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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 5

Safety and tolerability among participants with pregnancies in the safety population of the tuberculosis 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 = 30
 Pregnancies without exposure to study drugs, N = 67
Control, n = 13 RPT/MOX, n = 9 RPT, n = 8 Total, N = 30 Control, n = 22 RPT/MOX, n = 24 RPT, n = 21 Total, N = 67
Primary safety outcome
Participants with grade >3 AE during study treatment†
 2 (15.4)
 3 (33.3)
 0
 5 (16.7)
5 (22.7)
 2 (8.3)
 0
 7 (10.4)
Secondary safety outcomes
Participants with treatment-related grade >3 AE during study treatment†
 0
 1 (11.1)
 0
 1 (3.3)
2 (9.1)
 1 (4.2)
 0
 3 (4.5)
Other safety outcomes
Participants with any serious AE during study treatment† 1 (7.7) 1 (11.1) 0 2 (6.7) 3 (13.6) 1 (4.2) 0 4 (6.0)
Participants died 0 0 0 0 0 0 0 0
Participants with any AE resulting in discontinuation of study treatment 0 0 0 0 1 (4.5) 0 1 (4.8) 2 (3.0)
Participants with any grade >3 AE during 28 wks after randomization† 3 (23.1) 5 (55.6) 1 (12.5) 9 (30.0) 8 (36.4) 5 (20.8) 5 (23.8) 18 (26.9)
ALT or AST 5-fold ULN‡ 0 0 0 0 1 (4.5) 0 0 1 (1.5)
ALT or AST 10-fold ULN 0 0 0 0 0 0 0 0
Serum total bilirubin 3-fold ULN§ 0 0 0 0 0 0 0 0
ALT or AST 3-fold ULN plus serum total bilirubin 2-fold ULN (Hy’s law)
 0
 0
 0
 0
0
 0
 0
 0
AEs during pregnancy¶
Participants with grade >3 AE 1 (7.7) 2 (22.2) 0 3 (10.0) 0 0 0 0
Participants with treatment-related grade >3 AE 0 0 0 0 0 0 0 0
Participants with any AE
 1 (7.7)
 1 (11.1)
 0
 2 (6.7)
0
 0
 0
 0
Tolerability (microbiologically eligible analysis population)
Discontinuation of assigned treatment for any reason 7 (53.9) 4 (44.4) 3 (42.9) 14 (50.0) 1 (4.6) 1 (4.2) 2 (9.5) 4 (6.0)

*ALT, alanine aminotransferase; AST, aspartate aminotransferase; MOX, moxifloxacin; RPT, rifapentine; ULN, upper limit of normal range. †Pregnancies were excluded from this analysis (all pregnancies were reported as grade >3 AE in this trial). ‡>5-fold ULN corresponds to grade >3. §>3-fold ULN corresponds to grade >3. ¶Includes AEs (other than pregnancy) with onset date from estimated date of conception through date of pregnancy 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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