Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
- Registration Number
- NCT01896193
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOF+RBV 24 Weeks SOF SOF+RBV for 24 weeks SOF+RBV 16 Weeks SOF SOF+RBV for 16 weeks SOF+RBV 24 Weeks RBV SOF+RBV for 24 weeks SOF+RBV 16 Weeks RBV SOF+RBV for 16 weeks
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) Up to 24 weeks The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) 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.
Percentage of Participants Experiencing On-treatment Virologic Failure 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)Percentage of Participants Experiencing Virologic Relapse 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.
Trial Locations
- Locations (16)
Institute of Nutrition of Academy of Sciences
🇷🇺Moscow, Russian Federation
Saint-Petersburg Center for Prevention and Control of AIDS and Infectious Diseases
🇷🇺Saint-Petersburg, Russian Federation
Central Scientific Research Institution of Gastroenterology of Moscow Healthcare Department
🇷🇺Moscow, Russian Federation
Medical Military Academy n.a. S.M. Kirov
🇷🇺Saint-Petersburg, Russian Federation
Institution of Tumen Region
🇷🇺Moscow, Russian Federation
City Clinical Hospital 24
🇷🇺Moscow, Russian Federation
Institution of High Professional Education First Moscow State Medical University
🇷🇺Moscow, Russian Federation
Infectious Clinical Hospital No. 1
🇷🇺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
Medical Company Hepatolog
🇷🇺Samara, Russian Federation
Clinical Diagnostics and Research Center of Federal Bedgetary Institution
🇷🇺Moscow, Russian Federation
Scientific Research Institution of Emergency Care n.a. N.V. Sclifosovskiy of Moscow
🇷🇺Moscow, Russian Federation
Institution of Healthcare of Sverdlovsk Region
🇷🇺Moscow, Russian Federation
Krasnoyarsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
🇷🇺Moscow, Russian Federation
Stavropol State Medical University of Ministry of Healthcare
🇷🇺Moscow, Russian Federation