This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
Unnamed facility
Clermont-Ferrand, France
Unnamed facility
Clichy, France
Unnamed facility
Limoges, France
Unnamed facility
Toulouse, France
Unnamed facility
Villejuif, France
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 LDV/SOF Due to an Adverse Event
Time frame: Up to 12 weeks
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 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 Patients With Virologic Failure
Virologic failure was defined as either: * 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 * Relapse: * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment
Time frame: Up to posttreatment Week 24
Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12
Time frame: Baseline; Weeks 2, 4, 8, and 12
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