{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T01:01:23Z","timestamp":1773104483403,"version":"3.50.1"},"reference-count":64,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2023,5,30]],"date-time":"2023-05-30T00:00:00Z","timestamp":1685404800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"French national agency"},{"name":"Emerging infectious diseases"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,7,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Because NRTIs can have fetal toxicities, we evaluated a perinatal NRTI-sparing strategy to prevent perinatal HIV transmission. Our primary objective was to determine the proportion maintaining a viral load (VL) of &amp;lt;50 copies\/mL up to delivery on darunavir\/ritonavir monotherapy, without requiring treatment intensification.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In a one-arm, multicentre Phase 2 clinical trial, eligible patients in the first trimester of pregnancy on ART with plasma VL\u200a&amp;lt;\u200a50 copies\/mL received maintenance monotherapy with darunavir\/ritonavir, 600\/100 mg twice daily. VL was monitored monthly. ART was intensified in the case of VL\u200a&amp;gt;\u200a50 copies\/mL. Neonates received nevirapine prophylaxis for 14 days.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of 89 patients switching to darunavir\/ritonavir monotherapy, 4 miscarried before 22 weeks\u2019 gestation, 2 changed treatment for elevated liver enzymes without virological failure, and 83 were evaluable for the main outcome. Six had virological failure confirmed on a repeat sample (median VL\u200a=\u200a193 copies\/mL; range 78\u2013644), including two before switching to monotherapy. In these six cases, ART was intensified with tenofovir disoproxil fumarate\/emtricitabine. The success rate was 75\/83, 90.4% (95% CI, 81.9%\u201395.7%) considering two patients with VL missing at delivery as failures, and 77\/83, 92.8% (95% CI, 84.9%\u201397.3%) when considering them as successes since both had undetectable VL on darunavir\/ritonavir throughout pregnancy. In ITT, the last available VL before delivery was &amp;lt;50 copies\/mL in all of the patients. There was no case of perinatal HIV transmission.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Darunavir\/ritonavir maintenance monotherapy required intensification in nearly 10% of cases. This limits its widespread use, thus other regimens should be evaluated in order to limit exposure to antiretrovirals, particularly NRTIs, during pregnancy.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkad161","type":"journal-article","created":{"date-parts":[[2023,5,30]],"date-time":"2023-05-30T05:36:30Z","timestamp":1685424990000},"page":"1711-1722","source":"Crossref","is-referenced-by-count":5,"title":["Maintenance darunavir\/ritonavir monotherapy to prevent perinatal HIV transmission, ANRS-MIE <scp>168<\/scp> MONOGEST study"],"prefix":"10.1093","volume":"78","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5883-7597","authenticated-orcid":false,"given":"Laurent","family":"Mandelbrot","sequence":"first","affiliation":[{"name":"Assistance Publique-H\u00f4pitaux de Paris H\u00f4pital Louis Mourier Service de Gyn\u00e9cologie-Obst\u00e9trique , F-92700 Colombes , France"},{"name":"Universit\u00e9 Paris Cit\u00e9 , F-75006 Paris , France"},{"name":"INSERM, IAME , F-75018 Paris , France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roland","family":"Tubiana","sequence":"additional","affiliation":[{"name":"Assistance Publique-H\u00f4pitaux de Paris, H\u00f4pital Piti\u00e9-Salp\u00eatri\u00e8re, Service Maladies infectieuses , F-75013 Paris , France"},{"name":"INSERM, Sorbonne Universit\u00e9, Institut Pierre Louis d\u2019Epid\u00e9miologie et de Sant\u00e9 Publique (IPLESP UMRS 1136) , Paris , France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4920-8369","authenticated-orcid":false,"given":"Pierre","family":"Frange","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Paris Cit\u00e9 , F-75006 Paris , France"},{"name":"Laboratoire de microbiologie clinique, Groupe hospitalier Assistance Publique-H\u00f4pitaux de Paris (APHP) Centre\u2014Universit\u00e9 Paris Cit\u00e9, H\u00f4pital Necker-Enfants Malades , F-75015 Paris , 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