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

October 30, 2018 updated by: Gilead Sciences

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alcorcon, Spain
        • Hospital Universitario Fundacion Alcorcon
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Almeria, Spain
        • Complejo Hospitalario Torrecardenas
      • Badalona, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital Clinic de Barcelona
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Universitari de Bellvitge
      • Barcelona, Spain, 8035
        • Hospital Universitario Valle Hebron
      • Barcelona, Spain
        • Servei de d'Aparell Digestiu Corporació Sanitària Parc Taulí
      • Cordoba, Spain
        • Reina Sofia University Hospital
      • Coruna, Spain
        • Hospital Universitario de A Coruña
      • Madrid, Spain
        • Hospital Ramón Y Cajal
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Puerta de Hierro Majadahonda
      • Malaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Murcia, Spain
        • Hospital Universitario Virgen de La Arrixaca
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Pontevedra, Spain
        • Complexo Hospitalario Universitario de Montecelo
      • San Sebastian, Spain
        • Hospital Universitario Donostia
      • Santa Cruz de Tenerife, Spain
        • Hospital Univ. NuestraSeñora Candelaria
      • Sevilla, Spain
        • Hospital Universitario Virgen Del Rocio
      • Sevilla, Spain
        • Hospital De Valme
      • Valencia, Spain
        • La Fe Hospital
      • Valencia, Spain
        • Hospital Clinico Universitario
      • Valencia, Spain
        • Hospital General Valencia
      • Vigo, Spain
        • Hospital Universitario Álvaro Cunqueiro
      • Zaragoza, Spain
        • Hospital Clinico Universitario
    • Cantabria
      • Santander, Cantabria, Spain
        • Hospital Universitario Marques de Valdecilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOF/VEL
SOF/VEL FDC for 12 weeks
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Experimental: SOF/VEL + RBV
SOF/VEL FDC + RBV for 12 weeks
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
Time Frame: 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.
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
Posttreatment Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV RNA at Week 2
Time Frame: Week 2
Week 2
HCV RNA at Week 4
Time Frame: Week 4
Week 4
HCV RNA at Week 8
Time Frame: Week 8
Week 8
HCV RNA at Week 12
Time Frame: Week 12
Week 12
Change From Baseline in HCV RNA at Week 2
Time Frame: Baseline; Week 2
Baseline; Week 2
Change From Baseline in HCV RNA at Week 4
Time Frame: Baseline; Week 4
Baseline; Week 4
Change From Baseline in HCV RNA at Week 8
Time Frame: Baseline; Week 8
Baseline; Week 8
Change From Baseline in HCV RNA at Week 12
Time Frame: Baseline; Week 12
Baseline; Week 12
Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)
Time Frame: 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.
Posttreatment Week 4
Percentage of Participants Who Have HCV RNA < LLOQ at Week 2
Time Frame: Week 2
Week 2
Percentage of Participants Who Have HCV RNA < LLOQ at Week 4
Time Frame: Week 4
Week 4
Percentage of Participants Who Have HCV RNA < LLOQ at Week 8
Time Frame: Week 8
Week 8
Percentage of Participants Who Have HCV RNA < LLOQ at Week 12
Time Frame: Week 12
Week 12
Percentage of Participants With Virologic Failure
Time Frame: 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
Up to Posttreatment Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2016

Primary Completion (Actual)

October 6, 2017

Study Completion (Actual)

October 27, 2017

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 20, 2016

First Posted (Estimate)

May 24, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

October 30, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-342-2097
  • 2016-000417-73 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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