わが国のC型慢性肝炎患者における併存疾患と併用禁忌薬：実臨床データベース研究
直接作用型抗ウイルス薬（direct-acting antiviral：DAA）はC型慢性肝炎（chronic hepatitis C：CHC）患者の予後を改善するが，併存疾患を有する患者では薬物相互作用（drug-drug interaction：DDI）の影響を受けやすい可能性がある．Medical Data Visionのデータを用いて，日本人CHC患者173,796例の併存疾患の有病率および併用薬とDAAとの潜在的DDIを評価した．潜在的DDIはelbasvir＋grazoprevirおよびsofosbuvir/velpatasvirで最も少なく，paritaprevir/ombita...
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| Published in | 肝臓 Vol. 65; no. 8; pp. 368 - 390 |
|---|---|
| Main Authors | , |
| Format | Journal Article |
| Language | Japanese |
| Published |
一般社団法人 日本肝臓学会
01.08.2024
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0451-4203 1881-3593 |
| DOI | 10.2957/kanzo.65.368 |
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| Abstract | 直接作用型抗ウイルス薬（direct-acting antiviral：DAA）はC型慢性肝炎（chronic hepatitis C：CHC）患者の予後を改善するが，併存疾患を有する患者では薬物相互作用（drug-drug interaction：DDI）の影響を受けやすい可能性がある．Medical Data Visionのデータを用いて，日本人CHC患者173,796例の併存疾患の有病率および併用薬とDAAとの潜在的DDIを評価した．潜在的DDIはelbasvir＋grazoprevirおよびsofosbuvir/velpatasvirで最も少なく，paritaprevir/ombitasvir/ritonavirおよびdaclatasvir＋asunaprevirで最も多かった．DDIはDAAごとに異なっており，潜在的DDIを考慮したDAAの選択が必要であると考えられた． |
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| AbstractList | 直接作用型抗ウイルス薬（direct-acting antiviral：DAA）はC型慢性肝炎（chronic hepatitis C：CHC）患者の予後を改善するが，併存疾患を有する患者では薬物相互作用（drug-drug interaction：DDI）の影響を受けやすい可能性がある．Medical Data Visionのデータを用いて，日本人CHC患者173,796例の併存疾患の有病率および併用薬とDAAとの潜在的DDIを評価した．潜在的DDIはelbasvir＋grazoprevirおよびsofosbuvir/velpatasvirで最も少なく，paritaprevir/ombitasvir/ritonavirおよびdaclatasvir＋asunaprevirで最も多かった．DDIはDAAごとに異なっており，潜在的DDIを考慮したDAAの選択が必要であると考えられた． |
| Author | 堤, 武也 四柳, 宏 |
| Author_xml | – sequence: 1 fullname: 四柳, 宏 organization: 東京大学医科学研究所先端医療研究センター感染症分野 – sequence: 1 fullname: 堤, 武也 organization: 東京大学医科学研究所先端医療研究センター感染症分野 |
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| Copyright | 2024 一般社団法人 日本肝臓学会 |
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| References | 7) Cornberg M, Manns MP. The curing regimens of HCV: A SWOT analysis. Antivir Ther 2022; 27 (1-2): 13596535211072672 36) Zu Siederdissen CH, Maasoumy B, Marra F, et al. Drug-drug interactions with novel all oral interferon-free antiviral agents in a large real-world cohort. Clin Infect Dis 2016; 62 (5): 561-567 17) Ministry of Education. Culture, Sports, Science and Technology and Ministry of Health, Labour and Welfare. In: The ethical guidelines on biomedical research involving human subjects 6) Michielsen P, Ho E, Francque S. Does antiviral therapy reduce the risk of hepatocellular carcinoma in patients with chronic hepatitis C? Minerva Gastroenterol Dietol 2012; 58 (1): 65-79 26) Palleria C, Di Paolo A, Giofrè C, et al. Pharmacokinetic drug-drug interaction and their implication in clinical management. J Res Med Sci 2013; 18 (7): 601-610 13) Chayama K, Imamura M, Hayes C. Hepatitis C virus treatment update - A new era of all-oral HCV treatment. Adv Dig Med 2016; 3 (4): 153-160 41) Marcos-Fosch C, Cabezas J, Crespo J, et al. Anti-epileptic drugs and hepatitis C therapy: Real-world experience. J Hepatol 2021; 75 (4): 984-985 44) Finamore JM, Sperling MR, Zhan T, et al. Seizure outcome after switching antiepileptic drugs: A matched, prospective study. Epilepsia 2016; 57 (8): 1294-1300 8) Drafting Committee for Hepatitis Management Guidelines, the Japan Society of Hepatology. Japan Society of Hepatology guidelines for the management of hepatitis C virus infection: 2019 update. Hepatol Res 2020; 50 (7): 791-816 5) McAdam-Marx C, McGarry LJ, Hane CA, et al. All-cause and incremental per patient per year cost associated with chronic hepatitis C virus and associated liver complications in the United States: a managed care perspective. J Manag Care Pharm 2011; 17 (7): 531-546 18) Tamaki N, Kurosaki M, Tanaka K, et al. Noninvasive estimation of fibrosis progression overtime using the FIB-4 index in chronic hepatitis C. J Viral Hepat 2013; 20 (1): 72-76 2) Chung H, Ueda T, Kudo M. Changing trends in hepatitis C infection over the past 50 years in Japan. Intervirology 2010; 53 (1): 39-43 31) Mainar AS, Artieda RN, Hernández I, et al. Prevalence of the potential drug-drug interactions between pangenotypic direct-acting antivirals and the concomitant medications associated with patients with chronic hepatitis C virus infection in Spain. Gastroenterol Hepatol 2019; 42 (8): 465-475 29) Létinier L, Ferreira A, Marceron A, et al. Spontaneous reports of serious adverse drug reactions resulting from drug-drug interactions: An analysis from the French pharmacovigilance database. Front Pharmacol 2021; 11: 624562 43) Wang SP, Mintzer S, Skidmore CT, et al. Seizure recurrence and remission after switching antiepileptic drugs. Epilepsia 2013; 54 (1): 187-193 3) Higuchi M, Tanaka E, Kiyosawa K. Epidemiology and clinical aspects on hepatitis C. Jpn J Infect Dis 2002; 55 (3): 69-77 30) Magro L, Arzenton E, Leone R, et al. Identifying and characterizing serious adverse drug reactions associated with drug-drug interactions in a spontaneous reporting database. Front Pharmacol 2021; 11: 622862 37) Smolders EJ, Ter Horst PJG, Wolters S, et al. Cardiovascular risk management and hepatitis C: Combining drugs. Clin Pharmacokinet 2019; 58 (5): 565-592 32) Mangia A, Scaglione F, Toniutto P, et al. Drug-drug interactions in Italian patients with chronic hepatitis C treated with pangenotypic direct acting agents: insights from a real-world study. Int J Environ Res Public Health 2021; 18 (13): 7144 4) Kieran JA, Norris S, O'Leary A, et al. Hepatitis C in the era of direct-acting antivirals: real-world costs of untreated chronic hepatitis C; a cross-sectional study. BMC Infect Dis 2015; 15: 471 doi: 10.1186/s12879-015-1208-1 22) Zhang M, Holman CD, Price SD, et al. Comorbidity and repeat admission to hospital for adverse drug reactions in older adults: retrospective cohort study. BMJ 2009; 338: a2752 21) Vukotic R, Gamal N, Andreone P. Prospective, observational real-life study on eligibility for and outcomes of antiviral treatment with peginterferon alpha plus ribavirin in chronic hepatitis C. Dig Liver Dis 2015; 47 (2): 151-156 9) Ghany MG, Morgan TR, Panel A-IHCG. Hepatitis C guidance 2019 update: American Association for the Study of Liver Diseases-Infectious Diseases Society of America recommendations for testing, managing, and treating hepatitis C virus infection. Hepatology 2020; 71 (2): 686-721 20) Lauffenburger JC, Mayer CL, Hawke RL, et al. Medication use and medical comorbidity in patients with chronic hepatitis C from a US commercial claims database: high utilization of drugs with interaction potential. Eur J Gastroenterol Hepatol 2014; 26 (10): 1073-1082 47) Steixner-Kumar AA, Daguano Gastaldi V, Seidel J, et al. Preadult polytoxicomania-strong environmental underpinnings and first genetic hints. Mol Psychiatry 2021; 26 (7): 3211-3222 14) Mangoni AA, Jackson SH. Age-related changes in pharmacokinetics and pharmacodynamics: basic principles and practical applications. Br J Clin Pharmacol 2004; 57 (1): 6-14 27) Shi QP, He XD, Yu ML, et al. A 6-year retrospective study of adverse drug reactions due to drug-drug interactions between nervous system drugs. Int J Clin Pharmacol Ther 2014; 52 (5): 392-401 28) Jiang H, Lin Y, Ren W, et al. Adverse drug reactions and correlations with drug-drug interactions: A retrospective study of reports from 2011 to 2020. Front Pharmacol 2022; 13: 923939 12) Dick TB, Lindberg LS, Ramirez DD, et al. A clinician's guide to drug-drug interactions with direct-acting antiviral agents for the treatment of hepatitis C viral infection. Hepatology 2016; 63 (2): 634-643 42) Jobst B. The art of switching antiepileptic medications: keep trying or just let it be. Epilepsy Curr 2013; 13 (2): 76-77 11) Omata M, Kanda T, Wei L, et al. APASL consensus statements and recommendation on treatment of hepatitis C. Hepatol Int 2016; 10 (5): 702-726 39) Sharma SK, Sharma A, Kadhiravan T, et al. Rifamycins (rifampicin, rifabutin and rifapentine) compared to isoniazid for preventing tuberculosis in HIV-negative people at risk of active TB. Cochrane Database Syst Rev 2013; 2013 (7): CD007545 23) Dumbreck S, Flynn A, Nairn M, et al. Drug-disease and drug-drug interactions: systematic examination of recommendations in 12 UK national clinical guidelines. BMJ 2015; 350: h949 1) Soriano V, Labarga P, Barreiro P, et al. Drug interactions with new hepatitis C oral drugs. Expert Opin Drug Metab Toxicol 2015; 11 (3): 333-341 19) Bedossa P, Poynard T. An algorithm for the grading of activity in chronic hepatitis C. The METAVIR Cooperative Study Group. Hepatology 1996; 24 (2): 289-293 46) Sicras-Mainar A, Morillo-Verdugo R. Potential interactions between pangenotypic direct-acting antivirals and concomitant cardiovascular therapies in patients with chronic hepatitis C virus infection. J Int Med Res 2020; 48 (10): 300060520964659 10) European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C: Final update of the series. J Hepatol 2020; 73 (5): 1170-1218 24) Mitsutake S, Ishizaki T, Tsuchiya-Ito R, et al. Association of pharmacological treatments for hypertension, diabetes, and dyslipidemia with health checkup participation and identification of disease control factors among older adults in Tokyo, Japan. Prev Med Rep 2019; 17: 101033 33) Hsu PY, Wei YJ, Lee JJ, et al. Comedications and potential drug-drug interactions with direct-acting antivirals in hepatitis C patients on hemodialysis. Clin Mol Hepatol 2021; 27 (1): 186-196 40) World Health Organization. Treatment of tuberculosis: guidelines, 4th edition, World Health Organization, Geneva. 2010. https://apps.who.int/iris/handle/10665/44165 (2023年3月参照 25) Ruzicka DJ, Tetsuka J, Fujimoto G, et al. Comorbidities and co-medications in populations with and without chronic hepatitis C virus infection in Japan between 2015 and 2016. BMC Infect Dis 2018; 18 (1): 237 35) Vermehren J, Peiffer KH, Welsch C, et al. The efficacy and safety of direct acting antiviral treatment and clinical significance of drug-drug interactions in elderly patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther 2016; 44 (8): 856-865 34) Langness JA, Nguyen M, Wieland A, et al. Optimizing hepatitis C virus treatment through pharmacist interventions: Identification and management of drug-drug interactions. World J Gastroenterol 2017; 23 (9): 1618-1626 45) Burger D, Back D, Buggisch P, et al. Clinical management of drug-drug interactions in HCV therapy: challenges and solutions. J Hepatol 2013; 58 (4): 792-800 16) Harvoni (ledipasvir and sofosbuvir) [package insert]. US Food and Drug Administration website. October 2014. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205834s000lbl.pdf (2023年3月参照 38) Kuo MH, Tseng CW, Lee CH, et al. Drug-drug interactions between direct-acting antivirals and statins in the treatment of chronic hepatitis C. Tzu Chi Med J 2020; 32 (4): 331-338 15) Technivie (ombitasvir, paritaprevir and ritonavir) [package insert]. US Food and Drug Administration website. March 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf (2023年3月参照 |
| References_xml | – reference: 15) Technivie (ombitasvir, paritaprevir and ritonavir) [package insert]. US Food and Drug Administration website. March 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf (2023年3月参照) – reference: 9) Ghany MG, Morgan TR, Panel A-IHCG. Hepatitis C guidance 2019 update: American Association for the Study of Liver Diseases-Infectious Diseases Society of America recommendations for testing, managing, and treating hepatitis C virus infection. Hepatology 2020; 71 (2): 686-721 – reference: 12) Dick TB, Lindberg LS, Ramirez DD, et al. A clinician's guide to drug-drug interactions with direct-acting antiviral agents for the treatment of hepatitis C viral infection. Hepatology 2016; 63 (2): 634-643 – reference: 17) Ministry of Education. Culture, Sports, Science and Technology and Ministry of Health, Labour and Welfare. In: The ethical guidelines on biomedical research involving human subjects – reference: 21) Vukotic R, Gamal N, Andreone P. Prospective, observational real-life study on eligibility for and outcomes of antiviral treatment with peginterferon alpha plus ribavirin in chronic hepatitis C. Dig Liver Dis 2015; 47 (2): 151-156 – reference: 39) Sharma SK, Sharma A, Kadhiravan T, et al. Rifamycins (rifampicin, rifabutin and rifapentine) compared to isoniazid for preventing tuberculosis in HIV-negative people at risk of active TB. Cochrane Database Syst Rev 2013; 2013 (7): CD007545 – reference: 10) European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C: Final update of the series. J Hepatol 2020; 73 (5): 1170-1218 – reference: 29) Létinier L, Ferreira A, Marceron A, et al. Spontaneous reports of serious adverse drug reactions resulting from drug-drug interactions: An analysis from the French pharmacovigilance database. Front Pharmacol 2021; 11: 624562 – reference: 7) Cornberg M, Manns MP. The curing regimens of HCV: A SWOT analysis. Antivir Ther 2022; 27 (1-2): 13596535211072672 – reference: 33) Hsu PY, Wei YJ, Lee JJ, et al. Comedications and potential drug-drug interactions with direct-acting antivirals in hepatitis C patients on hemodialysis. Clin Mol Hepatol 2021; 27 (1): 186-196 – reference: 43) Wang SP, Mintzer S, Skidmore CT, et al. Seizure recurrence and remission after switching antiepileptic drugs. Epilepsia 2013; 54 (1): 187-193 – reference: 14) Mangoni AA, Jackson SH. Age-related changes in pharmacokinetics and pharmacodynamics: basic principles and practical applications. Br J Clin Pharmacol 2004; 57 (1): 6-14 – reference: 32) Mangia A, Scaglione F, Toniutto P, et al. Drug-drug interactions in Italian patients with chronic hepatitis C treated with pangenotypic direct acting agents: insights from a real-world study. Int J Environ Res Public Health 2021; 18 (13): 7144 – reference: 22) Zhang M, Holman CD, Price SD, et al. Comorbidity and repeat admission to hospital for adverse drug reactions in older adults: retrospective cohort study. BMJ 2009; 338: a2752 – reference: 27) Shi QP, He XD, Yu ML, et al. A 6-year retrospective study of adverse drug reactions due to drug-drug interactions between nervous system drugs. Int J Clin Pharmacol Ther 2014; 52 (5): 392-401 – reference: 28) Jiang H, Lin Y, Ren W, et al. Adverse drug reactions and correlations with drug-drug interactions: A retrospective study of reports from 2011 to 2020. Front Pharmacol 2022; 13: 923939 – reference: 35) Vermehren J, Peiffer KH, Welsch C, et al. The efficacy and safety of direct acting antiviral treatment and clinical significance of drug-drug interactions in elderly patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther 2016; 44 (8): 856-865 – reference: 45) Burger D, Back D, Buggisch P, et al. Clinical management of drug-drug interactions in HCV therapy: challenges and solutions. J Hepatol 2013; 58 (4): 792-800 – reference: 19) Bedossa P, Poynard T. An algorithm for the grading of activity in chronic hepatitis C. The METAVIR Cooperative Study Group. Hepatology 1996; 24 (2): 289-293 – reference: 47) Steixner-Kumar AA, Daguano Gastaldi V, Seidel J, et al. Preadult polytoxicomania-strong environmental underpinnings and first genetic hints. Mol Psychiatry 2021; 26 (7): 3211-3222 – reference: 3) Higuchi M, Tanaka E, Kiyosawa K. Epidemiology and clinical aspects on hepatitis C. Jpn J Infect Dis 2002; 55 (3): 69-77 – reference: 20) Lauffenburger JC, Mayer CL, Hawke RL, et al. Medication use and medical comorbidity in patients with chronic hepatitis C from a US commercial claims database: high utilization of drugs with interaction potential. Eur J Gastroenterol Hepatol 2014; 26 (10): 1073-1082 – reference: 46) Sicras-Mainar A, Morillo-Verdugo R. Potential interactions between pangenotypic direct-acting antivirals and concomitant cardiovascular therapies in patients with chronic hepatitis C virus infection. J Int Med Res 2020; 48 (10): 300060520964659 – reference: 11) Omata M, Kanda T, Wei L, et al. APASL consensus statements and recommendation on treatment of hepatitis C. Hepatol Int 2016; 10 (5): 702-726 – reference: 26) Palleria C, Di Paolo A, Giofrè C, et al. Pharmacokinetic drug-drug interaction and their implication in clinical management. J Res Med Sci 2013; 18 (7): 601-610 – reference: 31) Mainar AS, Artieda RN, Hernández I, et al. Prevalence of the potential drug-drug interactions between pangenotypic direct-acting antivirals and the concomitant medications associated with patients with chronic hepatitis C virus infection in Spain. Gastroenterol Hepatol 2019; 42 (8): 465-475 – reference: 34) Langness JA, Nguyen M, Wieland A, et al. Optimizing hepatitis C virus treatment through pharmacist interventions: Identification and management of drug-drug interactions. World J Gastroenterol 2017; 23 (9): 1618-1626 – reference: 37) Smolders EJ, Ter Horst PJG, Wolters S, et al. Cardiovascular risk management and hepatitis C: Combining drugs. Clin Pharmacokinet 2019; 58 (5): 565-592 – reference: 6) Michielsen P, Ho E, Francque S. Does antiviral therapy reduce the risk of hepatocellular carcinoma in patients with chronic hepatitis C? Minerva Gastroenterol Dietol 2012; 58 (1): 65-79 – reference: 18) Tamaki N, Kurosaki M, Tanaka K, et al. Noninvasive estimation of fibrosis progression overtime using the FIB-4 index in chronic hepatitis C. J Viral Hepat 2013; 20 (1): 72-76 – reference: 41) Marcos-Fosch C, Cabezas J, Crespo J, et al. Anti-epileptic drugs and hepatitis C therapy: Real-world experience. J Hepatol 2021; 75 (4): 984-985 – reference: 40) World Health Organization. Treatment of tuberculosis: guidelines, 4th edition, World Health Organization, Geneva. 2010. https://apps.who.int/iris/handle/10665/44165 (2023年3月参照) – reference: 23) Dumbreck S, Flynn A, Nairn M, et al. Drug-disease and drug-drug interactions: systematic examination of recommendations in 12 UK national clinical guidelines. BMJ 2015; 350: h949 – reference: 2) Chung H, Ueda T, Kudo M. Changing trends in hepatitis C infection over the past 50 years in Japan. Intervirology 2010; 53 (1): 39-43 – reference: 30) Magro L, Arzenton E, Leone R, et al. Identifying and characterizing serious adverse drug reactions associated with drug-drug interactions in a spontaneous reporting database. Front Pharmacol 2021; 11: 622862 – reference: 24) Mitsutake S, Ishizaki T, Tsuchiya-Ito R, et al. Association of pharmacological treatments for hypertension, diabetes, and dyslipidemia with health checkup participation and identification of disease control factors among older adults in Tokyo, Japan. Prev Med Rep 2019; 17: 101033 – reference: 1) Soriano V, Labarga P, Barreiro P, et al. Drug interactions with new hepatitis C oral drugs. Expert Opin Drug Metab Toxicol 2015; 11 (3): 333-341 – reference: 13) Chayama K, Imamura M, Hayes C. Hepatitis C virus treatment update - A new era of all-oral HCV treatment. Adv Dig Med 2016; 3 (4): 153-160 – reference: 44) Finamore JM, Sperling MR, Zhan T, et al. Seizure outcome after switching antiepileptic drugs: A matched, prospective study. Epilepsia 2016; 57 (8): 1294-1300 – reference: 36) Zu Siederdissen CH, Maasoumy B, Marra F, et al. Drug-drug interactions with novel all oral interferon-free antiviral agents in a large real-world cohort. Clin Infect Dis 2016; 62 (5): 561-567 – reference: 38) Kuo MH, Tseng CW, Lee CH, et al. Drug-drug interactions between direct-acting antivirals and statins in the treatment of chronic hepatitis C. Tzu Chi Med J 2020; 32 (4): 331-338 – reference: 8) Drafting Committee for Hepatitis Management Guidelines, the Japan Society of Hepatology. Japan Society of Hepatology guidelines for the management of hepatitis C virus infection: 2019 update. Hepatol Res 2020; 50 (7): 791-816 – reference: 25) Ruzicka DJ, Tetsuka J, Fujimoto G, et al. Comorbidities and co-medications in populations with and without chronic hepatitis C virus infection in Japan between 2015 and 2016. BMC Infect Dis 2018; 18 (1): 237 – reference: 4) Kieran JA, Norris S, O'Leary A, et al. Hepatitis C in the era of direct-acting antivirals: real-world costs of untreated chronic hepatitis C; a cross-sectional study. BMC Infect Dis 2015; 15: 471 doi: 10.1186/s12879-015-1208-1 – reference: 42) Jobst B. The art of switching antiepileptic medications: keep trying or just let it be. Epilepsy Curr 2013; 13 (2): 76-77 – reference: 5) McAdam-Marx C, McGarry LJ, Hane CA, et al. All-cause and incremental per patient per year cost associated with chronic hepatitis C virus and associated liver complications in the United States: a managed care perspective. J Manag Care Pharm 2011; 17 (7): 531-546 – reference: 16) Harvoni (ledipasvir and sofosbuvir) [package insert]. US Food and Drug Administration website. October 2014. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205834s000lbl.pdf (2023年3月参照) |
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| Title | わが国のC型慢性肝炎患者における併存疾患と併用禁忌薬：実臨床データベース研究 |
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| ispartofPNX | 肝臓, 2024/08/01, Vol.65(8), pp.368-390 |
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