Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection

Gilead Sciences111 enrolled

Overview

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

111

Conditions

Hepatitis C Virus Infection

Interventions

LDV/SOFDRUG

90/400 mg FDC tablet administered orally once daily

RBVDRUG

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Chronic genotype 3 HCV infection * HCV treatment-naive * HCV RNA \> 10,000 IU/mL at screening * Absence of cirrhosis or compensated cirrhosis * Screening laboratory values within defined thresholds * Use of two effective contraception methods if female of childbearing potential or sexually active male Key Exclusion Criteria: * Pregnant or nursing female or male with pregnant female partner * Coinfection with HIV or hepatitis B virus (HBV) * Current or prior history of clinical hepatic decompensation * Chronic use of systemic immunosuppressive agents * History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (15)

Unnamed facility

Calgary, Alberta, Canada

Unnamed facility

Edmonton, Alberta, Canada

Unnamed facility

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

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

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 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 SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.

Time frame: Posttreatment Week 4

Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12

Time frame: Weeks 1, 2, 4, 8, and 12

Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12

Time frame: Baseline; Weeks 1, 2, 4, 8, and 12

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.

Time frame: Up to Posttreatment Week 12

Data from ClinicalTrials.gov

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