This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
421
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Placebo to match SOF administered orally once daily
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
Time frame: Posttreatment Week 12
Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.
Time frame: Up to 24 weeks
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 was defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
Time frame: Posttreatment Weeks 4 and 24
Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA \> LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA \< LLOQ) while on treatment. Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
Time frame: Up to Posttreatment Week 24
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Placebo to match RBV administered orally in a divided daily dose
Medizinische Universitat Graz
Graz, Austria
Medizinische Universitat Wien
Vienna, Austria
Wilhelminenspital
Vienna, Austria
West Tallinn Central Hospital
Tallinn, Estonia
Tartu University Hospital
Tartu, Estonia
CHRU de Lille, Hopital Claude Huriez
CHRU Lille, France
CHU Estaing
Clermont-Ferrand, France
Hopital Beaujon
Clichy, France
Hopital Henri Mondor
Créteil, France
Département Hépatogastroentérologie - CHU de Grenoble
Grenoble, France
...and 67 more locations