NCT01604850

Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)

A Phase 3, Multicenter, Randomized, Double-Blind, Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	SOF	Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
DRUG	RBV	Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
DRUG	Placebo to match SOF	Placebo to match SOF was administered orally once daily.
DRUG	Placebo to match RBV	Placebo to match RBV was administered orally twice daily.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-02-01
• Completion: 2013-05-01
• First posted: 2012-05-24
• Last updated: 2014-05-28
• Results posted: 2014-05-01

Locations

67 sites across 4 countries: United States, Canada, New Zealand, Puerto Rico