Clinical trial NCT01896193: Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-07-11
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants Experiencing On-treatment Virologic Failure
timeFrame: Up to 24 weeks
measure: Percentage of Participants Experiencing Virologic Relapse
timeFrame: Up to Posttreatment Week 12
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of the Russian Academy of Sciences
city: Moscow
country: Russian Federation
facility: Central Scientific and Research Institute of Epidemiology of Rospotrebnadzor
city: Moscow
country: Russian Federation
facility: Central Scientific Research Institution of Gastroenterology of Moscow Healthcare Department
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 24
city: Moscow
country: Russian Federation
facility: Clinical Diagnostics and Research Center of Federal Bedgetary Institution
city: Moscow
country: Russian Federation
facility: Infectious Clinical Hospital No. 1
city: Moscow
country: Russian Federation
facility: Institute of Nutrition of Academy of Sciences
city: Moscow
country: Russian Federation
facility: Institution of Healthcare of Sverdlovsk Region
city: Moscow
country: Russian Federation
facility: Institution of High Professional Education First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: Institution of Tumen Region
city: Moscow
country: Russian Federation
facility: Krasnoyarsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
city: Moscow
country: Russian Federation
facility: Scientific Research Institution of Emergency Care n.a. N.V. Sclifosovskiy of Moscow
city: Moscow
country: Russian Federation
facility: Stavropol State Medical University of Ministry of Healthcare
city: Saint-Petersburg
country: Russian Federation
facility: Medical Military Academy n.a. S.M. Kirov
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg Center for Prevention and Control of AIDS and Infectious Diseases
city: Samara
country: Russian Federation
facility: Medical Company Hepatolog
Study officials:
affiliation: Gilead Sciences
name: Kathryn Kersey, MSc
role: STUDY_DIRECTOR
References:
citation: 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.