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Field efficacy of zidovudine, lamivudine and single-dose nevirapine to prevent peripartum HIV transmission

ANRS 1201/1202 DITRAME PLUS Study Groupa,b,c,d,e,

Epidemiology and Social

Objectives: In Africa, single-dose nevirapine (NVPsd), short regimens of zidovudine (ZDV) or ZDV + lamivudine (3TC) are recommended to prevent peripartum mother-to-child HIV transmission (PMTCT). We evaluated the 6-week field efficacy of two more PMTCT drug combinations.

Design: An open-label intervention cohort in Abidjan.

Methods: In 2001–2002, consenting women started oral ZDV 300 mg twice daily (bid) at ≥36 weeks of gestation, with 600 mg of ZDV + 200 mg NVPsd orally at beginning of labour. In 2002–2003, the antepartum regimen at ≥32 weeks comprised ZDV as previously + 3TC 150 mg bid; the labour dose comprised ZDV + NVPsd as previously + 300 mg 3TC orally. Neonates received ZDV syrup (2 mg/kg per 6 h) for 7 days + NVPsd syrup (2 mg/kg) on day 2 in both periods. Each woman was assisted to either use breast milk substitutes or breastfeed exclusively. Paediatric HIV infection was diagnosed by plasma HIV RNA viral load at 4 weeks, confirmed at 6 weeks. The reference group was a cohort receiving a short regimen of ZDV ≥ 36–38 weeks in 1995–2000 in the same population.

Results: A total of 1144 HIV-infected pregnant women were included: 351 with ZDV, 420 with ZDV + NVPsd and 373 with ZDV + 3TC + NVPsd; 1010 livebirths were eligible for analysis; 79 children were HIV-infected peripartum. Six-week transmission probability was 6.5% [95% confidence interval (CI), 3.9–9.1%) with ZDV + NVPsd, a 72% reduction compared with ZDV alone (95% CI, 52–88%; P = 0.0002 adjusted on maternal CD4, clinical stage and breastfeeding). It was 4.7% (95% CI, 2.4–7.0%) with ZDV + 3TC + NVPsd (P = 0.34 compared with ZDV + NVPsd).

Conclusions: A short-course of ZDV + NVPsd prevents most peripartum HIV transmission in Africa. This regimen could be added to international guidelines.

From the aUnité INSERM 593, Institut de Santé Publique, Epidémiologie et Développement (ISPED), Université Victor Segalen, Bordeaux, France

bProgramme PACCI, Centre Hospitalier Universitaire (CHU) de Treichville, Abidjan

cCentre de Diagnostic et de Recherches sur le SIDA (CeDReS), CHU de Treichville, Abidjan

dCHU de Yopougon, Abidjan, Côte d’Ivoire

eLaboratoire de Virologie Médicale, CHU Necker Enfants Malades, Paris, France.

*See Appendix.

Received 12 July, 2004

Revised 3 December, 2004

Accepted 14 December, 2004

Correspondence to Pr François Dabis, INSERM U.593, ISPED, Université Victor Segalen, 146 Rue Léo Saignat, 33076 Bordeaux Cedex, France. E-mail: francois.dabis@isped.u-bordeaux2.fr

© 2005 Lippincott Williams & Wilkins, Inc.