Use of different antiretroviral regimens during pregnancy in a cohort of 65 women in Italy
Background It is still unclear which antiretroviral (ARV) drugs to use in pregnancy to limit toxicity and teratogenesis and to control maternal infection. Methods Observational cohort study on 65 HIV positive pregnant women at 4 HIV care centres in Italy from 1/1/1997 to 31/12/2001. We recorded HIV-RNA and CD4+ once per trimester, ARV regimens used, drug-related toxicity, time and mode of delivery, treatment of mother/infant pairs according to ACTG 076. In infants we tested HIV-DNA PCR at 1 month (mo) and then every 3 mo till 15 mo. Results At conception, 20 patients (pts) (30.8%) were ARV naive, 13 (20%) on double therapy and 32 (49.2%) on HAART. 5 pts never stopped ARV, the others discontinued in the first trimester. ARV during pregnancy: a) naive: 8 pts ZDV alone, 8 ZDV+3TC, 4 HAART (2 NVP, 1 NFV, 1 both); b) pts on double therapy: 3 ZDV alone, 9 double therapy (5/6 pts on d4T switched to ZDV), 1 HAART (ZDV+3TC+NFV); c) pts in HAART: 7 double therapy, 1 ZDV alone, 24 HAART: successful regimens were maintained. 6/65 (9.2%) pts showed anemia, 2 switched from ZDV to d4T. Median CD4+: baseline 401/mmc (range 49-1298), 24w 427/mmc (63-900), 38w 438/mmc (51-1322). Median HIV-RNA: baseline 4713 cp/ml (range 49-460000), 24w 522 cp/ml (49-150000), 38w 650 cp/ml (49-400000). 1 pt developed PML at 20w. 54/65 deliveries to present, 1 vaginal; 1 pt underwent cesarean section at 32w for foetal distress. 52 infants were HIV DNA PCR negative at birth and in a median follow up of 447 days. 4 babies, all born to pts treated with both ZDV and 3TC, had anemia on postpartum ZDV therapy. 2 infants died (HIV-DNA not done): one for unknown reasons at 5 mo (mother not compliant) and one at 9 days for a congenital atrial septal defect. Conclusions HIV positive treated women can safely use the same ARV regimen during pregnancy. In our cohort no HIV transmission occurred, the only congenital anomaly was unrelated to ARV drugs and no severe toxicity was observed.
Melzi, Sara
S Melzi1, E Chiesa1, E Angeli2, M Mannazzu3, B Argenteri4, B Castelnuovo1, M Bongiovanni1, P Cicconi1, F Tordato1, S Sollima1, T Bini1, A d'Arminio Monforte1
1Institute of Infectious Diseases and Tropical Medicine, University of Milan, Italy; 2II Division of Infectious Diseases, L. Sacco Hospital - Milan, Italy; 3Clinic of Infectious Diseases, University of Sassari, Italy; 4I Division of Infectious Diseases, L. Sacco Hospital - Milan, Italy