The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy. Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
416
400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food
Tablet administered orally once daily with food
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)
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 Discontinued Study Drug Due to an Adverse Event (Primary Study)
Time frame: Up to 12 weeks
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment, respectively.
Time frame: Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
Time frame: Weeks 1, 2, 4, 8 and 12
Change From Baseline in HCV RNA (Primary Study)
Time frame: Baseline; Weeks 1, 2, 4, 8 and 12
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Time frame: Posttreatment Week 24
Percentage of Participants With Virologic Failure (Primary Study)
Virologic failure is 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.
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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
San Diego, California, United States
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San Francisco, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Englewood, Colorado, United States
Unnamed facility
Washington D.C., District of Columbia, United States
...and 76 more locations
Time frame: Up to Posttreatment Week 24
Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)
SVR4, SVR12 and SVR24 was defined as HCV RNA \< LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively.
Time frame: Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)
Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
Time frame: Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)
Change From Baseline in HCV RNA (Deferred Treatment Substudy)
Time frame: Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)
Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)
Virologic failure is 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 (Deferred Treatment Substudy)