Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India

Gilead Sciences

Status: Completed

Conditions: Hepatitis C Virus

Treatments: Drug: SOF

Study type: Observational

Funder types: Industry

Identifiers

NCT02592057

GS-US-334-1775

Details and patient eligibility

About

This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical practice in India.

Enrollment: 532 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HCV-infected patients living in India
• Treatment with a SOF-based regimen as determined by the patient's treating physician per the approved prescribing information.
• Patients who provide written and signed informed consent prior to initiation of treatment where required.

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 in a foreseeable future)

Trial design

532 participants in 1 patient group

SOF-based regimens

Description:

Adults with chronic HCV infection in India who are being treated with a SOF-based treatment regimen as per the approved prescribing information.

Treatment:

Drug: SOF