Table 3.
Adverse events and laboratory abnormalities.
| Maternal (N = 33) | Neonate (N = 29) | |
| AEs | ||
| Any AE | 26 (79) | 12 (41) |
| Most frequent AEs (occurring in ≥9% of participants in either group) | ||
| Back pain | 4 (12) | – |
| Gestational diabetes | 4 (12) | – |
| Anemia | 3 (9) | – |
| False labor | 3 (9) | – |
| Preeclampsia | 3 (9) | – |
| Neonatal jaundice | – | 3 (10) |
| Respiratory distress | – | 3 (10) |
| Drug-related AEs | 1 (3)a | 0 |
| SAEs | 6 (18)b | 5 (17)c |
| Drug-related SAEs | 1 (3)a | 0 |
| Grade ≥3 AEs | 2 (6) | 1 (3) |
| Drug-related grade ≥3 AEs | 0 | 0 |
| AEs leading to premature discontinuation of study drug | 0 | 0 |
| Death | 0 | 0 |
| Laboratory abnormalities | ||
| Any grade | 24 (73) | 5 (17) |
| Grade ≥3 | 6 (18) | 0 |
Data represent number (%) of participants. Median (Q1, Q3) duration of B/F/TAF exposure was 27 (23, 32) weeks.
a
False labor.
b
False labor (n = 3) and COVID-19, nonreassuring fetal heart rate pattern, preeclampsia, preterm premature rupture of membranes, and pyrexia (n = 1 for each).
c
Accessory auricle, atrial septal defect, sepsis neonatal, jaundice neonatal, neonatal asphyxia, and transient tachypnea of the newborn (n = 1 for each).
AE, adverse event; B/F/TAF, bictegravir/emtricitabine/tenofovir alafenamide; Q, quartile; SAE, serious adverse event.