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

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dc.contributor.authorJackson, J. Brooks
dc.contributor.authorMusoke, Philippa
dc.contributor.authorFleming, Thomas
dc.contributor.authorGuay, Laura A.
dc.contributor.authorBagenda, Danstan
dc.contributor.authorAllen, Melissa
dc.contributor.authorNakabiito, Clemensia
dc.contributor.authorSherman, Joseph
dc.contributor.authorBakaki, Paul
dc.contributor.authorOwor, Maxensia
dc.contributor.authorDucar, Constance
dc.contributor.authorDeseyve, Martina
dc.contributor.authorMwatha, Anthony
dc.contributor.authorEmel, Lynda
dc.contributor.authorDuefield, Corey
dc.contributor.authorMirochnick, Mark
dc.contributor.authorGlenn Fowler, Mary
dc.contributor.authorMofenson, Lynne
dc.contributor.authorMiotti, Paolo
dc.contributor.authorGigliotti, Maria
dc.contributor.authorBray, Dorothy
dc.contributor.authorMmiro, Francis
dc.date.accessioned2022-03-08T10:10:17Z
dc.date.available2022-03-08T10:10:17Z
dc.date.issued2003
dc.description.abstractIn 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 and efficacy data are now presented for all babies followed up to 18 months of age. Methods From November, 1997, to April, 1999, HIV-1 infected pregnant women in Kampala, Uganda, were randomly assigned nevirapine (200 mg at labour onset and 2 mg/kg for babies within 72 h of birth; regimen A) or zidovudine (600 mg orally at labour onset and 300 mg every 3 h until delivery, and 4 mg/kg orally twice daily for babies for 7 days, regimen B). Infant HIV-1 testing was done at birth, age 6–8 and 14–16 weeks, and age 12 months by HIV-1 RNA PCR, and by HIV-1 antibody at 18 months. HIV-1 transmission and HIV-1-free survival were assessed using Kaplan-Meier analysis. We recorded adverse experiences through 6–8 weeks postpartum for mothers, and 18 months for babies. Efficacy analyses were by intention to treat. Findings We enrolled 645 mothers to the study: 313 were assigned regimen A, 313 regimen B, and 19 placebo. Eight mothers were lost to follow-up before delivery. 99% of babies were breastfed (median duration 9 months). Estimated risks of HIV-1 transmission in the zidovudine and nevirapine groups were 10·3% and 8·1% at birth (p=0·35); 20·0% and 11·8% by age 6–8 weeks (p=0·0063); 22·1% and 13·5% by age 14–16 weeks (p=0·0064); and 25·8% and 15·7% by age 18 months (p=0·0023). Nevirapine was associated with a 41% (95% CI 16–59) reduction in relative risk of transmission through to age 18 months. Both regimens were well-tolerated with few serious side-effects. Interpretation Intrapartum/neonatal nevirapine significantly lowered HIV-1 transmission risk in a breastfeeding population in Uganda compared with a short intrapartum/neonatal zidovudine regimen. The absolute 8·2% reduction in transmission at 6–8 weeks was sustained at age 18 months (10·1% [95% CI 3·5–16·6]). This simple, inexpensive, welltolerated regimen has the potential to significantly decrease HIV-1 perinatal transmission in less-developed countries.en_US
dc.identifier.citationJackson, J. B., Musoke, P., Fleming, T., Guay, L. A., Bagenda, D., Allen, M., ... & Mmiro, F. (2003). 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. The Lancet, 362(9387), 859-868.en_US
dc.identifier.urihttps://www.sciencedirect.com/science/article/pii/S0140673603143413
dc.identifier.urihttps://nru.uncst.go.ug/xmlui/handle/123456789/2548
dc.language.isoenen_US
dc.publisherThe Lanceten_US
dc.subjectIntrapartumen_US
dc.subjectNeonatal single-dose nevirapineen_US
dc.subjectZidovudineen_US
dc.subjectMother-to-child transmission of HIV-1en_US
dc.subjectHIVNET 012en_US
dc.titleIntrapartum 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 trialen_US
dc.typeArticleen_US
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