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New and experimental hepatitis C treatment news

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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
New Merck combination pill Zepatier approved for hepatitis C treatment in the United States

Merck has received a US license for its direct-acting antiviral combination of grazoprevir and elbasvir, to be marketed as Zepatier. The combination of grazoprevir (an HCV protease inhibitor)

Published
01 February 2016
By
Keith Alcorn
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
AbbVie Initiates Enrollment of Six Global Phase 3 Clinical Studies for Once-Daily, Pan-Genotypic Hepatitis C Regimen

AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the initiation of six global Phase 3 clinical studies evaluating the safety and efficacy of its all-oral, once-daily, ribavirin-free investigational hepatitis C virus (HCV) regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, in patients with genotypes 1-6 (GT1-6) chronic HCV infection. The new investigational regimen evaluates treatment durations of 12 weeks and as short as eight weeks in genotype 1 patients.

Published
11 January 2016
From
AbbVie press release
Mylan Launches Generic Harvoni® (Ledipasvir/Sofosbuvir) Under the Brand Name MyHep LVIR™ in India

Mylan N.V. (NASDAQ, TASE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched generic Harvoni® (Ledipasvir 90 mg/Sofosbuvir 400 mg) tablets under the brand name MyHep LVIR™ in India.

Published
08 January 2016
From
Mylan press release
Inside the hepatitis C virus is a promising antiviral

A peptide derived from the hepatitis C virus (HCV) kills a broad range of viruses while leaving host cells unharmed by discriminating between the molecular make-up of their membranes, reveals a study published January 5 in the Biophysical Journal. The peptide was potent against a range of cholesterol-containing viruses, including West Nile, dengue, measles, and HIV.

Published
06 January 2016
From
Medical Xpress
Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.

Published
05 January 2016
From
Gilead press release
A quarter of people with HCV initially refused access to sofosbuvir/lepidasvir, says US study, but most successfully appeal

Insurers deny almost a quarter of requests for sofosbuvir/lepidasvir (Harvoni) to treat people with chronic hepatitis C virus (HCV) infection, investigators from Yale Liver Center report in

Published
29 December 2015
By
Michael Carter

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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.