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

Hepatitis C Virus Infection Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781558
• Other study ID #: GS-US-342-2097
• Secondary ID: 2016-000417-73
• Status: Completed
• Phase: Phase 2
• Start date: July 29, 2016
• Est. completion date: October 27, 2017

Study information

• Verified date: October 2018
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: October 27, 2017
• Est. primary completion date: October 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis C
• Hepatitis C Virus Infection
• Infection
• Virus Diseases

Intervention

Drug:
• SOF/VEL
400/100 mg FDC tablet administered orally once daily
• RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and = 75 kg = 1200 mg)

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundacion Alcorcon	Alcorcon
Spain	Hospital General Universitario De Alicante	Alicante
Spain	Complejo Hospitalario Torrecárdenas	Almeria
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Universitario Valle Hebron	Barcelona
Spain	Servei de d'Aparell Digestiu Corporació Sanitària Parc Taulí	Barcelona
Spain	Reina Sofía University Hospital	Cordoba
Spain	Hospital Universitario de A Coruña	Coruna
Spain	Hospital Puerta De Hierro Majadahonda	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Malaga
Spain	Hospital Universitario Virgen De La Arrixaca	Murcia
Spain	Hospital Universitario Central de asturias	Oviedo
Spain	Complexo Hospitalario Universitario de Montecelo	Pontevedra
Spain	Hospital Universitario Donostia	San Sebastian
Spain	Hospital Univ. NuestraSeñora Candelaria	Santa Cruz de Tenerife
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital de Valme	Sevilla
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Clinico Universitario	Valencia
Spain	Hospital General Valencia	Valencia
Spain	La Fe Hospital	Valencia
Spain	Hospital Universitario Alvaro Cunqueiro	Vigo
Spain	Hospital Clinico Universitario	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Posttreatment Week 12
Primary	Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event		Posttreatment Week 12
Secondary	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.	Posttreatment Week 4
Secondary	Percentage of Participants Who Have HCV RNA < LLOQ at Week 2		Week 2
Secondary	Percentage of Participants Who Have HCV RNA < LLOQ at Week 4		Week 4
Secondary	Percentage of Participants Who Have HCV RNA < LLOQ at Week 8		Week 8
Secondary	Percentage of Participants Who Have HCV RNA < LLOQ at Week 12		Week 12
Secondary	HCV RNA at Week 2		Week 2
Secondary	HCV RNA at Week 4		Week 4
Secondary	HCV RNA at Week 8		Week 8
Secondary	HCV RNA at Week 12		Week 12
Secondary	Change From Baseline in HCV RNA at Week 2		Baseline; Week 2
Secondary	Change From Baseline in HCV RNA at Week 4		Baseline; Week 4
Secondary	Change From Baseline in HCV RNA at Week 8		Baseline; Week 8
Secondary	Change From Baseline in HCV RNA at Week 12		Baseline; Week 12
Secondary	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	Up to Posttreatment Week 12