Pregnancy Outcomes after Exposure to Tuberculosis Treatment in Phase 3 Clinical Trial, 2016-2020 - PubMed (original) (raw)

Clinical Trial

. 2025 Dec;31(12):2233-2242.

doi: 10.3201/eid3112.250492.

William C Whitworth, Kia E Bryant, Meredith G Dixon, Kelly E Dooley, Nigel A Scott, Rosanna Boyd, Nicole E Brown, Kimberley N Chapman Hedges, Wendy Carr, Lakshmi P Peddareddy, Grace Muzanyi, Rodney Dawson, Ziyad Waja, Neil Martinson, Jyoti S V Mathad, Payam Nahid, Susan Swindells, Richard E Chaisson, Susan E Dorman, Patrick P J Phillips; AIDS Clinical Trials Group A5349,; Tuberculosis Trials Consortium Study 31

Clinical Trial

Pregnancy Outcomes after Exposure to Tuberculosis Treatment in Phase 3 Clinical Trial, 2016-2020

Ekaterina V Kurbatova et al. Emerg Infect Dis. 2025 Dec.

Abstract

A previous study demonstrated noninferior efficacy of 4-month rifapentine/moxifloxacin regimen for tuberculosis (TB) treatment compared with the standard regimen. We analyzed pregnancy outcomes of women who became pregnant during the study. Among 740 women, 97 (13.1%) became pregnant. Of 102 pregnancies (in 97 participants), 30 (29.4%) participants were exposed to study drugs. Fetal loss was reported for 3/13 (23.1%) in the control regimen, 1/9 (11.1%) in the rifapentine/moxifloxacin regimen, and 1/8 (12.5%) in the rifapentine regimen. Among 21 live births in exposed pregnancies (7 in each arm), 1 infant with a congenital anomaly was reported in a participant on the rifapentine regimen. Among women receiving a short rifapentine/moxifloxacin regimen for tuberculosis who became pregnant, we observed no elevated rates of fetal losses or congenital anomalies.

Keywords: bacteria; congenital anomaly; drug-susceptible tuberculosis treatment; fetal loss; pregnancy outcomes; rifapentine; tuberculosis and other mycobacteria.

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