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New and experimental hepatitis C treatment news

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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.

Published
29 June 2015
From
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.

Published
24 June 2015
From
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.

Published
20 May 2015
From
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.

Published
06 May 2015
From
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.

Published
09 April 2015
From
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.

Published
09 April 2015
From
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.

Published
09 April 2015
From
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.

Published
12 March 2015
From
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.

Published
26 February 2015
From
HIVandHepatitis.com
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.

Published
13 February 2015
From
Health News Review
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