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New and experimental hepatitis C treatment news

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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
UNITAID: 2015 Hepatitis C medicines technology and market landscape

This report takes stock of a rapidly changing market, where new products have the potential to become “blockbusters” almost overnight – but also risk becoming quickly outdated due to superior products entering the market.

Published
13 February 2015
From
UNITAID
FDA revokes breakthrough status for BMS hep C drug

The big biotech tells FierceBiotech in a statement that the agency has "informed Bristol-Myers Squibb that, due to the evolving HCV treatment landscape, the agency intends to rescind the breakthrough therapy designation for certain genotype 1 hepatitis C regimens related to daclatasvir." Bristol-Myers then went on to add that the decision will not impact its timetable on an NDA for daclatasvir, which faces a unique set of challenges all its own.

Published
11 February 2015
From
Fierce Biotech
Regulus Therapeutics reports top-line results from RG-101 clinical study for HCV treatment

All HCV patients treated with a single SC administration of 4 mg/kg of RG-101 responded with mean viral load reduction of 4.8 log10 at Day 29 and 9/14 patients are below the limit of quantification at Day 57.

Published
11 February 2015
From
Regulus Therapeutics press release
Promising data bodes well for all-Achillion hep C treatment

Achillion Pharmaceuticals Inc's experimental hepatitis C drug, when used with Gilead Sciences Inc's Sovaldi, eradicated signs of the virus in six weeks, the shortest duration and highest response achieved by any two-drug treatment.

Published
10 February 2015
From
Reuters
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