Table 4.
Six-week probability of peripartum infection, bivariate and multivariate Cox proportional hazard model for the risk of mother-to-child transmission of HIV according totreatment group (reference: ZDV): ANRS 1201/1202 DITRAME PLUS study
| Variables | Crude (Univariate) | Bivariate* | Multivariate** | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N=986† | Pr. Inf.§ | 95% CI | p§§ | HR# | 95% CI | HR | 95% CI | P | HR | 95% CI | p | |
| Treatment | 0.002 | |||||||||||
| ZDV | 303 | 12.5 | 8.7–16.3 | 1 | _ | NA | 1 | _ | ||||
| ZDV+NVPsd | 357 | 6.5 | 3.9–9.1 | 0.54 | 0.3–0.9 | 0.28 | 0.1–0.5 | 0.0002 | ||||
| ZDV+3TC+NVPsd | 326 | 4.7 | 2.4–7.0 | 0.39 | 0.2–0.7 | 0.24 | 0.1–0.5 | <0.0001 | ||||
| Maternal CD4 count | 0.0005 | <0.0001 | 0.0026 | |||||||||
| |0–200| | 147 | 15.6 | 10–22 | 3.61 | 1.9–6.9 | 4.47 | 2.3–8.6 | 3.83 | 1.9–7.7 | |||
| [200–350[ | 232 | 9.1 | 6–13 | 2.00 | 1.0–3.9 | 2.45 | 1.3–4.8 | 2.31 | l.l–4.6 | |||
| [350–500[ | 244 | 7.5 | 4–11 | 1.64 | 0.8–3.2 | 1.91 | 0.9–3.8 | 1.94 | 0.96–3.9 | |||
| ≥500 | 363 | 4.6 | 2–7 | 1 | - | 1 | - | 1 | - | |||
| WHO clinical stage | 0.002 | 0.0003 | 0.009 | |||||||||
| Stage 1–2 | 779 | 6.5 | 5– | 1 | - | 1 | - | 1 | - | |||
| Stage 3–4 | 207 | 13.4 | 9–19 | 2.08 | 1.3–3.3 | 2.50 | 1.5–4.1 | 1.98 | 1.2–3.3 | |||
| Maternal moderate anemia | 0.09 | 0.20 | 0.91 | |||||||||
| No | 396 | 5.9 | 4–8 | 1 | _ | 1 | _ | 1 | ||||
| Yes | 589 | 9.3 | 7–12 | 1.53 | 0.9–2.5 | 1.38 | 0.8–2.3 | 0.97 | 0.6–1.6 | |||
| Maternal age (for +10 years) | - | NA | - | 0.46 | 1.17 | 0.8–1.8 | 1.25 | 0.8–1.9 | 0.29 | 1.05 | 0.7–1.6 | 0.80 |
| Primigravida | 0.59 | 0.4 | 0.44 | |||||||||
| No | 889 | 8.1 | 6–10 | 1 | - | 1 | - | 1 | - | |||
| Yes | 97 | 6.5 | 2–12 | 0.80 | 0.3–1.8 | 0.69 | 0.3–1.6 | 0.71 | 0.3–1.7 | |||
| Prepartum treatment | 0.13 | 0.32 | 0.43 | |||||||||
| < 7 days | 47 | 16.2 | 5–27 | 1 | _ | 1 | _ | 1 | _ | |||
| [7–20] days | 247 | 8.4 | 5–12 | 0.53 | 0.2–1.2 | 0.52 | 0.2–1.2 | 0.56 | 0.2–1.4 | |||
| ≥ 21 days | 692 | 7.3 | 5–9 | 0.45 | 0.2–1.0 | 0.58 | 0.3–1.3 | 0.71 | 0.3–1.7 | |||
| Intrapartum treatment | 0.18 | 0.41 | 0.67 | |||||||||
| No | 91 | 11.5 | 5–18 | 1 | _ | 1 | _ | 1 | _ | |||
| Yes | 895 | 7.6 | 6–10 | 0.64 | 0.3–1.2 | 0.75 | 0.4–1.5 | 0.85 | 0.4–1.8 | |||
| Cesaerian section | 0.16 | 0.22 | 0.23 | |||||||||
| No | 939 | 8.3 | 7–10 | 1 | _ | 1 | _ | 1 | _ | |||
| Yes | 47 | 2.1 | 0–6 | 0.27 | 0.04–2.0 | 0.29 | 0.0–2.1 | 0.30 | 0.04–2.2 | |||
| Low birthweight | 0.0002 | 0.0003 | 0.0006 | |||||||||
| No | 863 | 6.8 | 5–9 | 1 | _ | 1 | _ | 1 | _ | |||
| Yes | 123 | 16.0 | 10–23 | 2.55 | 1.5–4.3 | 2.59 | 1.5–4.4 | 2.63 | 1.5–4.6 | |||
| Breastfed | 0.96 | 0.12 | 0.10 | |||||||||
| Never | 283 | 7.5 | 4–11 | 1 | - | 1 | - | 1 | - | |||
| Ever | 703 | 8.0 | 6–10 | 0.99 | 0.6–1.6 | 0.62 | 0.3–1.1 | 0.59 | 0.3–1.1 | |||
adjusted on treatment
variables with p<0.25 in bivariate analysis or p≤0.05 in the comparison of the three treatment groups (table 2)
Kaplan Meier probability of infection at 6 weeks
logrank test
univariate analysis = unadjusted Cox proportional hazards model
24 children/1010 eligible for the transmission analysis (table 1) are excluded for incomplete data
CI confidence interval HR hazard ratio 3TC = lamivudine; NVPsd = single-dose nevirapine during labour; ZDV =zidovudine Moderate anemia 7≤haenoglobinemia≤10g/dL Low birthweight <2500g