Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6 (ATOMIC)

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01329978

P7977-0724

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.

Enrollment: 332 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate
• Naive to previous HCV treatment

Exclusion criteria

• Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
• History of any other clinically significant chronic liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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332 participants in 3 patient groups

SOF+PEG+RBV 12 weeks

Experimental group

Description:

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

Treatment:

Drug: RBV

Drug: Sofosbuvir

Drug: PEG

SOF+PEG+RBV 24 weeks

Experimental group

Description:

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

Treatment:

Drug: RBV

Drug: Sofosbuvir

Drug: PEG

SOF+PEG+RBV 12 week/Rerandomization Group

Experimental group

Description:

Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks.

Treatment:

Drug: RBV

Drug: Sofosbuvir

Drug: PEG