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High adverse events with TB prevention in HIV-infected pregnant women

 

Key clinical point: Immediate tuberculosis prevention therapy with isoniazid (IPT) during pregnancy was associated with more adverse pregnancy outcomes than delayed IPT.

Major finding: The rate of adverse pregnancy outcomes was 23% with immediate IPT during pregnancy versus 17% for IPT delayed until 12 weeks postpartum (P =. 009).

Data source: Randomized trial in 156 HIV-infected pregnant women in seven countries that have high TB prevalence rates.

Disclosures: The study was sponsored by the U.S. National Institutes of Health. Dr. Gupta reported having nothing to disclose.

Source: Gupta A et al. CROI 2018, Abstract Number 142LB.


 

FROM CROI 2018

There were no significant differences seen in infant safety by treatment arm, a secondary endpoint.

“What did we learn? We learned that we had higher than expected adverse events that were at least possibly attributed to IPT in both arms. We did not reach our noninferiority margin partly because of the high rates, but we also did not find any major significant differences between the immediate and the deferred arm in terms of maternal safety when it was looked [at] by itself,” she said.

Although there were no significant differences in any maternal hepatotoxicity, grade 3 or greater infant adverse events, or maternal or infant death by treatment arm, “we did find an important distinction in terms of difference by adverse pregnancy outcomes, where immediate IPT was associated with more adverse pregnancy outcomes,” she said,

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