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New and experimental hepatitis C treatment news

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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
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
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