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

Chronic HCV Infection Clinical Trial

Official title:

A Phase 3b, Multi-Center, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Chronic Genotype 1 or 3 Hepatitis C Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074514
• Other study ID #: GS-US-334-0116
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2014
• Last updated: December 7, 2015
• Start date: March 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, randomized, open-label study to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir+ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or genotype 3 hepatitis C virus (HCV) infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HCV RNA =10^4 IU/mL at screening

• Confirmed chronic HCV genotype 1 or 3 infection

• HCV treatment naive

• Approximately 30% of subjects may have compensated cirrhosis at screening

Exclusion Criteria:

• Any other chronic liver disease

• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

• Current or prior history of clinical hepatic de-compensation

• Contraindication to RBV therapy, e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).

• Chronic use of systemically administered immunosuppressive agents

• History of solid organ transplantation

Study Design

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

Related Conditions & MeSH terms

• Chronic HCV Infection
• Infection

Intervention

Drug:
• Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
• RBV
RBV 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and = 75 kg = 1200 mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)	SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.	Posttreatment Week 12	No
Primary	Incidence of adverse events leading to permanent discontinuation of study drug		Up to 24 weeks	No
Secondary	Proportion of participants with sustained virologic response (SVR) at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)	SVR4 and SVR24 is 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	Proportion of participants with virologic failure and viral relapse	Virologic failure is defined as either: Virologic breakthrough (participant achieved undetectable HCV RNA levels during treatment but subsequently had detectable HCV RNA while continuing treatment), or; Non-response (HCV RNA = LLOQ through 16 or 24 weeks of treatment); Viral relapse is defined as: Participant achieved undetectable HCV RNA levels during treatment maintained undetectable HCV RNA for the duration of treatment or achieved undetectable HCV RNA within 4 weeks of the end of treatment but did not achieve SVR at 4, 12, or 24 weeks posttreatment.	Baseline to posttreatment Week 24	No