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.
Study Type
OBSERVATIONAL
Enrollment
1,081
90/400 mg tablet administered orally once daily
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.
Time frame: 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.
Time frame: Posttreatment Week 12
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.
Time frame: Up to Posttreatment Week 12
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