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Efficacy and safety of ledipasvir/sofosbuvir in 5,028 Mongolian patients infected with genotype 1 hepatitis C virus: A multicenter study

 Oidov Baatarkhuu  ;  Jae Seung Lee  ;  Jazag Amarsanaa  ;  Do Young Kim  ;  Sang Hoon Ahn  ;  Nyamsuren Naranzul  ;  Damba Enkhtuya  ;  Nagir Choijamts  ;  Purev Batbayar  ;  Radnaa Otgonbayar  ;  Bat-Ulzii Saruul  ;  Chuluunbaatar Gantuul  ;  Baljinnyam Gegeebadrakh  ;  Narangerel Tuvshinbayar  ;  Dorjgotov Badamsuren  ;  Galsan Ulzmaa  ;  Jamiyandorj Otgonbold  ;  Kwang-Hyub Han 
 CLINICAL AND MOLECULAR HEPATOLOGY, Vol.27(1) : 125-135, 2021-01 
Journal Title
Issue Date
Hepatitis C, Chronic ; Ledipasvir ; Mongolia ; Real-world ; Sofosbuvir
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%). Conclusion: 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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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Do Young(김도영)
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
Lee, Jae Seung(이재승) ORCID logo https://orcid.org/0000-0002-2371-0967
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
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