[ThOrD1427] Neonatal post-exposure prophylaxis with nevirapine and zidovudine reduces mother-to-child transmission of HIV

14th International AIDS Conference

Barcelona, Spain — July 7-12, 2002

[TITLE:] Neonatal post-exposure prophylaxis with nevirapine and zidovudine reduces mother-to-child transmission of HIV

[AUTHOR(S):] T E Taha, N Kumwenda, A Gibbons¹, D Hoover², S Fiscus³, V Lema, G Liomba, R Broadhead⁴

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. ThOrD1427

BACKGROUND: We hypothesized that a combined regimen of oral NVP and Zidovudine (ZDV) given directly to the newborn alone could reduce mother-to-child transmission (MTCT) of HIV.

METHODS: An open-label randomized clinical trial is in progress in Blantyre, Malawi. Counseling of women for HIV testing and enrollment was conducted postnatally. Infant cord blood samples from all deliveries were stored until a signed informed consent for testing was obtained. Babies of HIV positive women arriving very late for delivery were randomized to receive either NVP plus ZDV or NVP alone. Both NVP (2mg/Kg weight single dose) and ZDV (4mg/Kg weight twice daily for a week) were administered orally soon after birth. Babies were monitored for adverse events at birth, 1 week, 6 weeks, and 3,6,9 and 12 months. Venous blood samples from the baby were collected at birth and 6 weeks to detect HIV infection using RNA PCR. Proportions infected at 6 weeks among all babies and among those HIV negative at birth were estimated.

RESULTS: To this date, 1059 (of 1180 sample needed) babies have been enrolled (531 randomized to NVP+ZDV and 528 randomized to NVP alone). Of these, 809 have so far been PCR-tested for HIV through 6 weeks (408 in the NVP+ZDV arm and 401 in the NVP only arm). At 6 weeks, 14.7% (60/408) were HIV positive among those randomized to NVP+ZDV and 22.7% (91/401) among those randomized to NVP only (p=0.004, exact test). Among babies who were negative at birth but positive at 6 weeks, 7.2% (27/375) were in the NVP+ZDV arm and 12.1% (43/355) were in the NVP only arm (p=0.02, exact test). Serious adverse events were rare (about 2% in each arm).

CONCLUSIONS: Compared to NVP only, this post-exposure NVP+ZDV prophylactic regimen reduced overall MTCT of HIV by about 35% and by about 41% among those not infected at birth. This regimen is simple and targets only the baby, avoiding complexities of maternal regimens including development of drug resistance.

Presenting author: T E Taha

1Johns Hopkins University School of Public Health, Baltimore, MD, United States

2Rutgers University, Piscataway, United States

3University of N. Carolina, Chapel-Hill, United States

4University of Malawi College of Medicine, Blantyre, Malawi

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