Hepatitis C Virus Clinical Trial
Official title:
A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1, and an Open Label Assessment of PSI-7977 in Patients With HCV Genotypes 2 or 3
Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to
receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated
interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to
an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV
RNA level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in
a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA <
lower limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks
of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.
Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir
400 mg plus PEG+RBV for 12 weeks.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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