The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
400/100 mg tablet administered orally once daily
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Reina Sofía University Hospital
Córdoba, Spain
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
Time frame: Up to 12 weeks
Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Time frame: Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 2
Time frame: Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 4
Time frame: Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 8
Time frame: Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 12
Time frame: Week 12
HCV RNA at Week 2
Time frame: Week 2
HCV RNA at Week 4
Time frame: Week 4
HCV RNA at Week 8
Time frame: Week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Ramón Y Cajal
Madrid, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
La Fe Hospital
Valencia, Spain
Hospital Clinico Zaragoza
Zaragoza, Spain
Universität Bern
Bern, Switzerland
University Hospital Zurich
Zurich, Switzerland
...and 5 more locations
HCV RNA at Week 12
Time frame: Week 12
Change From Baseline in HCV RNA at Week 2
Time frame: Baseline; Week 2
Change From Baseline in HCV RNA at Week 4
Time frame: Baseline; Week 4
Change From Baseline in HCV RNA at Week 8
Time frame: Baseline; Week 8
Change From Baseline in HCV RNA at Week 12
Time frame: Baseline; Week 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 on 2 consecutive measurements 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 12 weeks of treatment) Virologic relapse: * HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement
Time frame: Up to Posttreatment Week 12