Liver Stiffness Decrease Post Ledipasvir/Sofosbuvir Combination Treatment in Mongolian Patients with Chronic Hepatitis C

( D. Munkh-orshikh ),( D. Enkhtuya ),( N. Choijamts ),( Ch. Gantuul ),( O. Baatarkhuu ) 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1

Aims: The prevalence of liver cancer in Mongolia is 7 times higher than that of world average, generally caused by HBV and HCV. The most prevalent cause of HCC in Mongolia, HCV, accompanied with liver stiffness and cirrhosis, is an emerging public health issue. Mongolia is one of the first countries that registered Ledipasvir/Sofosbuvir (LDV/SOF) regimen from developing countries. By the support of Access program run by Gilead Sciences, USA, we started HCV treatment program from January 2016. Methods: We followed and evaluated treatment outcome of patients with HCV infection using combination of 90 mg ledispavir/ 400 mg sofosbuvir (manufactured by Gilead Science) in 298 treatment nai¨ve patients. All patients were treated with LDV/SOF for 12 weeks and, their treatment was evaluated by quantitative HCV-RNA assays prior and W (week) 4 and W12 of treatment. Sustained virological response (SVR) after 12 weeks treatment was assessed. Virus genotype analysis using cDNA microarray, liver enzymes, CBC and drug related adverse events were assessed in every patient. The laboratory tests were conducted at National Center of Communicable Diseases and Happy Veritas Laboratories. Results: Out of 298 patients underwent treatment, 138 patients were examined for pre-treatment liver stiffness using Fibroscan. When patients were examined by Fibroscan test, 25% (n = 35) of assessed patients were F0 stage; 13.57% (n = 19) were F1 stage; 10% (n = 14) were F2 stage; 20.71% (n = 29) were F3 stage; and 30.72% (n = 43) were F4 stage. Patients (n = 35) with fibrosis stage F0 were omitted from post-treatment control examinations. The one hundred three patients were selected for further post-treatment fibrosis staging. The twenty three patients were successfully contacted and complied posttreatment Fibroscan scanning. 23/23 (100%) patients achieved SVR12. W, were all genotype 1b. Median ALT level significantly dropped during treatment from 121.19 ± 98.3 IU/L to 33.2 ± 14.7 IU/L and slightly increased by the end of treatment 41.4 ± 18.8 IU/L. The ninety one percent of the patients had improved in liver stiffness while remaining patients were observed increased stiffness. Conclusions: After treatment, 30.43% (n = 7) of patients moved to the F0 stage from liver stiffness. There are many studies that assess liver fibrosis after cure of HCV, but varying numbers were observed. We assess liver stiffness after treatment of HCV in Mongolian population for the first time. Though study population was small, we had 91% of.

Epidemiology and Prognosis of Hepatocellular Carcinoma in Mongolia

( Dashchirev Munkh-orshikh ),( S. Ariunaa ),( J. Chinburen ),( M. Shagdarsuren ),( J. Amarsanaa ),( Oidov Baatarkhuu ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1

Aims: Hepatocellular carcinoma (HCC) is the most common cancer in Mongolia, with an occurrence of 115 cases per 100,000 people. We aimed to investigate the clinical features, therapeutic modalities, overall survival, and prognostic factors for Mongolian patients with HCC. Methods: 195 patients with HCC were consecutively enrolled in our study. Diagnosis of HCC was made according to the EASL guidelines. Results: The mean age (108 males and 87 females) was 61.7 years. A large proportion of patients (n=165, 84.6%) had underlying liver cirrhosis. The most common etiology for HCC was HBV infection (n=67, 34.4%), followed by HCV infection (n=89, 45.6%). The mean tumor diameter was 6.0 ± 2.6 cm. Only 29 (14.9%) patients had a single lesion, while 39 (20.0%) had >3 lesions. Extra hepatic metastasis to the lung (n=23), bone (n=10), and lymph node (n=3) was detected in 36 (18.5%) patients. The mean serum AFP level was 196.0 ng/ml. Most patients had advanced HCC; 88 (45.1%) in stage III and 57 (29.2%) in stage IV. Surgical resection was performed in 27 (13.8%) patients, RFA in 23 (11.8%), and TACE in 107 (54.9%). In 38 (19.5%) patients with distant metastasis or poor liver function, the best supportive care was provided. When all the patients were categorized as ‘treated’ (n=156) and ‘not treated’ (n=39), the 3 year survival was significantly lower in the ‘not treated’ group than in the ‘treated’ group (11% vs 0%, P<0.001). Tumor diameter (<3 cm vs ≥3 cm), extra hepatic metastasis, TNM stage (I/II vs. III/IV), and treatment (or supportive care) were selected as independent predictors for survival. Conclusions: The number of patients diagnosed with an advanced stage of HCC in Mongolia is relatively high, and the survival rate of these patients is lower compared to other countries due to limited treatment modalities.

Risk Factors of Hepatitis B Virus Infection in Mongolia

( Dashchirev Munkh-orshikh ),( Badamnachin Batsukh ),( Ganbold Sarangua ),( Oidov Baatarkhuu ) 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1

Aims: To study risk factors of HBV transmission. Background: Mongolia introduced HBV vaccination into routine immunization schedules for newborns and children under1 year of age in 1991, which substantially decreased the incidence of HBV infection. Methods: The study was conducted 200 patients with acute HBV infection, treated in Mongolia from 2015-2017. Results: The mean age of the patients were 26±6.4, of those 57.5% were males and 42.5% were females and 41% were married. 17(8.5%) were vaccinated, 116 were unvaccinated and 67(33.5%) they don’t know whether they were vaccinated or not. 99(49.5%) survey participants were born before 1991, 87(43.5%) were bornbetween 1992-1997 and 14(7%) were born since 1997. A specially developed questionnaire was used to determine the risk factors for HBV infection (last six months): In the serology test, 178(89%) were HBsAg and anti-HBcIgM-both positive and 22(11%) were HBsAg positive and anti-HBcIgM negative. Conclusions: HBV vaccination is effective method for preventing HBV infection. Most common risk factors of HBV infection are household and sexual contacts of people with HBV and having multiple sexual partners.

Current Status New Direct Acting Anti-Viral Treatment of Hepatitis C in Mongolia

( Tserendorj Chinbayar ),( Dashchirev Munkh-orshikh ),( Oidov Baatarkhuu ) 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1

Aims: During last several years, internationally available diagnostics, treatments and medicines of HCV have changed dramatically. Interferon-based therapy for HCV has comparatively low result of treatment effect, more side effects, long treatment duration, high cost of single dose and limited option of treatment. Since introduction of direct antiviral agents including in 2011 Boceprevir, Telaprevir, in 2013 Simeprevir, Sofosbuvir, in 2014 Harvoni (ledipasvir/sofosbuvir), Daklinza (daclatasvir), Vikera Pack (ombitasvir/paritaprevir/dasabuvir), the new era HCV treatment came up. Thanks to those new drugs HCV infection became one of the curable diseases, and entire world is targeting free from HCV /WHO/. Therefore, there is need of to access milestones of diagnostic and treatment development of HCV in our country. Our study aims to determine implementation of global trend for HCV diagnostic and treatment in Mongolia. Methods: This study is qualitative one and we analyzed policy and strategic documents and statistics issued by Mongolian Government, Ministry of Health, National Center for Communicable Disease, Mongolian National University of Medical Sciences and other organizations. Results: Ministry of Health played very large role in introduction of new management of HCV into the country. It provided all the legal ground and support to service providers at all levels of care. New guideline was approved which includes all new schemes of the treatment, diagnostic methods, new drugs were registered, specialist doctors were trained and access of the new drug were widened thanks to joining the Access program from Gilead Sciences. It can be said that the tentative result of DAA treatment is successful, compare few years ago interferon treatment effect was fewer than 20 percent to the 99 percent effective of current new treatment. Conclusions: All those achievements show that Mongolia has been able to introduce a comprehensive and efficient short-term treatment for HCV and free the population of that disease which may increase the mortality level due to liver cancer.

Study on HBV Vaccination Coverage among Healthcare Workers in Mongolia

( Nyamsuren Naranzul ),( Dashchirev Munkh-orshikh ),( Baasankhuu Enkhtuvshin ),( Oidov Baatarkhuu ) 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1

Aims: To define HBV vaccination coverage among Mongolian healthcare workers. Introduction: Mongolia has a large burden of viral hepatitis, especially chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections, which are associated with cancer and cirrhosis. The occupational risk for transmission of HBV, HCV and HIV among healthcare workers (HCWs) is well recognized. Methods: This is a cross-sectional hospital based survey which will be conducted among healthcare workers to evaluate HBV vaccination coverage and KAP towards to the HBV infection and vaccination. In total, 1200 health care workers were attended to the survey. Results: More than half of survey respondents were had full 3 doses of HBV vaccination. About 4.5% of them had infected with HBV. About 64.0% of them were health workers who are currently working at risk position and most of them had contact with blood, blood products and other body fluids, as well as the risk of needle-stick injuries. 40.0% of respondents who had full doses of HBV vaccination and 56.9% of them had immune due to natural infection. Whereas, 16.7% of respondents who did not received full doses of HBV vaccination were had immune due to natural infection. In general, 1 of 2 respondents had immune due to natural infection. Conclusions: The HBV vaccination coverage among health workers are relatively sufficient. However, already infected percentages of among health workers are high in Mongolia.

Epidemiology and Genotype Distribution of HCV in Mongolia

( Sosorbaram Ariunaa ),( D. Munkh-orshikh ),( Ch. Bolormaa ),( B. Gansaikhan ),( Oidov Baatarkhuu ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1

Aims: Mongolia is a unique country with high endemicity for three blood borne hepatitis viruses, namely HBV, HCV and HDV. The number of patients with acute hepatitis decreased considerably with an estimated annual number of cases 13,000/ year in 1991 to 1700/year in 2013 in Mongolia.Hepatitis B and C virus infection are one of the major causes of liver cirrhosis and HCC in Mongolia. However, viral hepatitis C is still one of the serious public health concerns in Mongolia. To investigate of HCV infection among apparently healthy populations in Mongolia. Methods: The study population was consisted of 1512 subjects from 13 provinces and Ulaanbaatar city which is the capital city of Mongolia, and the age ranged from 0 to 80 years. Results: According to our study results, the prevalence of anti-HCV was 15.6%, and the HCV RNA was detected in 11 %; therefore, we can say that the prevalence of this infection is very high in Mongolia.The prevalence of anti-HCV and HCV RNA had a tendency to increase with age. The prevalence of anti-HCV and HCV RNA in population aged over 61 years was significantly higher than those aged 31 to 40 year. The history of dental care, surgery, and tattooing was significantly more frequent in anti-HCV positive subjects compared with anti-HCV negative subjects. Interestingly, the most of HCV infection is caused by genotype 1. However, Genotype 2 of HCV is very rare, less than 2 percent in Mongolia. The extreme predominance of HCV genotype 1b in the Mongolian population may be explained by the greater ethnic and genetic homogeneity of current Mongolian population. Conclusions: The epidemiological situation of HCV infection in Mongolia is catastrophic. This infection was evenly distributed in all areas and has endemic characteristics for the country. The rate of positive anti-HCV and HCV-RNA was increasing age-dependently. The predominant genotype of HCV in Mongolia is 1b.

Survey on Hepatitis B Vaccination Coverage among Mongolian Healthcare Workers

( Batzaya M ),( Naranzul N ),( Munkh-orshikh ),( Enkhtuvshin B ),( Baatarkhuu O ) 대한간학회 2021 춘·추계 학술대회 (KASL) Vol.2021 No.1

Functional Abnormalities of the Liver in Diabetic Patients with and without Viral Hepatitis C in Mongolia

( Altantuya Idkhuu ),( Dashchirev Munkh-orshikh ),( Baasankhuu Enkhtuvshin ),( Uranbaigali Enkhbayar ),( Oidov Baatarkhuu ) 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1

Aims: We aimed to compare liver function of diabetes mellitus patients with and without viral hepatitis C using the non-alcoholic fatty liver disease fibrosis score, aspartate transaminase to platelet ratio index, Fibrosis-4 Index, Mac-2-binding protein biomarker and ultrasonic liver stiffness measurements. Introduction: Diabetic patients with viral hepatitis have a high risk of liver cirrhosis. M2BPGi biomarker helps to determine the stage of liver fibrosis in those with fatty liver disease and viral hepatitis in Mongolia. Methods: The study was conducted based on convenience sampling of 123 patients from the General hospital outpatient clinic. Slightly more than half of the study participants were male (53%, n=64). Thirty-three of the diabetics with hepatitis (mean age 52.31±9.8 years) and 90 diabetics without hepatitis (mean age 53.26±8.58) agreed to participate. Anthropometric measurements, non-alcoholic fatty liver disease fibrosis score, aspartate transaminase to platelet ratio index, Fibrosis-4 Index, Mac-2-binding protein biomarker, and ultrasonic transient elastography measurements were compared using independent t-tests for continuous variables and Wilcoxon rank sum tests for ordinal variables. Results: The median values of the Fibrosis-4 Index for those with hepatitis C and without were 1.3 vs 0.9(P<.05), Mac-2-binding proteinbiomarker2.0 vs 1.3 (P<.0001), ultrasonic liver stiffness measurements 10.3 vs 6.9 (P<.0001),aspartate transaminase to platelet ratio 0.6 vs 0.3 (P<.001), and Non-alcoholic fatty liver disease fibrosis scores were -0.2 vs -0.9( P<.004), respectively. Conclusions: Diabetic patients with hepatitis had statistically significantly higher Mac-2-binding protein biomarker, NAFLD Fibrosis Scores than patients without hepatitis. However, other fibrosis test results were similar in diabetic patients with hepatitis and without hepatitis C.

Pegylated IFN-α 2a plus Ribavirin Combination Therapy Results in Mongolian Patients with Hepatitis C Virus Genotype 1b

( Оidov Baatarkhuu ),( Dashchirev Munkh-orshikh ),( G. Uugantsetseg ),( B. Davaakhuu ),( N. Naranzul ),( S. Ariunaa ),( Ch. Gantuul ),( Ch. Bolormaa ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

Aims: Mongolia is one of the highest prevalent of hepatitis C virus infection of the world. The standard therapy for patients with genotype 1 chronic hepatitis C (CHC) is a combination of peg-interferon alfa -2a and ribavirin for 48 weeks. However the most appropriate duration of treatment remains to be established because of treatment -related side effects and cost. To compare the efficacies of 24-week and 48-week treatments of peg-interferon alfa-2a plus ribavirin in Mongolian patients Methods: A total of 47 patients with genotype 1 CHC was treated between August 2008 and were randomly assigned to treatment and December 2013 and at least one dose of study medication, consisting of 180 mg of peginterferonalfa 2-a once weekly plus daily ribavirin(1000 or 1200mg, depending on body weight). Patients with undetectable HCV RNA at 24 weeks of treatment were allowed to choose either 24 or 48 weeks as the duration of their treatment ; 4 patients chose the 24 week treatment regimen and the 43 patients chose the 48-week regimen. Results: The SYR rate was higher in patients treated for 48 weeks than in those treated for24 weeks(74% vs 48.8%, p=0.0013). In the multivariate analysis, age < 52 years, platelets >148000mm3, and treatment duration for 48 weeks remained significant independent predictors of SVR. Fortheen of the 47 patients who relapsed in the 24-week treatment group received split 24-week therapy, and 3 patients was achieved SVR. The overall SVR rate did not differ significantly between the 24-week treatment group, including those who underwent 24-week split therapy 48.8%, and the 48-week treatment group (48.8% vs 74%). Conclusions: SVR rate was 74% of the patients in Mongolia.The 24-week therapy following failure is a useful treatment strategy for patients with genotype 1b chronic hepatitis C.

HCV Management in Mongolia

( Tsogzolmaa O. ),( Dashichirev Munkh-orshikh ),( Baasankhuu Enkhtuvshin ),( Oidov Baatarkhuu ) 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1

Aims: To determine situation and implementation of HCV policy management Introduction: Mongolia has a large burden of viral hepatitis, especially chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections, which are associated with cancer and cirrhosis. Therefore, there is need of to assess policy implementation, milestones of diagnostic and treatment development of HCV in our country. Methods: Descriptive study, analyzed policy and strategic documents and statistics issued by government organizations, reviewed treatment result published studies. Results: Since 2014, 19 policy documents were approved and updated national viral hepatitis guideline three times. In 2017 Mongolia established The Whole Liver Program (HPCE)2017-2020. It aims to eliminate HCV in Mongolia by 2020 and to significantly reduce viral hepatitisinduced liver cirrhosis and HCC related mortalities.Within the framework of the program, free general population hepatitis screening,two free-ofcharge HCV viral load testing and no-out-of-pocket-cost HCV treatment campaigns have been initiated nationwide. 959,320 people were screened viral hepatitis, 94,280 people were tested viral load, 19,896 people were treated. Conclusions: The HPCE Program in Mongolia is serving as a model for other countries in their fight against viral hepatitis.