The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
400/100 mg tablet administered orally once daily
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Unnamed facility
Ehime, Japan
Unnamed facility
Hiroshima, Japan
Unnamed facility
Ichikawa-shi, Japan
Unnamed facility
Iruma-gun, Japan
Unnamed facility
Kashihara, Japan
Unnamed facility
Kurume-shi, Japan
Unnamed facility
Kyoto, Japan
Unnamed facility
Maebashi, Japan
Unnamed facility
Musashino-shi, Japan
Unnamed facility
Nagoya, Japan
...and 8 more locations
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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Time frame: Posttreatment Week 4
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR 24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Time frame: Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ at Week 1
Time frame: Week 1
Percentage of Participants With HCV RNA < LLOQ at Week 2
Time frame: Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 3
Time frame: Week 3
Percentage of Participants With HCV RNA < LLOQ at Week 4
Time frame: Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 5
Time frame: Week 5
Percentage of Participants With HCV RNA < LLOQ at Week 6
Time frame: Week 6
Percentage of Participants With HCV RNA < LLOQ at Week 8
Time frame: Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 10
Time frame: Week 10
Percentage of Participants With HCV RNA < LLOQ at Week 12
Time frame: Week 12
Percentage of Participants With HCV RNA < LLOQ at Week 16
Time frame: Week 16
Percentage of Participants With HCV RNA < LLOQ at Week 20
Time frame: Week 20
Percentage of Participants With HCV RNA < LLOQ at Week 24
Time frame: Week 24
Change From Baseline in HCV RNA at Week 1
Time frame: Baseline; Week 1
Change From Baseline in HCV RNA at Week 2
Time frame: Baseline; Week 2
Change From Baseline in HCV RNA at Week 3
Time frame: Baseline; Week 3
Change From Baseline in HCV RNA at Week 4
Time frame: Baseline; Week 4
Change From Baseline in HCV RNA at Week 5
Time frame: Baseline; Week 5
Change From Baseline in HCV RNA at Week 6
Time frame: Baseline; Week 6
Change From Baseline in HCV RNA at Week 8
Time frame: Baseline; Week 8
Change From Baseline in HCV RNA at Week 10
Time frame: Baseline; Week 10
Change From Baseline in HCV RNA at Week 12
Time frame: Baseline; Week 12
Change From Baseline in HCV RNA at Week 16
Time frame: Baseline; Week 16
Change From Baseline in HCV RNA at Week 20
Time frame: Baseline; Week 20
Change From Baseline in HCV RNA at Week 24
Time frame: Baseline; Week 24
Percentage of Participants With Overall 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 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
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