The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
90/400 mg FDC tablet administered orally once daily
Unnamed facility
Berlin, Germany
Unnamed facility
Bonn, Germany
Unnamed facility
Frankfurt am Main, Germany
Unnamed facility
London, United Kingdom
Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Time frame: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 6 weeks
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)
SVR4 was defined as HCV RNA \< LLOQ 4 weeks after the last dose of study drug.
Time frame: Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time frame: Weeks 2, 4, and 6
Change From Baseline in HCV RNA at Weeks 2, 4, and 6
Time frame: Baseline; Weeks 2, 4, and 6
Percentage of Participants With Virologic Failure
Virologic failure was defined as: * On-treatment virologic failure * confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment (ie, breakthrough), * confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), * HCV RNA persistently ≥ LLOQ through end of treatment (ie, nonresponse) * Relapse * HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
Time frame: Up to Posttreatment Week 12
Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.
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Participants with HIV virologic rebound was defined as participants with at least two HIV RNA ≥ 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates.
Time frame: Day 1; Week 6
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
Time frame: Weeks 2, 4, 6, and Posttreatment Week 4
Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4
Time frame: Baseline; Week 6; Posttreatment Week 4