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New and experimental hepatitis C treatment news

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Janssen Acquires Investigational NS5A Inhibitor for the Treatment of Hepatitis C from GlaxoSmithKline

Janssen plans to initiate Phase 2 studies to evaluate the use of GSK2336805 in interferon-free combinations with the investigational protease inhibitor simeprevir (TMC435) and TMC647055, Janssen's non-nucleoside polymerase inhibitor, for the treatment of chronic hepatitis C in adult patients with compensated liver disease.

Published
08 October 2013
From
Janssen press release
Achillion's Hepatitis C Drug Still on Hold by U.S. FDA

Achillion Pharmaceuticals Inc. (ACHN) said U.S. regulators are keeping the company’s experimental hepatitis C drug sovaprevir on hold because of abnormal liver results. The shares plunged 45 percent in extended trading.

Published
30 September 2013
From
Bloomberg
Boehringer Ingelheim Expands Investigation of Interferon-free Hepatitis C Treatment Regimens to Reach More Patient Types through Presidio Pharmaceuticals Clinical Collaboration

First Phase 2a study includes Presidio's PPI-668 in genotype-1a infected patients; collaboration offers the potential to explore additional HCV genotypes in future trials.

Published
10 September 2013
From
PR Newswire (press release)
Merck demand triggers expanding patent war with Gilead over sofosbuvir

Gilead is rolling out its big legal guns to defend its control of the experimental hepatitis C drug sofosbuvir, one of the most valuable therapies in the industry's late-stage pipeline.

Published
02 September 2013
From
FierceBiotech
People with HIV/HCV-co-infection and advanced liver fibrosis can rapidly develop decompensated liver disease

People living with HIV who have hepatitis C virus (HCV) co-infection and advanced liver fibrosis can rapidly develop decompensated liver disease even though they do not

Published
02 September 2013
By
Michael Carter
FDA, academia and industry team up to end hepatitis C

A research consortium known as the Hepatitis C Therapeutic Registry and Research Network, or HCV-TARGET, has joined forces with the FDA to share national data on how newly approved therapies for hepatitis C are used and managed in routine practice.

Published
30 August 2013
From
University of Florida press release
Medivir announces interim results from Cohort 2 of the COSMOS study evaluating Simeprevir and Sofosbuvir in HCV patients with METAVIR scores F3-F4

In Hepatitis C patients with advanced liver fibrosis or cirrhosis (METAVIR F3 or F4) 12 weeks all oral treatment with simeprevir and sofosbuvir with or without ribavirin led to SVR4 rates of 96% and 100%, respectively. Once-daily simeprevir and sofosbuvir with or without ribavirin was generally safe and well tolerated

Published
29 August 2013
From
Medivir press release
Investigational oral regimen for hepatitis C shows promise in NIH trial

In a study of an all-oral drug regimen, a majority of volunteers with liver damage due to hepatitis C virus infection were cured following a six-month course of therapy that combined an experimental drug, sofosbuvir, with the licensed antiviral drug ribavirin. The results showed that the regimen was highly effective in clearing the virus and well tolerated in a group of patients who historically have had unfavorable prognoses.

Published
28 August 2013
From
Eurekalert Inf Dis
Vertex’s VX-135 partial hold signals heightened FDA scrutiny toward HCV drugs

The partial hold indicates the FDA is very sensitive about hepatotoxicity, even if it means making the development path more difficult, the US expert added.

Published
27 August 2013
From
Financial Times
Physicians are Foregoing Treatment of Their HCV Patients Until New Agents Become Available

BioTrends Research Group, one of the world’s leading research and advisory firms for specialized biopharmaceutical issues, finds that three-quarters of patients who have failed prior regimens, regardless of genotype, are not likely to re-treat their chronic hepatitis C virus (HCV) infection with a currently available regimen within the next year.

Published
06 August 2013
From
BioTrends

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