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The Tolerability of Sof/VEL for 12 Weeks in >1000 Patients Treated in the ASTRAL-1, ASTRAL-2, and ASTRAL-3 Studies: An Integrated Safety Analysis
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"Gilead filed the NDA for SOF/VEL on October 28, 2015, and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016."
http://www.natap.org/2016/HCV/010516_02.htm
Reported by Jules Levin
DDW 2016 May 22-24 San Diego, CA
DDW: Sofosbuvir/Velpatasvir for 12 Weeks Results in High SVR12 Rates in Patients With Negative Predictors of Response to Treatment: an Integrated Analysis of Efficacy From the ASTRAL-1, ASTRAL-2, and ASTRAL-3 Studies - (06/06/16)
High Efficacy of Sofosbuvir/Velpatasvir Across 7 HCV Genotypes and 46 Subtypes: Pooled Data From the ASTRAL1, 2 and 3 Trials (12/14/15)
High Efficacy of Sofosbuvir/Velpatasvir In HCV Genotypes 1-6 Infected Patients With Cirrhosis: Pooled Data From the ASTRAL 1, 2 and 3 Trials (12/14/15)
Mitchell L. Shiffman1, Norbert Brau2, Stefan Bourgeois3, Philippe Mathurin4, Paul J. Thuluvath5, W Jeffrey Fessel6, Stephen Ryder11, Guido Gerken7, Graham R. Foster8, Ira M. Jacobson9, Lin Liu10, Xiao Ding10, John McNally10, Anu Osinusi10, Chester Grabowski10, Scott Moon10, Diana Brainard10, Mani Subramanian10
1Bon Secours Virginia Health System, Richmond, Virginia, United States; 10Gilead Sciences, Foster City, California, United States; 11Queen's Medical Centre Campus, Nottingham, United Kingdom; 2VA Medical Center, Bronx, New York, United States; 3Campus Stuivenberg, Antwerp, Belgium; 4Centre Hospitalier Universitaire de Lille and Université Nord de France, Lille, France;
5Institute for Digestive Health and Liver Disease, Baltimore, Maryland, United States; 6Kaiser Permanente, San Francisco, California, United States; 7Medizinisches Zentrum - Klinik fur Gastroenterologie und Hepatologie, Essen, Germany; 8Queen Mary University of London, London, United Kingdom; 9Mount Sinai Beth Israel Medical Center, New York, New York, United States
Su1415
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