Back to resultsSofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
Primary Purpose
Hepatitis C Virus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SOF
RBV
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus
Eligibility Criteria
Inclusion Criteria:
- First generation Egyptian; must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry
- Treatment-experienced or treatment-naive
- Chronic genotype 4 HCV infection
- Not co-infected with HIV
- Screening laboratory values within defined thresholds
- Use of highly effective contraception methods
- Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Exclusion Criteria:
- History of any other clinically significant chronic liver disease
- Pregnant or nursing female or male with pregnant female partner
- History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol
- Excessive alcohol ingestion or significant drug abuse
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SOF+RBV 12 Weeks
SOF+RBV 24 Weeks
Arm Description
Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks.
Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants discontinuing any study drug due to an adverse event was summarized.
Secondary Outcome Measures
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Percentage of Participants Experiencing On-treatment Virologic Failure
On-treatment virologic failure was defined as:
Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01713283
Brief Title
Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
Official Title
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SOF+RBV 12 Weeks
Arm Type
Experimental
Arm Description
Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks.
Arm Title
SOF+RBV 24 Weeks
Arm Type
Experimental
Arm Description
Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
SOF
Other Intervention Name(s)
GS-7977, PSI-7977, Sovaldi®
Intervention Description
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Description
The percentage of participants discontinuing any study drug due to an adverse event was summarized.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants Experiencing On-treatment Virologic Failure
Description
On-treatment virologic failure was defined as:
Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
Time Frame
Up to 24 weeks
Title
Percentage of Participants Experiencing Viral Relapse
Description
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
Time Frame
Up to Posttreatment Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First generation Egyptian; must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry
Treatment-experienced or treatment-naive
Chronic genotype 4 HCV infection
Not co-infected with HIV
Screening laboratory values within defined thresholds
Use of highly effective contraception methods
Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Exclusion Criteria:
History of any other clinically significant chronic liver disease
Pregnant or nursing female or male with pregnant female partner
History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol
Excessive alcohol ingestion or significant drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Kersey, MSc
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
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