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

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.

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Key information

Conditions

Hepatitis C Virus Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Enterovirus Infections Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOF

Drug

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

Other names: Sovaldi®, GS-7977

RBV

Drug

Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Primary outcomes

Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)

Time frame: 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

Time frame: Up to 24 weeks

Secondary outcomes

Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection.

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Apr 24, 2013
Registry last updated: May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed