Early triple therapy vs mono/dual therapy for children with perinatal HIV infection.

The time at which antiretroviral therapy (ART) should be initiated in children with perinatal human immunodeficiency virus (HIV) infection remains controversial. In a cohort study, Berk et al1 reported clinical benefit from mono/dual ART started before 60 days of life in 10 children compared with treatment administered at 61 to 120 days of life in 16 children. The 23 children who received early triple ART were not investigated because none of them progressed to category C diagnosis by 3 years of age. We performed a similar analysis in a cohort study of a larger data set of children with a longer follow-up to evaluate the outcomes of early and very early triple ART. Methods. This was a post hoc analysis of data collected by the Italian Register for HIV Infection in Children, a network of 106 pediatric clinics distributed throughout Italy that is highly representative of the Italian population of perinatally HIV-infected children; details are described elsewhere. 2 Approval for the study was granted from the University of Florence and the ethics committees of the participating institutions, and written informed consent was obtained from children’s parents or legal guardians. Children infected with HIV born in 1988-2001 who received early ART treatment (_120 days of life) with at least 3 years of follow-up or earlier death were included. Treatments were considered if they were given continuously for at least 1 month in children who remained free of category C diagnoses for 1 month after initiating therapy.1 Children who progressed to triple ART after starting mono/dual ART were excluded from the analysis because of potential modification of the effect of the triple therapy. The following comparisons were performed using Kaplan- Meier analysis with the log-rank test: (1) mono/dual ART vs triple ART at age 120 days or younger; (2) very early (_60 days) vs early (61-120 days) mono/dual ART; and (3) very early vs early triple ART. Cox regression analysis was performed to evaluate the risk of progression to category C diagnosis adjusted for the year of study entry (before 1996 vs 1996 or later) and baseline CD4_ T-cell percentage.