The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
90/400 mg fixed- dose combination (FDC) tablet administered orally once daily
Massachusetts General Hospital
Boston, Massachusetts, United States
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method.
Time frame: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Time frame: First dose date up to Week 24
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.
Time frame: Posttreatment Week 4
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA \< LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.
Time frame: Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
The total number of participants with HCV RNA \< LLOQ was the sum of the number of participants with HCV RNA "\< LLOQ detected" plus the number of participants with HCV RNA "\< LLOQ target not detected (TND)". LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.
Time frame: Weeks 2, 4, 6, 8, 12, 16, 20, 24
HCV RNA
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Henry Ford Health System
Detroit, Michigan, United States
James J. Peters VA Hospital
The Bronx, New York, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Texas Liver Institute/American Research Corporation
San Antonio, Texas, United States
University of Washington/Harborview Medical Center
Seattle, Washington, United States
CUB Hopital Erasme
Brussels, Belgium
Cliniques Universitaires UCL Saint-Luc
Brussels, Belgium
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, Germany
Universitatsklinikum Hamburg-Eppendorf (UKE), Zentrum fur Innere Medizin - Studienambulanz Hepatol.
Hamburg, Germany
...and 11 more locations
Time frame: Weeks 2, 4, 6, 8, 12, 16, 20, 24
Change From Baseline in HCV RNA
Time frame: Weeks 2, 4, 6, 8, 12, 16, 20, 24
Percentage of Participants With 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: Baseline up to Posttreatment Week 24
Percentage of Participants Who Developed Resistance to LDV and SOF
Time frame: Baseline up to Posttreatment Week 24
Pharmacokinetics (PK) Parameter: AUCtau of LDV
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Time frame: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
PK Parameter: AUCtau of SOF
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Time frame: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Time frame: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
PK Parameter: Cmax of LDV
Cmax is defined as the population PK derived maximum concentration of the drug.
Time frame: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
PK Parameter: Cmax of SOF
Cmax is defined as the population PK derived maximum concentration of the drug.
Time frame: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
Cmax is defined as the population PK derived maximum concentration of the drug.
Time frame: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))