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Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02073656
First received: February 25, 2014
Last updated: August 30, 2016
Last verified: August 2016

February 25, 2014
August 30, 2016
February 2014
November 2014   (final data collection date for primary outcome measure)
  • Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
  • Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
  • Incidence of adverse events leading to permanent discontinuation of study drug(s) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02073656 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
  • Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12 [ Time Frame: Weeks 1, 2, 4, 6, 8, 10, and 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8 [ Time Frame: Baseline; Weeks 1, 2, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ] [ Designated as safety issue: No ]

    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.
  • Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment [ Time Frame: Weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24 [ Time Frame: Baseline; Week 12, Posttreatment Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24) [ Time Frame: Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy ] [ Designated as safety issue: No ]
    SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively.
  • For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24 [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy ] [ Designated as safety issue: No ]
  • For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8 [ Time Frame: Baseline; Weeks 2, 4, and 8 of Retreatment Substudy ] [ Designated as safety issue: No ]
  • For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 of Retreatment Substudy ] [ Designated as safety issue: No ]

    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.
  • Proportion of participants with sustained virologic response at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR24 is defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
  • Proportion of participants with HCV RNA < LLOQ on treatment [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in HCV RNA from baseline [ Time Frame: Baseline to posttreatment Week 24 ] [ Designated as safety issue: No ]
  • Proportion of participants with virologic failure [ Time Frame: Baseline to posttreatment Week 24 ] [ Designated as safety issue: No ]
    Virologic failure is defined as virologic breakthrough (participant achieved undetectable HCV RNA levels during treatment but subsequently had detectable HCV RNA while continuing treatment), nonresponse (HCV RNA ≥ LLOQ through 12 weeks of treatment), or relapse (participant achieved undetectable HCV RNA levels during treatment maintained undetectable HCV RNA for the duration of treatment or achieved undetectable HCV RNA within 4 weeks of the end of treatment but did not achieve SVR at 4, 12, or 24 weeks posttreatment).
  • For retreatment group only: Proportion of participants with sustained virologic response at 4, 12 and 24 weeks after discontinuation of therapy (SVR4, SVR12, and SVR24) [ Time Frame: Posttreatment Weeks 4, 12, and 24 ] [ Designated as safety issue: No ]
  • Proportion of participants that maintain HIV-1 RNA < 50 copies/mL while on treatment [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline of serum creatinine at end of treatment, posttreatment weeks 12 and 24 [ Time Frame: Week 12 and posttreatment weeks 12 and 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1.

Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C Virus
  • HIV
  • Drug: LDV/SOF
    90/400 mg FDC tablet administered orally once daily
    Other Names:
    • Harvoni®
    • GS-5885/GS-7977
  • 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)
  • Experimental: LDV/SOF 12 Weeks
    LDV/SOF for 12 weeks
    Intervention: Drug: LDV/SOF
  • Experimental: Retreatment Substudy
    LDV/SOF plus RBV for 24 weeks
    Interventions:
    • Drug: LDV/SOF
    • Drug: RBV

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
335
December 2015
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HCV RNA ≥ 10,000 IU/mL at screening
  • HCV genotype 1 or 4
  • HIV-1 infection
  • Cirrhosis determination, a fibroscan or liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject 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)
  • Hepatitis B virus (HBV) infection
  • Pregnant or nursing female
  • Chronic use of systemically administered immunosuppressive agents
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   New Zealand,   Puerto Rico
 
NCT02073656
GS-US-337-0115
Yes
Not Provided
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Jenny Yang, PharmD Gilead Sciences
Gilead Sciences
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP