3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

Addition of short course Combivir (CBV) to single dose Viramune (sdNVP) for the prevention of mother to child transmission (pMTCT) of HIV-1 can significantly decrease the subsequent development of maternal and paediatric NNRTI-resistant virus

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. TuFo0204

McIntyre J.A.¹, Martinson N., Gray G.E., Hopley M., Kimura T., Robinson P., Mayers D.
¹Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa, ²Boehringer Ingelheim ZA, Johannesburg, South Africa, ³Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, United States of America

INTRODUCTION: Single-dose nevirapine (sdNVP) given at the time of delivery has decreased MTCT in resource-poor settings, but concerns have been raised about development of NNRTI-resistance limiting future treatment. A trial of sdNVP+short course CBV was conducted to determine whether post-partum HIV-1 resistance could be reduced.

METHODS: A prospective, randomized three-arm study conducted in South Africa compares sdNVP, sdNVP+4 days CBV and sdNVP+7 days CBV for pMTCT; 300 mother-infant pairs were planned. The sdNVP arm was closed to accrual after an interim analysis. All 226 mothers randomized to the three arms have reached 6 weeks of follow-up. SdNVP was given to the mother during active labor and to the infant within 24-72 hours after delivery. CBV BID was initiated in mother during labor and ZDV/3TC in infants soon after delivery. Maternal NNRTI resistance at weeks 2 and 6 post-partum was the primary endpoint. Infant HIV-1 transmission was determined by HIV DNA or RNA at birth, 2 and 6 wks.

RESULTS: We evaluated 226 mothers and 228 infants with 6-week follow-up. Median entry CD4 count was 314 cells/mm³; median viral load was 4.49 log₁₀ copies/mL. Population sequencing of 2 and 6 week specimens showed NNRTI resistance in 39/68 (57%) mothers in sdNVP; 9/67 (13%) with sdNVP+CBV4; and 6/68 (9%) sdNVP+CBV7. The most common maternal NNRTI resistance mutations were: K103N, Y188C, Y181C, V106M, A190G, and V106A. No NRTI mutations, including 184, were detected. Among 228 evaluable infants, in-utero transmission was 21/228 (9.2%) and at 6weeks total transmission rate was 24/228 (10.5%). NNRTI resistance was detected in 7/9 (78%) infants in sdNVP; 1/8 (13%) in sdNVP+CBV4 and 0/7 (0%) in sdNVP+CBV7. No treatment-related serious adverse event concerns have been identified.

CONCLUSIONS: SdNVP+CBV can significantly decrease the subsequent development of maternal and paediatric drug resistant HIV-1. The optimal duration of CBV is uncertain and the two sdNVP+CBV arms remain open to accrual.

Download PDF of this abstract.

050724
TuFo0204
PMTCT, toxicity and resistance

Copyright © 2005 - International AIDS Society (IAS). All information and content relating to the abstracts from the 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, such as text, graphics, logos, button icons, images, audio clips, and software is protected by copyright. Permission is hereby granted for the non-commercial use or reproduction of the information on this web site, provided that the use of such information is accompanied by an acknowledgement that IAS is the source of the information and the name of the author of the article.

AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2005. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2005. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. Permission is hereby granted for the non-commercial use or reproduction of the information herein, provided that the use of such information is accompanied by an acknowledgement that IAS is the source of the information and the name of the author of the article.