title: Five-year follow-up of children with perinatal HIV-1 infection receiving early highly active antiretroviral therapy.
abstract: BACKGROUND
  Early highly active antiretroviral therapy (HAART), started within the first months of age, has been proven to be the optimal strategy to prevent immunological and clinical deterioration in perinatally HIV-infected children. Nevertheless, data about long-term follow-up of early treated children are lacking.
  
  
  METHODS
  We report data from 40 perinatally HIV-infected-children receiving early HAART, with a median follow-up period of 5.96 years (interquartile range [IQR]:4.21-7.62). Children were enrolled at birth in the Italian Register for HIV Infection in Children. Comparison with 91 infected children born in the same period, followed-up from birth, and receiving deferred treatment was also provided.
  
  
  RESULTS
  Nineteen children (47.5%) were still receiving their first HAART regimen at last follow-up. In the remaining children the first regimen was discontinued, after a median period of 3.77 years (IQR: 1.71-5.71) because of viral failure (8 cases), liver toxicity (1 case), structured therapy interruption (3 cases), or simplification/switch to a PI-sparing regimen (9 cases). Thirty-nine (97.5%) children showed CD4+ T-lymphocyte values>25%, and undetectable viral load was reached in 31 (77.5%) children at last visit. Early treated children displayed significantly lower viral load than not-early treated children, until 6 years of age, and higher median CD4+ T-lymphocyte percentages until 4 years of age. Twenty-seven (29.7%) not-early treated vs. 0/40 early treated children were in clinical category C at last follow-up (P < 0.0001).
  
  
  CONCLUSIONS
  Our findings suggest that clinical, virologic and immunological advantages from early-HAART are long-lasting. Recommendations indicating the long-term management of early treated children are needed.
authors.affiliation: Department of Pediatrics, University of Florence, Florence, Italy. echiappini@unifi.it
authors.forename: Elena
authors.initials: E
authors.lastname: Chiappini
authors.forename: Luisa
authors.initials: L
authors.lastname: Galli
authors.forename: Pier-Angelo
authors.initials: PA
authors.lastname: Tovo
authors.forename: Clara
authors.initials: C
authors.lastname: Gabiano
authors.forename: Catiuscia
authors.initials: C
authors.lastname: Lisi
authors.forename: Stefania
authors.initials: S
authors.lastname: Bernardi
authors.forename: Alessandra
authors.initials: A
authors.lastname: Viganò
authors.forename: Alfredo
authors.initials: A
authors.lastname: Guarino
authors.forename: Carlo
authors.initials: C
authors.lastname: Giaquinto
authors.forename: Susanna
authors.initials: S
authors.lastname: Esposito
authors.forename: Raffaele
authors.initials: R
authors.lastname: Badolato
authors.forename: Cesare
authors.initials: C
authors.lastname: Di Bari
authors.forename: Raffaella
authors.initials: R
authors.lastname: Rosso
authors.forename: Orazio
authors.initials: O
authors.lastname: Genovese
authors.forename: Massimo
authors.initials: M
authors.lastname: Masi
authors.forename: Antonio
authors.initials: A
authors.lastname: Mazza
authors.forename: Maurizio
authors.initials: M
authors.lastname: de Martino
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D018791:CD4 Lymphocyte Count; D002648:Child; D002675:Child, Preschool; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D007223:Infant; D007558:Italy; D012367:RNA, Viral / Q000032:analysis; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral