International AIDS Society


Now 12307 members from 182 countries | 

Abstract



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

McIntyre J.A.1, Martinson N.1, Gray G.E.1, Hopley M.2, Kimura T.3, Robinson P.3, Mayers D.3

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.





The 3rd IAS Conference on HIV Pathogenesis and Treatment
Abstract no. TuFo0204


Suggested Citation
"McIntyreJ.A., et al. 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. Fora: The 3rd IAS Conference on HIV Pathogenesis and Treatment: Abstract no. TuFo0204"