{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T16:36:37Z","timestamp":1791218197732,"version":"4.1.0"},"reference-count":29,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2013,4,30]],"date-time":"2013-04-30T00:00:00Z","timestamp":1367280000000},"content-version":"vor","delay-in-days":119,"URL":"http:\/\/creativecommons.org\/licenses\/by\/3.0\/"}],"funder":[{"name":"French National Agency on AIDS"},{"DOI":"10.13039\/501100003323","name":"Agence Nationale de Recherches sur le SIDA","doi-asserted-by":"crossref","award":["12136"],"award-info":[{"award-number":["12136"]}],"id":[{"id":"10.13039\/501100003323","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of the International AIDS Society"],"published-print":{"date-parts":[[2013,1]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Tenofovir (TDF) with emtricitabine (FTC) and zidovudine (ZDV) is a recognized alternate first\u2010line antiretroviral (ART) regimen for patients who cannot start treatment with non\u2010nucleoside reverse transcriptase inhibitors (NNRTIs). Clinical studies comparing TDF+FTC+ZDV to other regimens are lacking.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Participants in a trial of early ART in C\u00f4te d'Ivoire (Temprano ANRS 12136) started treatment with TDF\/FTC plus either efavirenz (EFV) or ZDV (HIV\u20101+2 dually infected patients and women refusing contraception or previously treated with nevirapine). We compared rates of upper digestive serious adverse events (sAEs) between TDF\/FTC+EFV and TDF\/FTC+ZDV patients during the first six months of treatment. sAEs were defined as either grade 3\u20134 AEs or persistent grade 1\u20132 AEs leading to drug discontinuation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 197 patients (76% women, median CD4 count 395\/mm<jats:sup>3<\/jats:sup>) started therapy with TDF\/FTC, 126 with EFV and 71 with ZDV. During the first six months of ART, 94 patients had digestive AEs (nausea\/vomiting) of any grade (EFV 36\/126, 29%; ZDV 58\/71, 82%, p&lt;0.0001), including 20 sAEs (EFV 3\/126, 5%; ZDV 17\/71, 24%, p&lt;0.0001). In\u2010patients on TDF\/FTC+ZDV with digestive AEs, the median time to the first symptom was two days (IQR: 1\u20134). Plasma ZDV (Cmax) distributions and pill ZDV dosages were normal. Patients with digestive AEs had higher haemoglobin levels and tended to have higher body mass indices and more frequent past histories of cotrimoxazole (CTX) prophylaxis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>We observed an unexpectedly high rate of digestive sAEs in West African adults, mostly women, who started a 3\u2010nuc ART with TDF\/FTC+ZDV in C\u00f4te d'Ivoire. These adults were participating in a trial of early ART and had much higher CD4 counts than those who currently routinely start ART in sub\u2010Saharan Africa. They all received CTX concomitantly with ZDV. We suggest that further early prescriptions of TDF+XTC+ZDV should be carefully monitored and that whenever possible, the rate of early upper digestive adverse events should be compared to that occurring in\u2010patients taking other drug regimens.<\/jats:p><jats:p><jats:bold>Clinical Trial Number<\/jats:bold>: NCT00495651.<\/jats:p><\/jats:sec>","DOI":"10.7448\/ias.16.1.18059","type":"journal-article","created":{"date-parts":[[2013,4,30]],"date-time":"2013-04-30T14:09:34Z","timestamp":1367330974000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Early upper digestive tract side effects of zidovudine with tenofovir plus emtricitabine in West African adults with high CD4 counts"],"prefix":"10.1002","volume":"16","author":[{"given":"Eric","family":"Ouattara","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Danel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raoul","family":"Moh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delphine","family":"Gabillard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilles","family":"Peytavin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Romuald","family":"Konan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00e9rome Le","family":"Carrou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franck","family":"Bohoussou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Serge P","family":"Eholie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"Anglaret","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,4,30]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e3282f768f8"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e32834564e9"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e32830007cd"},{"key":"e_1_2_8_5_1","unstructured":"WHO.Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach.2010revision. [cited 2011 May 12]. Available from:http:\/\/whqlibdoc.who.int\/publications\/2010\/9789241599764_eng.pdf"},{"issue":"6","key":"e_1_2_8_6_1","first-page":"388","article-title":"Triple nucleoside reverse transcriptase inhibitor vs","volume":"6","author":"Cuzin L","year":"2005","journal-title":"non\u2010nucleoside reverse transcriptase inhibitor\u2010containing regimens as first\u2010line therapy: efficacy and durability in a prospective cohort of French HIV\u2010infected patients. HIV Med"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa031772"},{"issue":"6","key":"e_1_2_8_8_1","doi-asserted-by":"crossref","first-page":"827","DOI":"10.1177\/135965350601100615","article-title":"Antiretroviral efficacy and virological profile of a zidovudine\/lamivudine\/tenofovir disoproxil fumarate combination therapy in antiretroviral\u2010naive patients","volume":"11","author":"Masquelier B","year":"2006","journal-title":"Antivir Ther"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1105243"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1293.2009.00786.x"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0378-4347(00)83075-3"},{"issue":"4","key":"e_1_2_8_12_1","first-page":"408","article-title":"Zidovudine","volume":"37","author":"Langtry HD","year":"1989","journal-title":"A review of its pharmaco\u2010dynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs"},{"key":"e_1_2_8_13_1","unstructured":"Agence Nationale de recherche sur le Sida et les h\u00e9patites virales (ANRS).Echelle ANRS de cotation de la gravit\u00e9 des \u00e9v\u00e9nements ind\u00e9sirables chez l'adulte.Version no6 du 9 Septembre 2003. [cited 2012 July 16]. Available from:http:\/\/www.anrs.fr\/content\/download\/1537\/10048\/file\/ANRS\u2010GradeEI\u2010V6\u2010Fr\u20102003.pdf"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(02)80057-1"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1086\/339751"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198909143211106"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.aids.0000233572.59522.45"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1086\/518349"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1293.2005.00288.x"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2885.1995.tb00588.x"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1097\/00042560-199601010-00006"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.tpj.6500171"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1097\/00008571-199910000-00006"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1097\/00002030-199304000-00001"},{"issue":"6","key":"e_1_2_8_25_1","first-page":"551","article-title":"Trimethoprim, alone or in combination with sulphamethoxazole, decreases the renal excretion of zidovudine and its glucuronide","volume":"34","author":"Chatton JY","year":"1992","journal-title":"Br J Clin Pharmacol"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1155\/2000\/640718"},{"issue":"5","key":"e_1_2_8_27_1","doi-asserted-by":"crossref","first-page":"1231","DOI":"10.1128\/AAC.40.5.1231","article-title":"Zidovudine, trimethoprim, and dapsone pharmacokinetic interactions in patients with human immunodeficiency virus infection","volume":"40","author":"Lee BL","year":"1996","journal-title":"Antimicrob Agents Chemother"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/0006-2952(92)90303-Z"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.1991.tb05607.x"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1177\/135965350501000510"}],"container-title":["Journal of the International AIDS Society"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.7448%2FIAS.16.1.18059","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.7448\/IAS.16.1.18059","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,18]],"date-time":"2023-09-18T08:20:58Z","timestamp":1695025258000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.7448\/IAS.16.1.18059"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,1]]},"references-count":29,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2013,1]]}},"alternative-id":["10.7448\/IAS.16.1.18059"],"URL":"https:\/\/doi.org\/10.7448\/ias.16.1.18059","archive":["Portico"],"relation":{},"ISSN":["1758-2652","1758-2652"],"issn-type":[{"value":"1758-2652","type":"print"},{"value":"1758-2652","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,1]]},"assertion":[{"value":"2012-09-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2013-03-22","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2013-04-30","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"18059"}}