Concern regarding single dose nevirapine

[Guest guest]

Dear FORUM,

The Concern regarding single dose nevirapine was their since the inception of

this regimen.The following news from South africa should be an eye opener to

other countries including India

Ajith

E-mail: <trc_ajisudha@...>

S. Africa to Limit Use of AIDS Drug Nevirapine

By Quinn

JOHANNESBURG (Reuters) Jul 13 - 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 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 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 antiretroviral 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. (Additional reporting by

Wambui Chege in Johannesburg).