Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV

Phase 3

Completed

Brief Summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

Recruitment & Eligibility

Inclusion Criteria

Willing and able to provide written informed consent
HCV RNA ≥ 10^4 IU/mL at screening
Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)
HCV treatment-naive or treatment-experienced
Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)

Key

Exclusion Criteria

Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug
Pregnant or nursing female or male with pregnant female partner
Chronic liver disease of a non HCV etiology
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Arm && Interventions

Group	Intervention	Description
SOF/VEL	SOF/VEL	SOF/VEL FDC for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HCV RNA < LLOQ On Treatment	Weeks 1, 2, 4, 6, 8, 10, and 12
Change From Baseline in HCV RNA	Baseline and up to Week 12
Percentage of Participants With Overall Virologic Failure	Up to Posttreatment Week 24	Virologic failure was defined as: (1) 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) or (2) Virologic relapse: confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)	Posttreatment Week 4	SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)	Posttreatment Week 24	SVR 24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.

Locations (38): Beijing Ditan Hospital
🇨🇳
Chaoyang, Beijing, China
Nanfang Hospital of Southern Medical University
🇨🇳
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University
🇨🇳
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳
Nanning, Guangxi, China
Tongji Hospital Affiliated to Tongji Medicine University
🇨🇳
Wuhan, Hubei, China
Xiangyan Hospital, Central South University
🇨🇳
Changsha, Hunan, China
Shanghai Public Health Clinical Center
🇨🇳
Hongkou, Shanghai, China
Shanghai Ruijin Hospital
🇨🇳
Huangpu, Shanghai, China
West China Hospital, Sichuan University
🇨🇳
Chengdu, Sichuan, China
Peking University First Hospital
🇨🇳
Beijing, China
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Beijing Ditan Hospital
🇨🇳Chaoyang, Beijing, China