Phase 2
Completed N=292
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
Chronic Hepatitis C Infection
Source: ClinicalTrials.gov NCT01260350 ↗
Enrolled (actual)
292
Serious AEs
3.1%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Participants Who Experienced Adverse Events — 10; 9; 10; 11 Percentage of participants
Summary
This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced Adverse Events |
10; 9; 10; 11; 10; 10 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) |
100.0; 100.0; 100.0; 100.0; 60.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LOD at Week 6 |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LOD at Week 8 |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LOD at Week 12 |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 6 |
-5.52; -5.44; -5.23; -5.20; -6.23; -4.94 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 8 |
-5.52; -5.44; -5.23; -5.20; -4.59; -4.94 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 12 |
-5.52; -5.44; -5.23; -5.20; -4.59; -5.70 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic Genotype 2 or 3 HCV-infection or Genotype 1, serum HCV RNA ≥ 50,000 IU/mL
- Not co-infected with HIV
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
- History of any other clinically significant chronic liver disease
- Pregnant or nursing female or male with pregnant female partner
- History of significant drug allergy to nucleoside/nucleotide analogs.
- Participation in a clinical study within 3 months prior to first dose
- Positive result for significant drug use at Screening
Data sourced from ClinicalTrials.gov (NCT01260350). 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. Informational only — not medical advice.