국내 만성 B형 간염 환자의 경구용 항바이러스제 사용 현황 분석

Analysis of Drug Utilization in Patients with Chronic Hepatitis B

  • Lee, Yu Jeong (Department of Pharmacy, Pusan National University Hospital) ;
  • Bae, Sung Jin (Department of Pharmacy, Pusan National University Hospital) ;
  • Je, Nam Kyung (College of Pharmacy, Pusan National University)
  • 투고 : 2016.05.19
  • 심사 : 2016.08.09
  • 발행 : 2016.09.30

초록

Background: The treatment goal for patients with chronic hepatitis B infection is to prevent progression of the disease to cirrhosis and hepatocellular carcinoma. Current therapies include standard and pegylated interferon-alfa and nucleoside/nucleotide analogues: lamivudine, adefovir, entecavir, telbivudine, clevudine, and tenofovir. This study aims to analyze changes in the prescribing patterns of chronic hepatitis B (CHB) medications in South Korea between 2013 and 2014. Methods: A cross-sectional study was conducted using National Patients Sample data compiled by the Health Insurance Review and Assessment Service from 2013 and 2014. Patients with CHB were identified with Korean Standard Classification of Diseases code-6 (B18.0 and B18.1) and those who were maintaining active prescriptions with CHB medications covering the index date (December $1^{st}$, each year) were included. The utilization of antiviral therapy was investigated during 2013 and 2014. Results: A total of 4,204 and 4,552 patients in 2013 and 2014 respectively, were included in the analysis. The proportion of male patients was two of third and the patients 41-60 years old accounted for 60% of all analyzed patients. The most utilized drug was entecavir (55.1% in 2013 and 44.8% in 2014) and the second most utilized drug was tenofovir in both years (18.8% in 2013 and 29.0% in 2014). The percentage of combination therapy was 13.6% and 13.1% in 2013 and 2014, respectively. The proportion of tenofovir prescriptions was increased in 2014 compared with 2013. Conclusion: With the development of new drugs and the changes in clinical practice guidelines, the prescription pattern of the antiviral agents for patients with CHB has changed. The rate of utilization of tenofovir has increased.

키워드

참고문헌

  1. World Health Organization. Hepatitis B. Fact Sheet No. 204. Available from http://www.who.int/mediacentre/factsheets/fs204/en/. Accessed August 5, 2016.
  2. NCBI. Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. Genev: World Health Organization; 2015 Mar. Available from http://www.ncbi.nlm.nih.gov/books/NBK305553/. Accessed August 5, 2016.
  3. Sarin SK, Kumar M, Lau GK, et al. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int 2016;10(1):1-98.
  4. Ott JJ, Stevens GA, Groeger J, et al. Global epidemiology of hepatitis B virus infection: new estimates of age-specific HBsAg seroprevalence and endemicity. Vaccine 2012;30(12):2212-9. https://doi.org/10.1016/j.vaccine.2011.12.116
  5. Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380(9859):2095-128. https://doi.org/10.1016/S0140-6736(12)61728-0
  6. Schweitzer A, Horn J, Mikolajczyk RT, et al. Estimations of worldwide prevalence of chronic hepatitis B virus infection: A systematic review of data published between 1965 and 2013. Lancet 2015;386(10003):1546-55. https://doi.org/10.1016/S0140-6736(15)61412-X
  7. Ministry of Health and Welfare. 2014 Korea Natinal Health & Nutrition Examination Survey VI 2nd. Available from http://stat.mohw.go.kr/. Accessed August 3, 2016.
  8. Lee JM, Ahn SH, Chang HY, et al. Reappraisal of HBV genotypes and clinical significance in Koreans using MALDI-TOF mass spectrometry. Korean J Hepatol 2004;10(4):260-70.
  9. Sunbul M. Hepatitis B virus genotypes: global distribution and clinical importance. World J Gastroenterol 2014;20(18):5427-34. https://doi.org/10.3748/wjg.v20.i18.5427
  10. Kim H, Jee YM, Song BC, et al. Molecular epidemiology of hepatitis B virus (HBV) genotypes and serotypes in patients with chronic HBV infection in Korea. Intervirology 2007;50(1):52-7. https://doi.org/10.1159/000096313
  11. The Korean Association for the Study of the Liver. KASL clinical practice guidelines: management of chronic hepatitis B. Clin Mol Hepatol 2016;22(1):18-75. https://doi.org/10.3350/cmh.2016.22.1.18
  12. Su MH, Lu AL, Li SH, et al. Long-term lamivudine for chronic hepatitis B and cirrhosis: A real-life cohort study. World J Gastroenterol 2015;21(46):13087-94. https://doi.org/10.3748/wjg.v21.i46.13087
  13. Kong HK, Shon HS, Choi KE, et al. Prescribing Patterns of Antivirals for Chronic Hepatitis B. Kor J Clin Pharm 2012;22(1):81-6.
  14. Jeong JY. Current and future of reimbursement criteria in liver disease:Reimbursement status of drugs for the treatment of hepatitis B in Asia countries and the situation and prospects in Korea. Taehan Kan Hakhoe Chi 2012;2012(2):84-9.
  15. Ministry of Health and Welfare Notification No.2013-75. Amendment of details of applicable standards and methods of reimbursement (drugs). Available from http://www.mohw.go.kr/front_new/jb/sjb0406ls.jsp?PAR_MENU_ID=03&MENU_ID=030406. Accessed July 25, 2016.
  16. The Korean Association for the Study of the Liver. KASL clinical practice guidelines update: management of chronic hepatitis B drug resistance. Available from http://www.kasl.org/bbs/index.html?code=guide&category=&gubun=&idx=\&page=1&number=2160&mode=view&order=&sort=&keyfield=&key=. Accessed July 27, 2016.
  17. Ministry of Health and Welfare Notification No.2015-68. Amendment of details of applicable standards and methods of reimbursement (drugs). Available from http://www.mohw.go.kr/front_new/jb/sjb 040 6ls.jsp?PAR_MENU_ID=03&MENU_ID=030406 Accessed August 7, 2016
  18. Kim R. Introduction of Health Insurance Review and Assessment services' national patients sample. HIRA Policy Trends 2012;6:37-47.
  19. Park SH. Trends in the seroprevalence of hepatitis B surface antigen in the South Korean population. Int J Infect Dis 16(9):e669-e72. https://doi.org/10.1097/00006454-200007000-00024
  20. Park B, Jung KW, Oh CM, et al. Ten-Year Changes in the Hepatitis B Prevalence in the Birth Cohorts in Korea: Results From Nationally Representative Cross-Sectional Surveys. Medicine 2015;94(41):e1469. https://doi.org/10.1097/MD.0000000000001469
  21. The Korean Association for the Study of the Liver. KASL Clinical Practice Guidelines: management of chronic hepatitis B. Clin Mol Hepatol 2012;18(2):109-62. https://doi.org/10.3350/cmh.2012.18.2.109
  22. Yim HJ, Hwang SG. Options for the management of antiviral resistance during hepatitis B therapy: reflections on battles over a decade. Clin Mol Hepatol 2013;19(3):195-209. https://doi.org/10.3350/cmh.2013.19.3.195
  23. Wiens A, Lenzi L, Venson R, et al. Comparative efficacy of oral nucleoside or nucleotide analog monotherapy used in chronic hepatitis B: a mixed-treatment comparison meta-analysis. Pharmacotherapy 2013;33(2):144-51. https://doi.org/10.1002/phar.1188
  24. Singal AK, Fontana RJ. Meta-analysis: oral anti-viral agents in adults with decompensated hepatitis B virus cirrhosis. Aliment Pharmacol Ther 2012;35(6):674-89. https://doi.org/10.1111/j.1365-2036.2011.04990.x
  25. Peters MG, Hann HW, Martin P, et al. Adefovir dipivoxil alone or in combination with lamivudine in patients with lamivudine-resistant chronic hepatitis B. Gastroenterology 2004;126(1):91-101. https://doi.org/10.1053/j.gastro.2003.10.051
  26. Rapti I, Dimou E, Mitsoula P, et al. Adding-on versus switching-to adefovir therapy in lamivudine-resistant HBeAg-negative chronic hepatitis B. Hepatology 2007;45(2):307-13. https://doi.org/10.1002/hep.21534