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blasts detractors of AIDS drug
The Financial Gazette
A UGANDAN doctor
has accused those raising concerns about the safety of nevirapine,
an anti-retroviral drug also being used in the prevention of mother-to-child
transmission of HIV, of being "deceptive" and "insincere".
Dr Sam Okuonzi
of the Ugandan National Council for Children said in an article
in the New Vision those who were raising these concerns did not
have the interests of children and HIV-positive mothers at heart.
have been attributed to single dose nevirapine. But when used over
a long period by men and non-pregnant mothers, the drug can cause
skin rash, liver disease and occasional fatality," he said. "This
is not how nevirapine is used in PMTCT (prevention of mother-to-child
responding to a series of articles that have been published by Associated
Press which said that the head of the AIDS Programme at the National
Institutes of Health (NIH) in the United States had doctored reports
about the safety of nevirapine following clinical trials in Uganda.
also known as viramune, is manufactured by a German company, Boehringer
Ingelheim, and is used as a triple combination for the treatment
of AIDS while it is used as a single dose for PMTCT.
The drug is
currently being given free to a number of governments in sub-Saharan
Africa and is recommended by the World Health Organisation.
Fishbein, an expert hired by the NIH to review the results of the
Ugandan clinical trials, argues that investigators in Uganda focused
only on showing that nevirapine worked and overlooked its dangerous
it would appear, is not to be regarded as highly as American life,"
he was quoted by Reuters news agency as saying.
however, argue that though it has several disadvantages, its advantages
far outweigh these disadvantages.
is not the optimal solution, but it is working and there is no better
help in very poor countries to prevent HIV-positive mothers passing
the virus on to their children," a spokesman for the drug manufacturer
was quoted as saying.
The same sentiments
were echoed by the United States Food and Drug Administration (FDA),
which approves the use of drugs in that country.
In a public
health advisory statement on nevirapine on January 23, the FDA said
in spite of the potential serious and life-threatening liver toxicity
and skin rashes with nevirapine, there were multiple reasons why
nevirapine remained an important part of an HIV treatment regimen.
It said triple
antiretroviral regimens had been shown to have a huge impact on
the reduction of AIDS morbidity and mortality.
The FDA has
just approved the use of a generic drug manufactured by a South
African company. It has nevirapine as one of the combinations.
The FDA said
symptomatic liver toxicity, which normally occurs only a few weeks
after treatment and may cause liver failure, has not been reported
with the use of single doses of nevirapine to the mother and to
the child for prevention of perinatal HIV infection.
is that nevirapine is available in liquid form, which can be given
to children, while many antiretrovirals are not.
About 800 000
babies in Africa are born HIV-positive each year.
Though the FDA
warns health care providers to weigh the benefits and risks associated
with nevirapine before prescribing it to patients, it says the underlying
disease must be considered as part of the risk benefit analysis
when treating HIV-infected patients.
will progress to AIDS and death if untreated. Treatment with combination
antiretroviral drugs, including nevirapine, can slow clinical progression
and may delay the development of AIDS or death for years."
The FDA, however,
says nevirapine should not be used on women with CD4+ cell counts
greater than 250 cells per cubic millimetre of blood unless the
benefits outweigh the risks.
CD4 cells, or helper cells, boost the person's immune system and
are the ones attacked by HIV. The normal count is anywhere between
500 and 1500 cells per cubic millimetre of blood.
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