Phase 3 Study of Sofosbuvir and Ribavirin

(FISSION Trial)

Recruiting in Palo Alto (17 mi)

+96 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Gilead Sciences

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.

Research Team

Eligibility Criteria

Inclusion Criteria

Chronic Genotype 2 or 3 HCV-infection

Naive to all HCV antiviral treatment(s)

Treatment Details

Interventions

• PEG (Interferon)
• Ribavirin (Anti-viral)
• Sofosbuvir (Anti-viral)

Participant Groups

Group I: Sofosbuvir+RBV Experimental Treatment 2 Interventions

Participants were randomized to receive sofosbuvir+RBV for 12 weeks.

Group II: PEG+RBV Active Control 2 Interventions

Participants were randomized to receive PEG+RBV for 24 weeks.

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine