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.
Citations
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Long-Term Outcomes of Ledipasvir/Sofosbuvir Treatment in Hepatitis C: Viral Suppression, Hepatocellular Carcinoma, and Mortality in Mongolia Amgalan Byambasuren, Buyankhishig Gyarvuulkhasuren, Byambatsogt Erdenebat, Khurelbaatar Nyamdavaa, Oidov Baatarkhuu Viruses.2025; 17(6): 743. CrossRef
Hepatitis C Virus Infection in Mongolia: Updated Provincial Data on Prevalence, Genotype Distribution, and Age-Specific Risk Factors Amgalan Byambasuren, Myagmarjaltsan Baatarzorigt, Munkhtuya Otgon, Byambasuren Bat-Amgalan, Mandakhnaran Purevkhuu, Naranzul Nyamsuren, Enkh-Amar Ayush, Dashchirev Munkh-Orshikh, Khurelbaatar Nyamdavaa, Oidov Baatarkhuu Viruses.2025; 17(12): 1602. CrossRef
Real-life experience of ledipasvir and sofosbuvir for HCV infected Korean patients: a multicenter cohort study Soon Kyu Lee, Sung Won Lee, Hae Lim Lee, Hee Yeon Kim, Chang Wook Kim, Do Seon Song, U Im Chang, Jin Mo Yang, Sun Hong Yoo, Jung Hyun Kwon, Soon Woo Nam, Seok-Hwan Kim, Myeong Jun Song, Jaejun Lee, Hyun Yang, Si Hyun Bae, Ji Won Han, Heechul Nam, Pil Soo The Korean Journal of Internal Medicine.2022; 37(6): 1167. CrossRef
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Oidov Baatarkhuu, Hye Won Lee, Jacob George, Dashchirev Munkh-Orshikh, Baasankhuu Enkhtuvshin, Sosorbaram Ariunaa, Mohammed Eslam, Sang Hoon Ahn, Kwang-Hyub Han, Do Young Kim
Clin Mol Hepatol 2017;23(2):147-153. Published online May 2, 2017
Background/Aims Mongolia has one of the highest hepatitis A, C, B and D infection incidences worldwide. We sought to investigate changes in the proportion of acute viral hepatitis types in Mongolia over the last decade.
Methods The cohort comprised 546 consecutive patients clinically diagnosed with acute viral hepatitis from January 2012 to December 2014 in Ulaanbaatar Hospital, Mongolia. A time trend analysis investigating the change in proportion of acute hepatitis A virus, hepatitis C virus (HCV), hepatitis B virus (HBV) and hepatitis delta virus (HDV) infection among the cohort with respect to a previous published study was undertaken.
Results Acute hepatitis A, B and C was diagnosed in 50.9%, 26.2% and 6.0% of the cohort. Notably, 16.8% of the cohort had a dual infection. The etiologies of acute viral hepatitis were varied by age groups. The most common cause of acute viral hepatitis among 2-19 year olds was hepatitis A, HBV and superinfection with HDV among 20-40 year olds, and HCV among 40-49 year olds. Patients with more than one hepatitis virus infection were significantly older, more likely to be male and had a higher prevalence of all risk factors for disease acquisition. These patients also had more severe liver disease at presentation compared to those with mono-infection.
Conclusions Acute viral hepatitis is still prevalent in Mongolia. Thus, the need for proper infection control is increasing in this country.
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