PMID- 33242929
OWN - NLM
STAT- MEDLINE
DCOM- 20210921
LR  - 20210921
IS  - 2287-285X (Electronic)
IS  - 2287-2728 (Print)
IS  - 2287-2728 (Linking)
VI  - 27
IP  - 1
DP  - 2021 Jan
TI  - Efficacy and safety of ledipasvir/sofosbuvir in 5,028 Mongolian patients infected 
      with genotype 1 hepatitis C virus: A multicenter study.
PG  - 125-135
LID - 10.3350/cmh.2020.0023 [doi]
AB  - 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 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.
FAU - Baatarkhuu, Oidov
AU  - Baatarkhuu O
AD  - Department of Infectious Diseases, School of Medicine, Mongolian National 
      University of Medical Sciences, Ulaanbaatar, Mongolia.
AD  - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 
      Korea.
AD  - Mongolian Academy of Medical Sciences, Ulaanbaatar, Mongolia.
AD  - Mongolian Association for the Study of Liver Diseases, Ulaanbaatar, Mongolia.
FAU - Lee, Jae Seung
AU  - Lee JS
AD  - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Amarsanaa, Jazag
AU  - Amarsanaa J
AD  - Mongolian Association for the Study of Liver Diseases, Ulaanbaatar, Mongolia.
AD  - Department of Hepatology, Happy Veritas Liver Diagnostics Center, Ulaanbaatar, 
      Mongolia.
FAU - Kim, Do Young
AU  - Kim DY
AD  - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Ahn, Sang Hoon
AU  - Ahn SH
AD  - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Naranzul, Nyamsuren
AU  - Naranzul N
AD  - Department of Infectious Diseases, School of Medicine, Mongolian National 
      University of Medical Sciences, Ulaanbaatar, Mongolia.
AD  - Mongolian Association for the Study of Liver Diseases, Ulaanbaatar, Mongolia.
FAU - Enkhtuya, Damba
AU  - Enkhtuya D
AD  - Mongolian Association for the Study of Liver Diseases, Ulaanbaatar, Mongolia.
AD  - Department of Hepatology, Happy Veritas Liver Diagnostics Center, Ulaanbaatar, 
      Mongolia.
FAU - Choijamts, Nagir
AU  - Choijamts N
AD  - Mongolian Association for the Study of Liver Diseases, Ulaanbaatar, Mongolia.
AD  - Department of Hepatology, Happy Veritas Liver Diagnostics Center, Ulaanbaatar, 
      Mongolia.
FAU - Batbayar, Purev
AU  - Batbayar P
AD  - Mongolian Association for the Study of Liver Diseases, Ulaanbaatar, Mongolia.
AD  - Department of Hepatology, Happy Veritas Liver Diagnostics Center, Ulaanbaatar, 
      Mongolia.
FAU - Otgonbayar, Radnaa
AU  - Otgonbayar R
AD  - Department of Internal Medicine, University General Hospital, Mongolian National 
      University of Medical Sciences, Ulaanbaatar, Mongolia.
FAU - Saruul, Bat-Ulzii
AU  - Saruul BU
AD  - Mongolian Association for the Study of Liver Diseases, Ulaanbaatar, Mongolia.
AD  - Department of Hepatology, National Center for Communicable Diseases, Ulaanbaatar, 
      Mongolia.
FAU - Gantuul, Chuluunbaatar
AU  - Gantuul C
AD  - Mongolian Association for the Study of Liver Diseases, Ulaanbaatar, Mongolia.
AD  - Department of Hepatology, National Center for Communicable Diseases, Ulaanbaatar, 
      Mongolia.
FAU - Gegeebadrakh, Baljinnyam
AU  - Gegeebadrakh B
AD  - Mongolian Association for the Study of Liver Diseases, Ulaanbaatar, Mongolia.
AD  - Department of Gastroenterology, Second State Central Hospital, Ulaanbaatar, 
      Mongolia.
FAU - Tuvshinbayar, Narangerel
AU  - Tuvshinbayar N
AD  - Mongolian Association for the Study of Liver Diseases, Ulaanbaatar, Mongolia.
AD  - Department of Gastroenterology, Second State Central Hospital, Ulaanbaatar, 
      Mongolia.
FAU - Badamsuren, Dorjgotov
AU  - Badamsuren D
AD  - Mongolian Association for the Study of Liver Diseases, Ulaanbaatar, Mongolia.
AD  - Department of Gastroenterology, Third State Central Hospital, Ulaanbaatar, 
      Mongolia.
FAU - Ulzmaa, Galsan
AU  - Ulzmaa G
AD  - Mongolian Association for the Study of Liver Diseases, Ulaanbaatar, Mongolia.
AD  - Department of Gastroenterology, Third State Central Hospital, Ulaanbaatar, 
      Mongolia.
FAU - Otgonbold, Jamiyandorj
AU  - Otgonbold J
AD  - School of Dentistry, Mongolian National University of Medical Sciences, 
      Ulaanbaatar, Mongolia.
FAU - Han, Kwang-Hyub
AU  - Han KH
AD  - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 
      Korea.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20201127
PL  - Korea (South)
TA  - Clin Mol Hepatol
JT  - Clinical and molecular hepatology
JID - 101586730
RN  - 0 (Antiviral Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Fluorenes)
RN  - 013TE6E4WV (ledipasvir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
CIN - Clin Mol Hepatol. 2021 Jan;27(1):100-102. PMID: 33317234
MH  - Antiviral Agents/therapeutic use
MH  - Benzimidazoles/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Fluorenes/*therapeutic use
MH  - Genotype
MH  - Hepacivirus
MH  - *Hepatitis C/drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mongolia
MH  - Sofosbuvir/*therapeutic use
MH  - Treatment Outcome
PMC - PMC7820214
OTO - NOTNLM
OT  - Hepatitis C, Chronic
OT  - Ledipasvir
OT  - Mongolia
OT  - Real-world
OT  - Sofosbuvir
COIS- Conflicts of Interest: The authors have no conflicts of interests to disclose.
EDAT- 2020/11/28 06:00
MHDA- 2021/09/22 06:00
PMCR- 2021/01/01
CRDT- 2020/11/27 00:17
PHST- 2020/02/01 00:00 [received]
PHST- 2020/07/27 00:00 [accepted]
PHST- 2020/11/28 06:00 [pubmed]
PHST- 2021/09/22 06:00 [medline]
PHST- 2020/11/27 00:17 [entrez]
PHST- 2021/01/01 00:00 [pmc-release]
AID - cmh.2020.0023 [pii]
AID - cmh-2020-0023 [pii]
AID - 10.3350/cmh.2020.0023 [doi]
PST - ppublish
SO  - Clin Mol Hepatol. 2021 Jan;27(1):125-135. doi: 10.3350/cmh.2020.0023. Epub 2020 
      Nov 27.