AEGiS-13IAC: 24-month efficacy of short-course maternal zidovudine for the prevention of mother-to-child HIV-1 transmission in a breast feeding population: A~pooled analysis of two randomized clinical trials in West Africa.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

24-month efficacy of short-course maternal zidovudine for the prevention of mother-to-child HIV-1 transmission in a breast feeding population: A~pooled analysis of two randomized clinical trials in West Africa.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. TuOrB354)

Wiktor SZ, Leroy V, Ekpini ER, Alioum A, Karon J, Msellati P, Hudgens M, Meda M, Greenberg AE
S. Z. Wiktor, Centers for Desease Control and Prevention, Atlanta, United States, Tel.: +404 639 6100, Fax: +404 639 4268, E-mail: szw0@cdc.gov

OBJECTIVE: To assess the 24-month efficacy of a short course of oral zidovudine (ZDV) administered in late pregnancy to prevent mother-to-child HIV-1 transmission in a breast feeding population in West Africa.

METHODS: Data were pooled from two clinical trials: DITRAME conducted in Abidjan, Cote d'Ivoire and Bobo-Dioulasso, Burkina-Faso and RETROCI conducted in Abidjan. From 9/1995 to 2/1998, consenting HIV-1 seropositive women were randomized at 36-38 weeks gestation to receive ZDV (300 mg) or placebo: 1 tablet twice daily until labor, then oral therapy until delivery, then 1 tablet twice daily for 7 days (DITRAME only). HIV infection in children was defined as a positive HIV-1 PCR, or if age > 15 months, a positive HIV serologic test. Postnatal transmission was defined as a negative HIV-1 PCR at age é 30 days followed by HIV infection as defined above. Proportions infected were estimated nonparametrically, with cessation of breast feeding as a competing risk.

RESULTS: Among 662 live-born children, 22 had no HIV test. Median breast feeding duration was 13.8 months, with 56.4% of children still breast fed at 12 months and 28.7% at 24 months (p = 0.9 ZDV vs placebo); 11 children were formula fed from birth. Cumulative transmission risks (CTR) were (n = cumulative HIV infections): Follow-up: 6 weeks 3 months 6 months 12 months 18 months 24 months n CTR n CTR n CTR n CTR n CTR n CTR ZDV (N = 318) 42 14.1 50 16.4 52 16.9 58 18.5 67 21.6 68 22.1 Placebo (N = 322) 68 23.2 78 25.3 82 26.1 88 28.5 94 30.1 94 30.1* * (Risk difference at 24 months = 8%, 95% CI = 2.0% to 15.4%). The postnatal transmission risk was 9.4% in the ZDV and 8.6% in the placebo group among the 494 children at risk (95% CI for the difference, -4.6% to 5.5%).

CONCLUSION: In a breast feeding population, an oral short-course ZDV regimen significantly reduces overall mother-to-child HIV-1 transmission at 24 months of age. The high risk of postnatal transmission, which was similar for the ZDV and placebo groups, highlights the importance of identifying interventions to prevent this route of transmission.

Keywords: AEGIS, Zidovudine, HIV-1, Breast Feeding, HIV Infections, Mothers, Randomized Controlled Trials, HIV Seropositivity, Double-Blind Method, Population, Research, Africa, Cote d'Ivoire, Burkina Faso, Child, Human, Female, Pregnancy, transmission, prevention & control
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TuOrB354