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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-22

Study Completion Date

2018-11-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C Virus Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LDV/SOF

LDV/SOF FDC for 12 weeks

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

90/400 mg FDC tablet administered orally once daily

Interventions

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LDV/SOF

90/400 mg FDC tablet administered orally once daily

Intervention Type DRUG

Other Intervention Names

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Harvoni® GS-5885/GS-7977

Eligibility Criteria

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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

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No