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

A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Harvoni Treatment Regimen in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02951364

Enrollment

1081

Registered

2016-11-01

Start date

2016-12-05

Completion date

2021-06-11

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus

Keywords

observational

Brief summary

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.

Interventions

DRUGLDV/SOF

90/400 mg tablet administered orally once daily

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion 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/

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)	Up to 30 days following treatment	Incidence of adverse events (AEs) and special situation reports (SSRs) occurring during administration of Harvoni regimen or up to 30 days of treatments will be analyzed.
Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	The sustained virologic response (SVR) rate will be assessed at 12 weeks after completion (or discontinuation) of Harvoni treatment, defined as the proportion of participants with HCV RNA \< lower limit of quantification (LLOQ) from 2 weeks before Posttreatment Week 12 through Posttreatment Week 24 (based on when the participant's actual visit occurs). The treatment will be assessed as improved/success when HCV RNA \< LLOQ is achieved from 2 weeks before Posttreatment Week 12 through Posttreatment Week 24.

Secondary

Measure	Time frame	Description
Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)	Up to Posttreatment Week 12	Incidence of adverse events (AEs) and special situation reports (SSRs) occurring within 12 weeks after completion (or discontinuation) of treatments will be analyzed.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026