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IMPAACT P1078 Primary Results Released

P1078 Primary Results

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.

>> Read the NIAID press release


Reference: Gupta A, Montepiedra G, Aaron L, Theron G, McCarthy K, Bradford S, Chipato T, Vhembo T, Stranix-Chibanda L, Onyango-Makumbi C, Masheto GR, Violari A, Mmbaga BT, Aurpibul L, Bhosale R, Mave V, Rouzier V, Hesseling A, Shin K, Zimmer B, Costello D, Sterling TR, Chakhtoura N, Jean-Philippe P, and Weinberg A, for the IMPAACT P1078 TB APPRISE Study Team. Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women. N Engl J Med. 2019;381:1333-46. DOI: 10.1056/NEJMoa1813060.

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Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.