Phase 2
Completed N=101
Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection
Chronic HCV Infection
Source: ClinicalTrials.gov NCT01984294 ↗
Enrolled (actual)
101
Serious AEs
2.0%
Results posted
May 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 88.6; 90.6; 81.8 percentage of participants
Summary
This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment, approximately 60 having had prior treatment with a regimen containing pegylated interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus treatment-experienced and by HCV genotype (1a versus 1b).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
88.6; 90.6; 81.8 | — |
| PRIMARY Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event |
0; 3.1; 0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24) |
100.0; 100.0; 97.0; 91.4; 90.6; 84.8 | — |
| SECONDARY Percentage of Participants Experiencing On-treatment Virologic Failure |
0; 0; 0 | — |
| SECONDARY Percentage of Participants Experiencing Viral Relapse |
11.4; 9.4; 18.2 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18, with chronic genotype 1 HCV infection
- Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen
- HCV RNA > 10, 000 IU/mL at Screening
- Presence of compensated cirrhosis
- 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
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- 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 (NCT01984294). 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.