All women and their infants received the local standard of care for HIV. The investigators performed intensified TB case finding by using the WHO symptoms screening and exam, monitoring of signs and symptoms, conducting liver function tests, and screening for peripheral neuropathy.
“We had higher than expected adverse events in the study, but there was no statistical difference between arms,” she said.
In an intention-to-treat analysis, the rate of first maternal treatment-related grade 3 or greater adverse event or permanent drug discontinuation caused by toxicity (the primary endpoint) was 15.5% in the immediate IPT arm and 15.2% in the delayed IPT arm, a nonsignificant difference. The immediate therapy arm approached but did not quite reach the prespecified boundary of noninferiority, Dr. Gupta noted.
The per-protocol analysis of the primary endpoint was similar, at 17.6% vs. 17.8%, respectively.