"Council believes that the risk-benefit profile of
nevirapine monotherapy has changed and therefore no longer
recommends its use for the prevention of mother-to-child
transmission of HIV."
Soon followed by the pharmaceutical public relations
TAC goons:
"A spokesman for the Treatment Action Campaign, South
Africa's most powerful AIDS activist group, said it
supported the government on the need to review new
information about nevirapine, but did not think the drug
should be withdrawn."
S.Africa to limit use of AIDS drug nevirapine
By Andrew Quinn
JOHANNESBURG, July 13 (Reuters) - South Africa will no
longer recommend key anti-AIDS drug nevirapine for use on
its own to prevent HIV-positive mothers from passing the
virus to their babies, officials said on Tuesday.
National regulator, the Medicines Control Council, said new
data indicated nevirapine when used alone leads to
significant resistance to future doses in both mothers and
their babies. It now recommends using it only in combination
with other drugs.
"Recent studies conducted in South Africa using nevirapine
as a monotherapy for this purpose show significant
resistance of up to 50 percent," the MCC said in a
statement.
"Council believes that the risk-benefit profile of
nevirapine monotherapy has changed and therefore no longer
recommends its use for the prevention of mother-to-child
transmission of HIV."
The council's decision also applies to AZT, another drug
used in treating pregnant women. It now recommends that
both medicines now be used only in combination with other
treatments for preventing mother-to-child transmission of
HIV.
German drugmaker Boehringer Ingelheim, which holds the
patent on nevirapine, said it did not object to the use of
the drug in combination therapies but was concerned by
local media reports the MCC might withdraw the drug
altogether.
"We will be taking it up with the MCC very shortly. We've
heard they're considering de-registering the single product
and it's not an opinion that we share," said Kevin McKenna,
a company spokesman.
HIV-POSITIVE BABIES
The use of nevirapine has been highly politicised in South
Africa, which sees about 100,000 HIV-positive babies born
each year and has the world's highest AIDS caseload with
more than five million people infected.
AIDS activist groups went to court in 2002 to force the
government to provide nevirapine to pregnant women in state
hospitals -- winning an order which overruled official
concerns over the drug's safety and efficacy.
This year the government further broadened its AIDS drug
policy, launching a national roll-out of anti-retroviral
drugs in the public sector.
But last month the Health Ministry raised fresh concerns
about nevirapine, saying it had been presented with a new
study indicating that some mothers who have taken the drug
during a previous pregnancy may be becoming resistant to
its effects.
The study, which began a year ago, is being carried out by
Boehringer Ingelheim and government researchers.
The mother-to-child programme is widely used in South
Africa, with both HIV-positive expectant mothers and their
newborn children receiving doses of the drug which doctors
credit with saving thousands of lives.
A spokesman for the Treatment Action Campaign, South
Africa's most powerful AIDS activist group, said it
supported the government on the need to review new
information about nevirapine, but did not think the drug
should be withdrawn.
"We think that it would be wrong of the government to simply
withdraw nevirapine. What the government needs to do is to
introduce, as soon as possible, access to double drug
regimens or triple drug regimens for pregnant women," TAC
spokesman Mark Heywood told SAfm radio.
