Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

Phase 2CompletedNCT01909804

Gilead Sciences323 enrolled

Overview

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

323

Conditions

Hepatitis C

Interventions

SOFDRUG

400 mg tablet administered orally once daily

VELDRUG

Tablet administered orally once daily

RBVDRUG

200 mg 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

Inclusion Criteria: * Body mass index (BMI) ≥ 18 kg/m\^2 * HCV RNA ≥ 10000 IU/mL at screening * Prior treatment failure to a regimen including interferon with or without RBV * HCV genotype 1 or 3 * Chronic HCV infection * Cirrhosis determination * Use of highly effective contraception methods if female of childbearing potential or sexually active male Exclusion Criteria: * Current or prior history of clinically significant illness other than HCV * Screening ECG with clinically significant abnormalities * Prior exposure to HCV specific direct acting antiviral agent * Pregnant or nursing female or male with pregnant female partner * Chronic liver disease of non-HCV etiology * Hepatitis B * Active drug abuse * Use of any prohibited concomitant medications

Locations (49)

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 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 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 24

Data from ClinicalTrials.gov

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Long Beach, California, United States

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Los Angeles, California, United States

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Pasadena, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

...and 39 more locations