Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

Completed

• Conditions: Hepatitis C Virus Infection
• Interventions: Drug: SOF; Drug: COPE

• Registration Number: NCT02537379
• Lead Sponsor: Gilead Sciences

Brief Summary

This post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Copegus® tablets (ribavirin, COPE) will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-09-01
• Study Start: 2015-09-15
• Status Verified: 2017-06
• Primary Completion: 2017-06-05
• Study Completion: 2017-06-05
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 552

Inclusion Criteria

• Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis
• Patients who are prescribed SOF+COPE

Key

Exclusion Criteria

• None

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SOF+COPE	SOF	Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+COPE as part of routine clinical care at a participating clinical site.
SOF+COPE	COPE	Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+COPE as part of routine clinical care at a participating clinical site.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reaction (ADR) under real world settings	Up to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks	Approximately 12 weeks after treatment completion or discontinuation
Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)	Posttreatment Weeks 12 and 24	SVR12 and SVR24 are defined as HCV RNA \< the lower limit of quantification (LLOQ) 12 and 24 weeks following the last dose of study drug, respectively.