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NCT Number: NCT02480712

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.

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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 3

Primary location

Birmingham, Alabama, United States

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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:

  • HCV RNA ≥ 10^4 IU/mL at screening
  • HCV genotype 1, 2, 3, 4, 5, 6
  • Cirrhosis determination, a fibroscan or liver biopsy may be required
  • HIV-1 infection
  • Use of protocol specified method(s) of contraception
  • Screening laboratory values within defined thresholds

Key Exclusion Criteria:

  • Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
  • Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers)
  • Screening ECG with clinically significant abnormalities
  • Pregnant or nursing female or male with pregnant female partner
  • Infection with hepatitis B virus (HBV)
  • Use of any prohibited concomitant medications as described in the protocol
  • Chronic use of systemically administered immunosuppressive agents

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Treatment and study plan

SOF/VEL

Drug

400/100 mg fixed-dose combination (FDC) tablet administered orally once daily

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

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

    Time frame: Posttreatment Week 12

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    Time frame: Posttreatment Weeks 4 and 24

    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

  2. Percentage of Participants With HCV RNA < LLOQ on Treatment

    Time frame: Up to 12 Weeks

  3. HCV RNA Change From Baseline/Day 1

    Time frame: Baseline to Week 12

  4. Percentage of Participants With Virologic Failure

    Time frame: Up to Posttreatment Week 24

    Virologic failure was defined as:

    • On-treatment virologic failure:
    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ 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:
    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit

  5. Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment

    Time frame: Up to 12 Weeks

  6. Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12

    Time frame: Week 12; Posttreatment Week 12

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

Acronym: ASTRAL-5

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2015
Registry last updated
Nov 16, 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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