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Rash, Hepatotoxicity and Hyperbilirubinemia Among Kenyan Infants Born to HIV-infected Women Receiving Triple-antiretroviral Drugs for the Prevention of Mother-to-child HIV Transmission

Minniear, Timothy D. MD*†; Zeh, Clement PhD†‡; Polle, Nicholas PhD§; Masaba, Rose MD; Peters, Philip J. MD; Oyaro, Boaz BS; Akoth, Benta MD; Ndivo, Richard MD; Angira, Frank MD; Mills, Lisa A. MD†‡; Thomas, Timothy K. MD†‡

The Pediatric Infectious Disease Journal: November 2012 - Volume 31 - Issue 11 - p 1155–1157
doi: 10.1097/INF.0b013e318267ef6a
HIV Reports

We compared adverse events among breast-feeding neonates born to Kenyan mothers receiving triple-antiretroviral therapy, including either nevirapine or nelfinavir. Nevirapine-exposed infants had an absolute increase in the risk of rash but no significant risk differences for hepatotoxicity or high-risk hyperbilirubinemia compared with nelfinavir-exposed infants. From an infant-safety perspective, nevirapine-based regimens given during pregnancy and breast-feeding are viable options where alternatives to breast milk are not safe, affordable or feasible.

From the *Epidemic Intelligence Service and Division of HIV/AIDS Prevention, CDC, Atlanta, GA; Kenya Medical Research Institute/CDC Research and Public Health Collaboration, Kisumu, Kenya; and §Ministry of Health Kenya, Nairobi, Kenya.

Accepted for publication July 03, 2012.

Funding for the study was provided by Kenya Medical Research Institute (KEMRI) through a cooperative agreement with the US Centers for Disease Control and Prevention (US CDC). Study drugs were provided by GlaxoSmithKline and Boehringer Ingelheim. The study design, data collection instruments, data collection, data analysis, decision to publish and preparation of the manuscript were led by CDC and KEMRI staff based in Atlanta and at the KEMRI/CDC Research and Public Health Collaboration in Kisumu, Kenya. This publication has been approved by the Director of the Kenya Medical Research Institute. TDM, CZ, PJP, LAM and TKT were employed by CDC during part or all of this study. The authors have no other conflicts of interest or funding to disclose.

Address for correspondence: Timothy D. Minniear, MD, Centers for Disease Control and Prevention, 1600 Clifton Rd, MS E-45, Atlanta, GA 30333. E-mail:

© 2012 Lippincott Williams & Wilkins, Inc.