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
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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.
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