Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-29

Study Completion Date

2016-06-28

Brief Summary

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The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SOF/VEL/VOX

SOF/VEL/VOX for 12 weeks

Group Type EXPERIMENTAL

SOF/VEL/VOX

Intervention Type DRUG

400/100/100 mg FDC tablet administered orally once daily with food

SOF/VEL/VOX + RBV

SOF/VEL/VOX + RBV for 12 weeks

Group Type EXPERIMENTAL

SOF/VEL/VOX

Intervention Type DRUG

400/100/100 mg FDC tablet administered orally once daily with food

RBV

Intervention Type DRUG

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

Interventions

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SOF/VEL/VOX

400/100/100 mg FDC tablet administered orally once daily with food

Intervention Type DRUG

RBV

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

Intervention Type DRUG

Other Intervention Names

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GS-7977/GS-5816/GS-9857 Vosevi®

Eligibility Criteria

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Inclusion Criteria

* Individuals with chronic HCV genotype 1 infection
* Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response
* Absence of cirrhosis or presence of compensated cirrhosis
* Screening laboratory values within defined thresholds
* Must use specific contraceptive methods if female of childbearing potential or sexually active male

Exclusion Criteria

* Co-infection 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 individual's treatment, assessment or compliance with the protocol
* Pregnant or a nursing female

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No