Table 2.
Baseline and follow-up characteristics of pregnant women and children: ANRS 1201/1202 DITRAME PLUS study
| ZDV+3TC+NVPsd | ZDV+NVPsd | ZDV | PI | P2 | |
|---|---|---|---|---|---|
| Pregnant women enrolled | 372 | 402 | 346 | ||
| Median age in years (IQR) | 27 (23–30) | 26 (23–30) | 25 (22–30) | 0.03 | 0.31 |
| Median parity (IQR) | 1 (0–2) | 1 (1–3) | 1 (0–3) | 0.07 | 0.07 |
| Primigravida (%) | 27 (7.3) | 39 (9.7) | 52(15.2) | 0.002 | 0.05 |
| Median gestational age (IQR) at enrolment | 33 (32–34) | 36 (36–37) | 36 (36–37) | <0.0001 | <0.0001 |
| Median haemoglobinemia in g/dL (IQR) | 9.95 (9.2–10.8) | 9.90 (9.0–10.7) | 9.30 (8.5–10.3) | <0.0001 | 0.37 |
| % moderate anaemia (7–10g haemoglobin/dL) | 206 (55.4) | 224 (55.7) | 233 (68.3) | <0.0001 | 0.90 |
| Median lymphocyte CD4+ count/mm3 (IQR) | 412 (265–580) | 370 (243–552) | 502.5 (327–714) | 0.0003 | 0.03 |
| <200 CD4+ cells/mm3 (%) | 53 (14.3) | 75 (18.7) | 34(10.1) | 0.004 | 0.10 |
| WHO clinical stage 3–4 (%) | 73 (19.6) | 126(31.3) | 34(10.1) | <0.0001 | 0.0002 |
| WHO clinical stage 4/AIDS (%) | 0 | 9 (2.2) | 5 (1.5) | 0.007 | 0.004 |
| Indication for HAART (2003 WHO criteria) * | 75 (20.2) | 117(29.1) | 43 (12.4) | <0.0001 | 0.004 |
| Median log10 HIV-1 RNA plasma viral load at enrolment (IQR) | 4.45(3.94–5.1) | 4.40 (3.76–4.88) | ** | NA | 0.003 |
| Median duration of prepartum treatment in days (IQR) | 50 (34–63) | 29(18–40) | 21 (13–32) | <0.0001 | <0.0001 |
| Women who delivered | 349 | 380 | 335 | ||
| Delivered at home (%) | 39(11.2) | 35 (9.2) | 41 (12.4) | 0.36 | 0.38 |
| With cesaerian section (%) | 21 (6.0) | 19 (5.0) | 10 (3.0) | 0.16 | 0.55 |
| Intrapartum treatment taken (%) | 322 (92.5) | 354 (93.2) | 274 (83.3) | <0.0001 | 0.75 |
| Women with livebirths analysed | 336 | 375 | 331 | ||
| Maternal postpartum (one week) ZDV (%) | NA | NA | 308 (96.3) | ||
| Neonatal ZDV (one week) +NVPsd prophylaxis (%) | 298 (88.7) | 331 (88.3) | NA | NA | 0.86 |
| Children ever breastfed ≤4 weeks (%) | 223 (66.1) | 203 (54.1) | 323 (97.6) | <0.0001 | 0.0006 |
p1 test for difference between the three groups ZDV, ZDV+NVPsd, ZDV+3TC+NVPsd
p2 test for difference between the ZDV+NVPsd and ZDV+3TC+NVPsd groups; IQR interquartile range; NA not applicable
3TC = lamivudine; NVPsd = single-dose nevirapine during labour; ZDV = zidovudine
*
HAART = highly active antiretroviral therapy if WHO clinical stage 4 or WHO clinical stage 3 and CD4<350/mm3 or WHO clinical stage 1/2 and CD4<200/mm3
**
4.8 log10 for a sample of transmitting mothers and 3.7 for a sample of non transmitting mothers