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RISS 인기검색어
- 검색키워드
- 저자 : ( N. Choijamts ) (검색결과 2 건)
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Efficacy and Safety of Ledipasvir/Sofosbuvir Treatment of HCV Genotype 1b in Mongolia
( O. Baatarkuu ),( B. Enkhtuvshin ),( N. Lkhaasuren ),( B. Batsukh ),( G. Sarangua ),( D. Enkhtuya ),( N. Choijamts ),( J. Amarsanaa ) 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: The incident of liver cancer in Mongolia generally caused by HBV and HCV, and it is 7 times higher than that of world average. HCV, the most prevalent cause of HCC in Mongolia, is number one public health issue. Mongolia is one of the first countries that registered ledipasvir/sofosbuvir (LDV/SOF) regi men from developing countries. By the support of Access pro gram 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 ledis pavir/400 mg sofosbuvir (manufactured by Gilead Science) in 937 treatment naive and 83 treatment experienced 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: We conducted largest ever (415/1020) HCV genotype (GT) distribution study in Mongolian chronic HCV patients. 96.6% (n = 401) of assessed patients were GT1b; 0.7% (n = 3) were GT2; 0.2% (n = 1) were GT1a and b; 0.9% (n = 4) were GT1b and 2; 0.5% (n = 2) were GT1b and 6; 0.2% (n = 1) were GT5 and 0.2% (n = 1) were GT1b and 80 k mutants respective ly. 992/1020 (97.3%) patients achieved SVR12W, 28 (2.7%) patients who did not achieve SVR12 W were all genotype 1b. Median ALT level significantly dropped during treatment from 95.5 ± 84.1 IU/L to 27.2 ± 18.6 IU/L and slightly increased by the end of treatment 42.9 ± 17.4 IU/L. Total of 39 adverse events were observed in 595/1020 patients (58.3%). Single adverse events were observed in 401/1020 (39.3%) whereas 2 and more events were observed in 194 (19%) patients respec tively. Unreported adverse events such as partial facial palsy, AFP (alpha-fetoprotein) increase, melasma were observed. Conclusions: Treatment of HCV in Mongolia using all-oral dual DAA was divided in 3 phases due to shortness of drugs and logistics arrangements. We were able to include only stage-one patients in this study. We achieved 97.3% SVR12W for 3 months treatment with LDV/SOF this time. But viral relapse has to be determined repeatedly at weeks 24 and 48 post treatment. All viral relapses (n = 14) and non-responders (n = 14) were GT1 in our study. According to HCV genotype assess ment, there was no difference in treatment outcomes between patients who had different genotypes. HCV RNA clearance during treatment was no different than clinical trials, but the slight increase of ALT by the end of treatment was commonly observed. It might have happened due to rebound of immune reaction after clearance of HCV or a drug induced effect.
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( 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.
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