Overview

Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Ribavirin
Sofosbuvir
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.