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.
Conclusion: The data suggest virologic, immunologic, and clinical benefits from early administration of ART.
From the aDepartment of Paediatrics, University of Florence, Florence, Italy
bDepartment of Paediatrics, University of Turin, Turi, Italy
cBambino Gesù Children's Hospital, Rome, Italy
dDepartment of Paediatrics, Federico II University, Naples, Italy
eDepartment of Paediatrics, University of Brescia, Brescia, Italy
fDepartment of Paediatrics, University of Padua, Padua, Italy
gDepartment of Statistics, University of Florence, Florenc, Italy.
Received 21 December, 2004
Accepted 10 June, 2005
Correspondence to M. de Martino, Coordinator of the Italian Register for HIV Infection in Children, Department of Paediatrics, University of Florence, Via Luca Giordano, 13, I-50132 Florence, Italy. Tel: +39 055 566 2494; fax: +39 055 570 380; e-mail: email@example.com