[219] EFFECTIVENESS OF A SHORT COURSE OF ZIDOVUDINE + LAMIVUDINE AND PERIPARTUM NEVIRAPINE TO PREVENT HIV-1 MOTHER-TO-CHILD TRANSMISSION. THE ANRS 1201 DITRAME-PLUS TRIAL, ABIDJAN, COTE D'IVOIRE

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] EFFECTIVENESS OF A SHORT COURSE OF ZIDOVUDINE + LAMIVUDINE AND PERIPARTUM NEVIRAPINE TO PREVENT HIV-1 MOTHER-TO-CHILD TRANSMISSION. THE ANRS 1201 DITRAME-PLUS TRIAL, ABIDJAN, COTE D'IVOIRE

[AUTHOR(S):] F Dabis¹, DK Ekouevi^1,2, F Rouet³, L Bequet², I Viho², A Horo⁴, P Fassinou⁵, H Toure², C Welfens-Ekra⁴, V Leroy² for the ANRS Ditrame Plus Study Group
¹Unite INSERM 593, ISPED, Universite Victor Segalen, Bordeaux, France; ²Projet ANRS Ditrame Plus, Programme PACCI, Abidjan, Cote d'Ivoire; ³CeDReS, Programme PACCI, Abidjan, Cote d'Ivoire; ⁴Service de Gynecologie, CHU de Yopougon, Abidjan, Cote d'Ivoire; and ⁵Service de Pediatrie, CHU de Yopougon, Abidjan, Cote d'Ivoire

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 219
Antiviral Therapy 2003; 8(Suppl. 1):S236

[ABSTRACT:] Background: In Africa, short regimens of zidovudine (ZDV) or nevirapine (NVP) have demonstrated their efficacy for PMTCT with 6 week transmission rates of 14 and 12%, respectively. In the first part of the ANRS 1201 trial (March 2001–August 2002), the field efficacy of a short regimen of ZDV + peripartum NVP was demonstrated (6% transmission rate at 6 weeks).

Methods: An open-label non-randomized trial in Abidjan starting in September 2002. Consenting women with HIV infection start oral Combivir® [ZDV 300 mg + lamivudine (LAM) 150 mg bid] .32 weeks of gestation with an oral loading dose of 600 mg ZDV + 150 mg LAM + 200 mg NVP at beginning of labour. The maternel treatment (ZDV+LAM) continued 3 days postpartum. The neonate receives post-exposure prophylaxis for 1 week with ZDV syrup (2 mg/kg/6 h) + a single dose of NVP syrup (2 mg/kg) on day 3. Paediatric HIV infection is diagnosed when plasma HIV viral load is >5000 HIV RNA copies/ml (PCR) at 4 weeks, confirmed at 6 weeks. The reference groups are : 1) the ANRS 049 DITRAME cohort treated with a short regimen of ZDV (36 weeks in a randomized trial (Lancet. 1999 Dec 11;354(9195):2050-1) and in the subsequent open-label phase (AIDS. 2002 Mar 8;16(4):631-41); 2) and the first ANRS 1201 Ditrame Plus cohort treated with ZDV+NVP (CROI 2003).

Results: From September 2002 to February 2003, 209 HIV+ pregnant women have been included. Median age is 27 years (23–30), median CD4 count is 439/mm³ (14% <200/mm³). As of February 28, 139 women have delivered (137 live-births and 2 still-births). Among 99 children with 4–6 week follow-up, five have been diagnosed with HIV infection. The MTCT rate is 5.0% (95% CI: 1.7–11.4). All HIV-infected infants had in utero infection (RNA-positive day 7) and their mother had CD4 <500/mm³.

Conclusions: This preliminary analysis shows that the combination of ZDV+LAM+NVP prevents most peripartum transmission of HIV in Africa. Enrolment is ongoing to confirm efficacy and document safety.

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