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

Study Overview
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Brief Summary
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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).

Official Title
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A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Sovaldi 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: Sofosbuvir


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 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.

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 |
| --- | --- |
| Sofosbuvir<br>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 | Drug: Sofosbuvir<br>* 400 mg tablet administered orally once daily<br>* Other names: Sovaldi ®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing Any Adverse Events (AEs) Occurring During Administration of Sovaldi Regimens or Within 30 Days After Completion (or Discontinuation) of Sovaldi Treatment Regimens |  | First dose date up to 30 days posttreatment | 
| Proportion of Participants with HCV RNA < Lower Limit of Quantification (LLOQ) |  | 2 weeks before Posttreatment Week 12 through Week 24 Posttreatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing Any AEs Occurring During Administration of Sovaldi Regimens or Within 12 Weeks After Completion (or Discontinuation) of Sovaldi Treatment Regimens |  | First dose date up to 12 weeks posttreatment |