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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 MBBS, PhD*; Li, Qing PhD; Hoover, Donald R PhD, MPH; Mipando, Linda MN-CH§; Nkanaunena, Kondwani MSc§; Thigpen, Michael C MD; Taylor, Allan MD, MPH; Kumwenda, Johnstone FRCP; Fowler, Mary Glenn MD#; Mofenson, Lynne M MD**; Kumwenda, Newton I PhD, MPH*

JAIDS Journal of Acquired Immune Deficiency Syndromes: August 1st, 2011 - Volume 57 - Issue 4 - p 319-325
doi: 10.1097/QAI.0b013e318217877a
Epidemiology and Prevention

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.

From the *Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD; †Inherited Disease Branch, National Human Genome Research Institute, National Institutes of Health, Baltimore, MD; ‡Department of Statistics and biostatistics and Institute for Health, Health Care Policy and Aging Research, Rutgers University, Piscataway, NJ; §Center for Research for Mothers and Children, College of Medicine-Johns Hopkins University Research Project, Blantyre, Malawi; ‖Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA; ¶Department of Internal Medicine, College of Medicine, University of Malawi, Blantyre, Malawi; #Johns Hopkins University School of Medicine, Baltimore, MD; and **Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.

Received for publication December 14, 2010; accepted February 18, 2011.

Supported by a Cooperative Agreement (# 5 U50 PS022061-05; Award # U50/CC0222061) from the Centers for Disease Control and Prevention and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health. Qing Li was supported in part by the Intramural Research Program of the National Human Genome Research Institute, National Institutes of Health.

Presented in part at the XVIII International AIDS Conference; Vienna, Austria; July 18-23, 2010. Abstract # THPE0161; and at the 2nd International Workshop on HIV Pediatrics; Vienna, Austria; July 16-17, 2010. Abstract # O_04.

The findings and conclusions in this article are those of the authors and do not necessarily represent the views of the US Centers for Disease Control and Prevention or the National Institutes of Health. Use of trade names is for identification purposes only and does not constitute endorsement by the US Centers for Disease Control and Prevention, National Institutes of Health, or the Department of Health and Human Services.

Clinical Trial Registration number: NCT00115648.

Correspondences to: Dr Taha E. Taha, MBBS, PhD, Rm E7138, Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, 615 N. Wolfe Street, Baltimore, MD 21205 (e-mail ttaha@jhsph.edu).

© 2011 Lippincott Williams & Wilkins, Inc.