Safety and Efficacy of Starting Antiretroviral Therapy in the First Week of Life.
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Author list: Maswabi K, Ajibola G, Bennett K, Capparelli EV, Jean-Philippe P, Moyo S, Mohammed T, Batlang O, Sakoi M, Lockman S, Makhema J, Lichterfeld M, Kuritzkes DR, Hughes MD, Shapiro RL
Publication year: 2020
Journal acronym: Clin Infect Dis
ISSN: 1058-4838
eISSN: 1537-6591
Languages: English-Great Britain (EN-GB)
Abstract
BACKGROUND\nMETHODS\nRESULTS\nCONCLUSIONS\nEarly antiretroviral treatment (ART) is recommended for HIV-infected infants. However, few antiretroviral options are available for neonates.\nThe Early Infant Treatment Study in Botswana tested HIV-exposed infants using DNA PCR within 96 hours of birth, and HIV-infected infants started nevirapine (NVP) 6mg/kg BID, zidovudine (ZDV), and lamivudine (3TC) at age <7 days. Nevirapine trough concentrations were tested at 1 and 2 weeks. NVP was switched to lopinavir-ritonavir (LPV-r) at week 2, 3, 4, or 5 according to delivery gestational age (≥38, 37, 36, 35 weeks).\nForty HIV-infected infants started ART at median age 2 days (range 1-5). Nevirapine trough concentrations were highly variable and below therapeutic target (3000ng/mL) for 50% of 2-week measurements; concentrations did not correlate with viral decline at weeks 2, 4, or 12. Two deaths unrelated to ART occurred through 24 weeks. Only one unscheduled treatment modification was required. Within 4 weeks of transition to LPV-r, 9 (22.5%) had transient HIV RNA increases, likely due to poor LPV-r palatability. At 12 weeks, HIV-1 RNA was <40 copies/mL for 22 (55%) of 40 (93% <400 copies/mL); by 24 weeks, 27 (71%) of 38 were <40 copies/mL (84% <400 copies/mL). HIV-1 RNA response at 12 and 24 weeks did not differ by baseline HIV RNA, or other factors.\nNVP/ZDV/3TC started in the first week of life was safe and effective, even when trough NVP levels were below target. Transient viral increases occurred following transition to LPV-r, but by 12 and 24 weeks most children achieved and maintained viral suppression.
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