(HealthDay News) – For HIV-infected asymptomatic infants, early time-limited antiretroviral therapy (ART) is associated with better clinical and immunological outcomes, compared with deferred ART, according to a study published online Aug. 22 in The Lancet.
Mark F. Cotton, MMed, from Stellenbosch University in Tygerberg, South Africa, and colleagues compared early time-limited ART with deferred ART for HIV-infected asymptomatic infants younger than 12 weeks (median age, 7.4 weeks). Participants were randomly allocated to one of three groups: deferred ART (ART-Def; 125 infants), immediate ART for 40 weeks (ART-40W; 126 infants), or immediate ART for 96 weeks (ART-96W; 126 infants), with subsequent treatment interruption. Participants were followed for a median of 4.8 years.
The researchers found that the median time to ART initiation was 20 weeks in the ART-Def group. After interruption, the time to restarting ART was 33 weeks in ART-40W and 70 weeks in ART-96W; 19% and 32%, respectively, remained off ART at the end of the trial. The proportion of follow-up time spent on ART was 81%, 70%, and 69%, respectively, in the ART-Def, ART-40W, and ART-96W groups. The primary end point (time to failure of first-line ART or death) was reached by 38% of the ART-Def group, and by 25% and 21%, respectively, of the ART-40W and ART-96W groups. Compared with ART-Def, the hazard ratio was 0.59 for ART-40W and 0.47 for ART-96W.
“Early time-limited ART had better clinical and immunological outcomes than deferred ART, with no evidence of excess disease progression during subsequent treatment interruption and less overall ART exposure than deferred ART,” the authors write.