HCV New Drugs

This blog is all about current FDA approved drugs to treat the hepatitis C virus (HCV) with a focus on treating HCV according to genotype, using information extracted from peer-reviewed journals, liver meetings/conferences, and interactive learning activities.

Risk Of Developing Liver Cancer After HCV Treatment

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  • Epclusa® (Sofosbuvir/Velpatasvir)
  • Harvoni® (Ledipasvir/Sofosbuvir)
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  • Cure - Achieving sustained virologic response (SVR) in hepatitis C
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Saturday, April 30, 2011

What can new era of Hepatitis C antivirals offer by Ira Jacobson; HCV Standard of Care Controversy


HCV Standard of Care Controversy: report from FDA Hearing; what can new era of HCV antivirals offer by Ira Jacobson; Key Treatment Outcomes for Boceprevir & Telaprevir, Essentially Doubling SVR Rates

Reported by Jules Levin
A very important discussion occurred at the very end of the FDA meeting yesterday, that is what is the new "standard of care (SOC)" for HCV. Clearly after the 2 new HCV protease inhibitors are approved, probably within a month, boceprevir or telaprevir in combinatin with peginterferon+ribavirin become the new SOC. Does this make peg/rbv no longer the standard of care, FDA officials asked the committee to comment on. I say YES, it now becomes unethical to use Peg/rbv in new studies. Well, this affects the 2 phase 3 studies started recently by Tibotec for their new HCV protease inhibitor TMC435 and for
Boerhinger Ingelheim's new HCV protease inhibitor BI201335, which was announced yesterday that they started enrolling for their phase 3 study. In both studies peg/rbv is the comparator arm treatment. In addition for future planned studies what should the comparator study arm be: peg/ifn or one of the 2 new protease inhibitors plus peg/rbv. I say the latter. In addition this creates a conundrum for HCV/HIV coinfection because we have yet to characterize understand the outcome of treatment for coinfection with the 2 new HCV protease inhibitors in coinfected patients although recently preliminary data in a small group of coinfected patients receiving telaprevir+peg/rbv was presented at a conference yet the boceprevir coinfection study remains ongoing with no data yet reported. The drug-drug interactions between HIV ARTs and the 2 new HCV protease inhibitors are a concern and there are many unanswered questions about these interactions and how to use them together with the 2 new HCV drugs. In the coinfection telaprevir study patients were taking Reyataz/r or efavirenz and in preliminry analysis the early outcomes were pretty similar to that seen in HIV-uninfected but we have yet to see SVR data, the study was small, and there were serious interactions reported with some other key HIV ARTs. The other important issue NOT discussed yesterday is what should be the comparator arm SOC in future studies of new drugs in treatment-experienced patients. So why is this important. If you are for example studying the 2 new Pharmasset nucleotides in treatment-experienced patients, is using one of the new HCV PIs+peg/rbv acceptable considering this may perform less well, patients may not want to enroll in the study since they can get the new drugs through their clinicians and perhaps such a study is now not ethical...Continue reading...


Hepatitis C drug called a ‘miraculous advance’
SILVER SPRING, Md. — A new treatment for hepatitis C could soon be on the market if the Food and Drug Administration takes the advice of an advisory committee.
The committee unanimously approved the first of two new drugs to treat chronic hepatitis C genotype 1 infection. Hepatitis C is a chronic viral disease that causes inflammation and swelling of the liver.The drug, boceprevir, is a new class of protease inhibitor manufactured by pharmaceutical giant Merck & Co., and would be used in combination with ribavirin and peginterferon — the current standard of care. Boceprevir prevents the virus from replicating, and studies show the three-drug cocktail is more effective than the two-drug regimen

A big week for treatment of Hepatitis C Virus: 2 new drugs get FDA panel OK
There is an enormous amount of excitement in the medical community and in patients with Hepatitis C virus infections.  An estimated 170 million people have chronic hepatitis C virus (HCV) infection, and in many of those people liver cirrhosis and eventual liver transplantation is the only option.  Current treatment for patients is injection of interferon alfa and oral ribaviron for up to 12 months, and only 40-50% of treated patients respond positively to the treatment.  In the other 50-60% of patients who do not respond, the only path is retreatment with the same course of drugs, and chance of success the second time around is minimal.  Both Merck and Vertex have been developing oral HCV inhibitors  Both companies have tested these drugs in combination with interferon and ribaviron, and have demonstrated a tremendous increase in treatment success with this triple course of therapy.  Both companies were asked to present their data to a FDA panel of experts this week in preparation for a decision by the FDA for drug approval expected next month

New Drugs For Hepatitis C: Part 1 – Boceprevir And Telaprevir Provide Higher Cure Rates
This article is first in a two-part series that will discuss the benefits and drawbacks of two drugs, boceprevir and telaprevir, which are being developed for hepatitis C. Part 1 discusses the efficacy of the two drugs in clinical trials. Part 2 will discuss the complications and side effects for each drug.
A United States Food and Drug Administration advisory committee unanimously recommended this week that two new hepatitis C drugs, boceprevir and telaprevir, be approved. If the FDA follows the committee’s recommendations, people with hepatitis C – including those who are co-infected with HIV – will have promising new treatment choices. However, these new treatment options also have new side effects and potentially complicated dosing regimens.

From Medscape;
Advisory Panel Unanimously in Favor of Boceprevir for HCV The antivirals advisory panel for the US Food and Drug Administration on April 27 voted 18 to 0 in favor of boceprevir as a treatment for chronic hepatitis C virus infection.


  • Telaprevir for HCV Receives Advisory Panel's Vote of Approval The antivirals advisory panel for the Food and Drug Administration on April 28 voted 18 to 0 in favor of telaprevir as a treatment for chronic hepatitis C virus infection. Medscape Medical News, April 29, 2011


  • /
    Insulin Resistance Cuts HCV Cure Rate: Meta-Analysis
    Insulin resistance substantially decreases the chances of a sustained viral response to standard treatment for chronic hepatitis C virus (HCV) infection, according to meta-analyses by European researchers.

    DOI: 10.1002/hep.24390
    Cover image for Vol. 53 Issue 5Hepatitis C virus infected females have a higher risk of advanced fibrosis and graft loss after liver transplantation than males


  • jennifer C. Lai1,  elizabeth C. Verna2,  Robert S. Brown Jr2,  Jacqueline G. O'Leary3,  James F. Trotter3, Lisa M. Forman4, Jeffrey D. Duman4, Richard G. Foster4, R. Todd Stravitz5, Norah A. Terrault1,*,§, for the ConsoRtiUm to Study Health Outcomes in HCV Liver Transplant Recipients (CRUSH-C)



  • Abstract
    In natural history studies of hepatitis C virus (HCV) infection, women have a lower risk of disease progression to cirrhosis. Whether gender influences outcomes of HCV in the post-transplant setting is unknown. All patients transplanted for HCV-related liver disease from 2002-2007 at 5 U.S. transplant centers were included. The primary outcome was development of advanced disease, defined as biopsy-proven bridging fibrosis or cirrhosis. Secondary outcomes included death, graft loss, and graft loss with advanced recurrent disease. 1,264 patients were followed for a median of 3.0 years (IQR 1.8-4.7) – 304 (24%) were female. The cumulative rate of advanced disease at 3-years was 38% for females and 33% for males (p=0.31) but after adjustment for recipient age, donor age, donor anti-HCV positivity, post-transplant HCV treatment, cytomegalovirus infection and center, female gender was an independent predictor of advanced recurrent disease (HR, 1.31; 95%CI, 1.02-1.70; p=0.04). Among women, older donor age and treated acute rejection were the primary predictors of advanced disease. The unadjusted cumulative 3–year rates of patient and graft survival were numerically lower in females than males, 75% vs. 80% and 74% vs. 78%, and in multivariable analyses, female gender was an independent predictor for death (HR, 1.30; 95%CI, 1.01-1.67; p=0.04) and graft loss (HR, 1.31; 95%CI, 1.02-1.67; p=0.03).
    Conclusion:
    Female gender represents an under-recognized risk factor for advanced recurrent HCV disease and graft loss. Further studies are needed to determine whether modification of donor factors, immunosuppression, and post-transplant therapeutics can equalize HCV-specific outcomes in women and men. (HEPATOLOGY 2011.)

    Chronic Hepatitis C Treatment, Pegasys®, Designated For Priority Reviewby Ministry Of Health, Labour And Welfare For The Indication Of Hepatitis B
    30 April 2011
    Chugai Pharmaceutical Co., Ltd. (hereafter ''Chugai'') [Head Office: Chuo-ku, Tokyo. President: Osamu Nagayama] announced today that on April 11, the Japanese Ministry of Health, Labour and Welfare designated Pegasys®...

    US Appeals Court opens federal funding for stem cell research
    The US Federal Court of Appeals has overturned an August 2010 ban on federal funding of embryonic stem cell research, paving the way for broader exploration of how stem cells function and how they can be harnessed to treat a wide range of currently incurable diseases.
    Posted by HCV New Drugs at Saturday, April 30, 2011 No comments:
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    File Under boceprevir, HCV News, telaprevir

    Friday, April 29, 2011

    Hepatitis C News For Friday April 20th


    Today the drug company Merck announced they're ready to launch Boceprevir in May, depending on FDA approval. Both telaprevir and boceprevir have been recommended by the FDA advisory panel for the treatment of hepatitis C. On the sidebar of this blog you can view the highlights of the meeting. You may be interested in viewing a video by Melissa Palmer, M.D discussing treatment with both protease inhibitors.

    In The News;

    Medpage Today;
    FDA Panel Endorses Another Hep C Drug
    4/28/2011 MedPage Today Gastroenterology
    (MedPage Today) -- SILVER SPRING, Md. -- Hepatitis C patients will likely have two new treatment options after an FDA advisory committee unanimously endorsed a second new HCV drug in as many days.

    FDA Panel Endorses Boceprevir for Hepatitis C
    4/27/2011 MedPage Today Gastroenterology
    (MedPage Today) -- SILVER SPRING, Md. -- An FDA advisory committee has voted unanimously to recommend approval of the investigational drug boceprevir (Victrelis), in combination with peginterferon and ribavirin, to treat hepatitis C genotype 1.

    From HIV and Hepatitis
    .BI 201335 for Hepatitis C Moves into Phase 3 Trials
    .
    Vitamin D deficiency is associated with hepatitis C and poor response to interferon-alfa based therapy
    4/29/2011 GastroHep.com News
    Genetic polymorphisms within the vitamin D receptor and vitamin D deficiency are associated with chronic hepatitis C and poor response to interferon-alfa based therapy, finds the latest issue of the Journal of Hepatology.

    UK acute upper GI bleed rates declining
    4/29/2011 MedWire News - Gastroenterology
    Findings from a 2007 UK audit show that rates of acute upper gastrointestinal bleeding have fallen by 4% since 1993.

    Low-volume hospitals with certain systems seem to achieve better esophagectomy outcomes
    4/29/2011 GastroHep.com News
    A study in May's issue of the Annals of Surgery investigates the association between systems characteristics and mortality of esophagectomy at low-volume hospitals.

    HBV Rebound Common for Some Patients (CME/CE)
    4/28/2011 MedPage Today Gastroenterology
    (MedPage Today) -- In clinical practice, the hepatitis B virus often rebounds in patients taking nucleoside or nucleotide analogues, researchers reported.

    JAMA study reports on fatty liver disease in children and teens
    The largest study of its type has found that neither vitamin E, which is an antioxidant, nor the diabetes drug metformin, successfully reduced liver enzymes in nonalcoholic fatty liver disease in children or teens. The study also found that in patients with a severe type of fatty liver disease, a biopsy of the liver showed improvement in the injury pattern with vitamin E therapy.
    Contact: Cindy Fox Aisen

    Severity Of Hepatitis C And HIV Co-Infection In Mothers Contribute To HCV Transmission To Child
    New research shows that high maternal viral load and co-infection with human immunodeficiency virus (HIV) are the only risk factors associated with vertical transmission of the hepatitis C virus (HCV-VT). A variation in the infant's IL28B gene (CC) is associated independently with the spontaneous clearance of HCV genotype-1 among infected children. The status of IL28B in the mother or children did not increase risk of HCV-VT in this study. Findings are published in the May issue of Hepatology, a peer-reviewed journal of the American Association for the Study of Liver Diseases.

    Seven Tips to Boost HCV Therapy Adherence
    A successful Hepatitis C treatment outcome hinges on medication adherence. Review these seven tips for improving treatment adherence to maximize your chance of beating this virus.

    Related; Treating Hepatitis C; Improving Your Shot At A Cure

    'Urgent Need' for Research on Cancer Among Minorities: U.S. Report
    By Madonna Behen
    HealthDay Reporter by Madonna Behen
    healthday Reporter
    –
    THURSDAY, April 28 (HealthDay News) -- The United States urgently needs to expand research and improve understanding of cancer among minority populations, according to a special report issued Thursday by the President's Cancer Panel.

    While minorities currently account for roughly one-third of the U.S. population, they are expected to become the collective majority by the year 2050, according to the report.
    The panel noted that "minority and other underserved populations are disproportionately affected by certain cancers, are often diagnosed at later stages of disease, and frequently have lower rates of survival."
    What's more, the incidence of cancer among minority populations is projected to nearly double over the next 20 years.

    "Most of what we know about cancer is based on studies of non-Hispanic white people, but by the middle of the century that group will be only 38 percent of the population," said panel member Margaret L. Kripke, a professor emerita of immunology at the University of Texas M.D. Anderson Cancer Center in Houston. "We need more data on cancer among minority populations so that we can begin to implement specific preventive measures."

    The report recommends more research into sociological factors that may explain disparities in cancer mortality among minorities.
    "There have been a lot of studies in recent years trying to understand genetic differences associated with cancer susceptibility, but there are also cultural factors that can affect cancer mortality," said Kripke. "In some cultures, people are so afraid of a cancer diagnosis that they don't seek treatment until it's very late."
    Current cancer screening guidelines should be evaluated, the panel noted, "to determine their accuracy in assessing disease burden in diverse populations."

    "One-size-fits-all screening guidelines don't work," Kripke said. "For example, the breast cancer screening guidelines have been loosened up so that women can start having mammograms later and may be screened less often, but we know that there is an early age of onset of breast cancer among Latino populations, and so if you change the guidelines based on the majority of people, these women will be left out."
    Another recommendation is that "cultural competency" become an integral part of medical school as well as continuing education for all health-care providers and administrative staff.
    Dr. Otis W. Brawley, chief medical officer of the American Cancer Society, praised the report, and said it "hit all the right points."

    "The biggest thing we need to do is to get people access to care, the next thing is to make sure they get good quality care, and then we need to make sure that the care is delivered in a friendly environment where the patient feels welcome," said Brawley.

    "The first two are actually much easier to do than the third," he noted. "A lot of poor people, but especially poor blacks and poor Hispanics, are suspicious of the medical system, and think the hospital doesn't really want to care for them -- [that] they just want to bill them and utilize them to teach their medical students."
    Kripke acknowledged that many of the recommendations involve spending more money at a time when the health-care system is already financially strained.

    "For instance, we know that the best way to deliver cancer information to a patient whose primary language is not English is through a medical translator, but how many hospitals can afford to do that?" she said.
    The panel concluded that disparities in cancer care and research will ultimately be eliminated only by addressing the social factors involved in poor health outcomes, such as poverty, substandard housing, lower educational status and inadequate access to quality health care.

    More information
    You can access the full report here.

    Blacks with liver cancer get fewer transplants
    Reuters – 15 mins ago  
    NEW YORK (Reuters Health) - African Americans with liver cancer are less likely than whites to get a transplant for the disease, according to U.S. researchers. Full Story »

    Other Interesting News

    Probable Zoonotic Leprosy in the Southern U.S.
    April 28, 2011 | R.W. Truman
    and Others
    Mycobacterium leprae strains from armadillos and from U.S. patients with no foreign exposure were found to be highly similar genetically and different from strains found elsewhere in the world. These data suggest that the armadillo may be a source of leprosy in the United States.

    Armadillos Can Transmit Leprosy to Humans, Federal Researchers Confirm
    By GARDINER HARRIS
    About a third of leprosy cases each year in the United States are a result of contact with infected armadillos.
    .
    How do white blood cells detect invaders to destroy?
    Cedars-Sinai research offers model
    LOS ANGELES (April 28, 2011) – Scientists at Cedars-Sinai Medical Center have discovered how a molecular receptor on the surface of white blood cells identifies when invading fungi have established direct contact with the cell surface and pose an infectious threat.
    The receptor called Dectin-1, studied in the laboratory of David Underhill, PhD, an associate professor in Cedars-Sinai's Inflammatory Bowel and Immunobiology Research Institute, detects fungi and instructs white blood cells whether to expend the energy needed to devour the invading pathogens. The findings are featured as the cover story in the April 28 edition of Nature.
    Although scientists long have theorized how immune cells recognize microbial debris sloughed from invading organisms at some distance from themselves, this study establishes a model to explain how immune cells determine when pathogens are directly in contact with their surface and thus pose a significantly greater risk, demanding rapid destruction.

    The study is important because it moves scientists one step closer to understanding the mysteries of how our bodies mount an immune response to fight disease.
    In early stages of infection, white blood cells patrol the body looking for invading pathogens. Dectin-1, a receptor on the surface of white blood cells, recognizes specific components of fungal cell walls, and alerts or "switches on" the immune cells to prepare to fight the infection.

    "Our lab has been studying Dectin-1, which directs white blood cells to eat and kill the fungi that they encounter directly, but to ignore soluble material sloughed off of the fungal surface which does not pose an immediate threat," said Helen Goodridge, PhD, first author on the study and a researcher in the laboratory headed by Underhill. "This is important because phagocytosis and anti-microbial defense responses are energy-intensive and destructive, and should only be used when absolutely necessary."
    During phagocytosis, a white blood cell encounters a microbe, engulfs it, and eats it. Once inside the cell, the microbe can be killed using a combination of degradative enzymes, highly reactive chemicals, and an acidic environment.

    A molecular structure that the Underhill lab calls a "phagocytic synapse" forms at the surface of the white blood cell when Dectin-1 detects fungi. As a phagocytic synapse forms, two inhibitory proteins that block transmission of signals inside the white blood cell are pushed aside. This allows Dectin-1 to instruct the cell to respond. The phagocytic synapse does not form when Dectin-1 encounters soluble fungal debris, so the white blood cell does not respond.

    "The phagocytic synapse resembles another molecular structure, the 'immunological synapse.' It is critical at later stages of an immune response," said Underhill. "It appears that the phagocytic synapse may be an evolutionary precursor of the immunological synapse."

    ###
    The study was funded by the National Institutes of Health, the American Heart Association, and the Crohn's and Colitis Foundation of America. Underhill, who also directs the PhD Program in Biomedical Sciences and Translational Medicine at Cedars-Sinai, is the Medical Center's Janis and William Wetsman Family Chair in Inflammatory Bowel Disease Research.
    Nationally known for its high quality patient care, the Cedars-Sinai Health System includes a major research enterprise and ranks among the top 10 independent medical centers in terms of NIH research funding. With more than 850 research projects under way, Cedars-Sinai focuses on translational studies that move advances directly from the laboratory to the bedside.
    .
    Botox Side Effects; Allergan Must Pay $212 million
    Allergan was ordered by a federal court jury in Virginia to pay $212 million to a 67-year-old man who claimed he developed permanent brain damage after being injected with Botox to treat cramps and tremors in his hand in 2007. Douglas Ray was awarded $12 million in compensatory damages and $200 million in punitive damages, after convincing the jury Allergan failed to warn that injections could trigger an autoimmune reaction leading to brain damage.
    Posted by HCV New Drugs at Friday, April 29, 2011 No comments:
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    Merck Executive Sees FDA OK, Launch Of Boceprevir Hepatitis C Drug In May


    By Peter Loftus
    Of DOW JONES NEWSWIRES
    Merck & Co. (MRK) expects to launch a new hepatitis C drug in May, pending U.S. regulatory approval, an executive said Friday. 
    "We are ready to launch," Adam Schechter, president of Merck;s global human health unit, told analysts on a conference call. "We believe we have completed the studies required for approval, and we anticipate to launch in May."
    On Wednesday, a Food and Drug Administration advisory panel unanimously recommended the agency approve Merck's drug, boceprevir, which Merck proposes to sell under the brand Victrelis. An FDA decision is expected by mid-May.
    An FDA committee also recommended approval of a competing hepatitis C drug, telaprevir, from Vertex Pharmaceuticals Inc. (VRTX) and Johnson & Johnson (JNJ).
    Analysts see a multi-billion-dollar market for this new crop of hepatitis C drugs, with the Vertex/J&J drug having a competitive edge due to superior clinical-trial data.
    -Peter Loftus, Dow Jones Newswires; +1-215-982-5581; peter.loftus@dowjones.com 
    (END) Dow Jones Newswires
    April 29, 2011 09:18 ET (13:18 GMT)
    Copyright (c) 2011 Dow Jones & Company, Inc.
    Posted by HCV New Drugs at Friday, April 29, 2011 No comments:
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    File Under boceprevir

    Thursday, April 28, 2011

    New Video 2011/Hepatitis C Treatment W-Telaprevir Or Boceprevir for Hepatitis C

    Related Just In ; Video Part Two/Boceprevir/Telaprevir

    Part One...



    Melissa Palmer, M.D. on Telaprevir (Vertex Pharmaceuticals) & Boceprevir (Merck), the new protease inhibitor treatments for hepatitis C (HCV).
    Dr. Palmer is the author of the best-selling book "Dr. Melissa Palmer's Guide to Hepatitis & Liver Disease." Her website is http://www.liverdisease.com/
    Posted by HCV New Drugs at Thursday, April 28, 2011 No comments:
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    File Under boceprevir, telaprevir, video

    FDA Panel Backs Approval Of Telaprevir For Hepatitis C

    By Jennifer Corbett Dooren, Of DOW JONES NEWSWIRES
    WASHINGTON -(Dow Jones)-

    A Food and Drug Administration panel unanimously backed the approval of Vertex Pharmaceuticals Inc.'s (VRTX) proposed hepatitis C-drug telaprevir, saying it showed strong effectiveness, a day after also endorsing a similar product from Merck & Co. (MRK).

    The panel of non-FDA medical experts voted 18-to-0 on a question that asked whether the available data support approval of the telaprevir in combination with other hepatitis C drugs, pegylated interferon and ribavirin. The vote amounts to a recommendation that the agency approve telaprevir. The FDA usually follows the advice of its advisory panels but isn't required to.

    Wall Street analysts widely expect FDA to approve telaprevir and Merck's boceprevir as both have demonstrated significant effectiveness in improving the cure rates in patients who use standard therapy for hepatitis C. One panel member called telaprevir "stunning advance" in the treatment of hepatitis C.
    Both drugs are known as protease inhibitors and are designed to block an enzyme that helps the hepatitis C virus replicate. Vertex owns the North American rights to the telaprevir and would get a royalty on overseas sales from partner Johnson & Johnson (JNJ).

    The approval of the drugs, which could come in May, would pit Cambridge, Mass., Vertex against Merck, one of the world's biggest drugmakers, in a market that could triple to $12 billion after the introduction of the latest batch of drugs, according to Goldman Sachs.

    The two main studies Vertex submitted to the FDA in support of telaprevir showed more patients responded to treatment by achieving a so-called sustained virologic response -- essentially a cure -- and in a shorter period of time than current hepatitis-C therapy. A third study looked at extending treatment with a telaprevir-based regimen.

    One study that involved previously untreated patients showed 79% of patients receiving telaprevir in addition to current standard treatments of pegylated interferon and ribavirin had a sustained virologic response compared to 46% of patients not receiving telaprevir as part of their treatment regimens. In some cases, patients were successfully treated in a total of 24 weeks rather than the current 48 weeks of hepatitis C therapy.

    The agency said the risks of telaprevir were associated with skin reactions, such as rash, and anemia. The agency said such side effects were "common, sometimes severe, and in some cases treatment limiting." Anemia is a decrease in the number of red-blood cells.
    Vertex said rashes was managed in most patients with antihistamines and topical corticosteriods. The company said the significantly higher effectiveness of telaprevir. "In all subject categories has the potential to offer many more patients the benefits of eradicating [hepatitis C] and achieving a viral cure," the company said.

    Hepatitis C is a liver disease caused by infection with the hepatitis C virus, which is transmitted through contaminated blood. The infection can cause liver failure, liver cancer and is the leading cause of liver transplants, FDA said. About 3.2 million Americans are infected with hepatitis C.
    --By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com
    (END) Dow Jones Newswires
    Source
    04-28-111545ET Copyright (c) 2011 Dow Jones & Company, Inc.


    FDA panel endorses Vertex hepatitis C drug

    MATTHEW PERRONE, AP Health Writer

    Updated 04:20 p.m., Thursday, April 28, 2011

    WASHINGTON (AP) — Federal health experts say an experimental hepatitis C drug from Vertex Pharmaceuticals Inc. is a significant step forward in treating the virus, despite a high rate of rashes among patients taking the tablet.

    The Food and Drug Administration's panel of experts voted unanimously, 18-0, that telaprevir is a safe and effective treatment for hepatitis C. The agency generally follows the recommendations of its panels. A final decision is expected by May 23.

    Panelists commended the Massachusetts-based drugmaker for developing a drug that appears to raise the cure rate for hepatitis C from roughly 40 percent with current therapies to nearly 80 percent.
    The most significant side effect with the tablet-based drug was a rash, which affected more than half of all patients. Panelists said the issue could be addressed by educating patients and doctors through materials and a toll-free hotline.

    The FDA convened its two-day meeting to review two new drugs that block the enzyme which allows the hepatitis virus to reproduce. On Wednesday the same panel unanimously recommended approval for Merck's drug boceprevir. Both Merck and Vertex have spent more than 15 years developing more effective therapies for the virus that infects about 3.2 million people in the U.S., or about 1.5 percent of the population.

    Like HIV drugs, the new drugs from Merck and Vertex will be prescribed as part of a cocktail with two older drugs to help lower viral levels.

    Thursday's panel discussion highlighted several advantages of Vertex's drugs over its Merck counterpart. The cure rate for new patients taking telaprevir ranged between 75 and 79 percent, compared with 60 and 65 percent for boceprevir. Additionally, most panelists said that patients who had previously failed treatment for the virus could likely achieve a cure within six months — half the time needed with older drugs — when taking telaprevir. When reviewing Merck's drug Wednesday, the panel said those patients would likely need a full year's worth of treatment with the entire drug cocktail.
    Elsewhere in Thursday's discussion, Vertex executives said they were exploring a twice-daily regimen of telaprevir. The drugs presented this week by both Vertex and Merck require patients to take three tablets a day.

    Vertex Pharmaceuticals' telaprevir is expected to garner sales of up to $3 billion annually. That's more than the $700 to $800 million expected for Merck's boceprevir, based on analyst estimates.
    Vertex Pharmaceuticals is based in Cambridge, Mass., and was founded in 1989 by a former Merck & Co. scientist. If approved, telaprevir would be the company's first commercialized product in the U.S.
    Vertex holds marketing rights for North America, while Johnson & Johnson will market the drug in other parts of the world. Eli Lilly and Co. will receive an undisclosed percent of royalties because of its collaborative work on the drug between 1997 and 2002.


    Read more: http://www.timesunion.com/news/article/FDA-panel-endorses-Vertex-hepatitis-C-drug-1356927.php#ixzz1KqrfVSET
    Posted by HCV New Drugs at Thursday, April 28, 2011 No comments:
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    File Under HCV News, telaprevir

    FDA May See Advantages for Telaprevir Over Boceprevir

    Related; FDA advisory panel recommends approval of boceprevir

    The FDA advisory panel unanimously backed the approval of Vertex Pharmaceuticals proposed hepatitis C-drug telaprevir.

    Hepatitis C News; European Gastroenterologists Will Prescribe Telaprevir and Boceprevir to Nonresponder and Treatment-Naive Patients Following Launch

    FDA May See Advantages for Telaprevir Over Boceprevir

    By: JOSEPH HAAS, The Pink Sheet
    04/27/11

    For hepatitis C treatment, telaprevir may be suited for response-guided therapy in a larger population than boceprevir and may show greater efficacy in null responders, according to briefing materials for a Food and Drug Administration advisory committee.

    Telaprevir goes before the Antiviral Products Advisory Committee on April 28; boceprevir is to be reviewed April 27.

    Both of the protease inhibitors look to be headed for fairly easy reviews, with little concern raised in the FDA’s briefing documents on the efficacy.

    Telaprevir and boceprevir are intended to improve therapy for chronic hepatitis C virus (HCV), adding a direct-acting antiviral to the current standard of care, a weekly injection of pegylated interferon and ribavirin, a daily tablet.

    The course of therapy currently takes 48 weeks and is efficacious in fewer than half of all patients. With significant side effect profiles, including flulike symptoms and anemia, many patients discontinue therapy before completion. Both Vertex Pharmaceuticals (telaprevir) and Merck (boceprevir) hope to position their oral protease inhibitors as increasing the rate of sustained virologic response (viral cure) and reducing the duration of treatment for many patients.

    Like Merck, Vertex is seeking a label that would authorize response-guided therapy (RGT) for patients who demonstrate initial improvement after receiving its drug. Vertex proposes RGT for patients who achieve extended virologic response, defined as undetectable levels of HCV RNA at weeks 4 and 12 of treatment. For telaprevir, RGT would consist of 12 weeks of combination treatment with standard of care followed by another 12 weeks on just peginterferon and ribavirin.

    Vertex is asking the FDA to approve RGT in the treatment-naive population and in prior relapsers – patients who achieved cure previously on standard of care but then relapsed following treatment.
    The briefing documents indicate support for Vertex’s position, which Robert W. Baird & Co. analyst Thomas Russo said would be "a clinically important, and unexpected, win at this stage," in an April 26 note.

    Extended Virologic Response Seen as Good Predictor for RGT
    Vertex backs its rationale for using RGT in prior relapsers who achieve extended virologic response with a retrospective viral dynamic simulation of prior relapsers using results from a pair of phase II studies included in the New Drug Application. The company found a sustained virologic response (SVR) rate greater than 90% in prior relapse patients who achieved extended virologic response after treatment with telaprevir.
    "[Vertex] hypothesized that these interferon-sensitive subjects could be re-treated with a shorter course of therapy," the FDA briefing documents stated. "Because there are not adequate randomized, controlled trial data, we will ask the advisory committee to consider the evidence supporting effectiveness in this subgroup."
    The FDA is asking the panelists to discuss the evidence supporting RGT at each of the drug reviews.
    Telaprevir could also gain an advantage over boceprevir in the scope of the patient population, based on its effects in nonresponders. The agency questioned boceprevir’s potential efficacy in null responders in its briefing documents for that drug’s review.

    The telaprevir briefing material, on the other hand, indicated that telaprevir might be significantly more effective than the current standard of care in curing this population. Vertex’s phase III REALIZE trial – which tested telaprevir in null responders, partial responders, and prior relapsers – produced a 31% SVR rate for null responders, compared with 3% for controls.

    Another sign of confidence in the efficacy profile comes from an FDA reanalysis of the efficacy data from Vertex’s three phase III trials. In the treatment-naive population, the FDA determined that telaprevir produced an SVR rate of 79%, greater than the 75% reported by Vertex, in the phase III ADVANCE study. The SVR rate for the control group in that trial was unchanged, at 46%.

    Signs of Concern About Safety, Specific Populations
    In terms of the safety profile, the FDA is seeking the panel’s input on the significance of the rash that was commonly associated with telaprevir use, sometimes to a severe and treatment-limiting degree, as well as anemia, which occurred more frequently and sometimes more severely in patients receiving telaprevir than patients on standard of care. Anemia is also a concern with boceprevir, but not rash.
    The FDA noted that rash was reported in 56% of patients receiving telaprevir, compared with 32% of patients receiving standard care. In most cases, the rash was mild to moderate, but it was severe in 1% of cases and resulted in treatment discontinuation in 6% of cases.

    While anemia is a known toxicity related to treatment with ribavirin, the FDA noted that telaprevir (and boceprevir) exacerbates the potential for the disorder. Subjects treated with telaprevir had a higher frequency of anemia (36% vs. 15% of control group patients). Telaprevir-related anemia often was more severe than that occurring in patients not receiving telaprevir. Anemia-related serious adverse events were reported in 2.5% of patients receiving telaprevir but in less than 1% of control patients.
    The FDA also asked the panel to comment on whether there are sufficient data to recommend that telaprevir be used in specific populations, including African Americans and patients with cirrhosis. Phase III data for telaprevir and boceprevir have suggested that the Vertex drug may be more efficacious in African American HCV patients, who historically have lower SVR rates than other patients on standard of care.
    Elsevier Global Medical News and "The Pink Sheet" are published by Elsevier.

    Vertex offers a blockbuster case for telaprevir
    April 28, 2011 — 10:08am ET | By John Carroll

    Vertex execs spent a good deal of this morning's FDA panel review on the hepatitis C drug telaprevir addressing one of the key safety concerns that regulators have with the drug. Tackling the rash triggered in some patients head on, the developer emphasized that only a relative handful of cases were discovered during the trial process and the patients could be quickly switched to the standard of care.
    Telaprevir "produces substantial clinical benefit compared to the current treatment," Vertex Chief Medical Officer Robert Kauffman told the panel, according to a report from Reuters. There's not likely to be much argument on that point, however, and barring a nasty surprise even the safety issues aren't likely to derail telaprevir at this point.

    "Rash rates (were) higher in Phase III program but discontinuation due to rash was low," messaged TheStreet's Adam Feuerstein this morning as he live-blogged the Vertex defense. And most of the cases of rash were mild to moderate, he added. Feuerstein as well as Reuters highlighted Vertex's remark that it is already gathering data on a twice-daily dosage of telaprevir, which could improve compliance compared to the thrice-daily program that the Boston biotech wants to win an endorsement on today.
    There's intense interest in today's vote, which follows a unanimous recommendation for Merck's competing hepatitis C drug boceprevir. FDA regulators indicated in their staff review that telaprevir's cure rate in one trial hit 79 percent, even higher than Vertex investigators had reported. And while they appeared concerned about the rash and anemia triggered in some patients, regulators have also expressed a keen interest in seeing a new standard of care introduced for hepatitis C patients, who frequently can't continue on the current standard of care that is available.
    - here's a link to Feuerstein's live blog
    - here's the report from Reuters

    Vertex offers a blockbuster case for telaprevir - FierceBiotech http://www.fiercebiotech.com/story/vertex-offers-blockbuster-case-telaprevir/2011-04-28#ixzz1KqHwnM3A
    Posted by HCV New Drugs at Thursday, April 28, 2011 No comments:
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    File Under boceprevir, telaprevir

    Hepatitis C Therapy; Adherence to Treatment and Quality of Life

    From Liver International

    Adherence to Treatment and Quality of Life during Hepatitis C Therapy

    A Prospective, Real-life, Observational Study
    Patrick Marcellin; Michel Chousterman; Thierry Fontanges; Denis Ouzan; Michel Rotily; Marina Varastet; Jean-Philippe Lang; Pascal Melin; Patrice Cacoub

    Abstract and Introduction

    Abstract
    Background: Adherence is important for therapy of chronic diseases, but has still not been well studied in real life in chronic hepatitis C.

    Aims: To assess adherence to hepatitis C combination therapy in routine clinical practice and to identify factors associated with imperfect adherence.

    Methods: This cohort study included unselected chronic hepatitis C patients initiating peginterferon α-2b plus ribavirin. 100% adherence was defined by taking all the prescribed doses of both drugs for the full initially intended duration, as declared by the patient or believed by the physician. Quality of life was assessed using the short-form health survey (SF-36) questionnaire.
    Results: 1860 patients were analysed, including 72% treatment-naive, 36% genotype 2/3, 23% psychiatric, 44% drug addicts and 3% human immunodeficiency virus (HIV)-positive patients. Early treatment discontinuation occurred in 30% of patients. Overall, 38% of patients reported 100% adherence. Patient- and physician-reported adherences were discordant, with a 20–30% overestimation by physicians. HIV co-infection [odds ratio (OR) 2.52, 95% confidence interval (CI) 1.36–4.67], no drug use during follow-up (2.37, 1.30–4.31), genotype 3 (1.55, 1.20–2.00) and treatment-naive (1.32, 1.03–1.69) were associated with 100% adherence. Quality of life worsened during treatment but returned to baseline after the end of treatment.
    Conclusions: Imperfect adherence to combination therapy is common in routine patients. Adherence is markedly overestimated by physicians and is associated with some patient's baseline characteristics. Knowledge of these factors might help identify patients who are most in need of intervention and plan more frequent and accurate follow-up.

    Introduction
    The current standard of care for chronic hepatitis C is the antiviral combination therapy with peginterferon α and ribavirin.[1,2] Peginterferon is administered subcutaneously once a week and ribavirin orally twice daily. Successful treatment, i.e. achievement of a sustained virological response, has been obtained in 79–93% of genotype 2 or 3 hepatitis C virus (HCV) patients after 24 weeks of treatment; as well as in 41–52% of genotype 1 patients and 77% of genotype 4 patients after 48 weeks of treatment in clinical trials.[3–6] Good adherence to treatment is believed to enhance the rate of sustained virological response, as shown in patients from prior trials who received ≥80% of both their total peginterferon and ribavirin doses for ≥80% of the expected duration of therapy.[7] However, adverse effects of interferon-based therapy – mainly flu-like symptoms, neuropsychiatric disorders, anaemia and neutropenia – are significant, justify frequent dose reduction of peginterferon and ribavirin and represent one major cause of premature treatment discontinuation.[8] Shortened antiviral therapy may be considered in some patients depending on genotype, baseline viral load and viral kinetics,[9–11] but only a minority of patients are concerned in routine practice, at least in France.

    These data originate from randomised, controlled clinical trials. However, many patients in routine clinical practice are nonresponders or relapsers to previous interferon-based therapy and the majority present with a wide spectrum of comorbidities. In particular, the high prevalence of psychiatric or substance abuse disorders in patients with chronic HCV infection is well known.[12] Conversely, people with chronic psychiatric disorders[13,14] and intravenous drug users[15–17] are far more likely to be infected with HCV compared with the general population. In addition, one-fourth to one-third of human immunodeficiency virus (HIV)-infected patients are co-infected with HCV.[18,19] Besides strict contraindications, such diagnoses have constituted the most common reason patients have been denied treatment for HCV infection, not only in clinical trials[3,4] but also, until recently, in the real life.[20,21]

    We performed a cohort study in chronic hepatitis C patients to evaluate the adherence to peginterferon α-2b and ribavirin combination therapy and to identify factors associated with good adherence in a real-life setting. We also assessed the coherence between patient-reported and physician-reported adherence, and the health-related quality of life.

    Patients and Methods
    This prospective, multicentre, observational study was carried out in University hospitals, non-University hospitals and private practice offices involved in the management of hepatitis C in France. All patients aged ≥18 years with chronic hepatitis C and initiating combination therapy with peginterferon α-2b and ribavirin were proposed to participate in the survey, whether naive for hepatitis C therapy or not. In accordance with the French law, Ethics Committee's approval was not required as the protocol was strictly observational and usual practice was unchanged. However, all patients gave informed consent to participate. Approval of the 'Commission Nationale de l'Informatique et des Libertés' was obtained, ensuring that patient data were kept confidential according to the French regulation.

    As for all observational studies, there were no protocol-specific procedures or study visits. Patients saw their physician as per usual practice in the centre. The investigator and the patient completed an anonymous questionnaire each at inclusion, every 3 months during treatment and 6 months after the end of treatment. Patients filled in their questionnaires in the waiting room and either gave it back to the physician in a sealed envelope or returned it using a prepaid envelope.

    Physicians recorded the socio-demographical characteristics, history of hepatitis C, selected comorbidities, process of care, concomitant treatments and adverse events. Comorbidities included past and current psychiatric history, HIV or HBsAg positivity, chronic diseases and use of psychoactive products. History of hepatitis C included source and duration of infection, viral load documented by quantitative PCR (Amplicor™, Roche Diagnostics, France), HCV genotype, liver fibrosis and necro-inflammation (Metavir, FibroTest-ActiTest®,[22] Knodell score) and previous antiviral treatment. Process of care included the intended antiviral treatment regimen (drug doses and duration), any subsequent treatment modification (dose modification or treatment discontinuation), the reason for modification and patient's therapeutic education. Patients recorded the antiviral medication actually taken and self-assessed their quality of life using the validated French translation of the MOS 36-item short-form health survey (SF-36) questionnaire.[23] Each SF-36 subscore ranges from 0 (worse) to 100 (best), except health transition, which ranges from 0 (best) to 100 (worse).

    Outcomes
    At each visit under treatment, patients reported the number of missed peginterferon injections in the past month (the last four injections) or missed ribavirin intakes in the past week (the last 14 intakes). To estimate patient-reported adherence at a given time point, we took into account the 'actual' doses as reported by the patient at each visit and compared it with the most recent physician prescription (thus integrating modifications of prescription that could have occurred over time). To estimate the patient-reported overall adherence, we took into account the adherence estimated at each visit, the actual treatment duration and the treatment duration initially intended by the physician. As a result, patients who declared having taken all the prescribed doses of both products for the full initially intended treatment duration were classified as 100% adherent. Those who declared having taken ≥80% of at least one product for ≥80% of the initially planned duration were classified as ≥80% adherent.

    Physician-reported adherence at a given visit and overall was estimated similarly, using the response to the following questions: 'In your opinion, how many times did the patient missed a peginterferon injection in the past month (the last 4 administrations)?' or 'In your opinion, how many times did the patient missed a ribavirin intake in the past week (the last 14 intakes)?'.

    Statistical Analysis
    Statistical analysis was conducted using sas 8.2 (SAS Institute Inc., Cary, NC, USA). Tests were two-sided and type I error was set at 0.05. Descriptive statistics were performed using all available data. Bivariate group comparisons were carried out using the Kruskal–Wallis, chi-square or Fisher's exact test as appropriate. The relationships between adherence and a set of potential explanatory variables were analysed by forward stepwise logistic regressions. These variables included those for which the groups differed significantly (P<0.05) at baseline in bivariate analyses (100 vs. <100% adherence and/or ≥80 vs. <80% adherence), and variables expected to be related to adherence. The quality of life data were analysed as recommended in the SF-36 manual and interpretation guide.[23]

    Results

    Patients
    A total of 184 investigators enrolled and followed up 2001 HCV patients in the survey between November 2002 and January 2005. Of these patients, 141 were excluded from analysis because they did not receive combination therapy with peginterferon α-2b and ribavirin combination therapy (n=37), duration of combination therapy was not available (n=79) or virological data were not available (n=25). Compared with the analysed population, excluded patients were more often genotype 1 carriers (66 vs. 55%, P=0.013) and less often genotype 3 carriers (185 vs. 25%, P=0.072). They had more severe liver disease (Metavir A2–A3: 66 vs. 54%, P=0.022; F3–F4: 47 vs. 34%, P=0.007), and had received more often a previous HCV treatment (43 vs. 28%, P<0.001). All other baseline data were not significantly different.
    The analysed population included 1860 patients. Their baseline characteristics are provided in Table 1. Most of them (72%) were naive for hepatitis C therapy and 36% had genotype 2 or 3 HCV infection. Liver disease was assessed by biopsy in the majority of patients (n=1606, 86%) and estimated using noninvasive markers in the remaining patients. Two-thirds of patients had significant fibrosis (F2, F3, F4: 65%), including 15% of cirrhotics.

    Comorbidities were frequent. The cohort included 22% of psychiatric patients, 44% of drug users and 3% of HIV-co-infected patients. Current psychiatric disorders were diagnosed by a psychiatrist in 62% of the cases and included mainly depressive (n=203, 11%), anxiety (n=129, 7%), psychotic (n=19, 1%) and bipolar (n=8, 0.4%) disorders. Other comorbid chronic diseases were hypertension (n=176, 36%), diabetes mellitus (n=107, 22%) and asthma (n=42, 9%). Health-related quality of life was altered, each SF-36 subscore being moderately lower than that in the general population in France.[23]

    Antiviral Treatment
    The mean dose regimen initially prescribed was 1.37 μg/kg/week (median 1.5, n=1837) for peginterferon α-2b and 922 mg/day (median 1000, n=1820) for ribavirin. A total of 1089 (58.5%) patients received various forms of therapeutic education at the discretion of the physician during the first 3 months of treatment. The average dose of both drugs progressively decreased over time, reaching 0.89 μg/kg/week (median 0.8, n=1729) for peginterferon and 595 mg/day (median 545, n=1728) for ribavirin at month 12. According to the physician, 915/1860 (49%) patients did not complete therapy as intended initially. The main reason for not doing so was virological criteria (n=302, 16%), lost to follow-up (n=244, 13%), safety (n=182, 10%), patient's request (n=78, 4%), another reason (n=51) or not specified (n=58). However, as calculated subsequently, only 563 (30%) patients had 'insufficient' treatment duration, i.e. <80% of the recommended duration (24 weeks with genotype 2 or 3, 48 weeks with the other genotypes). Adverse events were reported in 1598 (86%) patients overall.

    Adherence to Treatment
    Patient-reported adherence to combination therapy was 100% for the full initially intended treatment duration (overall adherence) in 580/1510 (38%) patients; it was ≥80% in 747 (50%) patients. The proportion of patients with good adherence at a given time point was stable over time, at 53–58% for 100% adherence and 64–66% for ≥80% adherence (Fig. 1).

    Proportion of patients with 100% and ≥80% adherence to combination therapy (patient report).


    Patient- and physician-reported adherences to treatment were discordant. As shown quarterly in Figure 2, the proportion of patients reporting a 100% adherence to peginterferon at a given time point was 76–79%, whereas physicians believed it was above 97%. Moreover, the proportion of patients reporting a 100% adherence to ribavirin was 62–66%, whereas physicians believed it was above 90%.

    Figure 2.
    Proportion of patients with 100% adherence to (A) peginterferon α-2b and (B) ribavirin over time, as reported by the patient and as perceived by the physician.

    Adherence to ribavirin was always worse than adherence to peginterferon (Fig. 2) and adherence to both products (Fig. 1) was always worse than adherence to ribavirin. Therefore, most patients with imperfect adherence to one product were different from those with imperfect adherence to the other product.
    Bivariate comparison of patients who took 100% of both products for the full initially intended treatment duration with those who did not is provided in Table 2. They differed significantly for the following items. 100% adherent patients had longer transport time to the physician office (P=0.001). They were more often genotype 2 or 3 HCV carriers (P=0.009) and naive for antiviral HCV therapy (P=0.037). In addition, they had less frequent diabetes (P=0.026), they consumed lower alcohol amounts at baseline (P=0.023) and they were less often regular drug users (P=0.017), but were more often HIV co-infected (P=0.003). They also used illicit drugs less frequently during follow-up (P=0.007) and, although not significantly, drunk less frequently >20g/day alcohol (P=0.053). They did not differ markedly for the HCV treatment actually received and occurrence of adverse events.

    The potential explanatory variables proposed to the multivariate model included genotype, remoteness of the centre (transport time), Metavir activity and fibrosis scores, sex, age, BMI, previous HCV treatment, serum HCV RNA, HIV co-infection, psychiatric disorders (ever and at baseline), diabetes, alcohol consumption >20g/day (at baseline and during follow-up), drug use (at baseline and during follow-up) and therapeutic education. As a result (Table 3), the factors significantly associated with 100% adherence to combination therapy were HIV co-infection, no illicit drug use during follow-up, HCV genotype 3, HCV treatment-naive and, to a lower extent (odds ratio close to 1), remoteness of the centre.

    Quality of Life
    The change from baseline of SF-36 subscores is displayed in Figure 3. During the treatment period (up to month 12), all physical and mental domains progressively worsened, in particular those reflecting problems at work or in daily activities that result from the physical (role physical) and mental (role emotional) status. The mean change from baseline of the mental and physical composite scores, which integrate all SF-36 domains except health transition, was, respectively, −6.4 and −6.5 points at month 6, and −5.7 and −5.3 points at month 12. The health transition score, which estimates the change of perceived health condition compared with 1 year before, also worsened during treatment as shown by a mean change from baseline at +6.6 points at month 6 and +5.5 points at month 12. After the end of treatment, quality of life was returned above the pretreatment level; the mean change from baseline was +2.6, +2.4 and −6.2 points for the mental composite score, physical composite scores and health transition score respectively.

    Figure 3.
    Mean change from baseline of SF-36 subscores (point). MCS, mental composite score; PCS, physical composite score. Physical domains: BP, bodily pain; GH, general health; PF, physical functioning; RP, role physical. Mental domains: MH, mental health; RE, role emotional; SF, social functioning; VT, vitality. HT, health transition



    Almost all SF-36 domains were significantly worse at baseline in patients who reported an adherence <100% compared with patients with 100% adherence (P<0.05 for PF, BP, GH, VT, SF, MH, PCS and HT; not significant for RP, RE and MCS). During and after treatment, changes of quality of life were parallel in both groups; there were no significant differences between groups for the change from baseline of each SF-36 subscore, whatever the time point.

    Discussion
    To our knowledge, this is the largest study assessing adherence to HCV therapy using data on dose taking. Imperfect adherence was common. Overall, only 38% of our routine patients reported strict adherence to peginterferon α-2b and ribavirin, i.e. full-dose, persistent therapy as initially intended by the physician. In addition, 76–79% of patients on treatment reported having taken all peginterferon doses in the last 4 weeks; 62–66% reported having taken all ribavirin doses in the last 7 days; and 53–58% reported having taken all doses of both drugs at months 3, 6, 9 and 12. We also provide information on adherence in terms of early treatment discontinuation (30%) and dose decreases, as usually referred to by clinicians in HCV infection.
    Our results add to the literature as among the few studies that assessed adherence in terms of dose taking, none did so in the whole population of routine HCV patients and over the whole treatment period. In a clinical trial including 401 mono-infected HCV patients,[24] at least 95% of patients reported having taken all peginterferon doses in the past 4 weeks at months 1, 3, 6, 9 and 12; the rate of patients who reported having taken all ribavirin doses in the past 4 days decreased from 91% at month 1 to 43% at month 12. In a cross-sectional study involving 180 routine HCV patients,[25] 7% of patients reported having missed at least one peginterferon dose in the last 4 weeks and 21% having missed at least one ribavirin dose in the last 7 days. Patients were under treatment since 19.3 ± 13.4 weeks in average. In a retrospective study where adherence was estimated using pharmacy refill data in 188 HCV US Veterans,[26] 73% of patients were found with at least 100% adherence to peginterferon and 68% with at least 100% adherence to ribavirin during the initial 3 months of treatment. Lastly, in a cohort of 63 HCV/HIV-co-infected patients,[27] 23% of patients discontinued treatment early and 98% of those on treatment reported having taken all peginterferon and ribavirin doses in the past 2 weeks at months 3, 6 and 12. Such a high adherence is not surprising as dose-taking adherence is nowadays routinely stressed in HIV patient care.

    However, the ability of physicians to recognise nonadherence was poor. Our study physicians markedly overestimated adherence to combination therapy, by 20–30% compared with patient self-report. This phenomenon has already been shown in other chronic diseases such as HIV infection or diabetes but not yet in chronic HCV infection.[28,29] Several reasons exist including for example poor or judgemental provider–patient communication.[30,31] Moreover, in this indication, electronic monitoring has provided much lower rates of adherence than self-reported adherence,[24] suggesting that patients also overestimate adherence to combination therapy. This medication-taking behaviour is also well known in other chronic disorders.[30] Therefore, healthcare providers should be more vigilant about adherence to HCV combination therapy in their daily management, especially in terms of missed ribavirin doses. Indeed, standard ribavirin dosing is complex and ribavirin dose reductions, at least in the first weeks of treatment, may alter virological outcome.[26, 32–34] Patient-related reasons for nonadherence may include forgetfulness, the decision to omit doses, lack of information and emotional factors.[30] Clinician-related reasons may include, in addition to poor communication with the patient, failing to explain the treatment benefits and side effects and not giving consideration to a patient's lifestyle. More flexibility in indication for treatment could have a positive impact on the individual prognosis of patients and the overall control of the disease burden. Although there is no perfect method to assess adherence to medication, patient self-report is probably the simplest and most effective method of measurement.

    This study provides other clinically relevant information. Patients who did not present with the following baseline characteristics of HCV infection, HIV co-infection, HCV genotype 3 and HCV treatment-naive, and patients who used illicit drugs during HCV treatment were at higher risk of imperfect adherence. Interestingly, adherence was not associated with history of addiction or psychiatric disorders, suggesting that these conditions should no longer limit access to HCV antiviral therapy. In addition, treating intravenous drug users should have a positive impact on prevention of transmission, with a chance of reducing the incidence of new cases. Knowledge of factors predictive of poor adherence is a useful resource for physicians to help identify patients who are most in need of intervention and plan more frequent and accurate follow-up.
    Careful assessment of health-related quality of life was regularly performed in our patients using a validated questionnaire. As expected, quality of life was impaired before treatment initiation compared with the general population[23,35] and both the mental and physical domains worsened during treatment. However, 6 months after the end of treatment, it was returned to baseline, even slightly better than before treatment. Quality of life changes were parallel in patients with perfect and imperfect adherence. These results confirm previous reports of temporary worsening.[36,37] Therefore, physicians should reassure patients and encourage them to persist with therapy despite frequent side effects and worsened quality of life.

    In conclusion, this cohort study brings potential clinically relevant information by emphasising the following points. Imperfect adherence to combination therapy with peginterferon plus ribavirin is common in routine chronic hepatitis C patients. Adherence is markedly overestimated by physicians and is associated with some patient's baseline characteristics. These findings suggest that assessment of adherence to HCV combination therapy by physicians should be improved. This could be easily carried out by the wide use of standardised adherence measurement tools such as a self-questionnaire, keeping in mind that patients may overestimate the true figures. The need to enhance communication would be triggered by discordance between the physician and patient assessments. Knowledge of baseline characteristics associated with adherence might help adjust the monitoring in a subset of patients at higher risk of nonadherence.

    • References
    • http://www.medscape.com/viewarticle/740570
    Posted by HCV New Drugs at Thursday, April 28, 2011 No comments:
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    New Hepatitis C Drugs In The News; Telaprevir and Boceprevir



    April 28 The FDA advisory panel unanimously backed the approval of Vertex Pharmaceuticals proposed hepatitis C-drug telaprevir.

    April 27 - VICTRELIS (boceprevir) was unanimously recommended for approval by the FDA Advisory Committee .

    In The News;

    FDA Panel Endorses Boceprevir for Hepatitis C

    By Emily P. Walker, Washington Correspondent, MedPage Today
    Published: April 27, 2011
    SILVER SPRING, Md. --

    An FDA advisory committee has voted unanimously to recommend approval of the investigational drug boceprevir (Victrelis), in combination with peginterferon and ribavirin, to treat hepatitis C genotype 1.

    The agency's Antiviral Drugs Advisory Committee voted 18-0 Wednesday that boceprevir, made by Merck, appears to be a safe and effective new option to treat a disease that affects between three and four million people in U.S.

    The panel was expected to endorse the drug -- and the FDA is expected to approve it -- since clinical trials showed that in the difficult-to-treat genotype 1 patients boceprevir yielded sustained virological response rates as high as 67%.

    In contrast, the rate for patients getting the standard regimen of pegylated interferon injections and ribavirin pills was about 40%.

    The drug is one of two hepatitis C virus (HCV) protease inhibitors that will be reviewed during the panel's two-day meeting this week. The other is telaprevir -- slated for review on Thursday -- which exhibited even higher sustained response rates than boceprevir.

    If the FDA approves the two new drugs as expected, they would be the first HCV protease inhibitors to reach market and are thought to represent a major advance in therapy for genotype 1 hepatitis C.
    Until now, treatment has relied on boosting the immune system, rather than attacking the virus directly.
    Panelist Lawrence Friedman, MD, chair of the Department of Medicine at Newton-Wellesley Hospital in Newton, Mass., said when he first started seeing HCV patients, there was no treatment at all.
    "To go to 60% or 70% [sustained response] really seems like a dream come true," he said. "I think this is a major advance, so I'm very enthusiastic about this drug."

    Both boceprevir and telaprevir have attracted major buzz among physicians and patients on the basis of excellent-looking clinical trial results, most recently from two of boceprevir's pivotal studies published in the New England Journal of Medicine last month.

    On Wednesday, the panel discussed Merck's trial data, which suggest that adding boceprevir to the standard peginterferon-ribavirin combination doubles or triples the sustained viral response rates among certain subsets of patients.
    For instance, in one of the trials, in patients who had never been treated for HCV, 40% of the control group receiving the conventional regimen had a sustained response versus about 70% of patients with boceprevir added.

    Analyzing data of patients with previous partial or unsustained responses to the standard regimen showed that 21% achieved a sustained response with a second round of the same treatment, whereas approximately 60% did when that second round included boceprevir.
    The core treatment regimen with boceprevir tested in the trials included a four-week lead-in period with peginterferon and ribavirin with boceprevir then added for 44 weeks. But some of the trials also included a regimen in which the duration of boceprevir treatment could be extended based on how well a patient was responding to treatment after eight and 24 weeks.

    Merck would like the drug's label to allow longer treatment for patients with detectable HCV RNA at eight weeks but who achieve a full virologic response at 24 weeks, as some data suggested that such a regimen improves the sustained response rate.

    But the panel expressed concern over that type of "response-guided therapy," in part because it would make HCV treatment even more complicated.

    Panelists also discussed the hematologic side effects associated with boceprevir -- including anemia, neutropenia, and thrombocytopenia -- all of which were more common in patients treated with boceprevir -- but they were ultimately convinced that anemia is a manageable side effect during treatment with boceprevir and is reversible after the drug is stopped.

    The FDA is expected to make decisions on both boceprevir and telaprevir in May and physicians who treat HCV patients are eagerly awaiting approval. The anticipation has led some doctors to postpone treatment until the drugs are available, according to Donald Gardenier, DNP, of Mount Sinai School of Medicine in New York City.

    The delays are based on the expectation that "the new treatments will be both more effective and administered over shorter courses," Gardenier said in an email to MedPage Today.
    For most patients, the delay will have "little or no downside," he said.

    "Chronic hepatitis C progresses slowly and the goal of treatment is to prevent the long-term consequences, so a delay of a few months is not significant for most patients," Gardenier said.
    In some cases, such as where liver disease is advanced, doctors would go ahead with standard treatment, he added, "although that happens less frequently as the availability of the new medications comes closer."
    Once the drug is approved, it still has to be made and shipped and insurers need to agree to pay for it, he noted. Currently, experts are expecting to see the drug in the clinic by late summer or early fall.
    "In the meantime, we are actively planning for handling what we anticipate will be a corresponding increase in patient volume," Gardenier said.

    New Drugs For Hepatitis C Called Game Changers
    by Richard Knox
    April 28
    With declarations that a new day is dawning in the treatment of hepatitis C, members of a federal advisory panel unanimously approved the first of two new drugs to treat the stubborn liver infection on Wednesday.
    The committee is expected to green light the second hep-C drug today. Few doubt the Food and Drug Administration will clear the new drugs for market, possibly as soon as next month.
    "This changes the game completely," says Dr. Victoria Cargill of the National Institutes of Health, acting chair of the FDA's advisory committee. "I can look into the faces of the people (with hepatitis C) and offer them some hope."
     
    "I can't wait to get back and talk to my patients about it," enthused panel member Dr. Barbara McGovern of Tufts Medical School in Boston.
    Studies show that the new drugs – so-called protease inhibitors that interfere with the hep-C virus' ability to replicate – eliminate the virus in 65 to 80 percent of patients. Standard treatments, which involve the drugs ribavirin and pegylated interfereon, cure less than half of patients.
    Many patients with hepatitis C have reportedly been delaying treatment in the hope of more effective new drugs.
    The drug approved Wednesday, by an 18-0 vote, is Merck's boceprevir, which will carry the brand name Victrelis. Studies indicate it is somewhat less effective than Vertex Pharmaceutical's telepravir, which is up for a vote today. Both are effective in many cases against the worst form of hepatitis C, type 1.
    Analysts predict Merck will pull in around $800 million a year from boceprevir, while Vertex might sell $3 billion worth of teleprevir. At least 3.2 million Americans have hepatitis C. The strongest risk factors are a history of injection drug use, multiple sex partners and blood transfusion before 1992.
    Yet enthusiasm for the drugs is tempered by a lot of questions about who is likely to benefit and how to manage serious side effects, such as anemia and severe rashes. The advisory panel came up with three dozen post-marketing studies it wants Merck to do.
    "I do think you have to be somewhat of a Talmudic scholar to prescribe this drug," says panel member Dr. Lawrence Friedman of Massachusetts General Hospital.
    That's because many hepatitis C patients were excluded from efficacy studies – for instance, if they had failed on standard treatments, or if they were resistant to conventional drugs.
    Advisory committee members also complained about the lack of information on African-American patients, who often don't respond as well to standard hepatitis C therapy. Cargill, who specializes in treating minorities with HIV infection, says this is a big concern. "I practice in a setting where approximately 95 percent of our patients are co-infected with hepatitis C" and HIV, she says.
    Committee members also worry about the complexity of taking the new drugs (which are added to conventional treatments), patients' ability to adhere to treatment, the need to monitor them for signs of anemia, and the drugs' value for patients who have not responded to standard treatment.
    But ultimately the panelists agreed that the benefits of the new pills clearly outweigh the risks. And this isn't the end of the story. Panel member Doris Strader of the University of Vermont points out that "there are drugs (for hepatitis C) coming along that may be better and simpler to use."

    USciences Hosts Making the Connections: A Panel Discussion on Hepatitis C Prevention and Treatment
    Released: 4/27/2011 5:00 PM EDT

    Source: University of the Sciences

    Newswise — Mayes College of Healthcare Business and Policy at University of the Sciences is hosting a panel discussion on hepatitis C prevention and treatment, on Thursday, April 28, 2011, from 5 to 7 p.m. The event will take place in the McNeil Science and Technology Center (43rd St. at Woodland Ave., Philadelphia, Pa. 19104).

    The panel of distinguished panel speakers will discuss the impact of the national strategy for preventing and treating hepatitis C and how the new pipeline of drugs will impact public health and patient care in the greater Philadelphia region.

    Moderator Andrew Peterson, PharmD, PhD, Dean of Mayes College of Healthcare Business and Policy at USciences, will guide the panel that includes:
    • Martin Black, MD, Chief of the Liver Unit and Liver Transplantation Director at Temple University School of Medicine
    • Amy Jessop, PhD, MPH, Director of HepTREC at USciences’ Mayes College
    • Tracy Swan, Hepatitis/HIV Project Director for the Treatment Action Group
    • John Ward, MD, Director of the Division of Viral Hepatitis at Centers for Disease Control and Prevention
    Making the Connections: A Panel Discussion on Hepatitis C Prevention and Treatment is made possible by an unrestricted educational grant from AstraZeneca Pharmaceuticals. This panel discussion is a component of year-long theme focusing on hepatitis that Mayes College is incorporating into its culture through classroom work, events, speakers, and student activities.

    At University of the Sciences, students embark on a challenging learning experience in a proving ground for successful professionals in the science and healthcare-related fields. A private institution dedicated to education, research, and service, and distinguished as the nation’s first college of pharmacy, the University has produced leaders in the science and healthcare marketplaces since its founding in 1821. Students in USciences’ five colleges learn to excel in scientific analysis and to apply their skills to improving healthcare in the lives of people worldwide through such disciplines as pharmacy, biology, physical therapy, healthcare business, and health policy. For more information, visit usciences.edu.
    – Twitter @USciences –

    Pediatric Liver Trial Misses Primary Endpoint
    By Kristina Fiore, Staff Writer, MedPage Today
    Published: April 26, 2011
    Neither vitamin E nor metformin significantly decreased alanine aminotransferase (ALT) levels in children and adolescents with nonalcoholic fatty liver disease (NAFLD), researchers say.

    But, although the trial missed this primary endpoint of significant reductions in ALT levels compared with placebo, the vitamin may be able to mitigate the more progressive form of the disease, Joel Lavine, MD, PhD, of Columbia University Medical Center in New York, and colleagues reported in the April 27 issue of the Journal of the American Medical Association.

    "The data suggest that children treated with vitamin E who had biopsy-proven nonalcoholic steatohepatitis (NASH) had significant improvement in secondary histologic outcomes with vitamin E," they wrote...continue reading...





    Liver Cancer
    .
    San Diego’s Polaris Group, which seemed to spring out of nowhere, is moving to begin a late-stage clinical trial of ADI-PEG 20 for treating the most common type of liver cancer. The drug, also known as pegylated arginine deiminase, is intended to deprive tumor cells of arginine, an essential amino acid they need to survive and grow.

    Related;
    San Diego’s Polaris Moves to Late-Stage Test of Drug for Liver Cancer and Other “Arginine-Dependant” Tumors
    Bruce V. Bigelow 4/27/11
    Bor-Wen Wu says he had the North Star in mind in 2006 when he founded San Diego’s Polaris Group, a small holding company with a promising lead drug candidate for treating liver cancer, malignant melanoma, and other related cancers. As an explorer in science, Wu says, “I need a North Star to tell me where to go.”
    Yet the path Wu has followed has been anything but a sure and constant course. In his quest to develop the drug ADI-PEG 20, Wu has formed eight companies since 2002 that are affiliated with Polaris; raised more than $60 million from individual investors in Taiwan; and battled to retain control of ADI-PEG after paying millions to acquire a predecessor company, Phoenix Pharmacologics of Lexington, KY.
    Despite a sometimes-circuitous path, though, Wu has kept the Polaris Group focused on a distant goal. The FDA recently approved the company’s plans for a late-stage clinical trial of ADI-PEG 20, an enzyme also known as pegylated arginine deiminase. ADI-PEG 20 is incredibly effective in breaking down arginine, an amino acid that is critical to the growth of hepatocellular carcinoma—the primary type of liver cancer.
    Among cancer drugs in Phase 3 trials, Wu boasts, “We’re not the first in class. We’re the only one in the class. There’s nothing in the rear-view mirror.”
    A study published last year in the British Journal of Cancer estimates there are 500,000 new cases of hepatocellular cancer diagnosed worldwide annually, with a five-year survival rate of less than 10 percent in the United States and Europe. Polaris, which contends the liver cancer is far more prevalent in Asia, estimates that worldwide deaths from hepatocellular carcinoma is closer to 700,000 people a year, with more than 330,000, or nearly half, in China.
    ADI-PEG 20 represents an especially hot area of cancer research, which has focused on finding ways to starve tumors by depriving them of key nutrients. In the case of liver cancer, Wu says a key genetic mutation that triggers hepatocellular carcinoma coincides with the specific gene that makes arginine in normal cells. The company says the correlation is more than 70 percent in the patients studied so far. As a result, most liver tumor cells are unable to manufacture their own arginine and depend on some other source of
     …Next Page »

    Bruce V. Bigelow is the editor of Xconomy San Diego. You can e-mail him at bbigelow@xconomy.com or call 858-202-0492

    Hepatitis B
    .
    Trends in mortality after diagnosis of hepatitis B or C infection: 1992–2006
    Journal of Hepatology, 04/27/2011

    Walter SR et al. - Improvements in hepatitis B virus (HBV) treatment and uptake have most likely reduced non- hepatitis C virus (HCV) liver-related mortality. HCV drug-related mortality remained low compared to pre-2002 levels, likely due to changes in opiate supply, and maintenance or improvement in harm reduction strategies.

    Methods

    • HBV and HCV cases notified to the New South Wales (NSW) Health Department between 1992 and 2006 were linked to cause of death data and HIV/AIDS notifications.
    • Mortality rates and standardised mortality ratios (SMRs) were calculated using person time methodology, with NSW population rates used as a comparison.
    • The study cohort comprised 42,480 individuals with HBV mono-infection and 82,034 with HCV mono-infection.

    Results• HIV co-infection increased the overall mortality rate three to 10-fold compared to mono-infected groups.

    • Liver-related deaths were associated with high excess risk of mortality in both HBV and HCV groups (SMR 10.0, 95% CI 9.0-11.1; 15.8, 95% CI 14.8-16.8).
    • Drug-related deaths among the HCV group also represented an elevated excess risk (SMR 15.4, 95% CI 14.5-16.3).
    • Rates of hepatocellular carcinoma (HCC)-related death remained steady in both groups.
    • A decrease in non-HCC liver-related deaths was seen in the HBV group between 1997 and 2006, but not in the HCV group.
    • After a sharp decrease between 1999 and 2002, drug-related mortality rates in the HCV group have been stable.

    Hepatitis B Virus Re-Emerges With Long-Term Nucleoside Analog Treatment
    28 April 2011
    A rebound of the Hepatitis B virus is common in patients receiving nucleoside analogs for chronic hepatitis B, according to a study from U-M hepatologists. But nearly 40% of the rebounds or virological breakthroughs (VBTs)...
    /
    Complementary Medicine / Alternative Medicine

    NIH launches Web resource on complementary and alternative medicine

    Evidence-based information for health care providers
    A new online resource, designed to give health care providers easy access to evidence-based information on complementary and alternative medicine (CAM), was unveiled today by the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health.
    With this new resource, providers will have the tools necessary to learn about the various CAM practices and products and be better able to discuss the safety and effectiveness of complementary and alternative medicine with their patients.
    The portal on the NCCAM website at nccam.nih.gov is tailored to fit the needs of all health care providers, including physicians, nurses and nurse practitioners, physician assistants, and CAM providers. It includes information on the safety and efficacy of a range of common health practices that lie outside of mainstream medicine — natural products, such as dietary supplements, herbs, and probiotics, as well as mind-body practices such as meditation, chiropractic, acupuncture, and massage.
    This resource was developed based on a series of NCCAM-sponsored focus groups where health care providers identified the need for an evidence-based, one-stop place to help answer their patients’ questions on CAM. With this need in mind, NCCAM developed a resource that provides reliable, objective, and evidenced-based information on CAM, including:
    • links to relevant clinical practice guidelines
    • safety and effectiveness information
    • links to systematic reviews
    • summaries of research studies
    • scientific literature searches
    • programs for continuing education credit
    • patient fact sheets
    • NCCAM's Time to Talk tool kit on communicating about CAM.
    Americans annually spend nearly $34 billion out-of-pocket on CAM products and practices. Surveys show that nearly 40 percent of American adults and 12 percent of American children use some form of CAM. Other surveys show that patients do not regularly discuss these practices with their health care providers. In fact, a recent study of Americans aged 50 and older found that overall two-thirds of respondents had not discussed CAM with their health care provider.
    "NCCAM is charged to study and provide evidence-based information on the safety and efficacy of CAM health practices that are readily available and already used by a great number of people," said Josephine P. Briggs, M.D., director of NCCAM. "As a physician, I understand the need to have easily accessible and accurate information on all health practices. This Web resource is a way for NCCAM to share this valuable information with all providers."

    To use this resource, please visit http://nccam.nih.gov/health/providers/.
    NCCAM's Time to Talk campaign encourages patients to tell their providers about CAM use and providers to ask about it by offering tools and resources — such as wallet cards, posters, and tip sheets — all of which are available for free at http://nccam.nih.gov/timetotalk/.

    The mission of the National Center for Complementary and Alternative Medicine (NCCAM) is to define, through rigorous scientific investigation, the usefulness and safety of complementary and alternative medicine (CAM) interventions and their roles in improving health and health care. For additional information, call NCCAM’s Clearinghouse toll free at 1-888-644-6226, or visit the NCCAM Web site at nccam.nih.gov.
    About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.

    Ginkgo Biloba Reduces Pain And Inflammation In Rats
    27 April 2011
    Experiments in rats show that a standardized ginkgo extract-injected either into the spinal canal or directly into the injured area-effectively reduces inflammation and some types of pain, according to a report in the May...
    Posted by HCV New Drugs at Thursday, April 28, 2011 No comments:
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    The above links offer data about interferon-free regimens approved to treat HCV, with learning activities,  editorials, and tips from patient bloggers who understand the ups and downs of liver disease, in addition to a list of outstanding hepatitis C websites, blogs and support forums.

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    I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading articles about the treatment and management of hepatitis C.

    The controversy over expensive new drugs for hepatitis C
    Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"
    Latest Update Feb 12, 2019 
    Lancet Study: 
    Direct-acting antivirals reduce risk of premature mortality and liver cancer for people with chronic hepatitis C 
    These findings firmly counter those of a Cochrane review of direct-acting antiviral treatment trials that could neither confirm nor reject if direct-acting antivirals had an effect on long-term HCV-related morbidity and mortality. They also provide the best evidence to date to support guidance documents that recommend direct-acting antiviral treatment for all patients with chronic HCV infection.

    The Controversy 
    Rebuttal over Cochrane Review of DAAs 
    A systematic review published by the Cochrane Collaboration suggested achieving SVR (cure) for patients using hepatitis C direct-acting antivirals (DAAs) doesn't correlate with any long term benefits. View each rebuttal and all ongoing media coverage.

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