This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
324
Sustained virologic response (SVR) defined as undetectable HCV RNA 24 weeks after treatment cessation
Time frame: 24 weeks of off-treatment follow-up
Safety and tolerability of therapy as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse events
Time frame: Through up to 48 weeks treatment period and 24 weeks of off-treatment follow-up
Emergence of viral resistance following initiation of therapy with GS-9190 and GS-9256
Time frame: Through up to 48 weeks treatment period, 24 weeks of off-treatment follow-up, and up to 48 weeks of follow-up in the Resistance Registry Substudy
Viral dynamics and steady state pharmacokinetics of GS-9190 and GS-9256 when administered in combination with PEG and RBV; measured by HCV RNA levels and plasma concentrations of GS-9190 and GS-9256 over time
Time frame: Through Week 4 of therapy
Long-term assessment of plasma HCV RNA in subjects who achieve SVR
Plasma HCV RNA will be measured at approximately 6, 12, 24, and 36 months after Week 72.
Time frame: 36 months following Week 72
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks
placebo matching GS-9190 capsule BID, 24 weeks
GS-9256 capsule, 150 mg BID, 24 weeks
peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks
ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks
placebo matching GS-9190 capsule BID, 24 weeks
placebo matching GS-9256 capsule BID, 24 weeks
peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks
ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), 48 weeks
Mayo Clinic
Phoenix, Arizona, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Scripps Clinic
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Medical Associates Research Group
San Diego, California, United States
Kaiser Permanente
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
South Denver Gastroenterology
Englewood, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Miami Center for Liver Diseases
Miami, Florida, United States
...and 104 more locations