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논문 기본 정보

자료유형
학술저널
저자정보
Oidov Baatarkhuu (Department of Infectious Diseases School of Medicine Mongolian National University of Medical Sci) Jae Seung Lee (Department of Internal Medicine Yonsei University College of Medicine) Jazag Amarsanaa (Department of Hepatology Happy Veritas Liver Diagnostics Center) Do Young Kim (Department of Internal Medicine Yonsei University College of Medicine) Sang Hoon Ahn (Department of Internal Medicine Yonsei University College of Medicine) Nyamsuren Naranzul (Department of Infectious Diseases Mongolian National University of Medical Sciences) Damba Enkhtuya (Department of Hepatology Happy Veritas Liver Diagnostics Center) Nagir Choijamts (Department of Hepatology Happy Veritas Liver Diagnostics Center) Purev Batbayar (Department of Hepatology Happy Veritas Liver Diagnostics Center) Radnaa Otgonbayar (Department of Internal Medicine University General Hospital) Bat-Ulzii Saruul (Department of Hepatology National Center for Communicable Diseases) Chuluunbaatar Gantuul (Department of Hepatology National Center for Communicable Diseases) Baljinnyam Gegeebadrakh (Department of Gastroenterology Second State Central Hospital) Narangerel Tuvshinbayar (Department of Gastroenterology Second State Central Hospital) Dorjgotov Badamsuren (Department of Gastroenterology Third State Central Hospital) Galsan Ulzmaa (Department of Gastroenterology Third State Central Hospital) Jamiyandorj Otgonbold (School of Dentistry Mongolian National University of Medical Sciences) Kwang-Hyub Han (Department of Internal Medicine Yonsei University College of Medicine)
저널정보
대한간학회 Clinical and Molecular Hepatology Clinical and Molecular Hepatology 제27권 제1호
발행연도
2021.1
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125 - 135 (11page)

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Background/Aims: Ledipasvir/sofosbuvir (LDV/SOF) shows high efficacy and safety in patients with genotype 1-hepatitis C virus (HCV). We aimed to investigate the efficacy and safety of LDV/SOF in real-world Mongolian patients. Methods: Between 2015 to 2019, 23 (0.5%) and 5,005 patients (99.5%) with genotype 1a and 1b HCV, respectively, were treated with a fixed-dose tablet containing 90 mg ledipasvir and 400 mg sofosbuvir for 12 weeks, and 81 patients (1.6%) with previous experience of interferon (IFN)-based treatment received additional 1,000 mg ribavirin. HCV RNA was measured at 4, 12, and 24 weeks after the first dose to determine rapid virologic response, end of treatment response (ETR), and sustained virologic response at 12 weeks after end of treatment (SVR12). Results: Most patients (n=5,008; 99.6%) achieved ETR and SVR12 without virologic relapse. Patients with genotype 1a showed low rates of ETR and SVR12 in only 16 patients (69.6%). There was no significant difference in SVR12 rate between patients regardless of IFN experience (n=81; 1.6%), cirrhosis (n=1,151; 22.9%), HCV RNA >6×106 IU/mL (n=866; 17.2%), or liver stiffness >9.6 kPa (n=1,721; 34.2%) (100.0%, 99.3%, 99.4%, and 99.4%, respectively). No severe adverse events (AEs) were reported, and there was no dose reduction or interruption due to AE. The most common AEs were headache (n=472; 9.4%), fatigue (n=306; 6.2%), abdominal discomfort (n=295; 5.9%), and skin rash (n=141; 2.8%). Conclusions: LDV/SOF showed high efficacy and safety for patients with genotype 1, especially 1b HCV, in Mongolia. The real-world data might be applicable to patients in other Asian-Pacific countries.

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