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

Hepatitis C Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896193
• Other study ID #: GS-US-334-0119
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2013
• Last updated: May 7, 2015
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
• RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (< 75 kg = 1000 mg and = 75 kg = 1200 mg)

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	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	No
Secondary	Percentage of Participants Experiencing On-treatment Virologic Failure	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	No
Secondary	Percentage of Participants Experiencing Virologic Relapse	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	No