Pregnant Women With Multidrug-Resistant/Rifampicin-Resistant Tuberculosis 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 or clofazimine (BDLLfx/BDLCfz) in pregnant women with multidrug-resistant/rifampicin-resistant tuberculosis (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 6 weeks, 6 months, and 12 months. RESULTS: Of 25 pregnant women with MDR/RR-TB, 21 received BDLLfx/BDLCfz; 12 (57%) were diagnosed with human immunodeficiency virus. Although 10 of the 21 (48%) treated women developed anemia, 18 (86%) had favorable treatment outcomes. All 21 infants were born alive, with a median gestational age 39 weeks (interquartile range [IQR], 38-40 weeks) and median birth weight 3160 g (IQR, 2818-3308 g). Three women had unfavorable pregnancy outcomes, with infants born prematurely (2 with low birth weight and 1 who developed respiratory distress syndrome). Of the 18 infants evaluated at 12 months, 10 (56%) had possible or confirmed unfavorable outcomes. Two infants had confirmed congenital anomalies and 3 possible congenital anomalies, but only 1 had first-trimester drug exposure. One infant died, another was diagnosed with MDR/RR-TB and started on treatment, and 3 infants had signs/symptoms of tuberculosis, necessitating referral for care. CONCLUSIONS: These limited data suggest 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 unfavorable infant outcomes.