Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

Phase 2CompletedNCT02202980

Gilead Sciences273 enrolled

Overview

This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

273

Conditions

Chronic Hepatitis C

Interventions

LDV/SOFDRUG

90/400 mg FDC tablet administered orally once daily

RBVDRUG

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)

SOF/VELDRUG

400/100 mg FDC tablet administered orally once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Willing and able to provide written informed consent * Chronic HCV infection * Cirrhosis determination (liver biopsy may be required) * Screening laboratory values within specified limits * Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception * Specific genotype, prior medical history, or concurrent disease as required by the specific study group Key Exclusion Criteria: * History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol * Pregnant or nursing female, or male with pregnant female partner * Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) * Use of any prohibited concomitant medications Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (2)

Unnamed facility

Auckland, New Zealand

Unnamed facility

Christchurch, New Zealand

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 24 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

Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit

Time frame: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)

Data from ClinicalTrials.gov

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