NCT01641640

Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection

A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Sofosbuvir 400 mg tablet administered orally once daily
DRUG	RBV	Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
DRUG	PEG	Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-01-01
• Completion: 2013-04-01
• First posted: 2012-07-17
• Last updated: 2014-05-08
• Results posted: 2014-05-08

Locations

56 sites across 2 countries: United States, Puerto Rico