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[e-drug] Nevirapine and breastfeeding study: Lack of reduced risk for infants

E-DRUG: Nevirapine and breastfeeding study: Lack of reduced risk for infants
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Six-Week Course Of Antiretroviral Nevirapine Did Not Clearly Reduce Risk Of HIV 
Among Breastfed Infants, Study Finds
********************************* 

Medical News Today
30 July 2008  
www.medicalnewstoday.com/articles/116605.php

Full text available at The Lancet:
www.thelancet.com/journals/lancet/article/PIIS0140673608611149/fulltext

A six-week extended course of the antiretroviral drug nevirapine did not 
clearly show a reduced risk of mother-to-child HIV transmission among breastfed 
infants, according to a study published Saturday in the journal Lancet, the New 
York Times reports. According to the Times, breastfeeding "presents a 
life-and-death dilemma" for HIV-positive mothers in developing countries. 
Although using formula can reduce the risk of MTCT, when formula is mixed with 
dirty water, it can increase the risk of death among infants from causes such 
as diarrhea and malnutrition. In most developing nations, women will continue 
to breastfeed because it is traditional, formula is expensive and because using 
formula "announces" that a woman is HIV-positive, according to the Times. At 
least 150,000 infants contract HIV through breastfeeding annually, experts 
estimate.

In an effort to prevent MTCT, researchers have "stumbled into their own 
terrible dilemma," the Times reports. A single dose of nevirapine can prevent 
MTCT, but a single dose is not always effective. In addition, nevirapine can 
have side effects, and some infants develop liver failure, rashes or low white 
blood cell counts. Resistance to nevirapine also develops quickly, meaning that 
an infant who receives nevirapine and still contracts HIV will be unable to 
combination therapies that contain it or any related drug (McNeil, New York 
Times, 7/29).

For the study, researchers administered nevirapine to infants in Ethiopia, 
India and Uganda whose mothers were HIV-positive (Britt, Bloomberg, 7/25). The 
infants were randomly assigned to receive a single dose of the drug, while the 
other half received a six-week course (Bollinger et al., Lancet, 7/26). The 
study found that infants who took daily doses of nevirapine for six weeks 
reduced their risk of MTCT by 15% (Bloomberg, 7/25). "Although a six-week 
regimen of daily nevirapine might be associated with a reduction in the risk of 
HIV transmission at six weeks of age, the lack of a significant reduction in 
the primary endpoint -- risk of HIV transmission at six months -- suggests that 
a longer course of daily infant nevirapine to prevent HIV transmission via 
breastmilk might be more effective where access to affordable and safe 
replacement feeding is not yet available and where the risks of replacement 
feeding are high," the researchers wrote (Lancet, 7/26).

However, three members of the research team led by Mrudula Phadke of the 
Maharshtra University of Health Sciences in Nashik, India, in a letter to the 
journal wrote that it is "wrong that a drug that has not shown significant 
benefit and which has serious toxic side effects in 38.4% of babies should be 
tried for longer." The study's design of six months was based on the 10 to 14 
days that it takes nevirapine to build up in infants' blood, the three 
researchers wrote in the letter, adding that the finding that incidence was 
lower after six weeks "does not reflect the effect of six weeks of treatment at 
all." Instead of using nevirapine, HIV/AIDS experts should focus on methods to 
make infant formula more available and acceptable to HIV-positive mothers in 
developing countries, the researchers added.

The disagreement among the study's authors is unusual, Lancet editors Pia Pini 
and Sabine Kleinert wrote in an accompanying commentary. They added that NIH, 
which funded the study, said there was no "breach of research integrity." They 
added, "In our opinion, publication of these important data, with complete 
disclosure, is the best course of action." Jeffrey Stringer and Benjamin Chi 
from the University of Alabama-Birmingham wrote in an accompanying commentary 
that "[e]xtended infant prophylaxis with nevirapine is simple enough to be 
implemented almost anywhere. It represents a long-awaited, if partial, solution 
to a mother's impossible choice. We should not delay" (Bloomberg, 7/25).

The study is available online. The letter also is available online.

Reprinted with kind permission from 
<http://www.kaisernetwork.org>http://www.kaisernetwork.org. You can view the 
entire Kaiser Daily Health Policy Report, search the archives, or sign up for 
email delivery at 
<http://www.kaisernetwork.org/dailyreports/healthpolicy>http://www.kaisernetwork.org/dailyreports/healthpolicy.
 The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a 
free service of The Henry J. Kaiser Family Foundation.

Copyright 2008 Advisory Board Company and Kaiser Family Foundation. All rights 
reserved.




__________________________________________________


Leela McCullough, Ed.D.
Director of Information Services

AED-SATELLIFE Center for Health Information and Technology
30 California Street, Watertown, MA 02472, USA
Tel: +617-926-9400    Fax: +617-926-1212
Email: lmccullough@aed.org
Web: http://www.healthnet.org



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