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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

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ClinicalTrials.gov Identifier: NCT02781558
Recruitment Status : Completed
First Posted : May 24, 2016
Results First Posted : October 30, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: SOF/VEL Drug: RBV Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 29, 2016
Actual Primary Completion Date : October 6, 2017
Actual Study Completion Date : October 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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:
  • GS-7977/GS-5816
  • Epclusa®

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:
  • GS-7977/GS-5816
  • Epclusa®

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)




Primary Outcome Measures :
  1. 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.

  2. 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 ]

Secondary Outcome Measures :
  1. 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.

  2. Percentage of Participants Who Have HCV RNA < LLOQ at Week 2 [ Time Frame: Week 2 ]
  3. Percentage of Participants Who Have HCV RNA < LLOQ at Week 4 [ Time Frame: Week 4 ]
  4. Percentage of Participants Who Have HCV RNA < LLOQ at Week 8 [ Time Frame: Week 8 ]
  5. Percentage of Participants Who Have HCV RNA < LLOQ at Week 12 [ Time Frame: Week 12 ]
  6. HCV RNA at Week 2 [ Time Frame: Week 2 ]
  7. HCV RNA at Week 4 [ Time Frame: Week 4 ]
  8. HCV RNA at Week 8 [ Time Frame: Week 8 ]
  9. HCV RNA at Week 12 [ Time Frame: Week 12 ]
  10. Change From Baseline in HCV RNA at Week 2 [ Time Frame: Baseline; Week 2 ]
  11. Change From Baseline in HCV RNA at Week 4 [ Time Frame: Baseline; Week 4 ]
  12. Change From Baseline in HCV RNA at Week 8 [ Time Frame: Baseline; Week 8 ]
  13. Change From Baseline in HCV RNA at Week 12 [ Time Frame: Baseline; Week 12 ]
  14. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781558


Locations
Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 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 Universitario Valle Hebron
Barcelona, Spain, 8035
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari de Bellvitge
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 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, Spain
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol: Original  [PDF] March 16, 2016
Study Protocol: Protocol Amendment 1  [PDF] April 4, 2016
Statistical Analysis Plan  [PDF] November 8, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02781558     History of Changes
Other Study ID Numbers: GS-US-342-2097
2016-000417-73 ( EudraCT Number )
First Posted: May 24, 2016    Key Record Dates
Results First Posted: October 30, 2018
Last Update Posted: November 27, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis C
Virus Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Ribavirin
Sofosbuvir
Sofosbuvir-velpatasvir drug combination
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents