{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,6,14]],"date-time":"2025-06-14T23:40:05Z","timestamp":1749944405001,"version":"3.41.0"},"reference-count":13,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"8","license":[{"start":{"date-parts":[[2024,5,17]],"date-time":"2024-05-17T00:00:00Z","timestamp":1715904000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University","award":["GA64\/25"],"award-info":[{"award-number":["GA64\/25"]}]},{"name":"Research Fund for HIV in Children and Youth, Faculty of Medicine, Chulalongkorn University"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n            <jats:title>Introduction:<\/jats:title>\n            <jats:p>Dolutegravir (DTG) dispersible tablet (DTG-DT) is a pediatric-friendly formulation. We aimed to describe the pharmacokinetics and virologic responses of generic DTG-DT in children weighing &lt;20\u2009kg.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods:<\/jats:title>\n            <jats:p>Children living with HIV-1 and &lt;7 years of age weighing 6 to &lt;20\u2009kg were eligible. A generic 10-mg scored DTG-DT was administered to children using 3 weight bands (WB): WB1 (6 to &lt;10\u2009kg), WB2 (10 to &lt;14\u2009kg) and WB3 (14 to &lt;20\u2009kg), at doses of 20\u2009mg (higher than World Health Organization recommendation of 15\u2009mg), 20\u2009mg and 25\u2009mg, respectively. Steady-state intensive pharmacokinetics (PK) was performed in fasting condition with blood sampling at predose and 1, 2, 3, 4, 6 and 24 hours postdose. DTG PK parameters were estimated using a noncompartmental analysis, and DTG trough concentrations (C<jats:sub>24<\/jats:sub>) and 24-hour area under the concentration-time curve were calculated. Comparisons were made with ODYSSEY and IMPAACT 2019. And 90% effective concentration of 0.32\u2009mg\/L was used as a reference individual DTG C<jats:sub>24<\/jats:sub> concentration.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>From August 2021 to March 2023, 29 Thai children with a median (interquartile range) age of 3.2 (1.5\u20134.8) years were enrolled; 8 in WB1, 9 in WB2 and 12 in WB3. All children were treatment experienced and 59% had HIV RNA &lt;200 copies\/mL. Overall geometric mean (coefficient of variation percentage) DTG C<jats:sub>24<\/jats:sub> was 1.0 (46%) mg\/L [WB1, 0.9 (53%); WB2, 0.9 (27%); WB3, 1.2 (51%)]. Geometric mean (coefficient of variation percentage) 24-hour area under the concentration-time curve was 83.2 (24%) mg h\/L [WB1, 84.3 (31%); WB2, 76.9 (16%); WB3, 87.6 (25%)]. At weeks 24 and 48, 90% and 92% of participants had plasma HIV RNA &lt;200 copies\/mL.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions:<\/jats:title>\n            <jats:p>Generic DTG-DT provided adequate drug exposure in children weighing 6 to &lt;20\u2009kg. The exploratory dose of DTG 20\u2009mg for children weighing 6 to &lt;10\u2009kg showed similar PK parameters to World Health Organization doses in the other WB.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1097\/inf.0000000000004366","type":"journal-article","created":{"date-parts":[[2024,5,18]],"date-time":"2024-05-18T05:54:07Z","timestamp":1716011647000},"page":"789-794","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":2,"title":["Pharmacokinetics of Generic Pediatric Dolutegravir Dispersible Tablet in Thai Young Children Living With HIV Weighing Below Twenty Kilograms"],"prefix":"10.1097","volume":"43","author":[{"given":"Athiporn","family":"Rungsapphaiboon","sequence":"first","affiliation":[{"name":"From the Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand"},{"name":"Department of Pediatrics, Khon Kaen Hospital, Khon Kaen, Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noppadol","family":"Wacharachaisurapol","sequence":"additional","affiliation":[{"name":"Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University"},{"name":"Department of Pharmacology, Center of Excellence in Clinical Pharmacokinetics and Pharmacogenomics, Faculty of Medicine, Chulalongkorn University"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8489-3288","authenticated-orcid":false,"given":"Suvaporn","family":"Anugulruengkitt","sequence":"additional","affiliation":[{"name":"From the Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand"},{"name":"Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1089-8806","authenticated-orcid":false,"given":"Pugpen","family":"Sirikutt","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Queen Sirikit National Institute of Child Health, Bangkok, Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6777-0905","authenticated-orcid":false,"given":"Chayapa","family":"Phasomsap","sequence":"additional","affiliation":[{"name":"Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7776-2781","authenticated-orcid":false,"given":"Monta","family":"Tawan","sequence":"additional","affiliation":[{"name":"Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4044-0951","authenticated-orcid":false,"given":"Chutima","family":"Saisaengjan","sequence":"additional","affiliation":[{"name":"Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yossawadee","family":"Na Nakorn","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Queen Sirikit National Institute of Child Health, Bangkok, Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3950-5383","authenticated-orcid":false,"given":"Nantika","family":"Paiboon","sequence":"additional","affiliation":[{"name":"From the Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wipaporn Natalie","family":"Songtaweesin","sequence":"additional","affiliation":[{"name":"From the Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand"},{"name":"Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yardpiroon","family":"Tawon","sequence":"additional","affiliation":[{"name":"PK Laboratory Department, AMS-PHPT Research Collaboration, Faculty of Associated Medical Science, Chiang Mai University, Chiang Mai, Thailand."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tim R.","family":"Cressey","sequence":"additional","affiliation":[{"name":"PK Laboratory Department, AMS-PHPT Research Collaboration, Faculty of Associated Medical Science, Chiang Mai University, Chiang Mai, Thailand."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1873-1867","authenticated-orcid":false,"given":"Thanyawee","family":"Puthanakit","sequence":"additional","affiliation":[{"name":"From the Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand"},{"name":"Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"on behalf of DTGkids Study Team","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","published-online":{"date-parts":[[2024,5,17]]},"reference":[{"key":"R3-20250614","doi-asserted-by":"crossref","first-page":"1737","DOI":"10.1097\/QAD.0b013e32834a1dd9","article-title":"Antiviral activity, safety, and pharmacokinetics\/pharmacodynamics of dolutegravir as 10-day monotherapy in HIV-1-infected 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