854 A Short Course of Zidovudine + Peripartum Nevirapine is Highly Efficacious in Preventing Mother-to-Child Transmission of HIV-1: The ANRS 1201 DITRAME-plus Study, Abidjan, Côte d’Ivoire F. Dabis*1, D. K. Ekouevi2,3, L. Bequet2,3, F. Rouet2,3, A. Horo4, P. Fassinou4, L. Dequae-Merchadou1, V. Leroy1, ANRS PACCI DITRAME Plus Study Group2,3 1INSERM U330, Bordeaux, France; 2Agence Natl de Res sur le SIDA, Paris, France; 3PACCI, Abidjan, Cote d'Ivoire, South Africa; and 4CHU Yopougon, Abidjan, Cote d'Ivoire
Background: In Africa, short regimens of zidovudine (ZDV) or nevirapine (NVP) have demonstrated their efficacy for preventing mother-to-child transmission (PMTCT) with 6-wk transmission rates of 14% and 12%, respectively. We evaluated the efficacy of a combined short course ZDV + peripartum NVP in a PMTCT package.
Methods: An open-label non randomized trial in Abidjan, Côte d’Ivoire, starting in March 2001. Consenting women with HIV infection start oral ZDV (300 mg bid) = 36 wks of gestation and before beginning of labor when an oral loading dose of 600 mg ZDV + 200 mg NVP is given. The neonate is treated for 1 week with ZDV syrup (2 mg/kg/6 hrs) + a single dose of NVP syrup (2 mg/kg on Day 3). Each woman receives a supplementation in multivitamins, iron, foliates, and malaria prophylaxis. From enrollment, she is also provided with advice and support to either use breast milk substitutes from birth or breast feed exclusively with rapid weaning by 4 months. Pediatric HIV infection is diagnosed by plasma HIV viral load > 5,000 HIV RNA copies/ml (bDNA Chiron) at 4 wks and confirmed at 6 weeks. The reference group is the ANRS 049 DITRAME cohort treated with a short regimen of ZDV = 36 wks in a randomized trial and in the subsequent open-label phase. The 6-wk MTCT rate in this group was 13.1% (n = 320) and 22.0% in the placebo arm of the randomized trial (n = 197).
Results: We included 402 HIV+ pregnant women until August 2002 when enrolment was closed. Median CD4 count is 378/mm3 (18% < 200, 30% = 500 CD4). Baseline mean plasma viral load is 4.1 log copies/ml. As of October 15, 371 women have delivered live-born singletons (6% by C-section); 22/331 children with 4-6 wk follow-up have been diagnosed with HIV infection. The MTCT rate is 6.7% (95% CI: 4.0-9.4%), a 49% reduction compared to the ZDV MTCT rate (p = 0.008 adjusted on maternal CD4) and a 70% reduction compared to the placebo. However, MTCT rate is still 18.6% with CD4 < 200 vs 21.2% with ZDV alone (p = 0.76). Transmission risk with ZDV + NVP is comparable when mothers opt for breast milk substitutes (7.6%, n = 158) or for exclusive breast feeding (5.9%, n = 173) (p = 0.43 adjusted for maternal CD4).
Conclusions: A ZDV + NVP regimen prevents most peripartum transmission of HIV in Africa irrespective of infant feeding choice, except with advanced maternal HIV disease. This combined treatment is one of the best options for short-course PMTCT and should be part of international guidelines.
