FIVE WOMEN DIE DURING ANTI-AIDS DRUG TRIAL IN SOUTH AFRICA

Agence France Presse 5 April 2000

Cape Town, April 5 (AFP) - Five South African women have died during an ongoing clinical trial of anti-retroviral AIDS drug Nevirapine, Health Minister Manto Tshabalala-Msimang told parliament Wednesday.

Two of the deaths were caused by hepatitis, while a link between Nevirapine and the other three fatalities was "probable," the minister said.

A total of 510 pregnant women who are HIV-positive are on the trial, which is being overseen by the country's Medicines Control Council (MCC).

Tshabalala-Msimang said the deaths in the Nevirapine trial underscored the need for caution.

"It would be immoral and unethical for government, despite the numerous requests that we are receiving ... to attempt to make policy decisions regarding the use of Nevirapine in our country, until the full results of the clinical trails of the drug are available."

This would be in June or July, she added.

AIDS activists have called on government to make available either Nevirapine or the more expensive drug AZT freely available to pregnant women who are HIV positive to prevent mother-child transmission of the disease.

But President Thabo Mbeki has banned the supply by the state of AZT to pregnant women, partly because of cost, but also because he maintains it could be dangerous for women's and babies' health, although it is prescribed for pregnant women in many other countries.

Tshabalala-Msimang told parliament that based on results of the Nevirapine trial so far, "there is a death rate of one percent and a liver toxicity profile of 11 percent."

"These are serious findings," she said."As a result, the MCC has halted any further recruitment of study subjects while full reports are being compiled on all serious adverse events, including the five deaths."

Nevirapine has been used in Uganda to reduce mother-child transmission of HIV but, according to Tshabalala-Msimang, trials in that country are still inconclusive.

Opposition parties called on the government not to halt the Nevirapine trial, saying the drug had proved itself in clinical trials in other countries to be at least as effective as AZT at a fraction of the cost.

"There are so many advantages to using the drug," said Sandy Kaylan of the main opposition Democratic Party.

"It is easy to administer ... and it is cheap," she said. "It reduces transmission in early infancy. There is nothing immoral in giving an HIV positive mother and her baby Nevirapine. You are giving them hope."

Supporting her, Kobus Gous of the New National Party pointed out that the clinical trial in question involved a "cocktail" of anti-AIDS drugs and that it had not been shown conclusively that Nevirapine caused the deaths.

Latest government figures show that 3.6 million South Africans -- nine percent of the population -- were HIV-positive in 1998. Projections by the UN AIDS programme indicate that by 1999 that figure will have risen to some 12.4 percent, or nearly five million people.