Phase 2
Completed N=100
Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
HCV Infection
Source: ClinicalTrials.gov NCT01987453 ↗
Enrolled (actual)
100
Serious AEs
6.0%
Results posted
Jan 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 98.0; 70.7; 100.0 Percentage of participants
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
98.0; 70.7; 100.0 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
5.9; 0; 0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
98.0; 73.2; 100.0; 98.0; 70.7; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ While on Treatment |
23.5; 31.7; 0; 98.0; 95.1; 100.0 | — |
| SECONDARY Change in HCV RNA From Baseline |
-4.47; -4.40; -3.75; -5.07; -5.06; -4.47 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0; 2.4; 0; 2.0; 27.5; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Willing and able to provide written informed consent
- Infection with HCV genotype 1
- HCV RNA > LLOQ at screening
- Participation in a prior Gilead-sponsored study
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
- Must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
- Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Key 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 (Groups 1 and 2 only)
- Hepatocellular carcinoma (HCC)
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01987453). 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.