{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,11]],"date-time":"2026-04-11T05:41:59Z","timestamp":1775886119923,"version":"3.50.1"},"reference-count":25,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:p>Isoniazid is a therapeutic agent for the treatment of latent tuberculosis infection. Genetic variants in the <jats:italic toggle=\"yes\">N<\/jats:italic>-acetyltransferase 2 (NAT2) are associated with the safety and pharmacokinetics of isoniazid. The study aimed to evaluate the safety and pharmacokinetics of a <jats:italic toggle=\"yes\">NAT2<\/jats:italic> genotype-guided regimen of isoniazid monotherapy. A randomized, open-label, parallel-group and multiple-dosing study was performed in healthy subjects. The subjects received isoniazid for 29\u2009days. The NAT2 slow acetylators (<jats:italic toggle=\"yes\">NAT2<\/jats:italic>*5\/*5, -*5\/*6, -*5\/*7, -*6\/*6, -*6\/*7, -*7\/*7) randomly received standard dose (300 mg, standard-treatment group) or reduced dose (200 mg, PGx-treatment group) of isoniazid. Also, all the NAT2 rapid acetylators (<jats:italic toggle=\"yes\">NAT2<\/jats:italic>*4\/*4) received isoniazid 300 mg (reference group). The safety and pharmacokinetics were evaluated during the study. The PGx-treatment group showed a more stable serum liver enzyme profile and a lower incidence of adverse drug reactions (ADRs) than the standard-treatment group. The emergence rates of ADRs were 12.5, 60 and 33.3% in the reference, standard-treatment and PGx-treatment groups, respectively. The PGx-treatment group showed higher plasma isoniazid concentrations than the reference group, although the PGx-treatment group received a reduced dose of isoniazid. Our results showed that a <jats:italic toggle=\"yes\">NAT2<\/jats:italic> genotype-guided regimen may reduce ADRs during isoniazid monotherapy without concern over insufficient drug exposure.<\/jats:p>","DOI":"10.1097\/fpc.0000000000000423","type":"journal-article","created":{"date-parts":[[2020,11,8]],"date-time":"2020-11-08T23:00:07Z","timestamp":1604876407000},"page":"68-73","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":16,"title":["A pilot study to investigate the utility of NAT2 genotype-guided isoniazid monotherapy regimens in NAT2 slow acetylators"],"prefix":"10.1097","volume":"31","author":[{"given":"Hyounggyoon","family":"Yoo","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sang","family":"Chun Ji","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joo-Youn","family":"Cho","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sang-Heon","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Hanyang University College of Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jihoon G.","family":"Yoon","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Yonsei University College of Medicine, Seoul, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Min","family":"Goo Lee","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Yonsei University College of Medicine, Seoul, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyung-Sang","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"In-Jin","family":"Jang","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jaeseong","family":"Oh","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and 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