This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
245
Sustained virologic response
Sustained virologic response (SVR) defined as undetectable hepatitis C virus (HCV) RNA 24 weeks after treatment cessation
Time frame: 24 weeks of off-treatment follow-up
Safety and tolerability of therapy
Safety and tolerability of therapy as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse events
Time frame: Through treatment period and 24 weeks of off-treatment follow-up
Emergence of viral resistance following initiation of therapy with GS 9190 and GS 9451
Time frame: Through 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
Viral dynamics and steady state pharmacokinetics of GS 9190 and GS 9451 when administered in combination with PEG and RBV; measured by HCV RNA levels and plasma concentrations of GS-9190 and GS-9451 over time
Time frame: Through Week 4 of therapy
Durability of response in subjects who achieve SVR
Time frame: 36 months following Week 72
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ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
GS-9451 tablet, 200 mg QD
placebo matching Tegobuvir (GS-9190) capsule BID
peginterferon alfa-2a (solution for injection) 180 µg/week
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
placebo matching Tegobuvir (GS-9190) capsule BID
placebo matching GS-9451 tablet QD
peginterferon alfa-2a (solution for injection) 180 µg/week
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Alabama Liver and Digestive Specialists
Montgomery, Alabama, United States
Mayo Clinic
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
eStudySite
Chula Vista, California, United States
Scripps Clinic
La Jolla, California, United States
eStudySite
La Mesa, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Synergy Clinical Research Center
National City, California, United States
...and 134 more locations