Phase 3
Completed N=687
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection
Chronic HCV Infection
Source: ClinicalTrials.gov NCT02021643 ↗
Enrolled (actual)
687
Serious AEs
2.3%
Results posted
Feb 2018
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 95.5; 100; 100; 94.2 percentage of participants
◆ Published Evidence
Established
30citations · ~3 / year
A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus.
Summary
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.
Linked Publications (3)
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A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus.
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Sofosbuvir plus ribavirin for the treatment of patients with chronic genotype 1 or 6 hepatitis C virus infection in Hong Kong.
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A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
95.5; 100; 100; 94.2; 96.8; 95.2 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
1; 1; 0; 2 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
96.8; 100; 100; 94.2; 97.5; 97.6 | — |
| SECONDARY Percentage of Participants With On-Treatment Virologic Failure |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
7; 0; 0; 6; 6; 6 | — |
| SECONDARY Change From Baseline in HCV RNA (log10 IU/mL) |
-4.81; -4.59; -4.36; -4.61; -4.46; -4.52 | — |
Eligibility Criteria
Key Inclusion Criteria
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- HCV treatment-naive (HCV genotype 1, 2, 3 or 6), defined as no prior exposure to any interferon (IFN), RBV, or other approved or experimental HCV-specific direct-acting antiviral agent, or HCV treatment-experienced (HCV genotype 1, 2, 3, or 6 only) with medical records that include sufficient detail of prior treatment with IFN to allow for categorization of prior response as either IFN Intolerant, non-responder, or experiences viral breakthrough or relapse
- HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy
Key Exclusion Criteria
- Current or prior history of any clinically-significant illness (other than HCV)
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non-HCV etiology
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02021643) and the linked publication. 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.