Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea

Gilead Sciences

Status: Completed

Conditions: Hepatitis C Virus

Treatments: Drug: Sofosbuvir

Study type: Observational

Funder types: Industry

Identifiers

NCT02907996

GS-US-334-1967

Details and patient eligibility

About

The objectives of this study are to collect and assess data related to safety and effectiveness of Sovaldi treatment regimens, per the approved prescribing information for Sovaldi, in routine clinical practice and report results to Korean Ministry of Food and Drug Safety (MFDS).

Enrollment: 2,033 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Individuals aged 12 years and older who are living in Korea
• Individuals with chronic HCV infection eligible for treatment with Sovaldi as indicated in the approved prescribing information for Sovaldi
• Individuals who have been informed of all pertinent aspects of the study and have voluntarily signed Personal Information Protection Act (PIPA) consent form; Pediatric individuals who have their legally authorized representatives sign the PIPA consent form

Key Exclusion Criteria:

• Individuals treated with Sovaldi outside of the approved prescribing information for Sovaldi in Korea
• Individuals who have a contra-indication (refer to the Korea prescribing information)
• Individuals who have a contra-indication to ribavirin or peginterferon alfa or daclatasvir
• Pregnant or breast feeding women
• Individuals who have previously been administered Sovaldi
• Individuals participating in a concurrent HCV clinical trial
• Individuals planning on leaving the country during the study period

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

Trial design

2,033 participants in 1 patient group

Sofosbuvir

Description:

Adult Korean participants with genotype 1, 2, 3, and 4 chronic HCV infection and pediatric Korean participants aged 12 to \<18 years with genotype 2 and 3 chronic HCV infection who are initiating commercial Sovaldi regimens

Treatment:

Drug: Sofosbuvir