Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
- Registration Number
- NCT03036852
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- Chronic HCV infected, male and non-pregnant/non-lactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV co-infection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimen for ≥8 weeks prior to screening.
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SOF/VEL SOF/VEL SOF/VEL for 12 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event First dose date up to Week 12
- Secondary Outcome Measures
Name Time Method PK Parameter: AUCtau of GS-331007 (Metabolite of SOF) 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)) AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Change From Baseline in HCV RNA Baseline; Weeks 2, 4, 6, 8, and 12 Percentage of Participants With HCV RNA < LLOQ on Treatment Weeks 2, 4, 6, 8, and 12 PK Parameter: Cmax of SOF 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)) Cmax is defined as the population PK derived maximum concentration of the drug.
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) Posttreatment Week 4 SVR4 was defined as HCV RNA \< LLOQ 4 weeks after stopping study treatment.
Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) Posttreatment Week 24 SVR24 was defined as HCV RNA \< LLOQ 24 weeks after stopping study treatment.
Percentage of Participants With Virologic Failure Baseline to Posttreatment Week 24 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 visitNumber 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 First dose date up to Posttreatment Week 24 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.
Pharmacokinetic (PK) Parameter: AUCtau of SOF 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)) AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
PK Parameter: AUCtau of VEL 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)) AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval.
PK Parameter: Cmax of GS-331007 (Metabolite of SOF) 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)) Cmax is defined as the population PK derived maximum concentration of the drug.
PK Parameter: Cmax of VEL 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)) Cmax is defined as the population PK derived maximum concentration of the drug.
PK Parameter: Ctau of VEL 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)) 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.
Trial Locations
- Locations (22)
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Auckland City Hospital
🇳🇿Grafton, Auckland, New Zealand
Chelsea and Westminster Hospital
🇬🇧London, United Kingdom
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
🇨🇦Montréal, Quebec, Canada
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Hamilton Health Sciences - McMaster University Medical Centre Site
🇨🇦Hamilton, Ontario, Canada
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Gordon and Leslie Diamond Health Care Center, Vancouver General Hospital, UBC Division of Gastroenterology
🇨🇦Vancouver, British Columbia, Canada
Barts Health NHS Trust
🇬🇧London, United Kingdom
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Kaye Edmonton Clinic
🇨🇦Edmonton, Alberta, Canada
Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
William Osler Health System- Brampton Civic Hospital
🇨🇦Brampton, Ontario, Canada
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
The Chaim Sheba Medical Centre
🇮🇱Ramat Gan, Israel
Hospital Universitario Puerta de Hierro - Majadahonda
🇪🇸Majadahonda, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Gartnavel General Hospital
🇬🇧Glasgow, United Kingdom