Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
- Registration Number
- NCT01713283
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOF+RBV 12 Weeks SOF Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks. SOF+RBV 24 Weeks SOF Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks. SOF+RBV 12 Weeks RBV Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks. SOF+RBV 24 Weeks RBV Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks.
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) Up to 24 weeks The percentage of participants discontinuing any study drug due to an adverse event was summarized.
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Experiencing On-treatment Virologic Failure Up to 24 weeks On-treatment virologic failure was defined as:
1. 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
2. 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
3. Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatmentPercentage of Participants Experiencing Viral Relapse Up to Posttreatment Week 24 Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR.
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) 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.