Phase 2
N=332
Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01329978 ↗Enrolled (actual)
332
Serious AEs
3.6%
Results posted
May 2014
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) — 90.4; 92.7; 91.0; 93.3 percentage of participants — p=0.77
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sofosbuvir (Drug); RBV (Drug); PEG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) |
90.4; 92.7; 91.0; 93.3; 94.7 | 0.77 |
| PRIMARY Percentage of Participants Who Experienced Adverse Events |
98.1; 96.8; 98.7; 98.7; 100.0; 96.2 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) |
90.4; 92.0; 91.0; 93.3; 94.7 | — |
| SECONDARY Change in HCV RNA at Week 2 |
-5.12; -5.07; -5.13 | — |
| SECONDARY Change in HCV RNA at Week 4 |
-5.33; -5.19; -5.24 | — |
| SECONDARY Change in HCV RNA at Week 8 |
-5.34; -5.17; -5.25 | — |
| SECONDARY Change in HCV RNA at Week 12 |
-5.36; -5.20; -5.25 | — |
| SECONDARY Percentage of Participants With HCV RNA < LOD at Week 2 |
68.6; 85.5; 77.1 | — |
| SECONDARY Percentage of Participants With HCV RNA Below < LOD at Week 4 |
98.0; 100.0; 98.7 | — |
| SECONDARY Percentage of Participants With HCV RNA Below < LOD at Week 8 |
100.0; 100.0; 99.3 | — |
| SECONDARY Percentage of Participants With HCV RNA Below < LOD at Week 12 |
100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA Below < LOD at Week 24 |
100.0; 100.0; 98.6 | — |
| SECONDARY Percentage of Participants With ALT Normalization at Week 12 |
78.3; 76.6; 67.6 | — |
| SECONDARY Percentage of Participants With ALT Normalization at Week 24 |
78.9; 94.3; 100.0 | — |
| SECONDARY Percentage of Participants With ALT Normalization at Post-treatment Week 4 |
89.5; 87.2; 95.2; 91.7; 100.0 | — |
| SECONDARY Percentage of Participants With Virologic Failure During Treatment |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse). |
5.9; 1.6; 3.9; 2.7; 2.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01329978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.