Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection

Phase 3CompletedNCT01975675

Gilead Sciences341 enrolled

Overview

This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

341

Conditions

Chronic HCV Infection

Interventions

LDV/SOFDRUG

LDV/SOF 90/400 mg FDC tablet administered orally once daily

RBVDRUG

RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Body weight ≥ 40 kg * HCV RNA ≥ 10\^5 IU/mL at screening Exclusion Criteria: * Current or prior history of any clinically-significant illness (other than HCV) * Pregnant or nursing female or male with pregnant female partner * Chronic liver disease of a non-HCV etiology * Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Locations (19)

Unnamed facility

Ichikawa, Chiba, Japan

Unnamed facility

Kurume, Fukuoka, Japan

Unnamed facility

Ōgaki, Gifu, Japan

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

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

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

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

Time frame: Up to 12 weeks

Secondary Outcomes

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

SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Time frame: Posttreatment Weeks 4 and 24

Percentage of Participants Experiencing 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.

Time frame: Up to Posttreatment Week 24

Data from ClinicalTrials.gov

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