Phase 2
Completed N=359
Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
Source: ClinicalTrials.gov NCT01826981 ↗Enrolled (actual)
359
Serious AEs
3.6%
Results posted
Sep 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 100; 90; 100; 100 percentage of participants
Summary
The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
100; 90; 100; 100; 64.0; 100 | — |
| PRIMARY Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
0; 0; 4.0; 0; 4.0; 0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment |
100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24) |
100.0; 100.0; 100.0; 100.0; 72.0; 100.0 | — |
| SECONDARY For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20) |
100; 100 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Experiencing Viral Relapse |
0; 10.0; 0; 0; 33.3; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic genotype 1, 2, 3, or 6 HCV infection
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
- Pregnant or nursing female or male with pregnant female partner
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
Data sourced from ClinicalTrials.gov (NCT01826981). 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.