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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatitis C Virus

Intervention / Treatment
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* Drug: LDV/SOF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LDV/SOF<br>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 | Drug: LDV/SOF<br>* 90/400 mg tablet administered orally once daily<br>* Other names: GS-5885/GS-7977;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs) | 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. | Up to 30 days following treatment | 
| Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 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. | Posttreatment Week 12 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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observational