Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission

Michael G. Hudgens, Taha E Taha, Saad B. Omer, Denise J. Jamieson, Hana Lee, Lynne M. Mofenson, Charles Chasela, Athena P. Kourtis, Newton Kumwenda, Andrea J Ruff, Abubaker Bedri, J. Brooks Jackson, Philippa Musoke, Robert C Bollinger, Nikhil Gupte, Michael C. Thigpen, Allan Taylor, Charles Van Der Horst

Research output: Contribution to journalArticle

Abstract

Background. In resource-limited settings, mothers infected with human immunodeficiency virus type 1 (HIV-1) face a difficult choice: breastfeed their infants but risk transmitting HIV-1 or not breastfeed their infants and risk the infants dying of other infectious diseases or malnutrition. Recent results from observational studies and randomized clinical trials indicate daily administration of nevirapine to the infant can prevent breast-milk HIV-1 transmission.Methods. Data from 5396 mother-infant pairs who participated in 5 randomized trials where the infant was HIV-1 negative at birth were pooled to estimate the efficacy of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission. Four daily regimens were compared: nevirapine for 6 weeks, 14 weeks, or 28 weeks, or nevirapine plus zidovudine for 14 weeks.Results. The estimated 28-week risk of HIV-1 transmission was 5.8% (95% confidence interval [CI], 4.3%-7.9%) for the 6-week nevirapine regimen, 3.7% (95% CI, 2.5%-5.4%) for the 14-week nevirapine regimen, 4.8% (95% CI, 3.5%-6.7%) for the 14-week nevirapine plus zidovudine regimen, and 1.8% (95% CI, 1.0%-3.1%) for the 28-week nevirapine regimen (log-rank test for trend, P

Original languageEnglish (US)
Pages (from-to)131-139
Number of pages9
JournalClinical Infectious Diseases
Volume56
Issue number1
DOIs
StatePublished - 2013

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Nevirapine
Human Milk
HIV-1
Confidence Intervals
Zidovudine
Mothers
Malnutrition
Observational Studies
Communicable Diseases
Randomized Controlled Trials
Parturition

Keywords

  • breast milk
  • HIV
  • nevirapine

ASJC Scopus subject areas

  • Infectious Diseases
  • Microbiology (medical)

Cite this

Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission. / Hudgens, Michael G.; Taha, Taha E; Omer, Saad B.; Jamieson, Denise J.; Lee, Hana; Mofenson, Lynne M.; Chasela, Charles; Kourtis, Athena P.; Kumwenda, Newton; Ruff, Andrea J; Bedri, Abubaker; Jackson, J. Brooks; Musoke, Philippa; Bollinger, Robert C; Gupte, Nikhil; Thigpen, Michael C.; Taylor, Allan; Van Der Horst, Charles.

In: Clinical Infectious Diseases, Vol. 56, No. 1, 2013, p. 131-139.

Research output: Contribution to journalArticle

Hudgens, MG, Taha, TE, Omer, SB, Jamieson, DJ, Lee, H, Mofenson, LM, Chasela, C, Kourtis, AP, Kumwenda, N, Ruff, AJ, Bedri, A, Jackson, JB, Musoke, P, Bollinger, RC, Gupte, N, Thigpen, MC, Taylor, A & Van Der Horst, C 2013, 'Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission', Clinical Infectious Diseases, vol. 56, no. 1, pp. 131-139. https://doi.org/10.1093/cid/cis808
Hudgens, Michael G. ; Taha, Taha E ; Omer, Saad B. ; Jamieson, Denise J. ; Lee, Hana ; Mofenson, Lynne M. ; Chasela, Charles ; Kourtis, Athena P. ; Kumwenda, Newton ; Ruff, Andrea J ; Bedri, Abubaker ; Jackson, J. Brooks ; Musoke, Philippa ; Bollinger, Robert C ; Gupte, Nikhil ; Thigpen, Michael C. ; Taylor, Allan ; Van Der Horst, Charles. / Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission. In: Clinical Infectious Diseases. 2013 ; Vol. 56, No. 1. pp. 131-139.
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AU - Taha, Taha E

AU - Omer, Saad B.

AU - Jamieson, Denise J.

AU - Lee, Hana

AU - Mofenson, Lynne M.

AU - Chasela, Charles

AU - Kourtis, Athena P.

AU - Kumwenda, Newton

AU - Ruff, Andrea J

AU - Bedri, Abubaker

AU - Jackson, J. Brooks

AU - Musoke, Philippa

AU - Bollinger, Robert C

AU - Gupte, Nikhil

AU - Thigpen, Michael C.

AU - Taylor, Allan

AU - Van Der Horst, Charles

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N2 - Background. In resource-limited settings, mothers infected with human immunodeficiency virus type 1 (HIV-1) face a difficult choice: breastfeed their infants but risk transmitting HIV-1 or not breastfeed their infants and risk the infants dying of other infectious diseases or malnutrition. Recent results from observational studies and randomized clinical trials indicate daily administration of nevirapine to the infant can prevent breast-milk HIV-1 transmission.Methods. Data from 5396 mother-infant pairs who participated in 5 randomized trials where the infant was HIV-1 negative at birth were pooled to estimate the efficacy of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission. Four daily regimens were compared: nevirapine for 6 weeks, 14 weeks, or 28 weeks, or nevirapine plus zidovudine for 14 weeks.Results. The estimated 28-week risk of HIV-1 transmission was 5.8% (95% confidence interval [CI], 4.3%-7.9%) for the 6-week nevirapine regimen, 3.7% (95% CI, 2.5%-5.4%) for the 14-week nevirapine regimen, 4.8% (95% CI, 3.5%-6.7%) for the 14-week nevirapine plus zidovudine regimen, and 1.8% (95% CI, 1.0%-3.1%) for the 28-week nevirapine regimen (log-rank test for trend, P

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