Virologic, immunologic and clinical benefits from early combined antiretroviral therapy in infants with perinatal HIV-1 infection

Objective: To investigate the impact of early versus deferred combined antiretroviraltreatment (ART) in asymptomatic or moderately symptomatic [Centers for DiseaseControl and Prevention (CDC) category N, A or B] infants with perinatal HIV-1infection.Methods: A multi-centre nationwide case–control study was conducted. Data from 30infants treated with combined ART with three or more drugs before 6 months of agewere compared with data from 103 infants starting ART with three or more drugs after 6months 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 CD4T-lymphocyte percentage between the two groups of children. Early-treated infantsshowed significantly lower viral loads than infants receiving deferred treatment at all thefollow-up periods. A higher proportion of early-treated infants than infants receivingdeferred treatment (73.3% versus 30.1%; P < 0.0001) reached an undetectable viralload. 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 ¼ 0.003) months of age. No earlytreatedinfant versus 20 of 103 (19.4%) infants receiving deferred ART (P ¼ 0.02)showed a CD4 T-lymphocyte percentage of less than 15% at one time point duringfollow-up. No CDC category A, B or C clinical event occurred in early-treated infantsover the follow-up period while 44 of 103 (42.7%) infants receiving deferred treatmentpresented a decline in the CDC category. Kaplan–Meier analyses revealed significantdifferences in CDC category A (P ¼ 0.0002), B (P ¼ 0.0003), and C (P ¼ 0.0018) eventfreesurvivals.Conclusion: The data suggest virologic, immunologic, and clinical benefits from earlyadministration of ART.