TY - JOUR
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
Y1 - 2011/8/1
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 - PEPI-Malawi
KW - breastfeeding
KW - infant postexposure prophylaxis
KW - motherto- child transmission of HIV
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U2 - 10.1097/QAI.0b013e318217877a
DO - 10.1097/QAI.0b013e318217877a
M3 - Article
C2 - 21423025
AN - SCOPUS:79959929512
SN - 1525-4135
VL - 57
SP - 319
EP - 325
JO - Journal of Acquired Immune Deficiency Syndromes
JF - Journal of Acquired Immune Deficiency Syndromes
IS - 4
ER -