Table 3.
Maternal grade 3 or higher adverse events, and infant baseline characteristics and infant grade 3 or higher adverse events*
| DTG+FTC/TAF | DTG+FTC/TDF | EFV/FTC/TDF | |
|---|---|---|---|
| Maternal outcome through 14 days after delivery | N = 217 | N = 215 | N = 211 |
| Women with any grade 3 or higher clinical or laboratory adverse event | 45 (20·7%) | 56 (26·0%) | 47 (22·3%) |
| Death** | 1 (0·5%) | 0 (0%) | 0 (0%) |
| Any grade 3 or higher clinical adverse event | 40 (18·4%) | 40 (18·6%) | 38 (18·0%) |
| Infection | 5 (2·3%) | 5 (2·3%) | 8 (3·8)% |
| Pregnancy/perinatal complication (excluding SB and PTD) | 25 (11·5%) | 28 (13·0%) | 27 (12·8%) |
| Gestational hypertension | 5 (2·3%) | 5 (2·3%) | 7 (3·3%) |
| Pre-eclampsia or eclampsia | 5 (2·3%) | 3 (1·4%) | 1 (0·5%) |
| Gestational diabetes | 0 (0%) | 1 (0·5%) | 0 (0%) |
| Premature rupture of membranes (term and preterm) | 5 (2·3%) | 5 (2·3%) | 5 (2·4%) |
| Hemorrhage (antepartum to 14 days postpartum) | 4 (1·8%) | 2 (0·9%) | 4 (1·9%) |
| Other pregnancy complication | 8 (3·7%) | 13 (6·0%) | 11 (5·2%) |
| Any grade 3 or higher laboratory-based adverse event | 9 (4·1%) | 20 (9·3%) | 15 (7·1%) |
| Low hemoglobin or reported anemia | 8 (3·7%) | 17 (7·9%) | 11 (5·2%) |
| Low creatinine clearance† | 1 (0·5%) | 1 (0·5%) | 2 (0·9%) |
| AST | 0 (0%) | 1 (0·5%) | 1 (0·5%) |
| Other maternal outcomes | |||
| Estimated creatinine clearance at delivery (mean mL/min)¶ | 148·5 | 134·9 | 155·3 |
| Creatinine at delivery (mean mg/dL) | 0·64 | 0·68 | 0·57 |
| Weekly weight gain (mean kg) | 0·378 | 0·319 | 0·291 |
| Weekly weight gain standardized to GA (mean kg) | 0·371 | 0·332 | 0·289 |
| Infant outcome, through 28 days of life | (N = 208) | (N = 202) | (N = 207) |
| Infants with any grade 3 or higher adverse event | 29 (13·9%) | 33 (16·3%) | 43 (20·8%) |
| Infection | 3 (1·4%) | 10 (5·0%) | 9 (4·3%) |
| Nervous system disorder# | 3 (1·4%) | 0 (0%) | 7 (3·4%) |
| Respiratory tract disorder | 11 (5·3%) | 6 (3·0%) | 10 (4·8%) |
| Hypoglycemia | 4 (1·9%) | 4 (2·0%) | 4 (1·9%) |
| Elevated creatinine | 2 (1·0%) | 5 (2·5%) | 4 (1·9%) |
| Elevated bilirubin | 1 (0·5%) | 1 (0·5%) | 0 (0%) |
| Other infant outcomes | |||
| Gestational age at birth (median weeks, range) | 39·7 (31·1, 43·8) | 39·9 (28·1, 43·9) | 39·6 (25·1, 44·4) |
| Birth weight (median grams) | 3,160 | 3,065 | 3,000 |
| Low birth weight (<2500 grams) | 13 (6.4%) | 19 (9.5%) | 24 (12%) |
| Very low birth weight (<1500 grams) | 0 | 1 (0.5%) | 2 (1.0%) |
| Birth weight >4kg | 8 (4·0%) | 3 (1·5%) | 4 (2·0%) |
| Died by 28 days after birth& | 2 (1·0%) | 3 (1·5%) | 10 (4·8%) |
| Born <37 weeks, of infants who died by 28 days | 1 (0·5%) | 0 (0%) | 3 (1·4%) |
| SGA, of infants who died by 28 days | 2 (1·0%) | 2 (1·0%) | 3 (1·5%) |
| Creatinine clearance at birth (mean mL/min)‡ | 52·5 | 53·3 | 49·6 |
| Creatinine at birth (mean mg/dL) | 0·62 | 0·56 | 0·50 |
Table 3 presents the numbers of women (and infants) with grade 3 or higher events; some women and infants may have each had more than 1 event, hence not all columns will total. Participants who experienced multiple grade 3 or higher events were reported at the highest-grade event in each row. Only the most frequent or relevant specific clinical events are listed; please see Tables S8 and S15 for detailed listings of reported events.
Maternal cause of death: one mother died of sepsis approximately 2 weeks following Cesarean section.
Defined as creatinine >1·8 x upper limit of normal or estimated creatinine clearance <60 mL/min by Cockgroft-Gault.
By Cockgroft-Gault.
Nervous system disorders: in DTG+FTC/TAF group: 2 infants with hypoxic-ischemic encephalopathy and 1 with seizure. In EFV/FTC/TDF group: 1 infant with bulging fontanelle, 1 with hydrocephalus and intraventricular hemorrhage, and 5 with hypoxic-ischemic encephalopathy.
Infant cause of death: DTG+FTC/TAF group: 1 Hypoxic ischemic encephalopathy. 1 Birth asphyxia. DTG+FTC/TDF group: 1 Birth asphyxia. 1 Probable pneumonia. 1 Unknown. EFV/FTC/TDF group: 3 Hypoxic ischemic encephalopathy. 1 Severe prematurity. 3 Neonatal sepsis. 1 Neonatal respiratory distress syndrome. 1 Fetal distress due to prolonged labor. 1 Unknown.
By Schwartz formula.