This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
351
tablet, 30 mg QD
tablet, 200 mg QD
(solution for injection) 180 µg/week
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Beverly Hills, California, United States
To evaluate the antiviral efficacy of response guided therapy.
To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA \< Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.
Time frame: Through 24 weeks post-treatment
To evaluate the safety and tolerability of each regimen.
The primary safety endpoint is any AE leading to permanent discontinuation of study drugs.
Time frame: Through 24 weeks post-treatment
To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV.
HCV RNA levels, pharmacokinetics and viral sequencing
Time frame: Through Day 10 on study
To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV.
Plasma samples will be collected and stored at each visit for possible resistance analysis.
Time frame: 12 or 24 weeks
To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV.
Plasma concentrations of the study drug over time will be summarized using descriptive statistics.
Time frame: Through 48 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Placebo to match GS-9451 QD
Unnamed facility
Coronado, California, United States
Unnamed facility
Costa Mesa, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Englewood, Colorado, United States
Unnamed facility
Bradenton, Florida, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Baltimore, Maryland, United States
...and 13 more locations