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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
, 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
Table 1
Baseline demographic characteristics of participants who became pregnant during a TB treatment-shortening trial, Tuberculosis Trials Consortium Study 31/AIDS Clinical Trials Group A5349, January 2016–July 2020*
| Characteristic | Exposed to study drugs during pregnancy, N = 30 |
Unexposed to study drugs during pregnancy, 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 | ||
| Age at conception, y, median (range) |
24 (19–35) |
24 (19–29) |
24 (21–33) |
24 (19–35) |
28 (22–38) |
25 (16–44) |
23 (18–41) |
26 (16–44) |
|
| Age at conception group, y | |||||||||
| 12–17† | 0 | 0 | 0 | 0 | 0 | 1 (4.2) | 0 | 1 (1.5) | |
| 18–34 | 11 (84.6) | 9 (100.0) | 8 (100.0) | 28 (93.3) | 18 (81.8) | 20 (83.3) | 17 (81.0) | 55 (82.1) | |
| >35 |
2 (15.4) |
0 |
0 |
2 (6.7) |
4 (18.2) |
3 (12.5) |
4 (19.0) |
11 (16.4) |
|
| Race‡ | |||||||||
| Asian | 0 | 0 | 1 (12.5) | 1 (3.3) | 2 (9.1) | 1 (4.2) | 0 | 3 (4.5) | |
| Black or African American | 12 (92.3) | 7 (77.8) | 5 (62.5) | 24 (80.0) | 18 (81.8) | 19 (79.2) | 18 (85.7) | 55 (82.1) | |
| White | 0 | 0 | 0 | 0 | 0 | 2 (8.3) | 0 | 2 (3.0) | |
| >1 race | 0 | 2 (22.2) | 2 (25.0) | 4 (13.3) | 1 (4.5) | 2 (8.3) | 3 (14.3) | 6 (9.0) | |
| Other | 1 (7.7) | 0 | 0 | 1 (3.3) | 0 | 0 | 0 | 0 | |
| Not reported |
0 |
0 |
0 |
0 |
1 (4.5) |
0 |
0 |
1 (1.5) |
|
| Geographic region | |||||||||
| Africa | 9 (69.2) | 7 (77.8) | 5 (62.5) | 21 (70.0) | 12 (54.5) | 16 (66.7) | 17 (81.0) | 45 (67.2) | |
| Asia | 0 | 0 | 1 (12.5) | 1 (3.3) | 2 (9.1) | 1 (4.2) | 0 | 3 (4.5) | |
| North America | 3 (23.1) | 2 (22.2) | 1 (12.5) | 6 (20.0) | 7 (31.8) | 5 (20.8) | 3 (14.3) | 15 (22.4) | |
| South America |
1 (7.7) |
0 |
1 (12.5) |
2 (6.7) |
1 (4.5) |
2 (8.3) |
1 (4.8) |
4 (6.0) |
|
| HIV-positive§ | 0 | 1 (11.1) | 0 | 1 (3.3) | 1 (4.5) | 3 (12.5) | 2 (9.5) | 6 (9.0) | |
| CD4 among HIV-positive, median (IQR) |
NA |
511 (511–511) |
NA |
511 (511–511) |
331 (331–331) |
355 (158–678) |
382 (374–389) |
365 (331–389) |
|
| Cavitation on baseline chest radiograph¶ | |||||||||
| Absent | 5 (38.5) | 3 (33.3) | 3 (37.5) | 11 (36.7) | 10 (45.5) | 7 (29.2) | 7 (33.3) | 24 (35.8) | |
| <4 cm | 6 (46.2) | 3 (33.3) | 3 (37.5) | 12 (40.0) | 7 (31.8) | 7 (29.2) | 9 (42.9) | 23 (34.3) | |
| >4 cm | 2 (15.4) | 3 (33.3) | 2 (25.0) | 7 (23.3) | 5 (22.7) | 9 (37.5) | 5 (23.8) | 19 (28.4) | |
| Missing |
0 |
0 |
0 |
0 |
0 |
1 (4.2) |
0 |
1 (1.5) |
|
| WHO sputum smear grade | |||||||||
| Negative | 0 | 0 | 0 | 0 | 1 (4.5) | 2 (8.3) | 1 (4.8) | 4 (6.0) | |
| Scanty or 1–9 AFB | 2 (15.4) | 2 (22.2) | 2 (25.0) | 6 (20.0) | 5 (22.7) | 2 (8.3) | 5 (23.8) | 12 (17.9) | |
| 1+ | 2 (15.4) | 3 (33.3) | 1 (12.5) | 6 (20.0) | 4 (18.2) | 4 (16.7) | 1 (4.8) | 9 (13.4) | |
| 2+ | 7 (53.8) | 4 (44.4) | 2 (25.0) | 13 (43.3) | 6 (27.3) | 11 (45.8) | 7 (33.3) | 24 (35.8) | |
| 3+ |
2 (15.4) |
0 |
3 (37.5) |
5 (16.7) |
6 (27.3) |
5 (20.8) |
7 (33.3) |
18 (26.9) |
|
| Participant weight, kg, median (range) | 49 (42–80) | 49 (43–56) | 51 (43–58) | 50 (42–80) | 51 (42–73) | 50 (40–88) | 50 (40–70) | 50 (40–88) | |
| BMI, kg/m2, median (range) |
19 (18–32) |
19 (17–23) |
19 (16–22) |
19 (16–32) |
20 (16–25) |
19 (15–32) |
19 (15–27) |
20 (15–32) |
|
| Current smoker |
2 (15.4) |
0 |
2 (25.0) |
4 (13.3) |
3 (13.6) |
3 (12.5) |
3 (14.3) |
9 (13.4) |
|
| Diabetes mellitus history |
2 (15.4) |
0 |
0 |
2 (6.7) |
2 (9.1) |
1 (4.2) |
1 (4.8) |
4 (6.0) |
|
| Prior episode of TB treatment | 0 | 0 | 1 (12.5) | 1 (3.3) | 1 (4.5) | 2 (8.3) | 1 (4.8) | 4 (6.0) | |
*Values are no. (%) except as indicated. Participants who had >1 pregnancy during trial are shown by exposure to the study drugs for their first pregnancy. AFB, acid-fast bacillus; ART, antiretroviral therapy; BMI, body mass index; IQR, interquartile range; MOX, moxifloxacin; NA, not applicable; RPT, rifapentine; TB, tuberculosis; WHO, World Health Organization. †Minimum age of eligibility for the trial was 12 years. No pregnancies were reported in female participants 12–15 years of age. ‡Race was self-reported by trial participants. §HIV-positive persons were required to be on efavirenz-based ART for a minimum of 30 days at the time of enrollment, or, if not on ART at enrollment, planned initiation of efavirenz-based ART before or at study week 8. ¶Cavity size refers to aggregate diameter of all cavities.
1Members of this group are listed at the end of this article.
2Members of this group are listed at the end of this article.