Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection

May 7, 2015 updated by: Gilead Sciences

A Phase 3b, Multicenter, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Genotype 1 and 3 Chronic HCV Infection.

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Central Clinical Hospital of the Russian Academy of Sciences
      • Moscow, Russian Federation
        • Central Scientific and Research Institute of Epidemiology of Rospotrebnadzor
      • Moscow, Russian Federation
        • Central Scientific Research Institution of Gastroenterology of Moscow Healthcare Department
      • Moscow, Russian Federation
        • City Clinical Hospital 24
      • Moscow, Russian Federation
        • Clinical Diagnostics and Research Center of Federal Bedgetary Institution
      • Moscow, Russian Federation
        • Infectious Clinical Hospital No. 1
      • Moscow, Russian Federation
        • Institute of Nutrition of Academy of Sciences
      • Moscow, Russian Federation
        • Institution of Healthcare of Sverdlovsk Region
      • Moscow, Russian Federation
        • Institution of High Professional Education First Moscow State Medical University
      • Moscow, Russian Federation
        • Institution of Tumen Region
      • Moscow, Russian Federation
        • Krasnoyarsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
      • Moscow, Russian Federation
        • Scientific Research Institution of Emergency Care n.a. N.V. Sclifosovskiy of Moscow
      • Moscow, Russian Federation
        • Stavropol State Medical University of Ministry of Healthcare
      • Saint-Petersburg, Russian Federation
        • Medical Military Academy n.a. S.M. Kirov
      • Saint-Petersburg, Russian Federation
        • Saint-Petersburg Center for Prevention and Control of AIDS and Infectious Diseases
      • Samara, Russian Federation
        • Medical Company Hepatolog

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Confirmed chronic genotype 1 or 3 HCV infection
  • HCV treatment-naive
  • Individuals will have cirrhosis status assessment; liver biopsy may be required.
  • Screening laboratory values within predefined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Contraindication to ribavirin therapy
  • Excessive alcohol ingestion as defined by protocol
  • History of solid organ transplantation
  • Current or prior history of clinical hepatic decompensation
  • History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOF+RBV 16 Weeks
SOF+RBV for 16 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 using weight-based dosing (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Experimental: SOF+RBV 24 Weeks
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 using weight-based dosing (< 75 kg = 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)
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.
Posttreatment Week 12
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Time Frame: Up to 24 weeks
The percentage of participants permanently 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)
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.
Posttreatment Weeks 4 and 24
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)
Up to 24 weeks
Percentage of Participants Experiencing Virologic Relapse
Time Frame: Up to Posttreatment Week 12
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Up to Posttreatment Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Kathryn Kersey, MSc, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 2, 2013

First Submitted That Met QC Criteria

July 8, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-334-0119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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