The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 332
- Locations
- 46
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SOF+PEG+RBV 12 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.
Intervention: Sofosbuvir (Drug)
SOF+PEG+RBV 12 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.
Intervention: RBV (Drug)
SOF+PEG+RBV 12 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.
Intervention: PEG (Drug)
SOF+PEG+RBV 24 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.
Intervention: Sofosbuvir (Drug)
SOF+PEG+RBV 24 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.
Intervention: RBV (Drug)
SOF+PEG+RBV 24 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.
Intervention: PEG (Drug)
SOF+PEG+RBV 12 week/Rerandomization Group
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.
Intervention: Sofosbuvir (Drug)
SOF+PEG+RBV 12 week/Rerandomization Group
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.
Intervention: RBV (Drug)
SOF+PEG+RBV 12 week/Rerandomization Group
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.
Intervention: PEG (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)
Time Frame: Post-treatment Week 24
SVR24 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 24 weeks after the last dose of study drug.
Percentage of Participants Who Experienced Adverse Events
Time Frame: Baseline (Day 1) to post-treatment Day 30
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Secondary Outcomes
- Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)(Post-treatment Week 12)
- Change in HCV RNA at Week 2(Baseline (Day 1) to Week 2)
- Change in HCV RNA at Week 4(Baseline (Day 1) to Week 4)
- Change in HCV RNA at Week 8(Baseline (Day 1) to Week 8)
- Change in HCV RNA at Week 12(Baseline (Day 1) to Week 12)
- Percentage of Participants With HCV RNA < LOD at Week 2(Week 2)
- Percentage of Participants With HCV RNA Below < LOD at Week 4(Week 4)
- Percentage of Participants With HCV RNA Below < LOD at Week 8(Week 8)
- Percentage of Participants With ALT Normalization at Week 12(Baseline (Day 1) to Week 12)
- Percentage of Participants With HCV RNA Below < LOD at Week 12(Week 12)
- Percentage of Participants With HCV RNA Below < LOD at Week 24(Week 24)
- Percentage of Participants With ALT Normalization at Week 24(Baseline (Day 1) to Week 24)
- Percentage of Participants With ALT Normalization at Post-treatment Week 4(Baseline (Day 1) to Post-treatment Week 4)
- Percentage of Participants With Virologic Failure During Treatment(Baseline (Day 1) to Week 24)
- Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).(End of treatment to Post-treatment Week 24)