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  • FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

    Specifically, the groups hope to learn about different responses that different patients experienced during clinical trials. Tracy Swan of Treatment Action Group points to relapses in a Harvoni clinical trial that occurred only among African-Americans. The groups also want to perform an independent analysis of poor prognostic factors among people who were not cured in order to identify a patient profile.

    29 June 2015 | Wall Street Journal (blog)
  • AbbVie Announces New Phase 3b Results in Genotype 1b Chronic Hepatitis C Patients with Compensated Liver Cirrhosis

    AbbVie, a global biopharmaceutical company, today announced TURQUOISE-III study results demonstrating 100 percent (n=60/60) sustained virologic response at 12 weeks post-treatment (SVR12) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis. These new results from AbbVie's Phase 3b study will be presented at the 15th Annual International Symposium on Viral Hepatitis and Liver Diseases in Berlin, Germany.

    24 June 2015 | AbbVie press release
  • Achillion partners with J&J to develop hepatitis C drugs

    Achillion Pharmaceuticals Inc said it will collaborate with Johnson & Johnson to develop and market its hepatitis C drugs including an oral regimen that could work on all genotypes and shorten treatment time.

    20 May 2015 | Reuters
  • ViiV Healthcare Begins Phase III Programme with dolutegravir/rilpivirine Combination for HIV Maintenance Therapy

    The Phase III programme will evaluate the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current INI-,NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed. In the clinical trials, dolutegravir and rilpivirine will be provided as individual tablets; development of the single-tablet formulation will be concurrent with conduct of the trials.

    06 May 2015 | Viiv Healthcare press release
  • Merck Faces Hep C Pricing Dilemma to Counter Gilead, Abbvie

    Merck has previously stated that it will seek approval for the grazoprevir/elbasvir combination pill in the middle of the year. If approved by the end of the year or in early 2016 -- and there's probably little risk the therapy won't be approved -- Merck's dilemma will be finding a way to grab market share for a new hepatitis C therapy without any clinical or convenience advantages over the existing competition.

    09 April 2015 | The Street
  • Grazoprevir/Elbasvir, Merck’s Investigational Chronic Hepatitis C Therapy, Granted FDA Breakthrough Therapy Designations

    Merck today announced that grazoprevir/elbasvir, an investigational single tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection, has received two new Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA) for the treatment of patients with chronic HCV genotype 4 (GT4) infection, and for the treatment of chronic HCV genotype 1 (GT1) infection in patients with end stage renal disease on hemodialysis.

    09 April 2015 | Merck press release
  • At 50 Cents a Pill, Allergy Drug Could Best $1000 Sovaldi, Harvoni

    Published today in the journal Science Translational Medicine, researchers from the National Institutes of Health (NIH) reported chlorcyclizine prevented hepatitis C infection in a petri dish and in humanized mice. They said it was effective and did and did not produce any significant cell toxicity when given along with existing drugs to treat hepatitis C.

    09 April 2015 | Healthline
  • FDA to review re-submitted Bristol-Myers hepatitis C drug

    U.S. regulators have accepted Bristol-Myers Squibb Co's re-submitted marketing application for an experimental hepatitis C treatment after the drugmaker was forced last year to withdraw its initial request.

    12 March 2015 | Reuters
  • New hepatitis C treatments highly effective for HIV/HCV coinfected people

    A pair of interferon-free combinations -- AbbVie's 3-drug Viekira Pak regimen and Gilead Science's sofosbuvir/ledipasvir (Harvoni) -- demonstrated good safety and cured more than 90% of genotype 1 HIV/HCV coinfected people, according to studies published in the February 23 advance edition of the Journal of the American Medical Association.

    26 February 2015 |
  • Health News Review analysis of Reuters' coverage of new hepatitis C drugs

    We wish that more stories would bring some skeptical thinking to their coverage of expensive new hepatitis C treatments. The emphasis on short-term effects obscures the lack of long-term data about benefits.

    13 February 2015 | Health News Review
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