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 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 ¼ 0.003) months of age. No earlytreated infant 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 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 ¼ 0.0002), B (P ¼ 0.0003), and C (P ¼ 0.0018) eventfree survivals. Conclusion: The data suggest virologic, immunologic, and clinical benefits from early administration of ART.