Table 3.
Maternal and neonatal biological tolerance to treatment, and neonatal mortality : ANRS 1201/1202 DITRAME PLUS study
| ZDV+3TC+NVPsd | ZDV+NVPsd | ZDV | p-value * | |
|---|---|---|---|---|
| Women who delivered | 349 | 380 | 335 | |
| Women with severe anaemia | 0/297 | 1/341 | 4/310 | 0.07 |
| (Haemoglobinemia <7 g/dL a) | (0%) | (0.3%) | (1.3%) | |
| Severe rash <Day 7 postpartum | 0 | 0 | 0 | NA |
| Children followed ≥1 day | 336 | 375 | 331 | |
| Children with severe anaemia (%) | 4/282 | 7/329 | 9/300 | 0.59 |
| (Haemoglobinemia <8 g/dL a) | (1.8%) | (2.1%) | (3.0%) | |
| Severe rash <Day 7 | 0 | 0 | 0 | NA |
| Low birthweight (<2500 g) (%) | 50/332 (15.1%) | 41/372 (11.0%) | 42/324 (13.0%) | 0.28 |
| Early neonatal deaths (≤7 days) | 6(1.8%) | 6(1.6%) | 7 (2.1%) | 0.86 |
| All neonatal deaths (<28 days) | 8 (2.4%) | 6(1.6%) | 7 (2.1%) | 0.74 |
3TC = lamivudine ; NVPsd = single-dose nevirapine during labour ; ZDV = zidovudine
NA: not applicable
a
at day 28 postpartum for ZDV+3TC+NVPsd and ZDV+NVPsd ; at day 45 postpartum for ZDV
*
test for difference between the three groups unadjusted for baseline differences