The IMPAACT Network is delighted to announce the publication of primary results from the IMPAACT P1078/TB APPRISE study in the 3 October 2019 issue of The New England Journal of Medicine.
IMPAACT P1078 was a Phase IV, randomized, double-blind, placebo-controlled study designed to evaluate the safety of immediate (antepartum) versus deferred (postpartum) isoniazid preventive therapy (IPT) among pregnant and postpartum women with HIV in settings with high prevalence of tuberculosis (TB). Preliminary results from the study were previously announced and presented at the Conference on Retroviruses and Opportunistic Infections in March 2018.
The study concluded that antepartum IPT is as safe as postpartum IPT with respect to maternal safety events. There were more adverse pregnancy outcomes among mother-infant pairs randomized to IPT during pregnancy than among pairs randomized to IPT after delivery. Among pairs randomized to IPT during pregnancy, there was a higher number of infants who died before birth and a higher number of infants who had low birth weight, compared to pairs randomized to take IPT after delivery.
Based on these results, the study team concluded that the WHO recommendation to initiate IPT during pregnancy in women with HIV who are on antiretroviral therapy needs re-evaluation.