Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
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.
1 other identifier
interventional
127
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2013
Shorter than P25 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 2, 2013
CompletedFirst Posted
Study publicly available on registry
July 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
April 17, 2015
CompletedMay 29, 2015
May 1, 2015
10 months
July 2, 2013
April 7, 2015
May 7, 2015
Conditions
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
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
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 12
Study Arms (2)
SOF+RBV 16 Weeks
EXPERIMENTALSOF+RBV for 16 weeks
SOF+RBV 24 Weeks
EXPERIMENTALSOF+RBV for 24 weeks
Interventions
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (16)
Central Clinical Hospital of the Russian Academy of Sciences
Moscow, Russia
Central Scientific and Research Institute of Epidemiology of Rospotrebnadzor
Moscow, Russia
Central Scientific Research Institution of Gastroenterology of Moscow Healthcare Department
Moscow, Russia
City Clinical Hospital 24
Moscow, Russia
Clinical Diagnostics and Research Center of Federal Bedgetary Institution
Moscow, Russia
Infectious Clinical Hospital No. 1
Moscow, Russia
Institute of Nutrition of Academy of Sciences
Moscow, Russia
Institution of Healthcare of Sverdlovsk Region
Moscow, Russia
Institution of High Professional Education First Moscow State Medical University
Moscow, Russia
Institution of Tumen Region
Moscow, Russia
Krasnoyarsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
Moscow, Russia
Scientific Research Institution of Emergency Care n.a. N.V. Sclifosovskiy of Moscow
Moscow, Russia
Stavropol State Medical University of Ministry of Healthcare
Moscow, Russia
Medical Military Academy n.a. S.M. Kirov
Saint Petersburg, Russia
Saint-Petersburg Center for Prevention and Control of AIDS and Infectious Diseases
Saint Petersburg, Russia
Medical Company Hepatolog
Samara, Russia
Related Publications (1)
Isakov V, Zhdanov K, Kersey K, Svarovskaia E, Massetto B, Zhu Y, Knox SJ, Bakulin I, Chulanov V. Efficacy of sofosbuvir plus ribavirin in treatment-naive patients with genotype-1 and -3 HCV infection: results from a Russian Phase IIIb study. Antivir Ther. 2016;21(8):671-678. doi: 10.3851/IMP3065. Epub 2016 Jul 4.
PMID: 27376706DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Kathryn Kersey, MSc
Gilead Sciences
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
July 2, 2013
First Posted
July 11, 2013
Study Start
June 1, 2013
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
May 29, 2015
Results First Posted
April 17, 2015
Record last verified: 2015-05