title: Virologic, immunologic, and clinical benefits from early combined antiretroviral therapy in infants with perinatal HIV-1 infection.
abstract: OBJECTIVE
  To investigate the impact of early versus deferred combined antiretroviral treatment (ART) in asymptomatic or moderately symptomatic [Centers for Disease Control and Prevention (CDC) category N, A or B] infants with perinatal HIV-1 infection.
  
  
  METHODS
  A multi-centre nationwide case-control study was conducted. Data from 30 infants treated with combined ART with three or more drugs before 6 months of age were compared with data from 103 infants starting ART with three or more drugs after 6 months of age. The median follow-up time was 4.1 years (range, 1.0-6.5 years).
  
  
  RESULTS
  No difference was evident in the first available viral load and CD4 T-lymphocyte percentage between the two groups of children. Early-treated infants showed significantly lower viral loads than infants receiving deferred treatment at all the follow-up periods. A higher proportion of early-treated infants than infants receiving deferred treatment (73.3% versus 30.1%; P < 0.0001) reached an undetectable viral load. Higher CD4 T-lymphocyte percentages were found in early-treated infants at 13-24 (P < 0.0001), 25-36 (P < 0.0001), and 37-48 (P = 0.003) months of age. No early-treated infant versus 20 of 103 (19.4%) infants receiving deferred ART (P = 0.02) showed a CD4 T-lymphocyte percentage of less than 15% at one time point during follow-up. No CDC category A, B or C clinical event occurred in early-treated infants over the follow-up period while 44 of 103 (42.7%) infants receiving deferred treatment presented a decline in the CDC category. Kaplan-Meier analyses revealed significant differences in CDC category A (P = 0.0002), B (P = 0.0003), and C (P = 0.0018) event-free survivals.
  
  
  CONCLUSIONS
  The data suggest virologic, immunologic, and clinical benefits from early administration of ART.
authors.affiliation: Department of Paediatrics, University of Florence, Florence, Italy.
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: Guido Castelli
authors.initials: GC
authors.lastname: Gattinara
authors.forename: Alfredo
authors.initials: A
authors.lastname: Guarino
authors.forename: Raffaele
authors.initials: R
authors.lastname: Badolato
authors.forename: Raffaele
authors.initials: R
authors.lastname: Baddato
authors.forename: Carlo
authors.initials: C
authors.lastname: Giaquinto
authors.forename: Catiuscia
authors.initials: C
authors.lastname: Lisi
authors.forename: Maurizio
authors.initials: M
authors.lastname: de Martino
mesh_terms: D000367:Age Factors; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D016516:CD4-CD8 Ratio; D002675:Child, Preschool; D018450:Disease Progression; D004334:Drug Administration Schedule; D004812:Epidemiologic Methods; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000635:transmission / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007223:Infant; D018445:Infectious Disease Transmission, Vertical; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents