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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF | Drug | 90/400 mg tablet administered orally once daily |
|
| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Adult Korean individuals and pediatric Korean individuals aged 12 to <18 years with genotype 1, 2, 4, 5, and 6 chronic HCV infection who are initiating commercial Harvoni regimen
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Seongnam-si | Gyeonggido | 13496 | South Korea | ||
| Hallym University Sacred Heart Hospital |
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| Anyang-si |
| 14068 |
| South Korea |
| SoonChunHyang University Bucheon Hospital | Bucheon-si | 14584 | South Korea |
| The Catholic University of Korea Bucheon ST. Mary's Hospital | Bucheon-si | 14647 | South Korea |
| Bumin Hospital Haeundae | Busan | 48094 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Good Gang-An Hospital | Busan | 48265 | South Korea |
| Dong-A University Medical Center | Busan | 49201 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Inje University Busan Paik Hospital | Busan | 614-735 | South Korea |
| Busan St. Mary's Hospital | Busan | South Korea |
| Busan Veterans Hospital | Busan | South Korea |
| Maryknoll Medical Center | Busan | South Korea |
| Changwon Fatima Hospital | Changwon | 51394 | South Korea |
| Dankook University Hospital | Cheonan | 31116 | South Korea |
| SoonChunHyang University Cheonan Hospital | Cheonan | 31151 | South Korea |
| Hallym University ChunCheon Sacred Heart Hospital | Chuncheon | 24253 | South Korea |
| Konkuk University Chungju Hospital | Chungju | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
| Kyungpook National University Hospital | Daegu | 700-721 | South Korea |
| Kyungpook national university medical center Chil-Gok | Daegu | 700-721 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Konyang University Hospital | Daejeon | 35365 | South Korea |
| GangNeung Asan Hospital | Gangneung-si | South Korea |
| Dongguk University Ilsan Hospital | Goyang | 10326 | South Korea |
| Myongji Hospital | Goyang | 10475 | South Korea |
| National Health Insurance Corporation Ilsan Hospital | Goyang-si | 10444 | South Korea |
| Kumi Cha Hospital | Gumi | 39295 | South Korea |
| Chosun University Hospital | Gwangju | 501-717 | South Korea |
| Kwangju Christian Hospital | Gwangju | South Korea |
| Hanyang University Guri Hospital | Gyeonggi-do | 11923 | South Korea |
| Dongguk University Gyeongju Hospital | Gyeongju | South Korea |
| Hallym University Dongtan Sacred Heart Hospital | Hwaseong-si | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | 58128 | South Korea |
| WonKwang University Hospital | Iksan | 54538 | South Korea |
| The Catholic University of Korea, Incheon St. Mary's Hospital | Incheon | 21431 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Gachon University Gil Medical Center | Incheon | 405-760 | South Korea |
| Cheju Halla General Hospital | Jeju City | 63127 | South Korea |
| Presbyterian Medical Center | Jeonju | 54987 | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Gyeongsang National University Hospital | Jinju | 660-702 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Seoul National University Hospital | Seoul | 03830 | South Korea |
| SoonChunHyang University Hospital | Seoul | 04401 | South Korea |
| Hanyang University Hospital | Seoul | 04763 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Kangdong Sacred Heart Hospital | Seoul | 05535 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| SMG - SNU Boramae Medical Center | Seoul | 07061 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Inje University Seoul Paik Hospital | Seoul | 100-032 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| Eulji General Hospital | Seoul | South Korea |
| Inje University Sanggye Paik Hospital | Seoul | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | 41931 | South Korea |
| The Catholic University of Korea Uijeongbu St. Mary's Hospital | Uijeongbu-si | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| DongKang Hospital | Ulsan | 44455 | South Korea |
| Ulsan Hospital | Ulsan | 44686 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | 49201 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | 50612 | South Korea |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
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