Microbicide – a topical gel that offers hope in the fight against AIDS, has the potential to be a female controlled product, enabling women at risk of HIV to use it for protection without partner consent, thus saving millions of lives worldwide.
Microbicides are compounds that can be applied inside the vagina to protect against sexually transmitted infections including HIV. They can be formulated as gels, creams, films, or suppositories and may or may not have spermicidal activity (contraceptive effect). Microbicides are fast gaining vaccine researcher's attention globally since they represent hope in the prospects for an AIDS vaccine.
A condom is still the most effective preventive method against infection. Since microbicides are female controlled, unlike condoms which require the consent of a male partner, and also taking into account the unwillingness of men in developing countries to use condoms, women could someday shield themselves by applying such topical microbicides. Its advantage also lies in the fact that it is undetectable, so women can protect themselves without their partner's knowledge or permission. This could help save lives of millions of women who are unable to insist on condoms, or refuse sex or trying to conceive.
Stephen Lewis, the United Nations special envoy for HIV/AIDS in Africa, supporter of microbicide development said it was desperately needed with its need having grown with awareness of women's vulnerability.
The International AIDS Conference which is to be held in Toronto next month will feature microbicide development as a major topic. Researchers who are attending the conference will be calling for an immediate doubling of funds, from $160 million annually to $320 million annually, to help accelerate a product to market and also to keep prospects in the research pipeline, said Zeta Rosenberg, who is CEO of the International Partnership for Microbicides. "Marriage and motherhood are becoming HIV risk factors in many places," Rosenberg said. The U.S. government tops the list in providing funds for microbicide research, seconded by The Bill and Melinda Gates Foundation and the British government.
But to convert ideas into marketable drugs requires large scale trials on thousand of individuals from several continents and to maintain research momentum and hasten microbicides to market, the world's funding for research must increase from $160 million in 2005 to $280 million in 2006 and the subsequent five years, she said.
Microbicides also finds strong backers in Melinda Gates, wife of Microsoft founder Bill Gates, and Graca Machel, wife of South Africa's Nelson Mandela.
10 products are currently under active development in pre-clinical trials, 16 products are currently in clinical trials and five products are in large scale efficacy trials. More than 15,000 women in Africa and India have enrolled in clinical trials of five products, any or all of which could be successful.
Though at present, an effective microbicide is not available, there is a possibility of the first product being available in the market by 2010, four years hence.
"The simmering excitement that maybe the breakthrough could come within four to seven years and potentially save the lives of millions of women, this is all building to a kind of crescendo at the moment," said Stephen Lewis.
Almost half of all HIV/AIDS cases across the world are women. According to UN estimates, women account for nearly 70 percent of infected cases. Worldwide, 62 percent of infected cases are girls from ages 15 to 24. More than 50 percent of HIV cases in sub-Saharan Africa are women from ages 15 to 49, with most being married to their lifetime sexual partner. In India, 22 percent of HIV cases are in housewives with a single partner.
"Marriage and motherhood are becoming HIV risk factors in many places," Zeta Rosenberg said.
The Beira General Hospital in Mozambique was recently visited by Stephen Lewis where the overcrowded women's ward contained 90 percent of AIDS cases. "They were lying in corridors, lying between the beds, lying on the beds, the stench of death was everywhere. They were all young women, they were all in their late teens and 20s and 30s. The sense of desperation was overpowering," he said. Contrasting this was the men's ward where there were empty beds.
Some causes of this disparity in the level of infection among men and women may be because of the physiology of women as their vaginal tissues are more easily damaged, there being more target cells. There are also numerous cases of rape among women and in developing nations, women have no property rights or economic assets, they are not able to force a husband or boyfriend to use a condom.
Some of the different products which are being tested are
• Carraguard, being tested in South Africa with funding from the Population Council, Gates Foundation and USAID.
• Cellulose sulfate being tested concurrently in 2 trials, one in Nigeria and one spanning Burkina Faso, Uganda, India, Kenya and South Africa, with funding from the Global Microbicide Program, Gates Foundation and USAID.
• PRO 2000 product of Indevus Pharmaceuticals, being tested in South Africa, Uganda and Tanzania.
• BufferGel, a vaginal defense enhancer, being developed by ReProtect, tested in southern Africa.
• Savvy, a membrane disruptive agent being tested by Cellegy Pharmaceuticals in Nigeria.
A big challenge is how to make Microbicide products available and affordable to women in poor countries. Manju Chatani, co-ordinator of the African Microbicides Advocacy Group said that some companies have already said to offer their products at subsidized rates. "We are convinced it will be affordable, as affordable as a condom." she said.
