Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

Gilead Sciences107 enrolled

Overview

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Hepatitis C Virus Infection

Interventions

SOF/VELDRUG

400/100 mg fixed-dose combination (FDC) tablet administered orally once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * HCV RNA ≥ 10\^4 IU/mL at screening * HCV genotype 1, 2, 3, 4, 5, 6 * Cirrhosis determination, a fibroscan or liver biopsy may be required * HIV-1 infection * Use of protocol specified method(s) of contraception * Screening laboratory values within defined thresholds Key Exclusion Criteria: * Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol * Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers) * Screening ECG with clinically significant abnormalities * Pregnant or nursing female or male with pregnant female partner * Infection with hepatitis B virus (HBV) * Use of any prohibited concomitant medications as described in the protocol * Chronic use of systemically administered immunosuppressive agents NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Locations (15)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

San Diego, California, United States

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

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 Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

Time frame: Posttreatment Weeks 4 and 24

Percentage of Participants With HCV RNA < LLOQ on Treatment

Time frame: Up to 12 Weeks

HCV RNA Change From Baseline/Day 1

Time frame: Baseline to Week 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

Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment

Data from ClinicalTrials.gov

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