Pregnant women with MDR/RR-TB and the all-oral 6-month regimen: experiences from a patient series in South Africa

Background: There is limited experience of the all-oral 6-month regimens containing bedaquiline, delamanid, linezolid and levofloxacin/clofazimine (BDLLfx/BDLCfz) in pregnant women with MDR/RR-TB. We report maternal treatment, pregnancy, and infant outcomes to 12 months of age in a cohort of pregnant women treated with these regimens.

Methods: We included pregnant women treated for MDR/RR-TB from September 2023 to January 2025 in KwaZulu-Natal, South Africa in a prospective observational study. Outcomes were collected through ongoing record reviews. Infant clinical assessments were conducted at six weeks, six and 12 months.

Results: Of 25 pregnant women with MDR/RR-TB, 21 received BDLLfx/BDLCfz; 12 (57%) were living with HIV. Although 10/21 (48%) of the women developed anaemia, 18 (86%) had favourable treatment outcomes. All 21 infants were born alive; median gestational age 39 weeks (interquartile range [IQR]:38-40) and median birth weight 3160g (IQR: 2818-3308). Three women had unfavourable pregnancy outcomes, with infants born prematurely, two with low birth weight, one of whom developed respiratory distress syndrome. Of the 18 infants evaluated at 12 months, ten (56%) had possible or confirmed unfavourable outcomes. Two infants had confirmed congenital anomalies and three possible congenital anomalies, but only one had first-trimester drug exposure. One infant died, another was diagnosed with MDR/RR-TB and started on treatment, and three infants had signs/symptoms of TB necessitating referral for care.

Conclusions: These limited data suggests that in pregnant women, the BDLLfx/BDLCfz regimens have improved treatment and pregnancy outcomes compared to prior regimens. However, there is a high prevalence of unfavourable infant outcomes.