[LbOr13] Preliminary analysis of a randomised controlled study to assess the role of post-exposure prophylaxis in reducing mother to child transmission of HIV-1

14th International AIDS Conference

Barcelona, Spain — July 7-12, 2002

[TITLE:] Preliminary analysis of a randomised controlled study to assess the role of post-exposure prophylaxis in reducing mother to child transmission of HIV-1

[AUTHOR(S):] Glenda Gray, Avye Violari, Matthew Chersich, Ronelle van Niekerk, James McIntyre¹, Mike Urban²

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. LbOR13

BACKGROUND: To date, Nevirapine prophylaxis to mother and infant provides the most feasible option for the prevention of Mother to child transmission (MTCT) of HIV-1 in developing countries. What is not known is the value of post-exposure prophylactic (PEP) antiretroviral therapy in reducing MTCT where women did not access therapy during pregnancy or labour. We are investigating the role of PEP in reducing the risk of MTCT comparing two drug regimens given to the HIV exposed infant in three hospitals in South Africa.

METHODS: Randomised open label trial of the use of single dose Nevirapine(NVP) vs. 6 weeks of Zidovudine(ZDV) administered post-natally to infants born to HIV infected women who have had no prior antiretroviral therapy. All eligible infants receive medication within 24 hours post-delivery and are advised about the risk and benefits of breastfeeding(BF) and formula feeding(FF). Infants are followed up for 6 months to ascertain their HIV status. BF infants are followed up until 3 months post BF.

RESULTS: A preliminary analysis was done on 781 infants who were randomised between October 2000 and February 2002. 773(98,9%) infants were evaluable on day 1, 14(1.8%) infants died with unknown HIV status and 192(25%) were lost to follow up. 589 were evaluable at week 6. The proportion of FF at 6 weeks was similar in both groups (82% NVP vs 83% ZDV).

	NVP	NVP	ZDV	ZDV
	n		n
Median CD4	383	438	398	423
Viral Load	383	18 400	398	18 100
No.(%) CR pos at Day 1	381	23 (6.2%)	378	22 (5.6%)
Additional No. (%)PCR pos at 6 weeks	285	20 (7.0%)	304	33 (11.0%)

Factors affecting postnatal transmission were maternal CD4<200(OR 3.1; 95%CI 1.4;7.0); maternal viral load <100 000(OR 0.40; 95%CI 0.2;0.86); and FF (OR 0.31; 95% CI 0.14;0.66).

CONCLUSIONS: Single dose NVP administered within 24 hours of birth was no different to 6 weeks ZDV in reducing post-partum MTCT.

Presenting author: Glenda Gray

1Glenda Gray, Avye Violari, Matthew Chersich, Ronelle van Niekerk, James McIntyre; Perinatal HIV Research Unit, Soweto, South A

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