100 000 moms got nevirapine
2003-08-03 16:28
Special Report
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Durban - Data will be presented at the Aids conference that begins in Durban on Sunday to show that 100 000 South African women have received nevirapine to prevent HIV transmission to their babies in the past two years.
Professor James McIntyre, one of the world's leading authorities on the prevention of mother-to-child transmission (PMTCT) and head of the Chris Hani Baragwanath PeriNatal HIV Unit gave these figures in an interview with Sapa.
"No serious safety issues had been found" had been found during the use of the drug on these women, McIntyre said.
A demand by the SA Medicines Control Council last week that Boehringer Ingleheim, makers of nevirapine, submit new efficacy data within 90 days or face the drug being withdrawn for use in PTMCT, is likely to dominate the conference and has aroused an international uproar.
MCC
McIntyre said it was the MCC's job "to review safety of medications, but they also have to consider public health implications".
"Since 1999 when the drug was first registered, there has been considerable evidence of its safety and efficacy.
"In the past two years, since nevirapine has been given at some South African public hospitals, easily 100 000 women and their babies have received single-dose nevirapine to prevent HIV transmission to babies without serious safety issues.
"It will be difficult to get efficacy data from this however, because these are not research projects."
Nonetheless, he said that in terms of efficacy, a previous SA-based study and one in progress at present with 600 mothers had shown about 11% of babies that received the single dose still become HIV positive.
Giving an indication of how many mothers have accessed treatment, McIntyre said that in the last year alone, "14 000 mothers had received it in KwaZulu-Natal, 8 000 at Chris Hani Baragwanath hospital, about 8 000 in western Gauteng and 10 000 in the Western Cape alone."
The conference has attracted 3 200 delegates from around the world, although organisers said they were being flooded with last-minute registrations and believed up to 4 000 delegates were likely.
Vaccine
The primary issues will be treatment access, vaccines and microbicides - the gels women use to prevent HIV infection.
Another key issue will be South Africa's first Aids vaccine trails - the 040 study - scheduled to begin on September 29, when the first 24 volunteers will be injected at Chris Hani Baragwanath hospital at Soweto, followed by a further 24 in Durban.
The vaccine is made from the Venezuelan Equine Encephalitis virus to simulate Clade C, the sub-type of HIV most commonly found in southern Africa.
The first two of five volunteers in the USA were vaccinated last week to test safety and dosage for use in the SA trial. The trial is being done in conjunction with the US National Institutes of Health.
Although there have been more than 60 Aids vaccine trials around the world, this is the first time that a candidate Clade C vaccine is being tested. Clade C dominates in southern Africa, China and India. HIV has 11 different subtypes from A to K.
Rape
Protests around the conference will also focus on the removal of a treatment clause for antiretrovirals to prevent HIV in rape survivors.
It was removed by Cabinet from government's new Sexual Offences Bill to be tabled before the Justice portfolio committee in parliament on Tuesday.
A special plenary has been introduced at the conference for its closing session on Wednesday to discuss: "Nevirapine for the Prevention of Mother to Child Transmission (PMTCT), is it safe? Does it work?" Two speakers have so far been confirmed for the panel - McIntyre and Kathy Wilford of the Washington-based Elizabeth Glaser Paediatric Aids Foundation.
- SAPA