Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.
15 July 2016 | Treatment Action Group
The combination of sofosbuvir and velpatasvir (SOF/VEL) for 12 weeks was authorized for use in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). SOF/VEL is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Physicians also have the flexibility to consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.
08 July 2016 | Gilead press release
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.
05 July 2016 | Healio
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.
04 July 2016 | HIVandHepatitis.com
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.
30 May 2016 | MSD press release
Epclusa is Gilead’s Third Sofosbuvir-Based Treatment to Receive a CHMP Positive Opinion for the Treatment of Chronic HCV Infection.
27 May 2016 | Gilled press relase
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.
08 February 2016 | Fair Pricing Coalition
Updated label provides new treatment option for patients with HIV-1 coinfection, advanced cirrhosis, and post-liver transplant HCV recurrence.
08 February 2016 | Bristol-Myers Squibb press release
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.
01 February 2016 | Bloomberg
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.
01 February 2016 | CATIE