NCT01188772

Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Sofosbuvir tablets were administered orally once daily.
DRUG	Placebo to match sofosbuvir	Placebo tablets to match sofosbuvir were administered orally once daily.
DRUG	PEG	Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.
DRUG	RBV	Ribavirin (RBV) was administered as a tablet orally according to package insert dosing recommendations (Genotype 1: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg; Genotype 2/3: 800 mg).

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-04-01
• Completion: 2012-05-01
• First posted: 2010-08-25
• Last updated: 2014-04-21
• Results posted: 2014-02-19

Locations

23 sites across 2 countries: United States, Puerto Rico