SOUTH AFRICA: Moving towards marketable microbicides

JOHANNESBURG, 7 Sep 2004 (PLUSNEWS) - Microbicides could avert an estimated 2.5 million HIV infections globally over the next three years, according to the South African Medical Research Council (MRC).

Vaginal microbicides that prevent HI-virus transmission are currently being tested in South Africa and could be available for sale in the country as early as 2008, said Neetha Morar, research manager of the MRC's HIV research and prevention unit.

Applied before sex, vaginal microbicides are substances that could kill, neutralise or block HIV and other sexually transmitted infections. They could also help prevent mother-to-child-transmission of the virus at birth, scientists said during a MRC briefing.

South Africa will be embarking on Phase III product trials in January 2005. The three major clinical trials to be headed by the MRC are part of the largest microbicide prevention programme in the world.

Phase III trials will test the safety and efficacy of newly developed medication, and involve thousands of HIV-negative female research participants over a period of three and a half years at an expected cost of US $45 million.

To protect HIV-negative research participants from possible infection, the MRC promotes condom use in combination with microbicides, explained Morar.

The three products, already tested successfully in the laboratory and during small-scale first- and second-phase trials, will be assessed at trial sites around the country.

Although MRC scientists expect the first microbicide to be ready in early 2008, it will have an effectiveness of 50 percent to 60 percent and will have to be used in combination with a condom, Morar said.

The HIV effectiveness of microbicide gels is expected to reach 85 percent to 97 percent by 2017 and be stand-alone products that do not need to be combined with condom use.

Accordingto the MRC, in developing countries the gel will be sold over the counter, while in developed countries it will initially be available as prescriptive medication only.

"For a microbicide to reach large acceptance in the population, it must be safe, affordable, available over the counter and easy to apply," Morar told PlusNews.

South African research participants indicated they would be willing to pay up to 10 rand (US $1.5) for the gel, and that the cost per usage should be similar to the cost of a condom.

For easy application, the gel will come in a tube similar to a toothpaste tube, with a reusable, plastic applicator, Morar explained.

Another important factor in the success of the product would be male acceptability, the scientist pointed out. Research had found between 83 percent and 95 percent of men were keen for their female partner to use vaginal microbicides, she claimed.

Community participation was also important to the successful usage of microbicides, Morar said, and throughout South Africa people needed to be trained and educated about vaginal microbicides "well before 2008".

[ENDS]