{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,25]],"date-time":"2026-02-25T12:44:27Z","timestamp":1772023467436,"version":"3.50.1"},"reference-count":22,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2022,4,18]],"date-time":"2022-04-18T00:00:00Z","timestamp":1650240000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,4,18]],"date-time":"2022-04-18T00:00:00Z","timestamp":1650240000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>An association between kidney disease and direct-acting antivirals against hepatitis C (DAAs) has been suggested, however the warning on the package insert (PI) of the drug varies among DAAs. In this study, the risk of decreased kidney function associated with DAAs marketed in Japan was investigated to determine whether the risk of kidney disease is a common adverse event and class effect of DAAs. Data for patients who were new users of DAAs marketed in Japan, with eGFR\u2009\u2265\u200945\u00a0mL\/min\/1.73 m<jats:sup>2<\/jats:sup> and without specific risk factors, were extracted from the MID-NET<jats:sup>\u00ae<\/jats:sup> medical information database network in Japan. Changes from the baseline on estimated glomerular filtration rate (eGFR) categories (eGFR\u00a0\u2265\u00a090, 90\u2009&gt;\u2009eGFR\u00a0\u2265\u00a060, 60\u2009&gt;\u2009eGFR\u00a0\u2265\u00a045, 45\u2009&gt;\u2009eGFR\u00a0\u2265\u00a030, 30\u2009&gt;\u2009eGFR\u00a0\u2265\u00a015, 15\u2009&gt;\u2009eGFR; unit: mL\/min\/1.73 m<jats:sup>2<\/jats:sup>) were used for evaluating the risk of decreased kidney function. Exposure groups for DAAs and relevant concomitant drugs were categorized into 10 patterns based on the PI. Among the 10 patterns, a significant increase in the incidence rate ratio (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.01) was observed in the prescription patterns of concomitant use of telaprevir with peginterferon alpha and ribavirin, concomitant use of daclatasvir hydrochloride with asunaprevir, and ombitasvir hydrate combined with paritaprevir hydrate and ritonavir, which were concomitantly used with ribavirin; such an increase was not observed in the other prescription patterns. The effects of DAAs on kidney function may differ among drugs, suggesting the possibility that the risk of kidney disease is not a class effect of DAAs and should be evaluated individually for each DAA.<\/jats:p>","DOI":"10.1007\/s43441-022-00400-5","type":"journal-article","created":{"date-parts":[[2022,4,18]],"date-time":"2022-04-18T17:08:28Z","timestamp":1650301708000},"page":"625-631","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Assessing the Risk of Decrease in Kidney Function in Patients Prescribed Direct-Acting Antivirals for Hepatitis C Utilizing the MID-NET\u00ae Medical Information Database Network in Japan"],"prefix":"10.1007","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8602-8295","authenticated-orcid":false,"given":"Tomoaki","family":"Hasegawa","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sono","family":"Sawada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1302-9430","authenticated-orcid":false,"given":"Chieko","family":"Ishiguro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0654-5656","authenticated-orcid":false,"given":"Takashi","family":"Ando","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kanae","family":"Kobayashi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noriyuki","family":"Komiyama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toyotaka","family":"Iguchi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1320-6190","authenticated-orcid":false,"given":"Takahiro","family":"Nonaka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0430-9887","authenticated-orcid":false,"given":"Yoshiaki","family":"Uyama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,4,18]]},"reference":[{"key":"400_CR1","unstructured":"Pharmaceuticals and medical devices agency; review and related services; list of approved products in the fiscal year 2011 2011 [Available from: https:\/\/www.pmda.go.jp\/files\/000229075.pdf]."},{"key":"400_CR2","unstructured":"Pharmaceuticals and Medical Devices Agency, information serach for new drugs, such as review reports, package inserts, and other related infromation [in Japanese] 2019 [Available from: https:\/\/www.pmda.go.jp\/PmdaSearch\/iyakuSearch\/]."},{"key":"400_CR3","unstructured":"Pharmaceuticals and Medical Devices Agency. Japanese Adverse Drug Event Report database [in Japanese] [Available from: https:\/\/www.pmda.go.jp\/safety\/info-services\/drugs\/adr-info\/suspected-adr\/0005.html]."},{"issue":"8","key":"400_CR4","doi-asserted-by":"publisher","first-page":"1096","DOI":"10.1016\/j.bcp.2012.07.032","volume":"84","author":"A Kunze","year":"2012","unstructured":"Kunze A, Huwyler J, Camenisch G, Gutmann H. Interaction of the antiviral drug telaprevir with renal and hepatic drug transporters. Biochem Pharmacol. 2012;84(8):1096\u2013102.","journal-title":"Biochem Pharmacol"},{"issue":"9","key":"400_CR5","doi-asserted-by":"publisher","first-page":"28879","DOI":"10.5812\/hepatmon.28879","volume":"15","author":"P Pradat","year":"2015","unstructured":"Pradat P, Virlogeux V, Maynard M, Leclercq M, Hatu G, Amiri M, et al. Increased ribavirin bioavailability associated with telaprevir use in hepatitis C patients treated with PEGylated-interferon\/ribavirin\/telaprevir triple therapy. Hepat Mon. 2015;15(9):28879.","journal-title":"Hepat Mon."},{"key":"400_CR6","doi-asserted-by":"publisher","first-page":"1395","DOI":"10.1002\/pds.4879","volume":"28","author":"M Yamaguchi","year":"2019","unstructured":"Yamaguchi M, Inomata S, Harada S, Matsuzaki Y, Kawaguchi M, Ujibe M, et al. Establishment of the MID-NET\u00ae medical information database network as a reliable and valuable database for drug safety assessments in Japan. Pharmacoepidemiol Drug Saf. 2019;28:1395\u2013404.","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"400_CR7","doi-asserted-by":"publisher","first-page":"601","DOI":"10.1002\/pds.4777","volume":"28","author":"K Yamada","year":"2019","unstructured":"Yamada K, Itoh M, Fujimura Y, Kimura M, Murata K, Nakashima N, et al. The utilization and challenges of Japan\u2019s MID-NET\u00ae medical information database network in post-marketing drug safety assessments: a summary of pilot pharmacoepidemiological studies. Pharmacoepidemiol Drug Saf. 2019;28:601\u20138.","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"400_CR8","unstructured":"Pharmaceuticals and Medical Devices Agency. Information for studies approved by the expert committee of MID-NET\u00ae [in Japanese]: Pharmaceuticals and Medical Devices Agency; [Available from: https:\/\/www.pmda.go.jp\/safety\/mid-net\/0010.html]."},{"key":"400_CR9","unstructured":"Act on the Pharmaceuticals and Medical Devices Agency (Act No. 192 of 2002) [in Japanese] [Available from: https:\/\/elaws.e-gov.go.jp\/document?lawid=414AC0000000192]."},{"key":"400_CR10","unstructured":"Pharmaceuticals and Medical Devices Agency. MIHARI Project [in Japanese] [Available from: https:\/\/www.pmda.go.jp\/safety\/surveillance-analysis\/0045.html]."},{"key":"400_CR11","unstructured":"Mitsubishi Tanabe Pharma Corporation Medical View Point: \u201cHanbaichushi no goannai TELAVIC tablet 250mg\u201d[Discontinuation of sale for TELAVIC tablet 250mg] [in Japanese] [Available from: https:\/\/di.mt-pharma.co.jp\/file\/info\/ifn_5193_P20092.pdf]."},{"key":"400_CR12","unstructured":"MSD Connect: \u201cVANIHEP capsule 150mg keikasochi-hinmokuikou no goannai\u201d[Discontinuation of sale for VANIHEP capsule 150mg] [in Japanese] [Available from: https:\/\/www.msdconnect.jp\/static\/mcijapan\/images\/nhi_vanihep_201704.pdf]."},{"key":"400_CR13","unstructured":"AbbVie A-CONNECT: \u201cSeizo-hanbaichushi ni tomonau keikasochi-manryo no oshirase VIEKIRAX\u00ae\u201d[Discontinuation of sale for VIEKIRAX\u00ae] [in Japanese] [Available from: https:\/\/a-connect.abbvie.co.jp\/-\/media\/assets\/pdf\/products\/info\/viekirax\/Viekirax_News_201903_001.pdf]."},{"key":"400_CR14","unstructured":"BMS HEALTHCARE: \u201cXimency no keikasochi-ikoukikan manryo no goannai\u201d [Discontinuation of sale for Ximency][in Japanese] [Available from: http:\/\/file.bmshealthcare.jp\/bmshealthcare\/pdf\/info\/News_XC2002.pdf]."},{"key":"400_CR15","unstructured":"Janssen: \u201cSovriad\u00ae capsule 100mg yakkakijun-keikasochi-ikou no goannai\u201d [Discontinuation of sale for Sovriad] [in Japanese] [Available from: https:\/\/www.janssen.com\/japan\/oshirase_sovriad]."},{"key":"400_CR16","unstructured":"The package insert of grazoprevir hydrate [in Japanese] [Available from: https:\/\/www.pmda.go.jp\/PmdaSearch\/iyakuDetail\/ResultDataSetPDF\/170050_6250043F1024_1_06]."},{"key":"400_CR17","unstructured":"Pharmaceuticals and Medical Devices Agency, Review report of daclatasvir hydrochloride coadministration with asunaprevir [in Japanese] 2015 [Available from: https:\/\/www.pmda.go.jp\/drugs\/2015\/P201500017\/670605000_22600AMX00764000_A100_1.pdf]."},{"key":"400_CR18","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/kisup.2012.73","volume":"3","author":"KDIGO","year":"2013","unstructured":"KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease.\nKidney Int Suppl. 2013;3:1\u2013150.","journal-title":"Kidney Int Suppl"},{"issue":"6","key":"400_CR19","doi-asserted-by":"publisher","first-page":"982","DOI":"10.1053\/j.ajkd.2008.12.034","volume":"53","author":"S Matsuo","year":"2009","unstructured":"Matsuo S, Imai E, Horio M, Yasuda Y, Tomita K, Nitta K, et al. Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009;53(6):982\u201392.","journal-title":"Am J Kidney Dis"},{"key":"400_CR20","first-page":"1037","volume":"60","author":"Japanese Society of Nephrology","year":"2018","unstructured":"Japanese Society of Nephrology. Evidence-based clinical practice guideline for CKD 2018. Jpn J Nephrol. 2018;60:1037\u2013193.","journal-title":"Jpn J Nephrol"},{"issue":"6","key":"400_CR21","doi-asserted-by":"publisher","first-page":"699","DOI":"10.1111\/jvh.12867","volume":"25","author":"MJ Alvarez-Ossorio","year":"2018","unstructured":"Alvarez-Ossorio MJ, Sarmento ECR, Granados R, Macias J, Morano-Amado LE, Rios MJ, et al. Impact of interferon-free regimens on the glomerular filtration rate during treatment of chronic hepatitis C in a real-life cohort. J Viral Hepat. 2018;25(6):699\u2013706.","journal-title":"J Viral Hepat"},{"key":"400_CR22","unstructured":"Safety measures taken for Telaprevir, Warning about risk of abnormal renal function [in Japanese] 2012 [Available from: https:\/\/www.pmda.go.jp\/safety\/info-services\/drugs\/calling-attention\/revision-of-precautions\/0236.html#4, https:\/\/www.pmda.go.jp\/files\/000144213.pdf]."}],"container-title":["Therapeutic Innovation &amp; Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-022-00400-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s43441-022-00400-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-022-00400-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,26]],"date-time":"2022-05-26T22:01:10Z","timestamp":1653602470000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s43441-022-00400-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,18]]},"references-count":22,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2022,7]]}},"alternative-id":["400"],"URL":"https:\/\/doi.org\/10.1007\/s43441-022-00400-5","relation":{},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"value":"2168-4790","type":"print"},{"value":"2168-4804","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,4,18]]},"assertion":[{"value":"21 October 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 March 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 April 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare that they have no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}