AEGiS-13IAC: The SAINT trial: nevirapine (NVP) versus zidovudine (ZDV)+lamivudine (3TC) in prevention of peripartum HIV transmission.

13th International AIDS Conference

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

The SAINT trial: nevirapine (NVP) versus zidovudine (ZDV)+lamivudine (3TC) in prevention of peripartum HIV transmission.

Int Conf AIDS 2000 Jul 9-14; 13:16 (abstract no.. LbOr2)

Moodley D
University of Natal Medical School, Congella, South Africa. Fax: +27-31-260-4241, E-mail: moodley j@med.und.ac.za.

BACKGROUND: Two short course anti-retroviral regimens, previously demonstrated to effectively prevent mother-to-child transmission (MTCT) of HIV-1 within 6 weeks of birth, were compared in a randomised open-label trial conducted in South Africa.

METHODS: There were 1306 HIV-1 infected pregnant women assigned to one of two arms: (Arm A) 200 mg of NVP during labour and 1 dose to mother and infant 24-48 hours post-delivery; OR (Arm B) multiple doses ZDV+3TC during labour and for 1 week to mother and infant post delivery. HIV-1 status of the infant was determined at birth (0-2 days) and at subsequent visits at 4 weeks and 6-12 weeks using the DNA (Roche Amplicor) assay. HIV-1 status at birth was confirmed using the RNA (Roche Amplicor) assay. The primary analysis focused ont he incidence of peripartum infections, defined as infection intrapartum and post-partum up to 10 weeks, confirmed at two consecutive visits. Intrauterine infections, neonatal deaths, and infants lost to follow-up were excluded from the primary analysis, but used in Kaplan-Meier estimates of all perinatal HIV infections.

RESULTS: Intrauterine infection rates were 7.1% (46/652) for NVP and 5.9% (38/649) for ZDV/3TC. Peripartum infection rates were 5.6% and 3.6% for NVP and ZDV/3TC respectively. There were 9 (1.4%) perinatal deaths in the NVP arm and 17 (2.6%) in the ZDV/3TC arm. MTCT rates by Kaplan-Meier estimates were 12.7% and 9.5% for NVP and ZDV/3TC arms respectively. There were no significant differences between arms (p>0.10).

CONCLUSIONS: Both regimens were effective, with results comparable to those observed with NVP in HIVNET 012 and with ZDV/3TC in PETRA Arm B. Compared to current south African MTCT rates in excess of 20%, both the simple NVP regimen and the more involved and expensive ZDV/3TC regimen demonstrated comparable efficacy in prevention of mother-to-child transmission of HIV-1 in the peripartum period.

Keywords: AEGIS, Zidovudine, Nevirapine, Lamivudine, HIV Infections, HIV-1, HIV Seropositivity, South Africa, Child, Human, Infant, Pregnancy, Female, transmission, prevention & control, AIDS
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