even lower. But that still might not be good enough for the Indian government. Indian officials are quick to point out that 80% of their populace are without insurance and that even at $900, the price of Sovaldi is beyond the reach of many. But this won’t necessarily stop hepatitis C patients in India from getting the drug. It is not uncommon for the Indian government to take actions that impact the ability of a foreign company to sell drugs in India that are deemed too expensive. For example, Novartis was never able to get a patent for its cancer drug, Glivec, in India, thus enabling local manufacturers to make and sell it. Even when patents are granted, the Indian Patents Act allows for compulsory licenses to be issued to local manufacturers for life-saving drugs that are deemed too costly. Even for drugs that have patent coverage and which are allowed on the market, India administers “drug caps” for the prices of hundreds of drugs including those for heart disease and diabetes, despite the fact that the prices for drugs in India are among the lowest in the world. It’s no wonder that Gilead has tried to be very accommodating with Sovaldi in India. The question is whether the actions it is taking will be enough to prevent compulsory licensing of its hepatitis C treatment. India often boasts of its expanding economy and, in fact, has 10% of its population with wealth equivalent to the average American or European as pointed out by Pfizer CEO Ian Read. Yet, despite the fact that Gilead has been very accommodating and has provided a cost structure that will be envied by the rest of the world, I believe that eventually the price of Sovaldi in India will be far lower than $900/patient.

For more information: http://tinyurl.com/ka6xvrc

HepC World News Week of August 3, 2014

Japan Approves New Hep C Treatment                                                    

Hiroshima, Japan - Japanese HCV patients in urgent need of care now have opportunity for cure, including older patients and those with compensated cirrhosis. Bristol-Myers Squibb Company announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza(R) (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra(R) (asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options. The Daklinza+Sunvepra Dual Regimen is Japan's first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis. "Japan has a unique hepatitis C patient population, many of whom are older and have been unable to take, or respond to, traditional therapies, so we have a real sense of urgency to treat these patients now," said a lead study investigator Kazuaki Chayama of Hiroshima University in Japan. "The approval of the Daklinza+Sunvepra Dual Regimen offers for the first time a treatment option that addresses many of the unmet needs for our HCV patients." Of the 1.2 million people living with HCV in Japan, approximately 70% have genotype 1b. Further, a significant number of patients with HCV in Japan are over the age of 65, leading to more disease-related complications and a decreased likelihood of tolerating interferon-based therapies, the historical standard of care for treating HCV. "The approval of Daklinza+Sunvepra in Japan reflects our strategic focus on developing a treatment option that meets the needs of the Japanese HCV patient population," said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. "This milestone underscores the company's commitment to delivering innovative medicines to patients with the highest unmet needs, and we believe Daklinza-based regimens will play a significant role in the evolution of HCV treatment for patients in Japan, and globally." The indications for Daklinza and Sunvepra in Japan are for the improvement of viraemia in either of the following patients with chronic hepatitis C genotype 1, or chronic hepatitis C genotype 1 with compensated cirrhosis: (1) patients who are ineligible or intolerant to interferon-based therapy, and (2) patients who have failed to respond to interferon-based therapy. The approval is supported by results from a Phase III study demonstrating that the 24-week regimen of Daklinza and Sunvepra achieved overall SVR(24) (sustained virologic response 24 weeks after the end of treatment; a functional cure) among 84.7% of Japanese HCV patients with genotype 1b. Among patients 65 years of age or older who were either interferon-ineligible or intolerant, 91.9% achieved SVR(24.) Further, patients with compensated cirrhosis present at baseline had overall SVR(24) rates of 90.9%. The regimen used in the Phase III study resulted in low rates of discontinuation (5%) due to adverse events (AEs). In addition, the rate of serious adverse events (SAEs) was low (5.9%) and few SAEs were experienced by more than one patient. Nasopharyngitis was the most common AE in the study (30.2%). Results from the HALLMARK-Dual study, the Phase III multinational clinical trial investigating the Daklinza+Sunvepra Dual Regimen among genotype 1b HCV patients, demonstrated similar results to the Japan registration study and support filings in countries that have a high prevalence of genotype 1b, such as Korea and Taiwan. Bristol-Myers Squibb's research efforts are focused on advancing late-stage compounds to deliver the most value to patients with hepatitis C. At the core of our pipeline is daclatasvir, a potent pan-genotypic NS5A complex inhibitor (in vitro), which continues to be investigated in multiple treatment regimens and in people with co-morbidities, and is undergoing regulatory review in the U.S. and Europe. Daclatasvir is being studied in combination with sofosbuvir in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing Phase III ALLY Program. In 2014, the U.S. Food and Drug Administration (FDA) granted Bristol-Myers Squibb's investigational Daclatasvir+Asunaprevir Dual Regimen Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV infection. In 2013, Bristol-Myers Squibb's investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation in the U.S., which helped to expedite the start of the ongoing Phase III UNITY Program. Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. The daclatasvir 3DAA regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.

For more information: http://online.wsj.com/article/PR-CO-20140707-903343.html

HepC World News Week of July 27, 2014

Poor treatment for hep C infection in UK                                                          

London, UK - Official figures for England show just 3% of people who develop chronic hepatitis C each year receive treatment to help clear the virus. The report, from Public Health England, says UK deaths from the condition have quadrupled in 16 years to some 400 in 2012. The number of admissions to hospital for serious liver complications has also risen fourfold to 2,400. Charities say the "shockingly low level of treatment" is failing patients. Hepatitis C, a viral infection spread through bodily fluids, currently affects more than 200,000 people in the UK. According to experts intravenous drug use is the most common way of acquiring the disease in the UK. Three-quarters of people with the virus go on to develop chronic disease - which can lead to liver cancer and permanent liver scarring (cirrhosis). But the report shows the majority of people who need antiviral drugs to help clear the virus, do not receive them. Officials say this is in part due to people being unaware they have the condition (it can have no symptoms in early years) and because of a lack of testing and treatment facilities for communities that need it most. They warn that an extra 2,700 people could face hepatitis-C-related liver cancer or cirrhosis in England over the next year if the situation does not improve. Experts predict if everyone had access to newer, more effective medications, some 8,000 people could be prevented from suffering these often fatal complications by 2025. Public Health England says there is an urgent need for better monitoring of patients and wider testing for people at risk. They call for treatment to be expanded to non-traditional settings such as prisons, primary care and drug treatment centres. Charles Gore, chief executive of the Hepatitis C Trust said: "We must accept the rising hospital episodes and deaths, the poor diagnosis rate and the shockingly low level of treatment means we are failing patients. "This report highlights the pressing need for immediate scale-up of the whole response to hepatitis C from prevention, through diagnosis and into treatment. "Deaths from hepatitis C are now eminently preventable. It is up to us to see that we do prevent them." Dr Paul Cosford of Public Health England said: "The landscape of hepatitis C treatment is changing rapidly and an era of vastly improved treatment is potentially on the way. "In the meantime, the disease burden is rising and there is still a pressing need for infected patients to be treated as soon as possible." Before improved blood screening was introduced in 1991, some people acquired the disease through contaminated transfusions. And experts say individuals who have dental or medical treatments in countries with high rates and poor control of hepatitis C may continue to be at risk.

For more information: http://tinyurl.com/p7mvnak

HepC World News Week of July 20, 2014

Hep C drugs could add $300 to every American's insurance premium                 

Chicago, IL - The payer panic over the cost of Gilead Sciences' pricey-and-wildly-successful hepatitis C drug Sovaldi has been well documented. But now, one of the two biggest pharmacy benefits managers in the U.S. says the debate over Sovaldi's $1,000-per-pill price is a symptom of a bigger anxiety. Specialty drugs, in two words. So, not just the new generation of highly effective, highly expensive hep C drugs, but a whole raft of drugs that stand to burden the U.S. healthcare system. And with that in mind, payers are going to have to develop an entire menu of ways to control their spending on pricey meds, CVS Caremark CMO Troyen Brennan and CSO William Shrank say in a JAMA commentary published online. As the two authors point out, it's not just the price of Sovaldi that's the trouble. The drug is highly effective and promises to save money on pricey hep C complications. "[T]he more important issue is the number of people eligible for treatment," the commentary notes. "Sofosbuvir is not really a per-unit cost outlier but is a 'total cost' outlier because of its high cost and very large population eligible for treatment." That's millions of people, and many billions of dollars. "The simple math is that treatment of patients with HCV could add $200 to $300 per year to every insured American's health insurance premium for each of the next 5 years," the authors write. Is it any wonder that insurers are trying all sorts of things to avoid the cost? Barring Sovaldi from formularies in spite of new treatment guidelines. Treating only the sickest patients. Demanding, in the case of Medicaid programs, additional state funding just to cover its cost. With more pricey specialty meds rolling out all the time, payers will be looking these and other strategies to save money. Consider, for instance, the state of Arkansas' choice to bar some cystic fibrosis patients from using Kalydeco, Vertex Pharmaceuticals' $300,000 treatment. "Effective approaches to control costs for high-priced medications need to be developed and evaluated to ensure broad, equitable, and appropriate use of these new interventions in an already stressed healthcare system," the commentary states.

For more information: http://tinyurl.com/mtd9mya

HepC World News Week of July 13, 2014

France health minister says EU will fight price of Gilead's Sovaldi                           

Paris - Resistance to the price that Gilead Sciences has put on Sovaldi, a drug that will cure millions of hepatitis C, is reaching a fever pitch. Now 14 European countries are banding together to press Gilead for deep discounts, saying that without them they will have to ration care. "If we accept such a high price, firstly we won't be able to treat everyone and we will also be creating a risk for our social security system, which means for other patients," News Daily reports French Health Minister Marisol Touraine telling BFMTV. Touraine said she has commitments from 13 other countries to share information on price as they haggle with Gilead. "For the first time, 14 European countries have made a commitment together," she said on TV. "We will therefore negotiate country by country as that's how it's done, but we will exchange information and discuss things between European countries." The U.K. drug price evaluator NICE has already indicated a reluctance to pay the asking price for Sovaldi, even at $57,000 for a 12-week course, compared to $84,000 in the U.S. Germany has resisted the $66,000 price being offered there. U.S. payers are shelling it out, despite some people screaming loudly about the injustice of it. Express Scripts has publicly said it is urging payers to refuse to pay for the drug as soon as another similar drug hits the market. Express Scripts CMO Steven Miller has said at the current price, it would cost the U.S. $300 billion to treat the patients who currently have hepatitis C in the country. But Gilead's first-quarter results indicate pay they are. Sovaldi generated $2.274 billion in revenue in its first full quarter on the market, making it the biggest launch and setting it up to surpass peak sales of Lipitor, the world's best-selling drug, perhaps in its first year on the market. The company has assured payers that the money they will save on liver transplants and other treatments will make the drug a bargain in the long run. Those kinds of assurances are not quelling demands that Gilead cut the price. According to News Daily, Medecins du Monde estimates if France paid for just over half of those with hepatitis C in that country, 230,000 sufferers, the cost would equal the current annual budget of the entire hospital network in Paris. Those kinds of estimates have roused dozens of medical associations to urge a price cut.

For more information: http://tinyurl.com/n9q52bu

HepC World News Week of July 6, 2014

HCV Drug Out of the Running                                                                            

Vienna, AU - The German pharmaceutical giant Boehringer Ingelheim is stopping development of faldaprevir, its hepatitis C virus (HCV) drug. In a statement, the company said HCV treatment has "significantly and rapidly evolved since the submission of the faldaprevir marketing applications to regulatory bodies around the world." As a result, the company said, "there is no longer an unmet medical need" for faldaprevir, an inhibitor of the HCV protease enzyme that was intended to be used with pegylated interferon and ribavirin. The drug yielded good results in clinical trials, and it was a gentler therapy than similar combinations currently on the market. But given the development of all-oral regimens that do not use interferon, faldaprevir was increasingly regarded as a dead end. In 2013, Peter Ferenci, MD, of the Medical University of Vienna, told MedPage Today the drug's development began in a clinical context in which its competitors were two other protease inhibitors -- telaprevir (Incivek) and boceprevir (Victrelis). Both are approved, in combination with interferon and ribavirin, but they have been associated with serious and sometimes dangerous adverse events. Both, for instance, cause significant anemia, and telaprevir has been associated with a life-threatening rash that in at least two cases led to death. Ferenci said the gentler side effect profile of faldaprevir, combined with more convenient dosing, might let the drug find a market while the interferon-free regimens are still being worked out. But other investigators said that, even if it were approved, they would only use it for the most serious cases; patients with less severe disease could wait for an interferon-free treatment regimen.

For more information: http://www.medpagetoday.com/InfectiousDisease/Hepatitis/46414

HepC World News Week of June 29, 2014

U.K. gatekeepers nix Sovaldi till Gilead ponies up more evidence                           

London, UK - Should the British health service pay for the expensive-yet-effective hepatitis C treatment Sovaldi? The U.K.'s cost-effectiveness gatekeepers say they're not convinced. With an $84,000 price tag in the U.S., Sovaldi has touched off a vociferous debate about cost and coverage, with top PBMs and insurers balking at the idea of spending billions on the drug, no matter how effective. Their bottom lines are at stake. But U.S. gatekeepers can't simply bar Sovaldi from their formularies. The National Institute for Health and Care Excellence (NICE) can. And in this early appraisal, NICE said it's "minded not to recommend" the drug for routine use by the National Health Service. The agency took issue with data on patients with particular genotypes of hepatitis C, and picked at the company's cost-effectiveness analysis. "The available evidence shows that sofosbuvir is an effective treatment for chronic hepatitis C in certain patients," Carole Longson, director of NICE's health evaluation center, said in a statement. "However, evidence is lacking for some subgroups of patients with chronic hepatitis C, and there are also substantial uncertainties in the evidence base presented by the manufacturer." It's an early guidance, with final word expected in October. In the realm of NICE's "not minded to" decisions, it's fairly positive. Chances are that Gilead can sway the outcome with additional evidence and number-crunching. But NICE's evaluation could spur price negotiations; often, the agency presses drug-makers for discounts or other cost-cutting schemes, and successfully. Already, Gilead has priced Sovaldi much lower in the U.K. than in the U.S., at about $57,000. Meanwhile, in the U.S., pharmacy benefits managers are casting about for ways to limit Sovaldi use, at least until the FDA approves other drugs in a much-anticipated new generation of hep C treatments. Some payers figure they can pit rival drug-makers against one another to gain price concessions. In the meantime, they're trying to reserve the drug for the sickest patients. Medicaid providers are demanding more state funding to cover the drug. But Sovaldi sales are flooding in, with more than $2 billion in the first quarter, and probably more than that for Q2. Analysts are skeptical that U.S. payers can squeeze big cost concessions out of hep C drug-makers even after competition heats up. But the fact that FDA is on the verge of approving a raft of new drugs is giving some PBMs a bit of a reprieve: As ISI Group analyst Mark Schoenebaum points out in a new note to investors, evidence is mounting that doctors are "warehousing" patients till the newest meds hit the market. Of course that's a temporary respite for payers--but it might give them time to strike deals with AbbVie and Bristol-Myers if not Gilead.

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

HepC World News Week of June 22, 2014

AbbVie readies production in anticipation of hep C treatment approval                        

Chicago, IL - AbbVie is awaiting the decisions of regulators for its closely followed new interferon-free, oral hepatitis C drug that will go head-to-head with Sovaldi. And it has lined up its production horses so that it will be ready to blast out of the gates if approvals are granted in the U.S. and Europe. The North Chicago drug-maker said this week that an €85 million ($115 million) expansion at its active pharmaceutical ingredient plant in Sligo, Ireland is complete. The new lines and 175 new employees are ready for production of APIs for the hep C treatment, as well as a host of other drugs in the AbbVie pipeline. "This expansion builds capacity for existing products and for potential therapies in our pipeline, such as our investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus (HCV) infection," Azita Saleki-Gerhardt, senior VP of operations, said in a statement. AbbVie, which was spun off from Abbott Laboratories at the beginning of last year, reaps more than half of its revenues from rheumatoid arthritis drug Humira, currently the best-selling drug in the world with 2013 sales of $11.2 billion. But in April it submitted its application to the FDA for its highly-anticipated hep C treatment and followed that up with an application in the EU in May. The multi-drug treatment has generated strong clinical data so is expected to be a convincing competitor to Sovaldi, the oral hep C drug that Gilead Sciences released late last year. Sovaldi has been such a big seller, generating $2.27 billion in the first full quarter, that it promises to unseat Humira as the world's best -selling products, and to do so quickly. But payers are looking forward to AbbVie's new hepatitis treatment, hoping they might be able to negotiate a discount to the $84,000 regimen cost of Sovaldi in the U.S., which they say is too high given the extensive hep C problem in the world. If AbbVie tries to grab market share by coming in with a lower price, it could pressure Gilead to drop the cost of Sovaldi. AbbVie has other promising drugs in its pipeline and said it needs the extra capacity at the plant for those, as well as existing products.

For more information: http://tinyurl.com/n6cn6dv

HepC World News Week of June 15, 2014

Medicare gives thumbs up to Sovaldi for most at risk                                                       

Washington, DC - The most effective weapon to date against hepatitis C, Gilead's ($GILD) new drug Sovaldi, has raised the ire of drug-cost watchdogs worldwide with its $84,000 price tag. That's not stopping the largest U.S. government payer from giving the product a major push. The Centers for Medicare & Medicaid Services (CMS) says in a memo that it will start covering hep C screening for adults at high risk for the virus or for any of its beneficiaries who were born between 1945 and 1965. Such testing is expected to boost prescriptions of Sovaldi, which cures most patients with 12 weeks of treatment. Ian Somaiya, an analyst at Nomura Securities International in New York, told Bloomberg he predicts the CMS action to increase the rate of hep C diagnoses. "The net of all this points to higher Sovaldi sales," he said. CMS's decision to cover testing for the virus follows recommendations by the Centers for Disease Control and the U.S. Preventive Services Task Force. The agency's memo notes that baby boomers are most at risk for the virus, and that military veterans account for two-thirds of the patients who suffer from it. The CMS ruling isn't likely to quell the controversy over Sovaldi's price. Last week, the product prompted a group of insurers, unions, and the AARP to demand a national dialogue on drug pricing. Their move came just days after America's Health Insurance Plans blasted Gilead for setting such a high price for the drug. Meanwhile, Merck ($MRK), AbbVie ($ABBV) and Bristol-Myers Squibb ($BMY) are getting ready to launch rival products, prompting some payers to brace themselves for more sky-high prices. Express Scripts CMO Steve Miller--one of the most outspoken critics of Sovaldi's price--said recently that that insurers are already talking with rival drug makers about pricing, even though the products have yet to be approved. The controversy doesn't seem to have slowed down Sovaldi's launch, however. The drug brought in $2.27 billion in sales in the first quarter of this year alone, beating analysts' estimates by $1 billion and making it the fastest drug launch in history.

For more information: http://tinyurl.com/kqf3lvu

HepC World News Week of June 8, 2014

Quebec First  Reimburse Sovaldi for the Treatment of Chronic Hep C                           

Montreal, PQ - Gilead Sciences Canada, Inc. is pleased to announce that the Health and Social Services Ministry has placed Sovaldi (sofosbuvir), the newest treatment for chronic hepatitis C virus (HCV) infection approved for sale in Canada, on the Liste de médicaments (effective June 2, 2014). With this listing, Quebec becomes the first Canadian province to provide access to Sovaldi for treatment-naïve patients with genotypes 1 and 4 HCV infection regardless of liver severity. The listing follows a Priority Review and evaluation by the Institut national d'excellence en santé et en services sociaux (INESSS) that concluded Sovaldi provides therapeutic and clinical value, is cost effective, is well tolerated, and offers important societal benefits for the broader population. INESSS reported several advantages of Sovaldi, including its short treatment duration (12 weeks), positive side effect profile (anemia and rashes), and administration of one pill once a day (with pegylated interferon and ribavirin) without the need for a specific diet. In addition, INESSS stated that Sovaldi fulfills a significant healthcare need in the treatment of genotype 4, as until now, only a combination of pegylated interferon and ribavirin had been used.  A recent analysis, "Health Care Resources Utilization in Hepatitis C Virus Infection and Cost Associated with Adverse Events: An Analysis of the Quebec Provincial Drug Reimbursement Program Database", noted that treatment with previous therapies resulted in lower treatment completion and cure rates than treatment with Sovaldi. In addition, previous therapies resulted in significant anemia management costs per patient. "Treatment with newer therapies at any stage of infection, with fewer side effects, is a goal that is both achievable and cost effective," said Dr. Marc Bilodeau, Associate Professor of Medicine, Université de Montréal, and a co-author of the article. "By intervening early, we can prevent progression to more advanced stages of disease and the associated adverse outcomes." Dr. Bilodeau added, "Quebec has recognized the health-system and societal benefits associated with newer hepatitis C treatment that improves upon the previous standard of care. As the first province to reimburse Sovaldi, Quebec has demonstrated its leadership in addressing this imminent public health issue and providing the opportunity for cure to more patients." In the most recent issue of the Canadian Journal of Gastroenterology and Hepatology, the article, "Burden of disease and cost of chronic hepatitis C virus infection in Canada", reports that Canada will experience a significant increase in cases of advanced HCV-related liver disease over the next 20 years. Estimates include: an 89 per cent increase in cases of compensated cirrhosis (scarring of the liver with no loss of function); an 80 per cent increase in cases of decompensated cirrhosis (severe scarring of the liver with advanced symptoms and loss of function); a 205 per cent increase in cases of liver cancer, and a 160 per cent increase in cases of liver-related deaths. The article also states that associated health care costs will increase dramatically, mainly attributable to cirrhosis and its complications including liver cancer and liver transplantation. Authors estimate a 60 per cent increase in longer-term health care costs associated with HCV until its peak is reached in 2032 (not including antiviral therapy, virology testing and indirect medical costs). "We are pleased that Quebec has recognized the clinical value of Sovaldi as a curative therapy for treatment-naïve patients living with genotype 1 or 4 hepatitis C, regardless of their disease severity," said Edward Gudaitis, General Manager, Gilead Sciences Canada, Inc. "Gilead also welcomes the province's affirmation that Sovaldi is a cost-effective medicine that has the potential to reduce the burden of this disease on the health care system. We look forward to the outcome of additional reviews of Sovaldi that are being conducted by other provinces and territories in Canada."

For more information: http://tinyurl.com/kzs9dce

HepC World News Week of June 1, 2014

For Sovaldi patients, expensive hepatitis C cure is priceless                                             

New York, NY - Despite the expensive price, new hepatitis C drugs such as Gilead Sciences' Sovaldi and Johnson & Johnson's Olysio have been welcomed by patients and physicians alike, CNBC reported Friday. "We're talking about curing people with 98 percent success rate," said remarked New York Queens Hospital hepatologist Ari Bunim, adding "it's a whole new ball game." Sovaldi costs $84 000 for a 12-week course of treatment, and the addition of Olysio can push the price beyond $140 000. However, doctors note that the cost of these therapies is relative, as liver transplantation and lifelong anti-rejection therapy are far more expensive, while interferon-based therapies have a similar cost due to their associated complications as well as a lower cure rate. Sovaldi generated $2 billion in revenue in the first quarter, while analysts expect sales of $5 billion for the current quarter. As many as three new treatments for hepatitis C could be launched by 2016, which could reduce the price of Sovaldi.

For more information: http://www.firstwordpharma.com/node/1212527#axzz32pBdl600

HepC World News Week of May 25, 2014

Why does Gilead's Sovaldi cost $84K in the US and $57K in Britain?                           

Auburndale, MA - The hue and cry over dramatic drug prices keeps getting louder, with trade groups and associations adding their voices. And in a more worrisome development for branded drug makers, insurers are stepping up their arm-twisting campaigns. At the moment, there's not a lot that payers can do in the U.S., without an official cost-effectiveness body to set parameters--and make tough choices. Otherwise, Gilead Sciences ($GILD) wouldn't have collected more than $2 billion from its high-priced poster child Sovaldi during the first quarter. But as Reuters reports, insurers are already pressing companies developing pricey drugs. And in the meantime--till Sovaldi rivals are approved later this year and early next--they're continuing to draw limits on patient eligibility for the expensive drug. Last week, a powerful private insurers' association scolded Gilead for the $84,000 price on the hepatitis C drug. This week, a coalition of other groups--from employers to unions to the powerful lobbying group AARP--is calling for a "national dialogue" on pricing. As AARP's Debra Whitman told Kaiser Health News, "This is an issue other countries have solved." In Germany and the U.K., Sovaldi's price is far less, because regulators actually consider cost as they decide whether to pay for particular treatments. In Germany--which launched a strict pricing program as part of budget cuts--Sovaldi costs $66,000 for a 12-week treatment course, Whitman said. In Britain, where the National Institute for Health and Care Excellence (NICE) measures the cost-effectiveness of new treatments, it's $57,000, she said. In the U.S., drugs are priced by companies, subject to mandatory Medicaid rebates and negotiated discounts with private insurers. But the negotiating power only goes so far; insurers have to cover new treatments if they're significantly better than older ones, so drug makers have the upper hand. In a way, insurers were blindsided by Sovaldi's price and its speedy uptake. Not so with the next round of hep C approvals. Express Scripts CMO Steve Miller tells Reuters that payers are already talking with rival companies about their pricing--months before approval. That's a once-unheard-of step. If those pricing talks don't work--and Merck ($MRK), at least, has said it's not interested in a price war--then insurers' only recourse will be to limit volume, Reimbursement Intelligence's John Whang told the news service. That presumably means strict prior authorization policies to direct expensive hep C drugs only to the sickest patients. In essence, insurers are taking on the task of cost-effectiveness decisions, and trying to negotiate; pharma companies retain their pricing edge. And the U.S. retains its distinction as the market that pays more--and in the process, funds a disproportionate share of R&D. "We are the only country in the world that pays exorbitant prices to provide innovation first here, but that's what we need and that's what the American people have come to expect," Sen. Richard Burr (R-NC) told Reuters. So far, even the groups calling for changes are fine with that--lawmakers "don't need to have a direct role," John Rother, president and CEO of the National Coalition on Health Care told Kaiser Health News. Rother calls the price tag on Sovaldi an "abuse of market power," but hopes companies will play ball. If talks with drugmakers don't work, then lobbyists may turn to lawmakers, he told Kaiser, but that's certainly not the preferred solution. "The hope is we can resolve this quickly and through the private sector."

For more information: http://tinyurl.com/k2omqkw
 

Medicaid Directors Question Need for $1,000 HCV Pill                            
 

Washington, DC - The evidence base for one of the star hepatitis C drugs is poor and the guidelines for its use are flawed, according to a report prepared for the National Association of Medicaid Directors. According to the report, studies of sofosbuvir (Sovaldi) are generally of poor quality, mostly directed by the drug's maker, and don't answer key questions, including whether the drug is better and safer than the current standard of care. The only available guidelines for its use -- guidelines created by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America -- are "methodologically flawed," according to the report, which was prepared by the Center for Evidence-Based Policy at Oregon Health and Science University in Portland. In addition, their authors and sponsors had "multiple and significant conflicts of interest," the report argued. In an emailed response to a MedPage Today request for comment, the manufacturer, Gilead Sciences of Foster City, Calif., said the drug "represents a significant therapeutic advance over existing therapies." It is also safe and well-tolerated, the company said, with most adverse events in clinical trials attributable to other drugs used in conjunction with sofosbuvir. A spokesman for the AASLD said the report’s authors had mistaken the nature of the joint publication with IDSA. In fact, Adrian Di Bisceglie, MD, of the St. Louis University School of Medicine said, "we have been careful to label what we issued as a guidance, not a practice guideline." The two societies, he said, "felt that given the importance of this emerging data on hepatitis C, the fact that these drugs would out there for physicians, some advice, some consolidation of the information, would be very useful to practitioners [and] to insurance companies." But the document was not meant to be a formal set of guidelines, he said. Sofosbuvir is widely regarded as the leading edge of a new wave of hepatitis C virus (HCV) drugs which promise routine cures for what is now a difficult-to-treat and costly illness. But the drug has been controversial because Gilead has set the price high — $1,000 a pill. The drug is taken once daily and a course of treatment can last 12 or 24 weeks — $84,000 or $168,000, respectively. The total cost would be higher, since other drugs must be used and treatment monitored carefully. Also, the CDC estimates that some 3 million Americans have chronic HCV, and might be candidates for treatment. The "unprecedented nexus of cost and widespread demand threaten to disrupt the healthcare landscape in the near term," according to Matt Salo, executive director of NAMD, in Washington. "The potential for eliminating hepatitis C is an exciting one," Salo said in a statement. But the cost and possible demand for sofosbuvir "requires careful consideration of how to responsibly decide how to best use this new treatment option.” Spokesmen for the AASLD and Gilead were not immediately available for comment. The current standard of care for genotype 1 HCV -- the most common variant in the U.S. -- is treatment with pegylated interferon-alfa, ribavirin, and a protease inhibitor, either boceprevir (Victrelis) or telaprevir (Incivek). Treatment of genotypes 2 and 3 involves just peginterferon and ribavirin. The interferon-based regimens have cure rates of 40% to 80%, depending on patient and disease characteristics, but are difficult and dangerous to take owing to a range of adverse effects. mThe so-called direct-acting agents, such as sofosbuvir, offer the promise of interferon-free regimens and improved success rates. The indication for sofosbuvir, through, suggests it be used without interferon only in a limited number of situations; for most patients it should still be used with peginterferon and ribavirin. Even in those cases, the company said, the drug "can reduce the time needed to cure the disease to just 12 weeks for most patients, while reducing the duration of interferon injections.” But the available published research, the report noted, consists of just 10 studies, reported in seven articles, most of which were non-comparative. No studies compared sofosbuvir in HCV genotype 1 patients with another regimen, the report said, and in particular, none compared the drug with the standard of care. The studies "do not provide sufficient evidence for the routine use of sofosbuvir-containing regimens," the report said. It added that response rates appear to be high in the trials -- all but one of which was sponsored by Gilead -- but are likely to be lower in "real world" clinical use. In its approval process, the FDA also looked at data from three unfinished studies, according to the report, but data from those have yet to be published and could not be reviewed. The guidelines, the report said, are "of poor methodologic quality and [do] not adhere to international or U.S. standards for guideline development. In particular, they do not give assessments of the quality of individual studies nor the strength of the evidence for recommendations." The AASLD agrees that those assessments are important, Di Bisceglie said, and form part of the society’s formal practice guidelines. In addition, the authors wrote, there is "substantial risk of conflict of interest" influencing the recommendations. Four of the five guideline panel chairs and 15 of the 21 panel members had financial relationships with Gilead. In its formal practice guidelines, Di Bisceglie said, the society "strives" to keep the proportion of participants with relevant links to industry below 50%. In addition, the authors wrote, there is "substantial risk of conflict of interest" influencing the recommendations. Four of the five guideline panel chairs and 15 of the 21 panel members had financial relationships with Gilead. The report is an important step that will help public and private payers make decisions about sofosbuvir, NAMD's Salo said. "Having the highest-quality evidence is critical to inform these decisions." The Medicaid directors are not the first to flag the cost issue. UnitedHealth Group, the nation's biggest insurer, said last month it spent $100 million on HCV drugs in the first quarter of 2014, contributing to the $2.27 billion the drug earned Gilead worldwide. And this week a spokeswoman for America's Health Insurance Plans said drug makers are pricing new medications -- specifically sofosbuvir -- at "unsustainable levels."

For more information: http://tinyurl.com/of6h2q8
 

HepC World News Week of May 18, 2014

Surgeon General urges Docs to test all Baby Boomers for Hep                          

Washington, DC - Acting Surgeon General Dr. Boris D. Lushniak has released a timely Surgeon General’s Perspective in the May issue of Public Health Reports. In publication since 1878, the peer-reviewed Public Health Reports is the official journal of the U.S. Public Health Service. In his column, Dr. Lushniak discusses the disproportionate prevalence of hepatitis C virus (HCV) infection in the U.S. among individuals born between 1945 and 1965, the silent nature of the disease’s progression, and the consequences of undiagnosed and untreated HCV infection. He also addresses the promising advances in HCV treatment that can now cure up to 90% of those treated and the aligned recommendations of the CDC and the U.S. Preventive Services Task Force that all individuals in that birth cohort – often referred to as “baby boomers” – be tested for HCV infection, regardless of risk history He observes, “As a fellow baby boomer, I am very concerned that one in 40 baby boomers—about 2.1 million people—are infected with HCV.” Dr. Lushniak, a Rear Admiral in the U.S. Public Health Service, urges physicians and other health care providers to test all baby boomers for HCV infection to prevent liver disease and death, declaring that “Now is the time to increase routine HCV testing of baby boomers, to provide prevention counseling to improve liver health, and to link infected people to care and treatment.” His well-timed call to action to healthcare providers about the importance of following the CDC and USPSTF HCV screening recommendations for baby boomers makes an important contribution to efforts detailed in the recently updated Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis to both educate providers to reduce viral hepatitis-related health disparities and improve viral hepatitis testing, care, and treatment across the United States. We are grateful to have the Surgeon General’s voice and his office’s participation in implementing the updated Action Plan, launched just last month and will continue to collaborate with them over the next three years as we pursue the plan’s goals. Please consider sharing the Surgeon General’s column with health care providers as well as the baby boomers in your life this month as we all work to raise awareness of the importance of HCV screening as a strategy to reduce the adverse health consequences of untreated hepatitis C. And if you are a baby boomer yourself and haven’t been tested for hepatitis C, call your provider and make an appointment!

For more information: http://tinyurl.com/q7hoejn

HepC World News Week of May 11, 20ashington, DC - Individual payers aren't alone in balking at the $84,000 price for Gilead Sciences' new hepatitis C treatment Sovaldi. Now, the leading insurance trade group has joined the soloists, backing their complaints with its own. America's Health Insurance Plans (AHIP) targeted Sovaldi in a blog post Tuesday, giving the Gilead ($GILD) drug kudos for effectiveness--and a big slap for cost. "Sovaldi has shown tremendous results, and it's the kind of medical innovation we need to sustain," the AHIP blog post states. "Unfortunately, the drug's maker … has priced it at an astronomical level that is not sustainable for consumers, innovation or society." Gilead has defended its pricing, saying that the drug might be expensive, but it cures patients and prevents costly hepatitis C complications like liver transplants. But the drug brought in more than $2 billion in first-quarter sales--after an approval in December--and could surpass $10 billion this year, some analysts say. That kind of cash flow touched off a new round of criticism. AHIP's comments follow loud protest from some pharmacy benefits managers, which worry that an expensive drug plus millions of hep C patients will equal disaster for their businesses. A California treatment-review panel dismissed Sovaldi as a "low value" treatment, strictly because of its price tag. Some private insurers and Medicaid programs are restricting Sovaldi to the sickest patients, at least for now; they're hoping that new competitors, set for approval later this year, will help spur some price competition. That strategy may work, but then again, other hep C drug developers have suggested that they're not interested in a pricing war. All of them, of course, want to profit off their own R&D efforts. But some payers intend to play hardball. Top PBM Express Scripts has said that it will compare the various drugs in the new crop of hep C treatments--and will exclude products if they're not considered to be worth their prices.

For more information:

http://www.fiercepharma.com/?utm_medium=nl&utm_source=internal
 

HepC World News Week of May 4, 2014

Hep C Cure Costs Pose Challenge for Medicare                                                      

Scottsdale, AZ - Walter Bianco has had hepatitis C for 40 years, and his time is running out. "The liver is at the stage next to becoming cirrhotic," the 65-year-old Arizona contractor says. Cirrhosis is severe scarring, whether from alcoholism or a chronic viral infection. It's a fateful step closer to liver failure or liver cancer. If he develops one of these complications, the only possible solution would be a hard-to-get liver transplant. "The alternative," Bianco says, "is death." Previous drug treatments didn't clear the virus from Bianco's system. But it's almost certain that potent new drugs for hep C could cure him. However, the private insurer that handles his medication coverage for the federal Medicare program has twice refused to pay for the drugs his doctor has prescribed. Doctors are seeing more and more patients approaching the end-stage of hep C infection. "There isn't day that goes by when I don't have a story very similar to Mr. Bianco's," says Dr. Hugo Vargas of Mayo Clinic in Scottsdale, Ariz., his liver specialist. Researchers estimate that 3 to 5 million Americans carry the insidious hep C virus. The biggest concentration is among those born between 1945 and 1965. Many, like Bianco, got hep C from injecting street drugs in their youth. He says he's been drug- and alcohol-free for 32 years, but the infection was permanent. Other baby boomers got the virus from transfusions before 1992, a period when blood wasn't screened. Some got it from sharing razors or toothbrushes, or from contaminated tattoo needles or hospital equipment. For some, transmission was sexual, although fortunately this isn't the highest-risk route. The timing of these infections spells trouble for Medicare, which insures Americans over 65. Hepatitis C is a slow-acting virus. Over a period of 20 to 40 years, it causes liver damage in about 70% of people it infects. A growing number of people who got infected in the 1960s through the 1990s have now "used up" the infection's latency period, notes Dr. Camilla Graham of Beth Israel Deaconess Hospital in Boston, "which is why we're now seeing this dramatic increase in the number of people developing complications and dying of hepatitis. And we expect this to continue to increase for the next 10 years." Another part of Medicare's problem is that new hep C medications are among the priciest of any drugs. One called Sovaldi, federally approved last December, costs $1,000 a pill -- or $84,000 for a typical 12-week treatment course. The other recently approved drug, Olysio, costs around $66,000. Others in the pipeline are expected to be similarly expensive. "People were very shocked about the price because it hit a psychological barrier in terms of 'this is too expensive,'" Graham says. She has a patient like Walter Bianco -- a 65-year-old woman whose severe liver damage puts her on the edge of liver failure. Graham believes her patient's best chance at cure lies in the use of both Sovaldi and Olysio. "We have about 160 people who were studied in a clinical trial called COSMOS that showed a very high cure rate -- 90% to 100% -- for even the most difficult-to-treat patients with this combination," she says. But, as in Bianco's case, the Medicare drug-benefit contractor that covers this patient has refused to approve payment. The apparent reason is that the FDA has not yet approved use of the two drugs in combination. (On May 7, Olysio's maker, Janssen Therapeutics, asked the agency for such approval.) But Graham notes that in the early days of successful antiviral drug treatment for HIV, payers allowed doctors to "mix and match" medications in "off-label" or unapproved combinations as they thought best. "Medicare has been slower to adopt off-label combinations than most of the other insurance plans," Graham says. Medicare officials wouldn't comment on coverage of new hep C drugs. A spokesman wrote in an email that the federal program turns such decisions over to private insurers that administer its drug plan, called Medicare Part D. However, advocates say Medicare officials are well aware of the program's looming exposure to the enormous costs of treating hep C. Some say it could run in the tens or hundreds of billions of dollars, though it's not clear over what period of time. One thing likely to accelerate demand for treatment: Medicare is expected to approve payment for routine blood tests for hep C infection soon. That will reveal many people who don't yet know they're infected -- and spark difficult conversations between patients and doctors on when to use the expensive new medications to clear the virus from their blood.

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