Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial

摘要: Summary Background In 1999, we reported safety and efficacy data for short-course nevirapine from a Ugandan perinatal HIV-1 prevention trial when 496 babies were followed up to age 14–16 weeks. Safety are now presented all 18 months of age. Methods From November, 1997, April, infected pregnant women in Kampala, Uganda, randomly assigned (200 mg at labour onset 2 mg/kg within 72 h birth; regimen A) or zidovudine (600 orally 300 every 3 until delivery, 4 twice daily 7 days, B). Infant testing was done birth, 6–8 weeks, 12 by RNA PCR, antibody months. transmission HIV-1-free survival assessed using Kaplan-Meier analysis. We recorded adverse experiences through weeks postpartum mothers, babies. Efficacy analyses intention treat. Findings enrolled 645 mothers the study: 313 A, B, 19 placebo. Eight lost follow-up before delivery. 99% breastfed (median duration 9 months). Estimated risks groups 10·3% 8·1% birth (p=0·35); 20·0% 11·8% (p=0·0063); 22·1% 13·5% (p=0·0064); 25·8% 15·7% (p=0·0023). Nevirapine associated with 41% (95% CI 16–59) reduction relative risk Both regimens well-tolerated few serious side-effects. Interpretation Intrapartum/neonatal significantly lowered breastfeeding population Uganda compared short intrapartum/neonatal regimen. The absolute 8·2% sustained (10·1% [95% 3·5–16·6]). This simple, inexpensive, has potential decrease less-developed countries.