Table 3:
Maternal Safety, Pregnancy Outcomes, and Infant Safety
| EFV | RAL | Total | P-value* | |
|---|---|---|---|---|
| Maternal Adverse events | N=197 | N=206 | N=403 | |
| Any Grade ≥3 AE | 59/197 (30%) | 61/206 (30%) | 120/403 (30%) | P=0·91 |
| Grade ≥3 Sign/Symptom | 14/197 (7%) | 11/206 (5%) | 25/403 (6%) | |
| Grade ≥3 Lab AE | 34/197 (17%) | 33/206 (16%) | 67/403 (17%) | |
| Hematologic | 22/197 (11%) | 24/206 (12%) | 46/403(11%) | |
| Chemistry | 13/197 (7%) | 9/206 (4%) | 22/403 (5%) | |
| Grade ≥3 Diagnoses | 31/197 (16%) | 34/206 (17%) | 65/403 (16%) | |
| Deaths (any reason)# | 0/197 (0%) | 1/206 (<0.5%) | 1/403 (<0.5%) | |
| Adverse pregnancy outcomes | ||||
| Stillbirth† | 1/194 (1%) | 3/200 (2%) | 4/394 (1%) | P=0·62 |
| Preterm birth (<37 weeks) | 20/190 (11%) | 24/195 (12%) | 44/385 (11%) | P=0·63 |
| Extremely preterm birth (<34 weeks) | 6/169 4%) | 4/171 (2%) | 10/340 (3%) | P=0·54 |
| Low birthweight (<2500 g) | 24/193 (12%) | 25/197 (13%) | 49/390 (13%) | P>0·99 |
| Extremely low birthweight (<1500 g) | 0/193 (0%) | 1/197 (1%) | 1/390 (<0.5%) | P>0·99 |
| HIV transmissions | ||||
| HIV-infected infantΔ | 6/184 (3%) | 1/190 (1%) | P=0·064 | |
| Infant Adverse Events | N=194 | N=199 | ||
| Any Grade ≥3 AE | 48/194 (25%) | 50/199 (25%) | 98/393 (25%) | P=0·94 |
| Grade ≥3 Sign/Symptom | 15/194 (8%) | 15/199 (8%) | 30/393 (8%) | |
| Grade ≥3 Lab AE | 22/194 (11%) | 17/199 (9%) | 39/393 (10%) | |
| Hematologic | 13/194 (7%) | 6/199 (3%) | 19/393 (5%) | |
| Chemistry | 11/194 (6%) | 11/199 (6%) | 22/393 (6%) | |
| Grade ≥3 Diagnosis | 32/194 (16%) | 34/199 (17%) | 66/393 (17%) | |
| Deaths (any reason)## | 1/194 (1%) | 1/199 (1%) | 2/393 (1%) |
EFV = Efavirenz; RAL = Raltegravir; AE = Adverse event
The p-value for the primary safety comparisons (proportion that experienced any grade ≥3 AE) was calculated via Cochran Mantel Haenszel test stratified by gestational age at entry. P-values for comparisons of adverse pregnancy outcomes and HIV transmissions were calculated via Fisher’s Exact test.
The maternal death was ruled a murder, attributed by the reporting site as unrelated to study treatment or conduct. The primary cause of death was liver-rupture due to trauma.
One woman in the raltegravir arm had discordant outcomes. Because one of the outcomes occurred prior to study entry (intra-uterine fetal demise), only the outcome for the infant who was delivered on-study (live birth) is included (see Results for further details).
Excluded infants (ten in the efavirenz arm and 9 in the raltegravir arm) had no positive HIV-infection test result, but also did not have sufficient negative test results to meet the definition of “HIV-uninfected”.
Both infant deaths were attributed by the reporting site as not related to study treatment or conduct. The primary causes of death were neonatal necrotizing enterocolitis (efavirenz arm) and presumed sudden infant death syndrome (raltegravir arm).