Phase 2
Completed N=100
Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
Chronic Hepatitis C Virus
Source: ClinicalTrials.gov NCT01726517 ↗
Enrolled (actual)
100
Serious AEs
4.0%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) — 95.0; 100.0; 94.7; 94.7 percentage of participants
Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
95.0; 100.0; 94.7; 94.7; 100.0 | — |
| PRIMARY Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24) |
100.0; 100.0; 100.0; 94.7; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse |
0; 0; 0; 0; 0; 5.0 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years, with chronic genotype 1 HCV infection
- HCV RNA equal to or greater than 10,000 IU/mL at screening
- 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
- Current or prior history of clinical hepatic decompensation
- 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 subject treatment, assessment or compliance with the protocol
Data sourced from ClinicalTrials.gov (NCT01726517). 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.