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

Phase 2CompletedNCT01987453

Gilead Sciences100 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

HCV Infection

Interventions

LDV/SOFDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (43)

Unnamed facility

Beverly Hills, California, United States

Unnamed facility

La Jolla, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.

Time frame: Post-treatment Week 12

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time frame: Up to 24 Weeks

Secondary Outcomes

Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.

Time frame: Posttreatment Weeks 4 and 24

Percentage of Participants With HCV RNA < LLOQ While on Treatment

Time frame: Baseline to Week 24

Change in HCV RNA From Baseline

Time frame: Baseline to Week 8

Percentage of Participants With Virologic Failure

Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit confirmed with 2 consecutive values or last available posttreatment measurement

Time frame: Up to posttreatment Week 24