However, the quality of evidence to support that statement is weak, primarily because pregnant women were typically excluded from IPT or other tuberculosis-prevention trials. In addition, isoniazid has been associated in retrospective studies with increased hepatotoxicity in women both during pregnancy and in the postpartum period, Dr. Gupta pointed out.
She and her colleagues conducted the phase 4 IMPAACT P1078 trial to test the hypothesis that IPT can be initiated safely during pregnancy. The study was conducted at centers in Botswana, Haiti, India, South Africa, Tanzania, Thailand, Uganda, and Zimbabwe.
HIV-infected pregnant women from 14 through 34 weeks of gestation who live in a high TB burden area (prevalence of 60 cases or more per 100,000 population) but had no evidence of TB infection were randomly assigned on a 1:1 basis to receive either immediate therapy with isoniazid 300 mg daily for 28 weeks, followed by placebo, or to the same dose of isoniazid started 12 weeks postpartum for 28 weeks. All patients also received vitamin B6 and a prenatal multivitamin until 40 weeks postpartum.
The participants were stratified by gestational age (14 to less than 24 weeks and 24 through 34 weeks). Women were excluded if they were suspected of having active TB, reported recent exposure, or had received TB treatment for more than 30 days in the past year. Women with recent acute hepatitis or peripheral neuropathy were excluded.