{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,24]],"date-time":"2025-09-24T08:19:49Z","timestamp":1758701989232,"version":"3.37.3"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2022,4,15]],"date-time":"2022-04-15T00:00:00Z","timestamp":1649980800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"MSD Investigator Studies Program"},{"name":"Lluita contra la SIDA Foundation"},{"name":"CIBER - Consorcio Centro de Investigaci\u00f3n Biom\u00e9dica en Red"},{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100004837","name":"Ministerio de Ciencia e Innovaci\u00f3n","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100004837","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Uni\u00f3n Europea \u2013 NextGenerationEU"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,6,29]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To evaluate the effect of haemodialysis on doravirine concentrations in people living with HIV (PLWH) undergoing routine haemodialysis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>An exploratory clinical trial that included PLWH undergoing intermittent haemodialysis was undertaken. After enrolment (day 1), doravirine 100\u2005mg once daily was added to stable combined ART for 5\u2005days. On day 6, blood samples were collected from each participant at the beginning and at the end of a dialysis session. Additionally, paired samples of blood entering (\u2018in\u2019) and leaving (\u2018out\u2019) the dialyser and the resulting dialysate were collected during the dialysis session to evaluate drug removal during dialysis. Doravirine concentrations in plasma and in the dialysate were determined by LC-MS\/MS. The ratio of doravirine concentrations in plasma after\/before the haemodialysis session and the haemodialysis extraction coefficient were calculated for each participant. The study was registered at https:\/\/www.clinicaltrials.gov (NCT04689737).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Eight participants (six male) were included. The median (range) age and BMI were 49.5 (28\u201367) years and 23.6 (17.9\u201334.2) kg\/m2, respectively. The doravirine dialysis extraction ratio was 34.3% (25.8%\u201341.4%). The ratio of doravirine concentrations in plasma after\/before the haemodialysis session was 0.8 (0.6\u20131.0). At the end of the haemodialysis session (time post-dose 20.8\u201327.3\u2005h), doravirine concentrations in plasma were 785 (101\u20131851) ng\/mL.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Despite moderate removal of doravirine by haemodialysis, trough doravirine concentrations in plasma after the haemodialysis sessions remained in excess of the protein-binding-adjusted EC50 (5\u2005ng\/mL). Doravirine dosage adjustments are unnecessary in PLWH undergoing intermittent haemodialysis.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkac126","type":"journal-article","created":{"date-parts":[[2022,4,14]],"date-time":"2022-04-14T11:13:13Z","timestamp":1649934793000},"page":"1989-1991","source":"Crossref","is-referenced-by-count":5,"title":["Removal of doravirine by haemodialysis in people living with HIV with end-stage renal disease"],"prefix":"10.1093","volume":"77","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4564-1963","authenticated-orcid":false,"given":"Jos\u00e9","family":"Molt\u00f3","sequence":"first","affiliation":[{"name":"Lluita contra la Sida Foundation, Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol , Badalona , Spain"},{"name":"Universitat Aut\u00f3noma de Barcelona (UAB) , Barcelona , Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas, ISCIII , Madrid , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fredzzia","family":"Graterol","sequence":"additional","affiliation":[{"name":"Nephrology Department, Hospital Universitari Germans Trias i Pujol , Badalona , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrian","family":"Curran","sequence":"additional","affiliation":[{"name":"Universitat Aut\u00f3noma de Barcelona (UAB) , Barcelona , Spain"},{"name":"Infectious Diseases Department, Hospital Universitari Vall d\u2019Hebron, Vall d\u2019Hebron Institut de Recerca , Barcelona , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natalia","family":"Ramos","sequence":"additional","affiliation":[{"name":"Nephrology Department, Hospital Universitari Vall d\u2019Hebron, Vall d\u2019Hebron Institut de Recerca , Barcelona , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arkaitz","family":"Imaz","sequence":"additional","affiliation":[{"name":"HIV and STI Unit, Infectious Diseases Department, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, L\u2019Hospitalet de Llobregat , Barcelona , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diego","family":"Sandoval","sequence":"additional","affiliation":[{"name":"Nephrology Department, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, L\u2019Hospitalet de Llobregat , Barcelona , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francisco","family":"P\u00e9rez","sequence":"additional","affiliation":[{"name":"Lluita contra la Sida Foundation, Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol , Badalona , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luc\u00eda","family":"Bail\u00f3n","sequence":"additional","affiliation":[{"name":"Lluita contra la Sida Foundation, Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol , Badalona , Spain"},{"name":"Universitat Aut\u00f3noma de Barcelona (UAB) , Barcelona , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saye","family":"Khoo","sequence":"additional","affiliation":[{"name":"Department of Molecular and Clinical Pharmacology, University of Liverpool , Liverpool , UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Else","sequence":"additional","affiliation":[{"name":"Department of Molecular and Clinical Pharmacology, University of Liverpool , Liverpool , UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roger","family":"Paredes","sequence":"additional","affiliation":[{"name":"Lluita contra la Sida Foundation, Infectious Diseases Department, Hospital Universitari Germans Trias i Pujol , Badalona , Spain"},{"name":"Universitat Aut\u00f3noma de Barcelona (UAB) , Barcelona , Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas, ISCIII , Madrid , Spain"},{"name":"IrsiCaixa Foundation, Hospital Universitari Germans Trias i Pujol , Badalona , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2022,4,15]]},"reference":[{"key":"2022070118371886800_dkac126-B1","doi-asserted-by":"crossref","first-page":"388","DOI":"10.5527\/wjn.v4.i3.388","article-title":"Epidemiology, clinical characteristics, and management of chronic kidney disease in human immunodeficiency virus-infected patients","volume":"4","author":"Ando","year":"2015","journal-title":"World J Nephrol"},{"key":"2022070118371886800_dkac126-B2","doi-asserted-by":"crossref","first-page":"340","DOI":"10.1097\/COH.0000000000000067","article-title":"HIV and the aging kidney","volume":"9","author":"Nadkarni","year":"2014","journal-title":"Curr Opin HIV AIDS"},{"key":"2022070118371886800_dkac126-B3","doi-asserted-by":"crossref","first-page":"2517","DOI":"10.1097\/QAD.0b013e3283320e12","article-title":"Clinical epidemiology of HIV-associated end-stage renal failure in the UK","volume":"23","author":"Bansi","year":"2009","journal-title":"AIDS"},{"key":"2022070118371886800_dkac126-B4","doi-asserted-by":"crossref","first-page":"628","DOI":"10.1053\/j.ajkd.2011.10.050","article-title":"Risk factors for ESRD in HIV-infected individuals: traditional and HIV-related factors","volume":"59","author":"Jotwani","year":"2012","journal-title":"Am J Kidney Dis"},{"key":"2022070118371886800_dkac126-B5","doi-asserted-by":"crossref","first-page":"127","DOI":"10.1111\/j.1468-1293.2012.01045.x","article-title":"End-stage renal disease and dialysis in HIV-positive patients: observations from a long-term cohort study with a follow-up of 22 years","volume":"14","author":"Bickel","year":"2013","journal-title":"HIV Med"},{"key":"2022070118371886800_dkac126-B6","doi-asserted-by":"crossref","first-page":"2435","DOI":"10.1097\/QAD.0b013e32827038ad","article-title":"End-stage renal disease and chronic kidney disease in a cohort of African-American HIV-infected and at-risk HIV-seronegative participants followed between 1988 and 2004","volume":"21","author":"Lucas","year":"2007","journal-title":"AIDS"},{"key":"2022070118371886800_dkac126-B7","doi-asserted-by":"crossref","first-page":"2019-11-1","DOI":"10.7573\/dic.2019-11-1","article-title":"HIV, drugs and the kidney","volume":"9","author":"Wearne","year":"2020","journal-title":"Drugs Context"},{"key":"2022070118371886800_dkac126-B8","doi-asserted-by":"crossref","first-page":"821","DOI":"10.1046\/j.1523-1755.2001.060003821.x","article-title":"An appraisal of antiretroviral drugs in hemodialysis","volume":"60","author":"Izzedine","year":"2001","journal-title":"Kidney Int"},{"key":"2022070118371886800_dkac126-B9","doi-asserted-by":"crossref","first-page":"779","DOI":"10.1086\/521168","article-title":"Antiretroviral drug dosing errors in HIV-infected patients undergoing hemodialysis","volume":"45","author":"Tourret","year":"2007","journal-title":"Clin Infect Dis"},{"key":"2022070118371886800_dkac126-B10","doi-asserted-by":"crossref","first-page":"306","DOI":"10.1097\/01.mnh.0000444912.40418.45","article-title":"Safety of medical therapy in patients with chronic kidney disease and end-stage renal disease","volume":"23","author":"Weir","year":"2014","journal-title":"Curr Opin Nephrol Hypertens"},{"key":"2022070118371886800_dkac126-B11","doi-asserted-by":"crossref","first-page":"425","DOI":"10.3851\/IMP3323","article-title":"Doravirine dose selection and 96-week safety and efficacy versus efavirenz in antiretroviral therapy-naive adults with HIV-1 infection in a Phase IIb trial","volume":"24","author":"Gatell","year":"2019","journal-title":"Antivir Ther"},{"key":"2022070118371886800_dkac126-B12","doi-asserted-by":"crossref","first-page":"e16","DOI":"10.1016\/S2352-3018(19)30336-4","article-title":"Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial","volume":"7","author":"Molina","year":"2020","journal-title":"Lancet HIV"},{"key":"2022070118371886800_dkac126-B13","doi-asserted-by":"crossref","first-page":"1553","DOI":"10.1007\/s40262-019-00806-9","article-title":"Clinical pharmacodynamics, pharmacokinetics, and drug interaction profile of doravirine","volume":"58","author":"Boyle","year":"2019","journal-title":"Clin Pharmacokinet"},{"key":"2022070118371886800_dkac126-B14","doi-asserted-by":"crossref","first-page":"e00326-18","DOI":"10.1128\/AAC.00326-18","article-title":"Severe renal impairment has minimal impact on doravirine pharmacokinetics","volume":"62","author":"Ankrom","year":"2018","journal-title":"Antimicrob Agents Chemother"},{"author":"Doravirine (Pifeltro) Prescribing Information","key":"2022070118371886800_dkac126-B15"},{"key":"2022070118371886800_dkac126-B16","doi-asserted-by":"crossref","first-page":"3278","DOI":"10.1093\/ndt\/gfs060","article-title":"Removal of water-soluble and protein-bound solutes with reversed mid-dilution versus post-dilution haemodiafiltration","volume":"27","author":"Eloot","year":"2012","journal-title":"Nephrol Dial Transplant"}],"container-title":["Journal of Antimicrobial Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jac\/article-pdf\/77\/7\/1989\/44373495\/dkac126.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jac\/article-pdf\/77\/7\/1989\/44373495\/dkac126.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,7,1]],"date-time":"2022-07-01T18:39:01Z","timestamp":1656700741000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jac\/article\/77\/7\/1989\/6568603"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,15]]},"references-count":16,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2022,4,15]]},"published-print":{"date-parts":[[2022,6,29]]}},"URL":"https:\/\/doi.org\/10.1093\/jac\/dkac126","relation":{},"ISSN":["0305-7453","1460-2091"],"issn-type":[{"type":"print","value":"0305-7453"},{"type":"electronic","value":"1460-2091"}],"subject":[],"published-other":{"date-parts":[[2022,7,1]]},"published":{"date-parts":[[2022,4,15]]}}}