Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatitis C Virus

Intervention / Treatment
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* Drug: SOF
* Drug: RBV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOF+RBV 12 Weeks<br>Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks. | Drug: SOF<br>* Sofosbuvir (SOF) 400 mg tablet administered orally once daily<br>* Other names: Sovaldi®;Drug: RBV<br>* 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)<br>|
| Experimental: SOF+RBV 24 Weeks<br>Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks. | Drug: SOF<br>* Sofosbuvir (SOF) 400 mg tablet administered orally once daily<br>* Other names: Sovaldi®;Drug: RBV<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Posttreatment Week 12 | 
| 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. | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Posttreatment Weeks 4 and 24 | 
| 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 | Up to 24 weeks | 
| 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. | Up to Posttreatment Week 24 |