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      • Ledipasvir and Sofosbuvir Fixed-Dose Combination without Ribavirin for 12 Weeks in Treatment-Naive Mongolian Patients with Hepatitis C: A Multi-Center Study

        ( O. Baatarkhuu ),( B. Davaakhuu ),( N. Naranzul ),( Ch. Gantuul ),( Ch. Bolormaa ),( P. Delgermaa ),( S. Ariunaa ),( G. Sarangua ),( G. Khishigjargal ),( D. Javzmaa ),( D. Ouyntuya ),( S. Nyamaa ),( 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

        Aims: In Mongolia, previous studies shown HCV prevalence is over 10% and 97-98% of people with HCV infection have infected with genotype 1b. In addition, Mongolia is on first place of HCC mortality rate per 100.000 population and this is eighth times higher than globally average rate. HCV prevalence among primary hepatic carcinoma patients is 35%-45%. Therefore activities on reducing chronic infection prevalence of hepatitis viruses and preventing complications of hepatitis viral infections have been conducted in the country. One of them is availability of Harvoni treatment for HCV patients since December 2015. To evaluate data on the antiviral efficacy and safety of direct acting antiviral (DAA) treatment with respect to sustained virological response (SVR) 12 weeks after completion of treatment. Methods: We retrospectively analyzed patient monitoring records and patient registration forms for HCV patients who received Harvoni treatment at NCCD, MNUMS, provinces and districts hospitals. Quantitative methods were applied in that retrospective study. Six hundred and forty-seven patients diagnosed as HCV and treated by Harvoni(ledipasvir/sofosbuvir) were attended the study. Results: There were totally 647 patients received Harvoni for HCV infection by September 2016. People who received treatment for less than 3 months there 31% and for longer than 3 months were 8%. Among them 91.9% have chronic hepatitis and first stage of liver cirrhosis and 8% have liver cirrhosis and carcinoma. After 1 month of treatment, HCV RNA tests result was negative for 98.8% of all Harvoni patients and for the rest 1.1% resulted in decrease of HCV RNA.After 3 month of trerapy, blood test result showed 100% recovery on transaminase level. 453/465, 10/465 and 2/465 of them were respectively genotype 1b, 2 and 1a. APRI score were pre-treatment 1.3±0.58 and post treatment 0.443±0.148. FIB4 score were pre-treatment 3.8±1.2 and post treatment 1.65±0.59. Occurrences of side effects were mild. 1.2%, 5.8% and 4.6% of them were respectively with CTP C, CTP B and CTP A scores. 88.2% of the participants were chronic hepatitis C and 1.7% of them were pre-treated by interferon. Conclusions: After treatment by Harvoni tablets, excellent SVR12 results were shown among the study participants’ and the favorable side-effect profile were observed for the Mongolian context.

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