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New and experimental hepatitis C treatment news

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FDA places RG-101 for HCV on clinical hold

The FDA has verbally notified Regulus Therapeutics that its investigational new drug RG-101 for the treatment of chronic hepatitis C virus infection has been placed on clinical hold after a second patient reported a serious adverse event, according to a news release.

Published
05 July 2016
From
Healio
FDA Approves Gilead's Epclusa Combo Pill for All Hepatitis C Genotypes

On June 28 the U.S. Food and Drug Administration (FDA) approved Gilead Sciences Epclusa, a new once-daily combination pill containing sofosbuvir and velpatasvir, for the treatment of adults with hepatitis C virus (HCV) genotypes 1 through 6 -- the first approved oral pangenotypic regimen. While it is more effective against more types of HCV, Epclusa will cost less than most earlier interferon-free direct-acting antiviral regimens.

Published
04 July 2016
From
HIVandHepatitis.com
Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union

Merck (NYSE:MRK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER™ (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment of chronic hepatitis C virus (HCV) in adult patients.

Published
30 May 2016
From
MSD press release
European CHMP Adopts Positive Opinion for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C

Epclusa is Gilead’s Third Sofosbuvir-Based Treatment to Receive a CHMP Positive Opinion for the Treatment of Chronic HCV Infection.

Published
27 May 2016
From
Gilled press relase
Fair Pricing Coalition Recognizes Merck’s Lower Price for Curative Hepatitis C Treatment, Calls for Manufacturers to Reduce Excessive Prices and Increase Patient Assistance

The Fair Pricing Coalition (FPC) today expressed appreciation for Merck’s & Co. Inc.’s decision to launch its new curative hepatitis C (HCV) treatment, Zepatier, at a price below existing HCV treatments in a tacit acknowledgement that existing high prices have hurt patients and are untenable for the market. Zepatier’s $54,600 list price is lower than the egregious prices for Gilead Sciences’ Harvoni ($94,500) and AbbVie’s Viekira Pak ($83,319), and represents a step in the right direction.

Published
08 February 2016
From
Fair Pricing Coalition
U.S. FDA Approves Expanded Use of Bristol-Myers Squibb’s Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

Updated label provides new treatment option for patients with HIV-1 coinfection, advanced cirrhosis, and post-liver transplant HCV recurrence.

Published
08 February 2016
From
Bristol-Myers Squibb press release
Merck Throws a Wrench in Drug Pricing

Volume may help Merck make up what it loses on price. AbbVie and Gilead's drugs are priced so high that many governments and insurers will only pay for them for patients that have severe liver scarring, given HCV's slow progression. Zepatier is priced at a point that could make it affordable to treat a much larger population at earlier stages of the disease.

Published
01 February 2016
From
Bloomberg
Zepatier for hepatitis C approved in Canada

On January 19, 2016, Health Canada licensed the use of Zepatier for the treatment of certain strains of hepatitis C virus (HCV) in adults. Canada is the first country to approve Zepatier. This drug is made by the pharmaceutical company Merck and should be available for order by drug stores early in February 2016.

Published
01 February 2016
From
CATIE
Merck Receives FDA Approval of ZEPATIER™ (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults

The U.S. Food and Drug Administration (FDA) has approved ZEPATIER™ (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV), following priority review by the FDA. ZEPATIER (pronounced ZEP-ah-teer) is a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50 mg) and the NS3/4A protease inhibitor grazoprevir (100 mg).

Published
29 January 2016
From
Merck press release
The 2016 Hepatitis C Drug Approval Outlook

Here’s what’s in store this year for new hepatitis C therapies, as well as approvals for new uses of existing treatments.

Published
18 January 2016
From
Poz

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Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.