Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis

Phase 2

Completed

• Conditions: Hepatitis C Virus Infection
• Interventions: Drug: SOF/VEL; Drug: RBV

• Registration Number: NCT02781558
• Lead Sponsor: Gilead Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-24
• Study Start: 2016-07-29
• Primary Completion: 2017-10-06
• Study Completion: 2017-10-27
• Status Verified: 2018-10
• Results First Submitted: 2018-10-04
• Results First Submitted QC: 2018-10-04
• Results First Posted: 2018-10-30
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• Willing and able to provide written informed consent
• Individuals with chronic genotype 3 HCV infection and compensated cirrhosis
• Individuals with or without HIV-1 coinfection

Key

Exclusion Criteria

• History of clinically significant illness or any other medical disorder that may interfere with individual's treatment assessment or compliance with the protocol
• Co-infection with active hepatitis B virus
• Laboratory results outside the acceptable ranges at screening
• Pregnant or nursing female
• Chronic liver disease not caused by HCV

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOF/VEL + RBV	SOF/VEL	SOF/VEL FDC + RBV for 12 weeks
SOF/VEL	SOF/VEL	SOF/VEL FDC for 12 weeks
SOF/VEL + RBV	RBV	SOF/VEL FDC + RBV for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event	Posttreatment Week 12

Secondary Outcome Measures

Name	Time	Method
HCV RNA at Week 2	Week 2
Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)	Posttreatment Week 4	SVR4 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.
Percentage of Participants Who Have HCV RNA < LLOQ at Week 2	Week 2
Percentage of Participants Who Have HCV RNA < LLOQ at Week 4	Week 4
Percentage of Participants Who Have HCV RNA < LLOQ at Week 8	Week 8
Percentage of Participants Who Have HCV RNA < LLOQ at Week 12	Week 12
HCV RNA at Week 4	Week 4
HCV RNA at Week 8	Week 8
HCV RNA at Week 12	Week 12
Change From Baseline in HCV RNA at Week 2	Baseline; Week 2
Change From Baseline in HCV RNA at Week 4	Baseline; Week 4
Change From Baseline in HCV RNA at Week 8	Baseline; Week 8
Change From Baseline in HCV RNA at Week 12	Baseline; Week 12
Percentage of Participants With Virologic Failure	Up to Posttreatment Week 12	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

Trial Locations

Locations (27)

Hospital Universitario Donostia; 🇪🇸 San Sebastian, Spain

Hospital Universitario Virgen De La Arrixaca; 🇪🇸 Murcia, Spain

Complexo Hospitalario Universitario de Montecelo; 🇪🇸 Pontevedra, Spain

Hospital General Valencia; 🇪🇸 Valencia, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Servei de d'Aparell Digestiu Corporació Sanitària Parc Taulí; 🇪🇸 Barcelona, Spain

Hospital Universitario de A Coruña; 🇪🇸 Coruna, Spain

Hospital Puerta De Hierro Majadahonda; 🇪🇸 Madrid, Spain

Hospital Clinico Universitario; 🇪🇸 Zaragoza, Spain

La Fe Hospital; 🇪🇸 Valencia, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Complejo Hospitalario Torrecárdenas; 🇪🇸 Almeria, Spain

Reina Sofía University Hospital; 🇪🇸 Cordoba, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Malaga, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital General Universitario De Alicante; 🇪🇸 Alicante, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Hospital Universitario Fundacion Alcorcon; 🇪🇸 Alcorcon, Spain

Hospital Universitario Valle Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital de Valme; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen Del Rocio; 🇪🇸 Sevilla, Spain

Hospital Universitario Central de asturias; 🇪🇸 Oviedo, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Univ. NuestraSeñora Candelaria; 🇪🇸 Santa Cruz de Tenerife, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Universitario Alvaro Cunqueiro; 🇪🇸 Vigo, Spain