Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection

Gilead Sciences111 enrolled

Overview

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection * Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1. * Cirrhosis determination by Fibroscan * Screening laboratory values within defined thresholds * Use of two effective contraception methods if female or male is of childbearing potential Key Exclusion Criteria: * Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol * Pregnant or nursing female * Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV) * Hepatocellular carcinoma (HCC) or other malignancy * Current or prior history of clinical hepatic decompensation Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (8)

Unnamed facility

Changhua, Taiwan

Unnamed facility

Chiayi City, Taiwan

Unnamed facility

Kaohsiung City, Taiwan

Unnamed facility

Keelung, Taiwan

Unnamed facility

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 quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug

Time frame: First dose date 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 (15 IU/mL) at 4 weeks after stopping study treatment.

Time frame: Posttreatment Week 4

Percentage of Participants With HCV RNA < LLOQ While on Treatment

LLOQ = 15 IU/mL

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

Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108

LLOQ = 15 IU/mL

Time frame: Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108

HCV RNA Change From Baseline While on Treatment

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

Percentage of Participants With Virologic Failure

Virologic failure was defined as : * Breakthrough (confirmed HCV RNA ≥ LLOQ \[15 IU/mL\] 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), or * Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)

Data from ClinicalTrials.gov

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