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A
Single Dose of Nevirapine to the Mother, Added to Oral Zidovudine
Prophylaxis, Is Highly Effective in Reducing Mother-to-Child Transmission
of HIV
To coincide
with presentations at the XVth International AIDS
Conference in Bangkok (July 11-16, 2004), this article was
published online on the website of The New England Journal
of Medicine (www.nejm.org) on July 9, 2004. It will appear in
the July 15, 2004 issue of the Journal.
When
added to zidovudine (Retrovir;
AZT) prophylaxis, a single dose of nevirapine (Viramune)
during labor can reduce the risk of mother-to-child HIV transmission,
new research shows. However, another report by the same group
suggests that this strategy is likely to diminish the effectiveness
of subsequent nevirapine-containing regimens.
Although
zidovudine prophylaxis decreases the rate of transmission
of the human immunodeficiency virus (HIV) type 1 substantially,
a large number of infants still become infected.
Investigators
of the Researchers of the Perinatal HIV Prevention Trial (Thailand)
hypothesized that the administration, in addition to zidovudine,
of a single dose of oral nevirapine to mothers during labor
and to neonates would further reduce transmission of HIV.
They
conducted a randomized, double blind trial of three treatment
regimens in Thai women who were receiving zidovudine therapy
during the third trimester of pregnancy.
In
one group, mothers and infants received a single dose
of nevirapine (nevirapine-nevirapine regimen);
In
another group, mothers and infants received nevirapine and
placebo, respectively (nevirapine-placebo regimen);
in
the last group, mothers and infants received placebo (placebo-placebo
regimen). The infants also received one week of zidovudine
therapy and were formula-fed.
The
end point of the study was infection with HIV in the
infants, established by virologic testing.
Results
Between
January 15, 2001, and February 28, 2003, a total of 1844
Thai women were enrolled.
At
the first interim analysis, the independent data monitoring
committee stopped enrollment in the placebo-placebo group.
Among women who delivered before the interim analysis,
the as-randomized Kaplan-Meier estimates of the transmission
rates were 1.1 percent in the nevirapine-nevirapine group and
6.3 percent in the placebo-placebo group (P<0.001).
The final per-protocol
transmission rate in the nevirapine-nevirapine group, 1.9
percent, was not significantly inferior to the rate in
the nevirapine-placebo group.
Nevirapine
had an effect within subgroups defined by known risk
factors such as viral load and CD4 count. No serious
adverse effects were associated with nevirapine therapy.
Conclusions
In
conclusion, the authors write, “A single dose of nevirapine
to the mother, with or without a dose of nevirapine to
the infant, added to oral zidovudine prophylaxis starting at
28 weeks' gestation, is highly effective in reducing mother-to-child
transmission of HIV.”
07/12/04
Reference
M
Lallemant and others (of the Perinatal HIV Prevention Trial (Thailand).
Single-Dose Perinatal Nevirapine plus Standard Zidovudine to Prevent
Mother-to-Child Transmission of HIV-1 in Thailand. Published at www.nejm.org July 9, 2004.
The
New England Journal of Medicine 351: 217-240. July 15, 2004.
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