Phase 3 Study of Sofosbuvir and Ribavirin (FISSION)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Sofosbuvir; Drug: PEG; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01497366

P7977-1231

Details and patient eligibility

About

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.

Enrollment: 527 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Genotype 2 or 3 HCV-infection
• Naive to all HCV antiviral treatment(s)

Exclusion criteria

• Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab
• History of any other clinically significant chronic liver disease
• A history consistent with decompensated liver disease
• History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study.
• Participation in a clinical study within 3 months prior to first dose

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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527 participants in 2 patient groups

Sofosbuvir+RBV

Experimental group

Description:

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

Treatment:

Drug: Sofosbuvir

Drug: RBV

PEG+RBV

Active Comparator group

Description:

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

Treatment:

Drug: PEG

Drug: RBV