SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Peg-IFN; Drug: RBV; Drug: SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01962441

2013-002641-11 (EudraCT Number)

GS-US-334-0153

Details and patient eligibility

About

This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.

Enrollment: 601 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female, age greater than or equal to 18 years.
• Confirmed chronic HCV infection.
• Subjects will have cirrhosis status assessment; liver biopsy may be required.
• Genotype 2 subjects must have cirrhosis of the liver to be eligible.
• Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event
• Infection with HCV genotype 2 or 3 as determined at Screening
• Body mass index (BMI) greater than or equal to 18 kg/m^2
• Screening laboratory values within predefined thresholds.
• Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.
• Subject must be of generally good health as determined by the Investigator.

Key Exclusion Criteria:

• Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase
• Pregnant or nursing female or male with pregnant female partner
• History of any other clinically significant chronic liver disease.
• HIV or chronic hepatitis B virus (HBV) infection.
• Malignancy with the exception of certain resolved skin cancers.
• Chronic use of systemically administered immunosuppressive agents.
• Clinically-relevant drug or alcohol abuse.
• History of solid organ transplantation.
• Current or prior history of clinical hepatic decompensation.
• History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
• Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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601 participants in 4 patient groups

SOF+RBV 16 weeks

Experimental group

Description:

SOF+RBV for 16 weeks

Treatment:

Drug: SOF

Drug: RBV

SOF+RBV 24 weeks

Experimental group

Description:

SOF+RBV for 24 weeks

Treatment:

Drug: SOF

Drug: RBV

SOF+RBV+Peg-IFN 12 weeks

Experimental group

Description:

SOF+RBV+Peg-IFN for 12 weeks

Treatment:

Drug: SOF

Drug: Peg-IFN

Drug: RBV

Retreatment Substudy

Experimental group

Description:

Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 weeks.

Treatment:

Drug: SOF

Drug: Peg-IFN

Drug: RBV