Clinical trial NCT02781558: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-05-24
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event
timeFrame: Posttreatment Week 12
Secondary outcomes:
measure: Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)
timeFrame: Posttreatment Week 4
measure: Percentage of Participants Who Have HCV RNA < LLOQ at Week 2
timeFrame: Week 2
measure: Percentage of Participants Who Have HCV RNA < LLOQ at Week 4
timeFrame: Week 4
measure: Percentage of Participants Who Have HCV RNA < LLOQ at Week 8
timeFrame: Week 8
measure: Percentage of Participants Who Have HCV RNA < LLOQ at Week 12
timeFrame: Week 12
measure: HCV RNA at Week 2
timeFrame: Week 2
measure: HCV RNA at Week 4
timeFrame: Week 4
measure: HCV RNA at Week 8
timeFrame: Week 8
measure: HCV RNA at Week 12
timeFrame: Week 12
measure: Change From Baseline in HCV RNA at Week 2
timeFrame: Baseline; Week 2
measure: Change From Baseline in HCV RNA at Week 4
timeFrame: Baseline; Week 4
measure: Change From Baseline in HCV RNA at Week 8
timeFrame: Baseline; Week 8
measure: Change From Baseline in HCV RNA at Week 12
timeFrame: Baseline; Week 12
measure: Percentage of Participants With Virologic Failure
timeFrame: Up to Posttreatment Week 12
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
city: Alicante
country: Spain
facility: Hospital General Universitario De Alicante
city: Almeria
country: Spain
facility: Complejo Hospitalario Torrecárdenas
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitario Valle Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Barcelona
country: Spain
facility: Servei de d'Aparell Digestiu Corporació Sanitària Parc Taulí
city: Cordoba
country: Spain
facility: Reina Sofía University Hospital
city: Coruna
country: Spain
facility: Hospital Universitario de A Coruña
city: Madrid
country: Spain
facility: Hospital Puerta De Hierro Majadahonda
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Murcia
country: Spain
facility: Hospital Universitario Virgen De La Arrixaca
city: Oviedo
country: Spain
facility: Hospital Universitario Central de asturias
city: Pontevedra
country: Spain
facility: Complexo Hospitalario Universitario de Montecelo
city: San Sebastian
country: Spain
facility: Hospital Universitario Donostia
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Univ. NuestraSeñora Candelaria
city: Sevilla
country: Spain
facility: Hospital de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario
city: Valencia
country: Spain
facility: Hospital General Valencia
city: Valencia
country: Spain
facility: La Fe Hospital
city: Vigo
country: Spain
facility: Hospital Universitario Alvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Esteban R, Pineda JA, Calleja JL, Casado M, Rodriguez M, Turnes J, Morano Amado LE, Morillas RM, Forns X, Pascasio Acevedo JM, Andrade RJ, Rivero A, Carrion JA, Lens S, Riveiro-Barciela M, McNabb B, Zhang G, Camus G, Stamm LM, Brainard DM, Subramanian GM, Buti M. Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis. Gastroenterology. 2018 Oct;155(4):1120-1127.e4. doi: 10.1053/j.gastro.2018.06.042. Epub 2018 Jun 27.