Ledipasvir-Sofosbuvir OK for Transplant Recipients With Hepatitis C

HealthDay News — For kidney transplant recipients with hepatitis C virus (HCV) genotype 1 or 4 infection, treatment with ledipasvir-sofosbuvir (Harvoni) for 12 or 24 weeks is safe and efficacious, according to a study published online Nov 15 in the Annals of Internal Medicine. Massimo Colombo, MD, from Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan, and colleagues conducted a randomized phase 2 trial to examine the safety and efficacy

AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C

- New extended-release formulation is the first all-oral, co-formulated treatment containing the three direct-acting antiviral components of VIEKIRA PAK® for adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection - The approval marks another milestone in AbbVie's ongoing commitment to therapeutic innovation for people living with GT1 HCV NORTH CHICAGO, Ill., July 25, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global bi...

Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, 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...

FDA Approves Expanded Use of 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 recurrenceFriday, February 5, 2016 12:47 pm EST--PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza™ (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without r

European Commission Approves Daklinza (daclatasvir) for the Treatment of Genotype 1, 3 and 4 Chronic Hepatitis C

European Commission Approves Daklinza (daclatasvir) for the Treatment of Genotype 1, 3 and 4 Chronic Hepatitis C Patients with HIV Coinfection, Advanced Cirrhosis and Post-liver Transplant Recurrence of HCVUpdated label provides additional treatment options for multiple HCV patient populations, including difficult-to-treat patients with decompensated cirrhosisHIV/HCV coinfected patients experience more rapid fibrosis progression than mono-infected HCV pati

FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4

January 28, 2016 - The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparen