Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection

Phase 3CompletedNCT02220998

Gilead Sciences269 enrolled

Overview

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

269

Conditions

Hepatitis C Virus Infection

Interventions

SOF/VELDRUG

SOF/VEL (400/100 mg) FDC tablet administered orally once daily

SOFDRUG

SOF 400 mg tablet administered orally once daily

RBVDRUG

RBV 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: * Willing and able to provide written informed consent * HCV RNA ≥ 10\^4 IU/mL * HCV genotype 2 * Chronic HCV infection (≥ 6 months) * Females of childbearing potential must have a negative serum pregnancy test * Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception * Must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator. Exclusion Criteria: * Current or prior history of clinically-significant illness (other than HCV that may interfere with treatment, assessment or compliance with the protocol; * Screening electrocardiogram (ECG) with clinically significant abnormalities * Laboratory results outside of acceptable ranges at Screening * Pregnant or nursing female or male with pregnant female partner * Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis) * Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Locations (51)

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 HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12

Time frame: Weeks 1, 2, 4, 6, 8, 10, and 12

Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12

Time frame: Baseline; Weeks 1, 2, 4, 6, 8, 10, 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 24

Data from ClinicalTrials.gov

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Long Beach, California, United States

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