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Completed

NCT Number: 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

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.

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Key information

Conditions

Hepatitis C Virus Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SOF/VEL

Drug

400/100 mg FDC tablet administered orally once daily

Other names: GS-7977/GS-5816, Epclusa®

RBV

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 24, 2016
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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