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Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection

Primary Purpose

Hepatitis C Infection With HIV Co-Infection

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LDV/SOF

About this trial

This is an interventional treatment trial for Hepatitis C Infection With HIV Co-Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Acute, untreated, hepatitis C infection, genotype 1 or 4, with an estimated duration less than 24 weeks
Confirmed HIV-1 infection
CD4 T cell count >200/μL for individuals receiving antiretroviral therapy (ART), CD4 T cell count > 500/μL at screening for individuals without ART
Use of two effective contraception methods if female of childbearing potential or sexually active male with female partner

Key Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
Chronic liver disease of a non HCV etiology
Coinfection with hepatitis B virus (HBV)
Treatment with any investigational drug or device within 60 days of the screening visit.
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LDV/SOF

Arm Description

LDV/SOF FDC for 6 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)

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

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

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)

SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug.

Percentage of Participants With HCV RNA < LLOQ on Treatment

Change From Baseline in HCV RNA at Weeks 2, 4, and 6

Percentage of Participants With Virologic Failure

Virologic failure was defined as: On-treatment virologic failure confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough), confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently ≥ LLOQ through end of treatment (ie, nonresponse) Relapse HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement

Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.

Participants with HIV virologic rebound was defined as participants with at least two HIV RNA ≥ 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates.

Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4

Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4

Full Information

NCT ID

NCT02457611

First Posted

May 27, 2015

Last Updated

October 19, 2018

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02457611

Brief Title

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection

Official Title

Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Infection With HIV Co-Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LDV/SOF

Arm Type

Experimental

Arm Description

LDV/SOF FDC for 6 weeks

Intervention Type

Drug

Intervention Name(s)

LDV/SOF

Other Intervention Name(s)

Harvoni®, GS-5885/GS-7977

Intervention Description

90/400 mg FDC tablet administered orally once daily

Primary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)

Description

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

Time Frame

Posttreatment Week 12

Title

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

Time Frame

Up to 6 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)

Description

SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug.

Time Frame

Posttreatment Week 4

Title

Percentage of Participants With HCV RNA < LLOQ on Treatment

Time Frame

Weeks 2, 4, and 6

Title

Change From Baseline in HCV RNA at Weeks 2, 4, and 6

Time Frame

Baseline; Weeks 2, 4, and 6

Title

Percentage of Participants With Virologic Failure

Description

Time Frame

Up to Posttreatment Week 12

Title

Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.

Description

Time Frame

Day 1; Week 6

Title

Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4

Time Frame

Weeks 2, 4, 6, and Posttreatment Week 4

Title

Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4

Time Frame

Baseline; Week 6; Posttreatment Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Acute, untreated, hepatitis C infection, genotype 1 or 4, with an estimated duration less than 24 weeks Confirmed HIV-1 infection CD4 T cell count >200/μL for individuals receiving antiretroviral therapy (ART), CD4 T cell count > 500/μL at screening for individuals without ART Use of two effective contraception methods if female of childbearing potential or sexually active male with female partner Key Exclusion Criteria: Pregnant or nursing female or male with pregnant female partner Chronic liver disease of a non HCV etiology Coinfection with hepatitis B virus (HBV) Treatment with any investigational drug or device within 60 days of the screening visit. History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol Note: Other protocol defined Inclusion/Exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

City

Berlin

Country

Germany

City

Bonn

Country

Germany

City

Frankfurt am Main

Country

Germany

City

London

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

http://www.gilead.com/research/disclosure-and-transparency

Citations:

PubMed Identifier

28397698

Citation

Rockstroh JK, Bhagani S, Hyland RH, Yun C, Dvory-Sobol H, Zheng W, Brainard DM, Ingiliz P, Lutz T, Boesecke C, Nelson M. Ledipasvir-sofosbuvir for 6 weeks to treat acute hepatitis C virus genotype 1 or 4 infection in patients with HIV coinfection: an open-label, single-arm trial. Lancet Gastroenterol Hepatol. 2017 May;2(5):347-353. doi: 10.1016/S2468-1253(17)30003-1. Epub 2017 Mar 1.

Results Reference

derived

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