The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.
Time frame: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
Time frame: First dose date up to Week 12
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ 4 weeks after stopping study treatment.
Time frame: Posttreatment Week 4
Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA \< LLOQ 24 weeks after stopping study treatment.
Time frame: Posttreatment Week 24
Change From Baseline in HCV RNA
Time frame: Baseline; Weeks 2, 4, 6, 8, and 12
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time frame: Weeks 2, 4, 6, 8, and 12
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
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Kaye Edmonton Clinic
Edmonton, Alberta, Canada
Gordon and Leslie Diamond Health Care Center, Vancouver General Hospital, UBC Division of Gastroenterology
Vancouver, British Columbia, Canada
William Osler Health System- Brampton Civic Hospital
Brampton, Ontario, Canada
Hamilton Health Sciences - McMaster University Medical Centre Site
Hamilton, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
Montreal, Quebec, Canada
Shaare Zedek Medical Center
Jerusalem, Israel
The Chaim Sheba Medical Centre
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
...and 12 more locations
Time frame: Baseline to Posttreatment Week 24
Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment
Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was \> 1000 IU/mL.
Time frame: First dose date up to Posttreatment Week 24
Pharmacokinetic (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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: AUCtau of VEL
AUCtau is defined as the population PK derived area under the concentration verses 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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Cmax of VEL
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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Ctau of VEL
Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose.
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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))