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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C Virus
• Intervention / Treatment: Drug: SOF; Drug: RBV

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Expanded Access

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Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOF+RBV 12 Weeks; Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks.	Drug: SOF; Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Other Names: Sovaldi®; GS-7977; PSI-7977; Drug: RBV; 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)
Experimental: SOF+RBV 24 Weeks; Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks.	Drug: SOF; Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Other Names: Sovaldi®; GS-7977; PSI-7977; Drug: RBV; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Kathryn Kersey, MSc, Gilead Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (Estimate): October 24, 2012

Study Record Updates

• Last Update Posted (Estimate): November 25, 2014
• Last Update Submitted That Met QC Criteria: November 18, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Anti-Infective Agents; Antiviral Agents; Sofosbuvir
• Other Study ID Numbers: GS-US-334-0114