This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
248
GS-5885 30 mg tablet administered orally once daily
GS-9451 200 mg tablet administered orally once daily
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Sustained virologic response (SVR)
Sustained virologic response (SVR, defined as plasma HCV RNA \< lower limit of quantification \[LLoQ\] at 24 weeks after treatment cessation) following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 or 12 weeks, or PEG/RBV for 24 weeks in IL28B CC subjects.
Time frame: 30 , 36 or 48 weeks
Safety and tolerability of therapy
Safety and tolerability of the therapy is measured by frequency of laboratory abnormalities , reported adverse events and discontinuations due to adverse events.
Time frame: Up to 48 weeks
Virologic response
Virologic response at Weeks 2, 4, 6, 8, 10, and 12 (depending on treatment arm) as measured by the rates of HCV RNA \< LLoQ and viral breakthrough and relapse
Time frame: Weeks 2, 4, 6, 8, 10, and 12
Compare SVR
Compare SVR following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 weeks versus 12 weeks.
Time frame: Weeks 30 and 36
Viral resistance
Characterize viral resistance to GS-5885 and GS-9451 when administered in combination with PEG/RBV
Time frame: Up to 96 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Axis Clinical Trials
Los Angeles, California, United States
Axis Clinical Trials
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
V.A. Greater Los Angeles Healthcare System
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
Research and Education, Inc.
San Diego, California, United States
San Jose Gastroenterology
San Jose, California, United States
Stanford University
Stanford, California, United States
South Denver Gastroenterology
Englewood, Colorado, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
...and 45 more locations