biostudies-literatureUnknown22(1)Chiappini E<h4>Background</h4>Early start of highly active antiretroviral therapy (HAART) in perinatally HIV-1 infected children is the optimal strategy to prevent immunological and clinical deterioration. To date, according to EMA, only 35% of antiretroviral drugs are licenced in children < 2 years of age and 60% in those aged 2-12 years, due to the lack of adequate paediatric clinical studies on pharmacokinetics, pharmacodynamics and drug safety in children.<h4>Methods</h4>An observational retrospective study investigating the rate and the outcomes of off-label prescription of HAART was conducted on 225 perinatally HIV-1 infected children enrolled in the Italian Register for HIV Infection in Children and followed-up from 2001 to 2018.<h4>Results</h4>22.2% (50/225) of included children were receivinBMC infectious diseases55https://www.ebi.ac.uk/biostudies/studies/S-EPMC8760752biostudies-literatureOff-label use of combined antiretroviral therapy, analysis of data collected by the Italian Register for HIV-1 infection in paediatrics in a large cohort of children.PMC8760752Carloni IParigi SFelici LBruzzese EBondi ENogare ERDNatale FDedoni MItalian Register for HIV Infection in ChildrenAbbagnato LRuggeri MGalli LTaramasso Lde Martino MConsolini RFaldella GLisi CRampon OChiriaco PGenovese OGabiano CGiacomet VAnzidei GAnastasio EBorea RPession AGiaquinto CDi Pietro GMEsposito SDodi IPortelli VErba PGiannini AMBernardi SZangari PTovo PABaldi Fde Martino AAntonellini ADessi CBigi MChiappini EDi Biagio APanto MGCellini MSalvini FOrlandi FCenderello GTommasi DPinzani RGovoni MROlmeo PZanaboni DRabusin MSaitta MCristiano LBadolato RGarazzino SMazza ATagliabue CCatania SCazzato SFabrizio LfalseOff-label use of combined antiretroviral therapy, analysis of data collected by the Italian Register for HIV-1 infection in paediatrics in a large cohort of children.<h4>Background</h4>Early start of highly active antiretroviral therapy (HAART) in perinatally HIV-1 infected children is the optimal strategy to prevent immunological and clinical deterioration. To date, according to EMA, only 35% of antiretroviral drugs are licenced in children < 2 years of age and 60% in those aged 2-12 years, due to the lack of adequate paediatric clinical studies on pharmacokinetics, pharmacodynamics and drug safety in children.<h4>Methods</h4>An observational retrospective study investigating the rate and the outcomes of off-label prescription of HAART was conducted on 225 perinatally HIV-1 infected children enrolled in the Italian Register for HIV Infection in Children and followed-up from 2001 to 2018.<h4>Results</h4>22.2% (50/225) of included children were receivin2022-01-01T00:00:00Z2022 Jan2026-05-08T14:05:01.14Z2022-02-11T15:26:22.72ZS-EPMC87607523503301810.1186/s12879-022-07026-w