TY - JOUR
T1 - Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda
T2 - HIVNET 012 randomised trial
AU - Guay, Laura A.
AU - Musoke, Philippa
AU - Fleming, Thomas
AU - Bagenda, Danstan
AU - Allen, Melissa
AU - Nakabiito, Clemensia
AU - Sherman, Joseph
AU - Bakaki, Paul
AU - Ducar, Constance
AU - Deseyve, Martina
AU - Emel, Lynda
AU - Mirochnick, Mark
AU - Fowler, Mary Glenn
AU - Mofenson, Lynne
AU - Miotti, Paolo
AU - Dransfield, Kevin
AU - Bray, Dorothy
AU - Mmiro, Francis
AU - Jackson, J. Brooks
PY - 1999/9/4
Y1 - 1999/9/4
N2 - Background. The AIDS Clinical Trials Group protocol 076 zidovudine prophylaxis regimen for HIV-1-infected pregnant women and their babies has been associated with a significant decrease in vertical HIV-1 transmission in non-breastfeeding women in developed countries. We compared the safety and efficacy of short-course nevirapine or zidovudine during labour and the first week of life. Methods. From November, 1997, to April, 1999, we enrolled 626 HIV-1-infected pregnant women at Mulago Hospital in Kampala, Uganda. We randomly assigned mothers nevirapine 200 mg orally at onset of labour and 2 mg/kg to babies within 72 h of birth, or zidovudine 600 mg orally to the mother at onset of labour and 300 mg every 3 h until delivery, and 4 mg/kg orally twice daily to babies for 7 days after birth. We tested babies for HIV-1 infection at birth, 6-8 weeks, and 14-16 weeks by HIV-1 RNA PCR. We assessed HIV-1 transmission and HIV-1-free survival with Kaplan-Meier analysis. Findings. Nearly all babies (98.8%) were breastfed, and 95.6% were still breastfeeding at age 14-16 weeks. The estimated risks of HIV-1 transmission in the zidovudine and nevirapine groups were: 10.4% and 8.2% at birth (p = 0.354); 21.3% and 11.9% by age 6-8 weeks (p = 0.0027); and 25.1% and 13.1% by age 14-16 weeks (p = 0.0006). The efficacy of nevirapine compared with zidovudine was 47% (95% CI 20-64) up to age 14-16 weeks. The two regimens were well tolerated and adverse events were similar in the two groups. Interpretation. Nevirapine lowered the risk of HIV-1 transmission during the first 14-16 weeks of life by nearly 50% in a breastfeeding population. This simple and inexpensive regimen could decrease mother-to-child HIV-1 transmission in less-developed countries.
AB - Background. The AIDS Clinical Trials Group protocol 076 zidovudine prophylaxis regimen for HIV-1-infected pregnant women and their babies has been associated with a significant decrease in vertical HIV-1 transmission in non-breastfeeding women in developed countries. We compared the safety and efficacy of short-course nevirapine or zidovudine during labour and the first week of life. Methods. From November, 1997, to April, 1999, we enrolled 626 HIV-1-infected pregnant women at Mulago Hospital in Kampala, Uganda. We randomly assigned mothers nevirapine 200 mg orally at onset of labour and 2 mg/kg to babies within 72 h of birth, or zidovudine 600 mg orally to the mother at onset of labour and 300 mg every 3 h until delivery, and 4 mg/kg orally twice daily to babies for 7 days after birth. We tested babies for HIV-1 infection at birth, 6-8 weeks, and 14-16 weeks by HIV-1 RNA PCR. We assessed HIV-1 transmission and HIV-1-free survival with Kaplan-Meier analysis. Findings. Nearly all babies (98.8%) were breastfed, and 95.6% were still breastfeeding at age 14-16 weeks. The estimated risks of HIV-1 transmission in the zidovudine and nevirapine groups were: 10.4% and 8.2% at birth (p = 0.354); 21.3% and 11.9% by age 6-8 weeks (p = 0.0027); and 25.1% and 13.1% by age 14-16 weeks (p = 0.0006). The efficacy of nevirapine compared with zidovudine was 47% (95% CI 20-64) up to age 14-16 weeks. The two regimens were well tolerated and adverse events were similar in the two groups. Interpretation. Nevirapine lowered the risk of HIV-1 transmission during the first 14-16 weeks of life by nearly 50% in a breastfeeding population. This simple and inexpensive regimen could decrease mother-to-child HIV-1 transmission in less-developed countries.
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U2 - 10.1016/S0140-6736(99)80008-7
DO - 10.1016/S0140-6736(99)80008-7
M3 - Article
C2 - 10485720
AN - SCOPUS:0033523454
VL - 354
SP - 795
EP - 802
JO - The Lancet
JF - The Lancet
SN - 0140-6736
IS - 9181
ER -