Phase 2
Completed N=111
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
Source: ClinicalTrials.gov NCT02413593 ↗Enrolled (actual)
111
Serious AEs
3.6%
Results posted
Feb 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 89.2 percentage of participants
Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
89.2 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0.9 | — |
| SECONDARY Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
91.9 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12 |
20.7; 64.9; 97.3; 100.0; 99.1 | — |
| SECONDARY Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 |
-4.33; -4.85; -5.05; -5.06; -5.06 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
7.2 | — |
Eligibility Criteria
Key Inclusion Criteria
- Chronic genotype 3 HCV infection
- HCV treatment-naive
- HCV RNA > 10, 000 IU/mL at screening
- Absence of cirrhosis or compensated cirrhosis
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Key Exclusion Criteria
- Pregnant or nursing female or male with pregnant female partner
- Coinfection 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 the individual's treatment, assessment, or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02413593). 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.