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

Gilead Sciences

Status: Completed

Conditions: HCV Infection

Treatments: Drug: Sovaldi

Study type: Observational

Funder types: Industry

Identifiers

NCT02783976

GS-US-334-1685

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

25 participants in 1 patient group

Sovaldi-based regimens

Description:

Adult patients with chronic HCV infection living in Mexico who take Sovaldi as part of routine clinical care at a participating clinical site.

Treatment:

Drug: Sovaldi