Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

Gilead Sciences333 enrolled

Overview

The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

333

Conditions

Hepatitis C Virus Infection

Interventions

SOF/VEL/VOX

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Willing and able to provide written informed consent * HCV RNA ≥ 10\^4 IU/mL at screening * Chronic HCV infection (≥ 6 months) * Treatment experienced with a direct acting antiviral medication not including a NS5A Inhibitor for HCV * Use of protocol specified methods of contraception Key Exclusion Criteria: * Current or prior history of clinically significant illness that may interfere with participation in the study * Screening ECG with clinically significant abnormalities * Laboratory results outside of acceptable ranges at screening * Pregnant or nursing female * Chronic liver disease not caused by HCV * Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (78)

Unnamed facility

Long Beach, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Palo Alto, California, United States

Unnamed facility

Pasadena, California, United States

Unnamed facility

Rialto, California, United States

Unnamed facility

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) at 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

Percentage of Participants Who Permanently Discontinue 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 SVR24 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 On Treatment

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

Change From Baseline in HCV RNA

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

Percentage of Participants With Virologic Failure

* 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