Postexposure prophylaxis of breastfeeding HIV-Exposed Infants with Antiretroviral Drugs to Age 14 Weeks: Updated efficacy results of the PEPI-Malawi Trial

Taha E Taha, Qing Li, Donald R. Hoover, Linda Mipando, Kondwani Nkanaunena, Michael C. Thigpen, Allan Taylor, Johnstone Kumwenda, Mary Glenn Fowler, Lynne M. Mofenson, Newton I. Kumwenda

Research output: Contribution to journalArticle

Abstract

Background: This analysis updates and extends efficacy estimates of the PEPI-Malawi trial through age 24 months at study completion in September 2009. Methods: Infants of breastfeeding HIV-infected women were randomized at birth to the following: (1) single-dose nevirapine (NVP) + 1-week zidovudine (ZDV) (control); (2) control + extended daily NVP (ExtNVP) through 14 weeks; (3) control + extended daily NVP + ZDV (ExtNVP/ZDV) through 14 weeks. We estimated rates of HIV infection, death and HIV infection, or death using Kaplan-Meier analysis. Results: This analysis includes 3126 infants uninfected at birth as follows: 1004 control, 1071 ExtNVP, and 1051 ExtNVP/ZDV. By 9 months, HIV infection rates were 5.0% in ExtNVP, 6.0% in ExtNVP/ZDV, and 11.1% in control (P <0.001 comparing extended regimens with control). At age 24 months, HIV infection rates had risen to ∼11% in the extended arms compared with 15.6% in the controls (P <0.05). The rates of HIV infection or death were also significantly lower in extended arms. There were no differences in severe adverse events with the exception of higher possibly related events in the ExtNVP/ZDV arm. Conclusions: Daily infant antiretroviral prophylaxis reduces postnatal HIV infection by ∼70% during the period of prophylaxis. But continued HIV transmission after prophylaxis stops suggests more prolonged infant prophylaxis is needed.

Original languageEnglish (US)
Pages (from-to)319-325
Number of pages7
JournalJournal of Acquired Immune Deficiency Syndromes
Volume57
Issue number4
DOIs
StatePublished - Aug 1 2011

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Malawi
Breast Feeding
Zidovudine
HIV Infections
HIV
Nevirapine
Pharmaceutical Preparations
Parturition
Kaplan-Meier Estimate

Keywords

  • breastfeeding
  • infant postexposure prophylaxis
  • motherto- child transmission of HIV
  • PEPI-Malawi

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

Postexposure prophylaxis of breastfeeding HIV-Exposed Infants with Antiretroviral Drugs to Age 14 Weeks : Updated efficacy results of the PEPI-Malawi Trial. / Taha, Taha E; Li, Qing; Hoover, Donald R.; Mipando, Linda; Nkanaunena, Kondwani; Thigpen, Michael C.; Taylor, Allan; Kumwenda, Johnstone; Fowler, Mary Glenn; Mofenson, Lynne M.; Kumwenda, Newton I.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 57, No. 4, 01.08.2011, p. 319-325.

Research output: Contribution to journalArticle

Taha, Taha E ; Li, Qing ; Hoover, Donald R. ; Mipando, Linda ; Nkanaunena, Kondwani ; Thigpen, Michael C. ; Taylor, Allan ; Kumwenda, Johnstone ; Fowler, Mary Glenn ; Mofenson, Lynne M. ; Kumwenda, Newton I. / Postexposure prophylaxis of breastfeeding HIV-Exposed Infants with Antiretroviral Drugs to Age 14 Weeks : Updated efficacy results of the PEPI-Malawi Trial. In: Journal of Acquired Immune Deficiency Syndromes. 2011 ; Vol. 57, No. 4. pp. 319-325.
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abstract = "Background: This analysis updates and extends efficacy estimates of the PEPI-Malawi trial through age 24 months at study completion in September 2009. Methods: Infants of breastfeeding HIV-infected women were randomized at birth to the following: (1) single-dose nevirapine (NVP) + 1-week zidovudine (ZDV) (control); (2) control + extended daily NVP (ExtNVP) through 14 weeks; (3) control + extended daily NVP + ZDV (ExtNVP/ZDV) through 14 weeks. We estimated rates of HIV infection, death and HIV infection, or death using Kaplan-Meier analysis. Results: This analysis includes 3126 infants uninfected at birth as follows: 1004 control, 1071 ExtNVP, and 1051 ExtNVP/ZDV. By 9 months, HIV infection rates were 5.0{\%} in ExtNVP, 6.0{\%} in ExtNVP/ZDV, and 11.1{\%} in control (P <0.001 comparing extended regimens with control). At age 24 months, HIV infection rates had risen to ∼11{\%} in the extended arms compared with 15.6{\%} in the controls (P <0.05). The rates of HIV infection or death were also significantly lower in extended arms. There were no differences in severe adverse events with the exception of higher possibly related events in the ExtNVP/ZDV arm. Conclusions: Daily infant antiretroviral prophylaxis reduces postnatal HIV infection by ∼70{\%} during the period of prophylaxis. But continued HIV transmission after prophylaxis stops suggests more prolonged infant prophylaxis is needed.",
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T1 - Postexposure prophylaxis of breastfeeding HIV-Exposed Infants with Antiretroviral Drugs to Age 14 Weeks

T2 - Updated efficacy results of the PEPI-Malawi Trial

AU - Taha, Taha E

AU - Li, Qing

AU - Hoover, Donald R.

AU - Mipando, Linda

AU - Nkanaunena, Kondwani

AU - Thigpen, Michael C.

AU - Taylor, Allan

AU - Kumwenda, Johnstone

AU - Fowler, Mary Glenn

AU - Mofenson, Lynne M.

AU - Kumwenda, Newton I.

PY - 2011/8/1

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N2 - Background: This analysis updates and extends efficacy estimates of the PEPI-Malawi trial through age 24 months at study completion in September 2009. Methods: Infants of breastfeeding HIV-infected women were randomized at birth to the following: (1) single-dose nevirapine (NVP) + 1-week zidovudine (ZDV) (control); (2) control + extended daily NVP (ExtNVP) through 14 weeks; (3) control + extended daily NVP + ZDV (ExtNVP/ZDV) through 14 weeks. We estimated rates of HIV infection, death and HIV infection, or death using Kaplan-Meier analysis. Results: This analysis includes 3126 infants uninfected at birth as follows: 1004 control, 1071 ExtNVP, and 1051 ExtNVP/ZDV. By 9 months, HIV infection rates were 5.0% in ExtNVP, 6.0% in ExtNVP/ZDV, and 11.1% in control (P <0.001 comparing extended regimens with control). At age 24 months, HIV infection rates had risen to ∼11% in the extended arms compared with 15.6% in the controls (P <0.05). The rates of HIV infection or death were also significantly lower in extended arms. There were no differences in severe adverse events with the exception of higher possibly related events in the ExtNVP/ZDV arm. Conclusions: Daily infant antiretroviral prophylaxis reduces postnatal HIV infection by ∼70% during the period of prophylaxis. But continued HIV transmission after prophylaxis stops suggests more prolonged infant prophylaxis is needed.

AB - Background: This analysis updates and extends efficacy estimates of the PEPI-Malawi trial through age 24 months at study completion in September 2009. Methods: Infants of breastfeeding HIV-infected women were randomized at birth to the following: (1) single-dose nevirapine (NVP) + 1-week zidovudine (ZDV) (control); (2) control + extended daily NVP (ExtNVP) through 14 weeks; (3) control + extended daily NVP + ZDV (ExtNVP/ZDV) through 14 weeks. We estimated rates of HIV infection, death and HIV infection, or death using Kaplan-Meier analysis. Results: This analysis includes 3126 infants uninfected at birth as follows: 1004 control, 1071 ExtNVP, and 1051 ExtNVP/ZDV. By 9 months, HIV infection rates were 5.0% in ExtNVP, 6.0% in ExtNVP/ZDV, and 11.1% in control (P <0.001 comparing extended regimens with control). At age 24 months, HIV infection rates had risen to ∼11% in the extended arms compared with 15.6% in the controls (P <0.05). The rates of HIV infection or death were also significantly lower in extended arms. There were no differences in severe adverse events with the exception of higher possibly related events in the ExtNVP/ZDV arm. Conclusions: Daily infant antiretroviral prophylaxis reduces postnatal HIV infection by ∼70% during the period of prophylaxis. But continued HIV transmission after prophylaxis stops suggests more prolonged infant prophylaxis is needed.

KW - breastfeeding

KW - infant postexposure prophylaxis

KW - motherto- child transmission of HIV

KW - PEPI-Malawi

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