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Post-marketing surveillance study to evaluate the real world safety and effectiveness of Maviret (Glecaprevir/Pibrentasvir) administered under a normal, routine treatment practice by Korean patients with Chronic Hepatitis C Genotypes 1 to 6
Patients with type C hepatitis genotypes 1-6 who had been prescribed Maviret (glecaprevir/pibrentasvir) in accordance with approved local label.
The sample size for this study is due to a requirement by local authorities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatitis C | Participants with Hepatitis C Genotypes 1 to 6 receiving Maviret (glecaprevir/pibrentasvir) for 8, 12, or 16 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | 12 weeks after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ persistently during treatment period. | Up to 30 weeks |
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Inclusion Criteria:
Exclusion Criteria:
- Patients with contraindications to the approved local labels for Maviret.
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Participants with Hepatitis C Genotypes 1 to 6 receiving Maviret (glecaprevir/pibrentasvir) for 8, 12, or 16 weeks.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SoonChunHyang University CheonAn Hospital /ID# 209996 | Cheonan-si | Chungcheongnam-do | 31151 | South Korea | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42104178 | Derived | Lee JW, Ahn SH, Park JG, Jeong JY, Yoon KT, Tak WY, Baek YH, Yu SJ, Song MJ, Seo YS, Jeong JY, Heo J. Observational, Post-marketing Surveillance of Safety and Effectiveness of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C. Infect Dis Ther. 2026 Jun;15(6):1747-1761. doi: 10.1007/s40121-026-01349-w. Epub 2026 May 8. |
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| Percentage of Participants With Post-treatment Relapse | Post-treatment relapse defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the end of treatment among participants who complete treatment and with HCV RNA levels < LLOQ at the end of treatment. | Up to 28 weeks |
| Hallym University Sacred Heart Hospital /ID# 210809 |
| Anyang |
| Gyeonggido |
| 14068 |
| South Korea |
| The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 216869 | Bucheon-si | Gyeonggido | 14647 | South Korea |
| Dongguk University Ilsan Hospital /ID# 210609 | Goyang | Gyeonggido | 10325 | South Korea |
| National health insurance Service ilsanhospital /ID# 209997 | Goyang | Gyeonggido | 10444 | South Korea |
| SoonChunHyang University Buchon Hospital /ID# 210618 | Habun | Gyeonggido | 14584 | South Korea |
| Seoul National University Bundang Hospital /ID# 210616 | Seongnam | Gyeonggido | 13620 | South Korea |
| The Catholic University of Korea, ST. Vincent's Hospital /ID# 216951 | Suwon | Gyeonggido | 16247 | South Korea |
| Ajou University Hospital /ID# 209995 | Suwon | Gyeonggido | 16499 | South Korea |
| The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 216949 | Uijeongbu-si | Gyeonggido | 11765 | South Korea |
| Pusan National University Yangsan Hospital /ID# 214960 | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Wonkwang University Hospital /Id# 210620 | Iksan | Jeonrabugdo | 54538 | South Korea |
| Kwangju Christian Hospital /ID# 210623 | Gwangju | Jeonranamdo | 61661 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 209636 | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| SMG-SNU Boramae Medical Center /ID# 210610 | Seoul | Seoul Teugbyeolsi | 07061 | South Korea |
| Dongnam Institute of Radiological & Medical Sciences /ID# 209991 | Busan | 46033 | South Korea |
| Good Samsun Hospital /ID# 209291 | Busan | 47007 | South Korea |
| Inje University Busan Paik Hospital /ID# 209992 | Busan | 47392 | South Korea |
| Inje University Haeundae Hospital /ID# 209993 | Busan | 48108 | South Korea |
| Maryknoll Medical Center /ID# 210957 | Busan | 48972 | South Korea |
| Dong-A University Hospital /ID# 209450 | Busan | 49201 | South Korea |
| Pusan National University Hospital /ID# 209813 | Busan | 49241 | South Korea |
| Kosin University Gospel Hospital /ID# 210608 | Busan | 49267 | South Korea |
| Samsung Changwon Hospital /ID# 211507 | Changwon | 51353 | South Korea |
| Samsung Changwon Hospital /ID# 211743 | Changwon | 51353 | South Korea |
| Dankook University Hospital /ID# 209297 | Cheonan | 31116 | South Korea |
| Chuncheon Sacred Heart Hospital /ID# 210612 | Chuncheon | 24253 | South Korea |
| Kyungpook National University Chilgok Hospital /ID# 209988 | Daegu | 41404 | South Korea |
| Keimyung University Dongsan Medical Center /ID# 212144 | Daegu | 41931 | South Korea |
| Keimyung University Dongsan Medical Center /ID# 212514 | Daegu | 41931 | South Korea |
| Kyungpook National University Hospital /ID# 209294 | Daegu | 41944 | South Korea |
| Yeungnam University Medical Center /ID# 209293 | Daegu | 42415 | South Korea |
| Kim Jun Hwan Sok Internal Medi /ID# 209292 | Daegu | 42488 | South Korea |
| The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 216952 | Daejeon | 34943 | South Korea |
| Chungnam National University Hospital /ID# 209637 | Daejeon | 35015 | South Korea |
| Myongji Hospital /ID# 215595 | Goyang | 10475 | South Korea |
| CHA Gumi Medical Center, CHA University /ID# 209994 | Gumi | 39295 | South Korea |
| Chosun University Hospital /ID# 210607 | Gwangju | 61453 | South Korea |
| The Catholic University of Korea Incheon St.Mary's Hospital /ID# 216950 | Incheon | 21431 | South Korea |
| Gachon University Gil Medical Center /ID# 212513 | Incheon | 21565 | South Korea |
| Inha University Hospital /ID# 210617 | Incheon | 22332 | South Korea |
| Jeju National University Hospital /ID# 214700 | Jeju City | 63238 | South Korea |
| Chonnam National University Hwasun Hospital /ID# 209990 | Jeonnam | 58128 | South Korea |
| Inje University Sanggye Paik Hospital /ID# 210811 | Seoul | 01755 | South Korea |
| Korea University Anam Hospital /ID# 210958 | Seoul | 02841 | South Korea |
| Seoul National University Hospital /ID# 210959 | Seoul | 03080 | South Korea |
| Seoul National University Hospital /ID# 211365 | Seoul | 03080 | South Korea |
| Seoul National University Hospital /ID# 211369 | Seoul | 03080 | South Korea |
| National Medical Center /ID# 209911 | Seoul | 04564 | South Korea |
| Kangdong Sacred Heart Hospital /ID# 210621 | Seoul | 05355 | South Korea |
| Asan Medical Center /ID# 210622 | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital /ID# 212512 | Seoul | 06273 | South Korea |
| Samsung Medical Center /ID# 209296 | Seoul | 06351 | South Korea |
| Samsung Medical Center /ID# 209635 | Seoul | 06351 | South Korea |
| Chung-Ang University Hostipal /ID# 209295 | Seoul | 06973 | South Korea |
| Ewha Womans University Mokdong Hospital /ID# 214961 | Seoul | 07985 | South Korea |
| Ewha Womans University Mokdong Hospital /ID# 216412 | Seoul | 07985 | South Korea |
| Korea University Guro Hospital /ID# 209989 | Seoul | 08308 | South Korea |
| St. Carollo General Hospital /ID# 210619 | Suncheon | 57931 | South Korea |
| Ulsan University Hospital /ID# 210810 | Ulsan | 44033 | South Korea |
| Wonju Severance Christian Hospital /ID# 210611 | Wŏnju | 26426 | South Korea |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| 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 |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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