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

NCT01838590 | Completed Phase 3 Results

• 1 other identifier: GS-US-334-0138
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis C Virus

Keywords

Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections; Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Antimetabolites; Molecular Mechanisms of Pharmacological Action; HCV genotype 4 (GT-4); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; GS-7977; Ribavirin; Open Label; Sofosbuvir; Additional relevant MeSH terms:; Hepatitis; Hepatitis, Chronic; Hepatitis C; Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

• 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

• Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

  Up to 24 weeks

Secondary Outcomes (3)

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

  Posttreatment Weeks 4 and 24

• Percentage of Participants Experiencing On-treatment Virologic Failure

  Up to 24 weeks

• Percentage of Participants Experiencing Virologic Relapse

  Up to Posttreatment Week 24

Study Arms (2)

SOF+RBV 12 Weeks

EXPERIMENTAL

Participants will receive SOF+RBV for 12 weeks.

Drug: SOF; Drug: RBV

SOF+RBV 24 Weeks

EXPERIMENTAL

Participants will receive SOF+RBV for 24 weeks.

Drug: SOF; Drug: RBV

Interventions

SOF DRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

Also known as: Sovaldi®, GS-7977

SOF+RBV 12 Weeks; SOF+RBV 24 Weeks

RBV DRUG

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

SOF+RBV 12 Weeks; SOF+RBV 24 Weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (2)

Unknown Facility

Al Mansurah, Egypt

Location

Unknown Facility

Cairo, Egypt

Location

MeSH Terms

Conditions

Hepatitis C; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections; Hepatitis; Hepatitis, Chronic; Hepatitis C, Chronic

Interventions

Sofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Kathryn Kersey

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: April 24, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 22, 2015
• Results First Posted: May 22, 2015

Record last verified: 2015-05

Locations

EG (2)