TABLE 3.
Serious adverse events, and pre-term deliveries in mothers and infants
| Dolutegravir | Efavirenz | Total | |
|---|---|---|---|
|
| |||
| Maternal SAEs | N = 137 (%) | N = 131 (%) | N = 268 (%) |
| Mothers with ≥1 SAE1 | 30 (21·9)2 | 14 (10·7)2 | 44 (16·4) |
| Mothers with ≥1 drug-related SAE | 1 (0·7) | 0 | 1 (0·4) |
| Mothers with ≥1 IRIS-related SAE | 1 (0·7) | 0 | 1 (0·4) |
| SYSTEM ORGAN CLASS | |||
| Blood and lymphatic system disorders | 2 (1·5) | 0 | 2 (0·7) |
| Gastrointestinal disorders | 1 (0·7) | 0 | 1 (0·4) |
| Infections and infestations | 5 (3·6) | 2 (1·5) | 7 (2·6) |
| Pregnancy, puerperium and perinatal conditions excl. stillbirths | 18 (13·1) | 10 (7·6) | 28 (10·4) |
| Renal and urinary disorders | 3 (2·2) | 0 | 3 (1·1) |
| Social circumstances | 1 (0·7) | 0 | 1 (0·4) |
| Vascular disorders | 0 | 1 (0·8) | 1 (0·4) |
|
| |||
| Deliveries with evaluable gestational age | N = 124 | N = 120 | N = 244 |
| Gestation3 at delivery (median; IQR) | 39 (37·2, 40·7) | 39 (37·3, 40·0) | 39 (37·3, 40·3) |
| Late pre-term (<37 weeks) | 21 (16·9) | 19 (15·8) | 40 (16·4) |
| Premature (< 34 weeks) | 3 (2·4) | 5 (4·2) | 8 (3·3) |
| Stillbirth | 3 (2·2) | 1 (0·8) | 4 (1·5) |
|
| |||
| Infant SAEs (242 live births) | N = 123 (%) | N = 119 (%) | N = 242 (%) |
| Birth weight (g; median; IQR) | 3180 (2800, 3440) (N = 109) | 3115(2860, 3420) (N = 118) | 3160 (2840, 3440) (N = 227) |
| Infants with ≥1 SAE | 61 (49·6) | 56(47·1) | 117 (48·3) |
| Infant deaths | 4 (3·3) | 2 (1·7) | 6 (2·5) |
| SYSTEM ORGAN CLASS | |||
| Congenital, familial and genetic disorders | 67 (54·5) | 71 (59·7) | 138 (57·0) |
| Ear and labyrinth disorders | 1 (0·8) | 0 | 1 (0·4) |
| Hepatobiliary disorders | 1 (0·8) | 0 | 1 (0·4) |
| Infections and infestations | 8 (6·5) | 6 (5·0) | 14 (5·8) |
| Injury, poisoning and procedural complications | 1 (0·8) | 0 | 1 (0·4) |
| Nervous system disorders | 1 (0·8) | 1 (0·8) | 2 (0·8) |
| Pregnancy, puerperium and perinatal conditions | 4 (3·3) | 7 (5·9) | 11 (4·5) |
| Respiratory, thoracic and mediastinal disorders | 8 (6·5) | 4 (3·4) | 12 (5·0) |
1
Including stillbirths.
2
P = 0·013, Chi-squared test
3
Gestation at delivery based on best estimate using recall of last menstrual period, fundal height and ultrasound dating, modified post-partum by the Ballard score.