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

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
SOF/VEL	SOF/VEL	Participants received SOF/VEL (400/100 mg) orally once daily for up to 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug	First dose date up to Week 12.1	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.
Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)	Posttreatment Week 12	SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4)	Posttreatment Week 4	SVR4 was defined as HCV RNA \< LLOQ (i.e.15 IU/mL) at 4 weeks after stopping study treatment.
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24)	Posttreatment Week 24	SVR24 was defined as HCV RNA \< LLOQ (i.e.15 IU/mL) at 24 weeks after stopping study treatment.
Percentage of Participants With Virologic Failure	First dose date up to posttreatment Week 24	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.

Locations (22): Chiba University Hospital
🇯🇵
Chiba, Japan
Fukui-ken Saiseikai Hospital
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Fukui, Japan
Japanese Red Cross Fukuoka Hospital
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Fukuoka-shi, Japan
Hiroshima University Hospital Institution Review Board
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Hiroshima-shi, Japan
Iizuka Hospital
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Iizuka, Japan
Nippon Medical School Hospital
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Inzai-shi, Japan
Saitama Medical University Hospital
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Iruma, Japan
Juntendo University Shizuoka Hospital
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Izunokuni, Japan
Nara Medical University Hospital
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Kashihara-shi, Japan
Toranomon Hospital Kajigaya
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Kawasaki-shi, Japan
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Chiba University Hospital
🇯🇵Chiba, Japan