Phase 3
Completed N=441
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
Chronic Hepatitis C Virus
Source: ClinicalTrials.gov NCT01768286 ↗
Enrolled (actual)
441
Serious AEs
2.1%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 93.6; 96.4; 99.1; 99.1 percentage of participants — p=<0.001
Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 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) |
93.6; 96.4; 99.1; 99.1 | <0.001 sig |
| PRIMARY Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
94.5; 96.4; 100.0; 99.1; 93.6; 96.4 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 1 |
26.6; 33.3; 20.2; 29.7 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 2 |
81.7; 82.9; 81.7; 83.8 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 4 |
100.0; 99.1; 99.1; 99.1 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 8 |
100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 12 |
99.1; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 24 |
100.0; 100.0 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 1 |
-4.57; -4.50; -4.47; -4.50 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 2 |
-5.08; -4.94; -4.99; -4.99 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 4 |
-5.16; -5.02; -5.06; -5.04 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 8 |
-5.16; -5.02; -5.06; -5.08 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0; 0; 0; 0.9; 6.5; 3.6 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 18, with chronic genotype 1 HCV infection
- HCV treatment-experienced, including patients who have previously failed a nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV regimen
- HCV RNA > 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
- Coinfection with HIV or hepatitis B virus
- Current or prior history of clinical hepatic decompensation
- Hepatocellular carcinoma 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 (NCT01768286). 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.