{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,13]],"date-time":"2025-05-13T15:19:49Z","timestamp":1747149589288,"version":"3.40.5"},"reference-count":34,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,10,17]],"date-time":"2024-10-17T00:00:00Z","timestamp":1729123200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100011093","name":"University of Phayao","doi-asserted-by":"publisher","award":["FF65\u2010UoE012","SPS\u201066006"],"award-info":[{"award-number":["FF65\u2010UoE012","SPS\u201066006"]}],"id":[{"id":"10.13039\/501100011093","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Tenofovir disoproxil fumarate (TDF) requires dosage adjustments from the standard 300 mg once daily to every 48\u201096 h for moderate\u2010to\u2010severe renal impairment to avoid excessive exposure. However, this extended interval can lead to variable drug exposure and inconvenience. This study aimed to utilize the population pharmacokinetic (PPK) models to optimize TDF dosing regimens for HIV\u2010infected patients with renal impairment. A systematic literature search was conducted across PubMed, Cochrane Library, and Scopus databases to identify relevant PPK studies of TDF in HIV\u2010infected patients. From the included studies, the PPK models and associated parameters were extracted. Monte Carlo simulations (n = 2000) were performed to generate concentration\u2013time profiles and derive PK parameters compared against reference ranges. For moderate renal impairment, the TDF 150 mg once\u2010daily regimen achieved cumulative exposure comparable to the approved 300 mg every\u2010other\u2010day regimen. In severe renal impairment, TDF 75\u2010100 mg administered once daily provided similar cumulative exposure as 300 mg every 72\u201096 h regimen while maintaining daily exposure comparable to the standard dose in patients with normal renal function. The approved extended dosing intervals of 72\u201096 h exhibited high drug exposure variability, initially resulting in supratherapeutic levels followed by suboptimal levels preceding the subsequent dose administration. In conclusion, administering smaller once\u2010daily doses of TDF maintains consistent daily drug exposure comparable to the standard dose in patients with normal renal function while reducing variability in drug exposure, potentially mitigating the risk of nephrotoxicity. However, additional clinical studies are required to confirm these findings.<\/jats:p>","DOI":"10.1002\/jcph.6153","type":"journal-article","created":{"date-parts":[[2024,10,17]],"date-time":"2024-10-17T08:33:39Z","timestamp":1729154019000},"page":"424-432","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Population Pharmacokinetic Simulations for Dose Optimization of Tenofovir Disoproxil Fumarate in HIV\u2010Infected Patients with Moderate\u2010to\u2010Severe Renal Impairment"],"prefix":"10.1002","volume":"65","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6169-0039","authenticated-orcid":false,"given":"Apinya","family":"Boonpeng","sequence":"first","affiliation":[{"name":"School of Pharmaceutical Sciences University of Phayao  Phayao Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noppaket","family":"Singkham","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences University of Phayao  Phayao Thailand"},{"name":"Unit of Excellence on Pharmacogenomic Pharmacokinetic and Pharmacotherapeutic Researches (UPPER) School of Pharmaceutical Sciences University of Phayao  Phayao Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chanadda","family":"Wutthikul","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences University of Phayao  Phayao Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thanawan","family":"Rattanakul","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences University of Phayao  Phayao Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pinmanee","family":"Weeket","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences University of Phayao  Phayao Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chananan","family":"Saengpraphanan","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences University of Phayao  Phayao Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rungrawin","family":"Plaengnok","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences University of Phayao  Phayao Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,10,17]]},"reference":[{"volume-title":"Guidelines for the use of antiretroviral agents in adults and adolescents with HIV","key":"e_1_2_10_2_1"},{"volume-title":"Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: Recommendations for a public health approach June 2016","author":"World Health Organization","key":"e_1_2_10_3_1"},{"volume-title":"Viread (Tenofovir Disoproxil Fumarate) tablets, for oral use: Prescribing information (Revised 2019)","key":"e_1_2_10_4_1"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200443090-00003"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e31815e7478"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1086\/598507"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.2217\/pgs.09.115"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.2217\/pgs-2017-0128"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dku129"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200645110-00005"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40780-016-0056-5"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000000958"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.4172\/2155-6113.1000477"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.3851\/IMP2761"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e31827ce4ee"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e32833202e2"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-013-0114-1"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-015-0236-8"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01064-08"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00761-07"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.45.10.2733-2739.2001"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1080\/17512433.2017.1321480"},{"volume-title":"Viread (tenofovir disoproxil fumarate) tablets: Clinical pharmacology biopharmaceutics reviews","author":"U.S. Food and drug administration","key":"e_1_2_10_24_1"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000000172"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00446-19"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciac313"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.5414\/CP202386"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/civ346"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1517\/14740331003627458"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-014-1712-z"},{"volume-title":"Epivir (lamivudine) tablets, for oral use: prescribing information (Revised 2017)","key":"e_1_2_10_32_1"},{"volume-title":"Emtriva (emtricitabine) tablets, for oral use: prescribing information (Revised 2012)","key":"e_1_2_10_33_1"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1177\/23259582221134751"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.3389\/fgene.2022.940661"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.6153","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,6]],"date-time":"2025-04-06T00:14:56Z","timestamp":1743898496000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.6153"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,17]]},"references-count":34,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["10.1002\/jcph.6153"],"URL":"https:\/\/doi.org\/10.1002\/jcph.6153","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"type":"print","value":"0091-2700"},{"type":"electronic","value":"1552-4604"}],"subject":[],"published":{"date-parts":[[2024,10,17]]},"assertion":[{"value":"2024-07-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-09-30","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-10-17","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}