Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: RBV; Drug: Placebo to match RBV; Drug: Placebo to match SOF; Drug: SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01682720

2012-001942-16 (EudraCT Number)

GS-US-334-0133

Details and patient eligibility

About

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

Enrollment: 421 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 with chronic genotype 2 or 3 HCV infection
• HCV RNA > 10,000 IU/mL at screening
• Subjects must be treatment naive or treatment experienced
• Presence or absence of cirrhosis; a liver biopsy may be required
• Healthy according to medical history and physical examination with the exception of HCV diagnosis
• Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication

Exclusion criteria

• Prior use of any other inhibitor of the HCV NS5B Polymerase
• History of any other clinically significant chronic liver disease
• Evidence of or history of decompensated liver disease
• HIV or chronic hepatitis B virus (HBV) infection
• Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
• Chronic use of immunosuppressive agents or immunomodulatory agents
• History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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421 participants in 3 patient groups, including a placebo group

Placebo 12 Weeks (GT2/3)

Placebo Comparator group

Description:

Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.

Treatment:

Drug: Placebo to match RBV

Drug: Placebo to match SOF

SOF 12 Weeks (GT2/3)

Experimental group

Description:

Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.

Treatment:

Drug: SOF

Drug: RBV

SOF 24 Weeks (GT3)

Experimental group

Description:

SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.

Treatment:

Drug: SOF

Drug: RBV