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

Kurbatova E.V.; Whitworth W.C.; Bryant K.E.; Dixon M.G.; Dooley K.E.; Scott N.A.; Boyd R.; Brown N.E.; Chapman Hedges K.N.; Carr W.; Peddareddy L.P.; Muzanyi G.; Dawson R.; Waja Z.; Martinson N.; Mathad J.S.V.; Nahid P.; Swindells S.; Chaisson R.E.; Dorman S.E.; Phillips P.P.J. · Emerging Infectious Diseases (2025) · DOI: 10.3201/eid3112.250492

Resumen

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.