Dr. Gupta noted that higher liver function test results were seen after delivery, regardless of whether the women were on IPT or what type of antiretroviral therapy they were receiving.
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,