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Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

Primary Purpose

Hepatitis C Virus Infection

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
LDV/SOF
RBV
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring HCV genotype 4 (GT-4), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, GS-7977, GS-5885, Ribavirin, Sofosbuvir, ledipasvir, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Virus Diseases, Antiviral Agents

Eligibility Criteria

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

Key Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
  • HCV genotype 4 at screening
  • HCV treatment naive or prior participation in this study or study GS-US-334-0138 (Cohorts 1 and 2 only)
  • Cohort 3 only: HCV treatment-experienced (previously received therapy for HCV infection with an interferon (IFN)-containing regimen, with or without RBV and/or an HCV NS3/NS4A protease inhibitor (PI)
  • Body mass index (BMI) ≥ 18 kg/m^2
  • Screening laboratory values within defined thresholds
  • Use of effective protocol-approved contraception methods

Key Exclusion Criteria:

  • History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Pregnant or nursing females or male with pregnant female partner
  • Clinically-relevant drug or alcohol abuse within 12 months of screening

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

LDV/SOF 8 wk TN (Cohort 1, Group 1)

LDV/SOF+RBV 8 wk TN (Cohort 1, Group 2)

LDV/SOF 12 wk TN (Cohort 1, Group 3)

LDV/SOF+RBV 12 wk TN (Cohort 1, Group 4)

LDV/SOF+RBV 12 wk TE (Cohort 2)

LDV/SOF 12 wk TE (Cohort 3, Group 1)

LDV/SOF+RBV 12 wk TE (Cohort 3, Group 2)

Arm Description

LDV/SOF for 8 weeks (treatment-naive (TN))

LDV/SOF+RBV for 8 weeks (treatment-naive)

LDV/SOF for 12 weeks (treatment-naive)

LDV/SOF+RBV for 12 weeks (treatment-naive)

Treatment-experienced (TE) participants who completed treatment in Gilead sponsored study GS-US-334-0138 or in Cohort 1 of this study and did not achieve SVR12 will receive LDV/SOF+RBV for 12 weeks.

LDV/SOF for 12 weeks (treatment-experienced)

LDV/SOF+RBV for 12 weeks (treatment-experienced)

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (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 Discontinued LDV/SOF Drug Due to an Adverse Event (AE)

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of study drug, respectively.
Percentage of Participants With Overall 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 8 weeks 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

Full Information

First Posted
June 27, 2015
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02487030
Brief Title
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
Official Title
A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 7, 2015 (Actual)
Primary Completion Date
November 11, 2016 (Actual)
Study Completion Date
February 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection
Keywords
HCV genotype 4 (GT-4), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, GS-7977, GS-5885, Ribavirin, Sofosbuvir, ledipasvir, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Virus Diseases, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LDV/SOF 8 wk TN (Cohort 1, Group 1)
Arm Type
Experimental
Arm Description
LDV/SOF for 8 weeks (treatment-naive (TN))
Arm Title
LDV/SOF+RBV 8 wk TN (Cohort 1, Group 2)
Arm Type
Experimental
Arm Description
LDV/SOF+RBV for 8 weeks (treatment-naive)
Arm Title
LDV/SOF 12 wk TN (Cohort 1, Group 3)
Arm Type
Experimental
Arm Description
LDV/SOF for 12 weeks (treatment-naive)
Arm Title
LDV/SOF+RBV 12 wk TN (Cohort 1, Group 4)
Arm Type
Experimental
Arm Description
LDV/SOF+RBV for 12 weeks (treatment-naive)
Arm Title
LDV/SOF+RBV 12 wk TE (Cohort 2)
Arm Type
Experimental
Arm Description
Treatment-experienced (TE) participants who completed treatment in Gilead sponsored study GS-US-334-0138 or in Cohort 1 of this study and did not achieve SVR12 will receive LDV/SOF+RBV for 12 weeks.
Arm Title
LDV/SOF 12 wk TE (Cohort 3, Group 1)
Arm Type
Experimental
Arm Description
LDV/SOF for 12 weeks (treatment-experienced)
Arm Title
LDV/SOF+RBV 12 wk TE (Cohort 3, Group 2)
Arm Type
Experimental
Arm Description
LDV/SOF+RBV for 12 weeks (treatment-experienced)
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
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
Tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (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 Discontinued LDV/SOF Drug Due to an Adverse Event (AE)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR24 were defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of study drug, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants With Overall Virologic Failure
Description
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 8 weeks 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
Time Frame
Up to Posttreatment Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Willing and able to provide written informed consent Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy HCV genotype 4 at screening HCV treatment naive or prior participation in this study or study GS-US-334-0138 (Cohorts 1 and 2 only) Cohort 3 only: HCV treatment-experienced (previously received therapy for HCV infection with an interferon (IFN)-containing regimen, with or without RBV and/or an HCV NS3/NS4A protease inhibitor (PI) Body mass index (BMI) ≥ 18 kg/m^2 Screening laboratory values within defined thresholds Use of effective protocol-approved contraception methods Key Exclusion Criteria: History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Pregnant or nursing females or male with pregnant female partner Clinically-relevant drug or alcohol abuse within 12 months of screening 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
Cairo
ZIP/Postal Code
11559
Country
Egypt
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
City
Mansourah
Country
Egypt
City
Shibin Al Kawm
Country
Egypt

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:
Citation
Shiha G, Waked I, Soliman R, Abdelrazek W, Hassany M, Fouad R, et al. Ledipasvir/sofosbuvir for 8 or 12 weeks with or without ribavirin in HCV genotype 4 patients in Egypt. [Abstract OP158]. Asian Pacific Association for the Study of the Liver (APASL); 2017 15-19 February; Shanghai, China
Results Reference
result
PubMed Identifier
29666174
Citation
Shiha G, Esmat G, Hassany M, Soliman R, Elbasiony M, Fouad R, Elsharkawy A, Hammad R, Abdel-Razek W, Zakareya T, Kersey K, Massetto B, Osinusi A, Lu S, Brainard DM, McHutchison JG, Waked I, Doss W. Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt. Gut. 2019 Apr;68(4):721-728. doi: 10.1136/gutjnl-2017-315906. Epub 2018 Apr 17.
Results Reference
derived

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Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

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