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Volume 31, Number 12—December 2025

CME ACTIVITY - Research

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

Ekaterina V. KurbatovaComments to Author , 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, and AIDS Clinical Trials Group A5349,1 and Tuberculosis Trials Consortium Study 312
Author affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA (E.V. Kurbatova, W.C. Whitworth, K.E. Bryant, M.G. Dixon, N.A. Scott, R. Boyd, N.E. Brown, K.N. Chapman Hedges, W. Carr, L.P Peddareddy); Vanderbilt University Medical Center, Nashville, Tennessee, USA (K.E. Dooley); Uganda–Case Western Reserve University Research Collaboration, Kampala, Uganda (G. Muzanyi); University of Cape Town Lung Institute, Cape Town, South Africa (R. Dawson); University of the Witwatersrand Perinatal HIV Research Unit, Johannesburg, South Africa (Z. Waja, N. Martinson); Weill Cornell Medical College, New York, New York, USA (J.S.V. Mathad); University of California Center for Tuberculosis, San Francisco, California, USA (P. Nahid, P.P.J. Phillips); University of Nebraska Medical Center, Omaha, Nebraska, USA (S. Swindells); Johns Hopkins University School of Medicine, Baltimore, Maryland, USA (R.E. Chaisson); Medical University of South Carolina, Charleston, South Carolina, USA (S.E. Dorman)

Main Article

Table 4

TB treatment outcomes in the microbiologically eligible population of the TB treatment-shortening trial, Tuberculosis Trials Consortium Study 31/AIDS Clinical Trials Group A5349, January 2016–July 2020*

Outcome Pregnancies with exposure to study drugs, N = 29
 Pregnancies without exposure to study drugs, N = 67
Control, n = 13 RPT/MOX, n = 9 RPT, n = 7 Total, N = 29 Control, n = 22 RPT/MOX, n = 24 RPT, n = 21 Total, N = 67
Favorable, total†
 6 (46.2)
 5 (55.6)
 4 (57.1)
 15 (51.7)
21 (95.5)
 23 (95.8)
 19 (90.5)
 63 (94.0)
Not favorable, total‡ 7 (53.8) 4 (44.4) 3 (42.9) 14 (48.3) 1 (4.5) 1 (4.2) 2 (9.5) 4 (6.0)
Unfavorable outcome, total 0 0 0 0 1 (4.5) 0 1 (4.8) 2 (3.0)
TB-related unfavorable outcome, total 0 0 0 0 1 (4.5) 0 0 1 (1.5)
Not seen at month 12; last culture positive 0 0 0 0 1 (4.5) 0 0 1 (1.5)
Not TB-related unfavorable outcome, total 0 0 0 0 0 0 1 (4.8) 1 (1.5)
Treatment changed because of adverse event 0 0 0 0 0 0 1 (4.8) 1 (1.5)
Not assessable outcome, total 7 (53.8) 4 (44.4) 3 (42.9) 14 (48.3) 0 1 (4.2) 1 (4.8) 2 (3.0)
Not seen at month 12; last culture negative 0 0 0 0 0 0 1 (4.8) 1 (1.5)
Withdrawn from treatment because of pregnancy 7 (53.8) 4 (44.4) 3 (42.9) 14 (48.3) 0 1 (4.2) 0 1 (1.5)

*Values are no. (%). Microbiologically eligible analysis population included the subset of all enrolled participants who receive a treatment assignment who, in addition, have culture confirmation of drug-susceptible TB at study entry. MOX, moxifloxacin; RPT, rifapentine; TB, tuberculosis. †All participants with favorable outcome had culture-negative status at month 12. ‡Participants with unfavorable and not assessable outcomes were considered to have a not favorable outcome.

Main Article

1Members of this group are listed at the end of this article.

2Members of this group are listed at the end of this article.

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