Maternal and infant outcomes among pregnant women treated for multidrug/rifampicin-resistant tuberculosis in South Africa.

BACKGROUND: Data on safety and efficacy of second-line tuberculosis drugs in pregnant women and their infants are severely limited due to exclusion from clinical trials and expanded access programmes. METHODS: Pregnant women starting treatment for multidrug/rifampicin-resistant (MDR/RR)-tuberculosis at King Dinuzulu Hospital in KwaZulu-Natal, South Africa from 1 January 2013 - 31 December 2017 were included. We conducted a record review to describe maternal treatment and pregnancy outcomes, and a clinical assessment to describe infant outcomes. RESULTS: Of 108 pregnant women treated for MDR/RR-tuberculosis, 88 (81%) were HIV-infected. Favourable MDR/RR-tuberculosis treatment outcomes were reported in 72 (67%) women. Ninety-nine (91%) of the 109 babies were born alive but, overall, 52 (48%) women had unfavourable pregnancy outcomes. Fifty-eight (54%) women received bedaquiline and 49 (45%) babies were exposed to bedaquiline in utero. Low birthweight was reported in more babies exposed to bedaquiline compared to babies not exposed (45% vs 26%; p=0.034). In multivariate analyses, bedaquiline and levofloxacin, drugs often used in combination, were both independently associated with increased risk of low birthweight. Of the 86 children evaluated at 12 months, 72 (84%) had favourable outcomes; 88% of babies exposed to bedaquiline were thriving and developing normally compared to 82% of the babies not exposed. CONCLUSIONS: MDR/RR-tuberculosis treatment outcomes among pregnant women were comparable to non-pregnant adults. Although more babies exposed to bedaquiline were of low birthweight, over 80% had gained weight and were developing normally at one year.