Phase 3
Completed N=647
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
Chronic Hepatitis C Virus
Source: ClinicalTrials.gov NCT01851330 ↗
Enrolled (actual)
647
Serious AEs
1.6%
Results posted
Dec 2014
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 94.0; 93.1; 96.3 percentage of participants — p=<0.001
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 in treatment-naive participants with chronic genotype 1 HCV infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
94.0; 93.1; 96.3 | <0.001 sig |
| PRIMARY Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug |
0; 0.9; 0.9 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
96.3; 94.9; 96.3; 94.0; 93.1; 96.3 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 2 |
88.4; 91.1; 91.2 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 4 |
100.0; 99.1; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 8 |
100.0; 100.0; 99.5 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 2 |
-5.06; -5.01; -4.99 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 4 |
-5.12; -5.05; -5.05 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 8 |
-5.12; -5.05; -5.04 | — |
| SECONDARY Percentage of Participants Experiencing Virologic Failure |
0; 0; 0; 5.1; 4.2; 1.4 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 18, with chronic genotype 1 HCV infection
- HCV treatment-naive
- HCV RNA > 10, 000 IU/mL at screening
- 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
- Presence of cirrhosis
- 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 subject treatment, assessment or compliance with the protocol
Data sourced from ClinicalTrials.gov (NCT01851330). 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.