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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Virus Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHA Bundang Medical Center, Seongnam-si, Gyeonggido, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LDV/SOF

Drug

90/400 mg tablet administered orally once daily

Other names: Harvoni®, GS-5885/GS-7977

Primary outcomes

Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)

Time frame: 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)

Time frame: 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 outcomes

Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Nov 1, 2016
Registry last updated: Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed