The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection and compensated cirrhosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event
Time frame: Posttreatment Week 12
Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)
SVR4 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.
Time frame: Posttreatment Week 4
Percentage of Participants Who Have HCV RNA < LLOQ at Week 2
Time frame: Week 2
Percentage of Participants Who Have HCV RNA < LLOQ at Week 4
Time frame: Week 4
Percentage of Participants Who Have HCV RNA < LLOQ at Week 8
Time frame: Week 8
Percentage of Participants Who Have 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Universitario de A Coruña
A Coruña, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, Spain
Hospital General Universitario De Alicante
Alicante, Spain
Complejo Hospitalario Torrecárdenas
Almería, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Universitario Valle Hebron
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
...and 18 more locations
HCV RNA at Week 8
Time frame: Week 8
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 8 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