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New and experimental hepatitis C treatment news

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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where new products have the potential to become “blockbusters” almost overnight – but also risk becoming quickly outdated due to superior products entering the market.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
Achillion Achieves 100% SVR12 in Phase 2 Trial Evaluating 6-Week Combination Treatment With ACH-3102

Achillion Pharmaceuticals, Inc. today announced updated interim results from the ongoing interferon-free, ribavirin-free, Phase 2 study to evaluate the efficacy, safety, and tolerability of six weeks of 50 mg of ACH-3102 and 400 mg of sofosbuvir, a marketed nucleotide polymerase inhibitor, in treatment-naïve genotype 1 HCV-infected patients.

Published
09 February 2015
From
Achillion press release
Merck says hepatitis C drugs to lose breakthrough status

Merck & Co on Wednesday said U.S. regulators intend to rescind the "breakthrough therapy" designation for its combination treatment for hepatitis C because other new drugs are available, a decision that could delay approval of the Merck product by several months.

Published
05 February 2015
From
Reuters
AbbVie Inc stock drops after expectations for Viekira Pak fall short

AbbVie shares fell 4.4% after market gathered from the company’s forecast that the new hepatitis C treatment may bring in just $2 billion in 2015, falling short of the high expectations.

Published
02 February 2015
From
Bidness Etc
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