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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.
Lancet. 2003 Sep 13; 362(9387):859-68.Lct

Abstract

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 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 2mg/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, regimenB). 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, well-tolerated regimen has the potential to significantly decrease HIV-1 perinatal transmission in less-developed countries.

Authors+Show Affiliations

Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA. bjackso@jhmi.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

13678973

Citation

Jackson, J Brooks, et al. "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." Lancet (London, England), vol. 362, no. 9387, 2003, pp. 859-68.
Jackson JB, Musoke P, Fleming T, et al. 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. Lancet. 2003;362(9387):859-68.
Jackson, J. B., Musoke, P., Fleming, T., Guay, L. A., Bagenda, D., Allen, M., Nakabiito, C., Sherman, J., Bakaki, P., Owor, M., Ducar, C., Deseyve, M., Mwatha, A., Emel, L., Duefield, C., Mirochnick, M., Fowler, M. G., Mofenson, L., Miotti, P., ... 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. Lancet (London, England), 362(9387), 859-68.
Jackson JB, et al. 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. Lancet. 2003 Sep 13;362(9387):859-68. PubMed PMID: 13678973.
* Article titles in AMA citation format should be in sentence-case
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: 18-month follow-up of the HIVNET 012 randomised trial. AU - Jackson,J Brooks, AU - Musoke,Philippa, AU - Fleming,Thomas, AU - Guay,Laura A, AU - Bagenda,Danstan, AU - Allen,Melissa, AU - Nakabiito,Clemensia, AU - Sherman,Joseph, AU - Bakaki,Paul, AU - Owor,Maxensia, AU - Ducar,Constance, AU - Deseyve,Martina, AU - Mwatha,Anthony, AU - Emel,Lynda, AU - Duefield,Corey, AU - Mirochnick,Mark, AU - Fowler,Mary Glenn, AU - Mofenson,Lynne, AU - Miotti,Paolo, AU - Gigliotti,Maria, AU - Bray,Dorothy, AU - Mmiro,Francis, PY - 2003/9/19/pubmed PY - 2003/11/5/medline PY - 2003/9/19/entrez SP - 859 EP - 68 JF - Lancet (London, England) JO - Lancet VL - 362 IS - 9387 N2 - 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 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 2mg/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, regimenB). 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, well-tolerated regimen has the potential to significantly decrease HIV-1 perinatal transmission in less-developed countries. SN - 1474-547X UR - https://www.unboundmedicine.com/medline/citation/13678973/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(03)14341-3 DB - PRIME DP - Unbound Medicine ER -