147
Participants
Start Date
August 31, 2010
Primary Completion Date
April 30, 2011
Study Completion Date
May 31, 2012
Sofosbuvir
Sofosbuvir tablets were administered orally once daily.
Placebo to match sofosbuvir
Placebo tablets to match sofosbuvir were administered orally once daily.
PEG
Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.
RBV
Ribavirin (RBV) was administered as a tablet orally according to package insert dosing recommendations (Genotype 1: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg; Genotype 2/3: 800 mg).
Alabama Liver and Digestive Specialists, Montgomery
Advanced Clinical Research Institute, Anaheim
SCTI Research Foundation, Coronado
Cedars Sinai Medical Center, Los Angeles
Dr. Jay Lalezari, San Francisco
Dr. Natalie Bzowej, San Francisco
Dr. David Nelson, Gainesville
Orlando Immunology Center, Orlando
Gastrointestinal Specialists of Georgia, Marietta
University of Chicago, Chicago
Dr. Mark Sulkowski, Lutherville
Liver Research Center Beth Israel Deaconess Medical Center, Boston
Kansas City Gastroenterology and Hepatology, Kansas City
Dr. Bruce Bacon, St Louis
North Shore University Hospital, Manhasset
Dr. Ira Jacobson, New York
Mount Sinai School of Medicine, New York
Dr. Jama Darling, Chapel Hill
Dr. Raj Reddy, Philadelphia
Columbia Gastroenterology and Liver Associates, Columbia
Dr. Eric Lawitz, San Antonio
Digestive Disease Institute Virginia Mason Medical Center, Seattle
Fundacion de Investigacion de Diego, Santurce
Lead Sponsor
Gilead Sciences
INDUSTRY