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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01896193
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : April 17, 2015
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: SOF Drug: RBV Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : June 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


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®
  • PSI-7977
  • GS-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®
  • PSI-7977
  • GS-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)




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896193


Locations
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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
Moscow, 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
Saint-Petersburg, Russian Federation
Medical Company Hepatolog
Samara, Russian Federation
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Kathryn Kersey, MSc Gilead Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01896193    
Other Study ID Numbers: GS-US-334-0119
First Posted: July 11, 2013    Key Record Dates
Results First Posted: April 17, 2015
Last Update Posted: May 29, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents