Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice

Completed

• Conditions: HCV Infection
• Interventions: Drug: Sovaldi

• Registration Number: NCT02783976
• Lead Sponsor: Gilead Sciences

Brief Summary

This study will collect and evaluate information on the safety and efficacy of Sovaldi-based regimens in routine clinical practice in Mexico. The primary objective of this study is to assess the rates of serious adverse events/reactions (SAEs/SADRs) and adverse events/reactions (AEs/ADRs) in adult participants with chronic hepatitis C virus (HCV) infection treated with Sovaldi in routine clinical practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-26
• Study Start: 2016-10-28
• Primary Completion: 2018-06-20
• Study Completion: 2018-06-20
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-28
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• HCV-infected patients living in Mexico
• Treatment with a Sovaldi-based regimen, per the approved prescribing information, as determined by the patient's treating physician

Key

Exclusion Criteria

• Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products)
• Patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country prior to their SVR12 visit)

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sovaldi-based regimens	Sovaldi	Adult patients with chronic HCV infection living in Mexico who take Sovaldi as part of routine clinical care at a participating clinical site.

Primary Outcome Measures

Name	Time	Method
Proportion of participants experiencing adverse drug reactions (ADRs), serious adverse events (SAEs), and adverse events (AEs) during the treatment period and posttreatment follow-up period	Up to Posttreatment Week 4

Secondary Outcome Measures

Name	Time	Method
Frequency of concurrent use of Sovaldi with amiodarone and another direct acting antiviral (DAA) or with potent intestinal P-gp inducers in routine clinical practice	Up to 24 weeks
Proportion of patients with sustained virologic response (SVR) at 12 weeks post treatment (SVR12), defined as HCV RNA < lower limit of quantification between 10 and 24 weeks post-treatment	Up to Posttreatment Week 24