Journal article
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 (British edition), Vol.362(9387), pp.859-868
09/13/2003
DOI: 10.1016/S0140-6736(03)14341-3
PMID: 13678973
Abstract
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 and efficacy data are now presented for all babies followed up to 18 months of age.
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.
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.
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, well-tolerated regimen has the potential to significantly decrease HIV-1 perinatal transmission in less-developed countries.
Details
- Title: Subtitle
- 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
- Creators
- J Brooks Jackson - Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USAPhilippa Musoke - Department of Paediatrics, Makerere University, Kampala, UgandaThomas Fleming - Department of Biostatistics, University of Washington, Seattle, WA, USALaura A Guay - Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USADanstan Bagenda - Department of Obstetrics and Gynaecology, Makerere University, KampalaMelissa Allen - Family Health International, Durham, NC, USAClemensia Nakabiito - Department of Obstetrics and Gynaecology, Makerere University, KampalaJoseph Sherman - Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USAPaul Bakaki - Department of Paediatrics, Makerere University, Kampala, UgandaMaxensia Owor - Department of Paediatrics, Makerere University, Kampala, UgandaConstance Ducar - Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USAMartina Deseyve - Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WAAnthony Mwatha - Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WALynda Emel - Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WACorey Duefield - Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USAMark Mirochnick - Department of Pediatrics, Boston University, Boston, MA, USAMary Glenn Fowler - Division of AIDS, NIAID/NIH, Bethesda, MDLynne Mofenson - Pediatric, Adolescent, and Maternal AIDS Branch, NICHD/NIH, Bethesda, MDPaolo Miotti - Division of AIDS, NIAID/NIH, Bethesda, MDMaria Gigliotti - Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USADorothy Bray - GlaxoWellcome, London, UKFrancis Mmiro - Department of Obstetrics and Gynaecology, Makerere University, Kampala
- Resource Type
- Journal article
- Publication Details
- The Lancet (British edition), Vol.362(9387), pp.859-868
- Publisher
- Elsevier Ltd
- DOI
- 10.1016/S0140-6736(03)14341-3
- PMID
- 13678973
- ISSN
- 0140-6736
- eISSN
- 1474-547X
- Language
- English
- Date published
- 09/13/2003
- Academic Unit
- Pathology; VPMA - Administration
- Record Identifier
- 9984046906602771
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