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

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

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 >6x106 lU/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.

Original languageEnglish
Pages (from-to)125-135
Number of pages11
JournalClinical and Molecular Hepatology
Volume27
Issue number1
DOIs
Publication statusPublished - 2021 Jan

Bibliographical note

Funding Information:
We greatly appreciate the cooperation of the Ministry of Health of Mongolia, University General Hospital of the Mongolian Na-tional University of Medical Sciences, Mongolian Academy of Medical Sciences, Happy Veritas Liver Diagnostics Center, Nation-al Center for Communicable Diseases, Second State Central Hos-pital, Third State Central Hospital and the Mongolian Association for the Study of Liver Diseases for their provision of field staff. We would like to express our special appreciation to Yonsei Uni-versity College of Medicine of Korea for their tremendous efforts in the presenting study.

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Molecular Biology

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