Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis

Gilead Sciences37 enrolled

Overview

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Virus Infection

Interventions

SOF/VELDRUG

Tablets administered orally once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Chronic HCV-infected males and non-pregnant/non-lactating females * Treatment-naïve or treatment-experienced individuals * Compensated cirrhosis at Screening Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (22)

Chiba University Hospital

Chiba, Japan

Fukui-ken Saiseikai Hospital

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)

SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug

TEAEs were defined as any AEs with an onset date on or after the study drug start and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of the study drug.

Time frame: First dose date up to Week 12.1

Secondary Outcomes

Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4)

SVR4 was defined as HCV RNA \< LLOQ (i.e.15 IU/mL) at 4 weeks after stopping study treatment.

Time frame: Posttreatment Week 4

Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24)

SVR24 was defined as HCV RNA \< LLOQ (i.e.15 IU/mL) at 24 weeks after stopping study treatment.

Time frame: Posttreatment Week 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 IL/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 end of treatment.

Data from ClinicalTrials.gov

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