Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea

Gilead Sciences

Status: Completed

Conditions: Hepatitis C Virus

Treatments: Drug: LDV/SOF

Study type: Observational

Funder types: Industry

Identifiers

NCT02951364

GS-US-337-1966

Details and patient eligibility

About

The primary objective of this post-marketing surveillance study is to collect and assess data related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF)) treatment regimen, per the approved Korea prescribing information for Harvoni, in routine clinical practice in Korea and to report the results to the Ministry of Food and Drug Safety (MFDS). Participants will be treated as part of routine practice at Korean healthcare centers by accredited physicians.

Enrollment: 1,081 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
• Adult individuals who have been informed of all pertinent aspects of the study and have voluntarily signed a Personal Information Protection Act (PIPA) consent form; Pediatric individuals who have the individuals' legally authorized representatives sign the PIPA consent form

Key Exclusion Criteria:

• Individuals treated with Harvoni outside of the approved prescribing information in Korea
• Individuals who have a contra-indication to Harvoni
• Individuals who have a contra-indication to ribavirin
• Pregnant or breastfeeding women
• Individuals who have previously been administered Harvoni
• 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

1,081 participants in 1 patient group

LDV/SOF

Description:

Adult Korean participants and pediatric Korean participants aged 12 to \<18 years with genotype 1, 2, 4, 5, and 6 chronic HCV infection who are initiating commercial Harvoni regimen

Treatment:

Drug: LDV/SOF