Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

Phase 3

Completed

• Conditions: Hepatitis C Virus
• Interventions: Drug: SOF; Drug: RBV

• Registration Number: NCT01838590
• Lead Sponsor: Gilead Sciences

Brief Summary

This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-19
• Study First Posted: 2013-04-24
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Status Verified: 2015-05
• Results First Submitted: 2015-05-05
• Results First Submitted QC: 2015-05-07
• Last Update Submitted: 2015-05-07
• Results First Posted: 2015-05-22
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Treatment experienced and naïve subjects
• Chronic genotype 4 HCV-infection
• Not co-infected with HIV
• Screening laboratory values within defined thresholds
• Use of highly effective contraception methods
• Subject 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 subject 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	RBV	Participants will receive SOF+RBV for 12 weeks.
SOF+RBV 24 Weeks	SOF	Participants will receive SOF+RBV for 24 weeks.
SOF+RBV 12 Weeks	SOF	Participants will receive SOF+RBV for 12 weeks.
SOF+RBV 24 Weeks	RBV	Participants will receive SOF+RBV for 24 weeks.

Primary Outcome Measures

Name	Time	Method
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.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
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 SVR 24 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	Up to 24 weeks	On-treatment virologic failure was defined as; * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or; * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Percentage of Participants Experiencing Virologic Relapse	Up to Posttreatment Week 24	Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.