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The next best hope in the fight against HIV/AIDS comes in the form of a virus-killing gel that puts the power of protection in women's hands.
Called microbicides, they are increasingly drawing worldwide attention and funding in light of the distant prospects for an AIDS vaccine and the unwillingness of men in developing countries to use condoms.
"It's just so desperately needed, I can't put words to it," said Stephen Lewis, the United Nations special envoy for HIV/AIDS in Africa and an advocate of microbicide development. "The need for a microbicide has grown with the awareness of women's vulnerability."
A microbicide is a simple-to-use vaginal gel or cream applied prior to sex. Its continuing development will be a major topic at next month's International AIDS Conference in Toronto.
Melinda Gates, who along with husband, Microsoft founder Bill Gates, has invested billions of dollars to fight HIV/AIDS, is also a strong backer of microbicides. So is Graca Machel, a women's rights advocate and wife of South Africa's Nelson Mandela.
Not a single microbicide is on the market now, but momentum is building with the possibility of the first product being available by 2010, potentially saving millions of lives.
Though still four years away, advocates say vaccine researchers have yet to figure out an immune response to the virus, making microbicides the nearest to an HIV-prevention breakthrough that there is.
More than 15,000 women in Africa and India are taking part in clinical trials of five products, one or more of which could soon become a success story.
"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," Lewis said.
Women now account for nearly half of all HIV/AIDS cases worldwide. In Africa, close to 70 per cent of infected people are women, according to UN estimates. Globally, 62 per cent of those aged 15 to 24 living with HIV/AIDS are girls and women.
Lewis recently visited the overcrowded women's ward at Beira General Hospital in Mozambique, where 90 per cent were hospitalized because of acquired immune deficiency syndrome.
"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.
In contrast, across the hall in the men's ward there were empty beds.
"There is just no way we can stop this tidal wave of infections among women without a new preventive option of some kind," said Anna Forbes, deputy director of the Global Campaign for Microbicides.
Researchers attending next month's AIDS conference are calling for an immediate doubling of funding for microbicides — from $160 million to $320 million a year — to help hasten a product to market and keep prospects in the research pipeline, said Zeta Rosenberg, CEO of the International Partnership for Microbicides, which is facilitating research. It's a small sum, advocates say, compared to the $15 billion set aside for the overall response to AIDS in 2006.
Earlier this month, leaders of the G-8 nations, including Canada, called for increased support for microbicide research but stopped short of a specific funding announcement.
"When you think about it, we're 25 years into a fatal pandemic without a woman-controlled prevention tool," said Forbes, an American AIDS activist. "Would that have happened for men? I don't think so."
About 60 microbicide products are now in various stages of research, 14 of which are in early safety studies on women. They come in the form of a gel, cream, sponge, suppository or vaginal ring that acts to block or kill the virus in the vagina during sexual intercourse. Some are also contraceptives.
A highlight at next month's conference will be when researchers present what are expected to be encouraging results of a safety study involving a vaginal ring. Its advantage is two-fold: It uses an anti-HIV drug to combat the virus and can work for more than 30 days.
The beauty of any microbicide is that it is undetectable, so a woman can protect herself without her partner's knowledge or permission.
The reasons for the disproportionate levels of infection among women — some call it the "feminization of AIDS" — are complex:
The physiology of women makes them twice as likely to acquire HIV from men as vice versa and the effect is even more pronounced among adolescent girls. During sex, the vaginal tissue sees more virus, is more easily damaged and there are more target cells.
Women are frequent targets for rape. Of the 250,000 women raped during the Rwandan genocide, about 70 per cent of the survivors were HIV-positive.
Poverty, violence and lack of education are all associated with higher rates of HIV infection, and in many developing countries women have no property rights or economic assets.
Millions of women in developing nations don't have the power to force a husband or boyfriend to use a condom, still the most effective preventive method against infection. As a result, 75 per cent of new infections among African women are acquired from a spouse or regular partner.
The stark statistics highlight the failure of the U.S. administration-backed "ABC" prevention campaign to fight AIDS: to abstain, be faithful or use condoms. When women are getting infected from husbands who are unfaithful, how does monogamy protect them?
Amid the enthusiasm, advocates caution against viewing microbicides as a magic bullet that will empower women overnight. For one thing, the first microbicide is likely to be only partially effective and will have to be applied at least within an hour before sex, Rosenberg said.
The five candidates now in large-scale trials are gels developed in the early to mid-1990s. Carraguard, BufferGel, Savvy, PRO2000, Ushercell (made by the small Canadian firm Polydex) — these are the leading products being tested for their safety and effectiveness in thousands of healthy HIV-negative women, mostly in poor neighbourhoods in Africa and India.
They have shown promise in smaller safety studies to combat HIV and also work against other sexually transmitted diseases like herpes, gonorrhea and chlamydia. Trial participants are given either a placebo or microbicide to use, but they're also given condoms and counselled to urge sex partners to use them.
Based on earlier studies, it's expected they will be between 30 and 60 per cent effective against HIV. Even so, researchers at the London School of Hygiene and Tropical Medicine say a microbicide that is only 60 per cent effective would prevent 2.5 million infections over three years.
More than 5,000 women are enrolled in the three-year Carraguard trials in South Africa and Botswana, trying out the gel to see if it protects against HIV and is safe for long-term use. Developed by the New-York based Population Council and funded by the Bill and Melinda Gates Foundation, the trial should end by mid-2007. Data should be available by the end of next year.
In some communities where the male preference is for a dry, tight vagina to enhance their pleasure during intercourse, women have objected that the gel causes too much wetness. However, other men and women in the same area have said it feels good, Forbes said.
"It makes you wonder if this preference for dryness is really something they endorse or if it's something they're taught they should like," she said.
In Cameroon, a microbicide called the Invisible Condom, funded by the Canadian Institutes of Health Research, is being tested in 450 women as part of a smaller safety study. Results are expected by early 2007, said researcher Dr. Michel Bergeron.
"We're very optimistic," said Bergeron, director of the infectious disease centre at Laval University in Quebec. "From what we've seen, we've had no major side effects up to now."
Bergeron said one of the toughest challenges for microbicide research has been the lack of funding. Pharmaceutical companies have been reluctant to invest in microbicide development, so research has relied on government, a few small companies and charitable organizations like the Gates and Rockefeller foundations.
In 2004, the Canadian government stepped forward and committed $15 million over three years to microbicide research in response to pressure from the Canadian AIDS Society, although advocates say it's time to renew that commitment. And several drug companies recently negotiated licensing arrangements with the International Partnership for Microbicides that allows free access to their HIV drugs.
"Given nobody was initially interested in microbicides except for a few women, I think we've done astonishingly," said Toronto AIDS activist Louise Binder, who says she contracted HIV from her husband years ago. He later died.
Binder said Canadian women, particularly aboriginals and sex-trade workers, would benefit equally as much from a microbicide as women in developing nations. The gay community is also pushing for more research into a rectal microbicide.
One of the biggest challenges will be how to make an effective virus-killing gel available — and affordable — to millions of women in poor nations.
Some companies have already said they will offer their product at subsidized rates, said Manju Chatani, co-ordinator of the African Microbicides Advocacy Group. A coalition of 250 scientists, advocates and policy-makers, the AMAG network is busy preparing men and women on the continent for the moment a product bursts onto the market.
We are convinced it will be affordable, she said.
At least as affordable as a condom
The next best hope in the fight against HIV/AIDS comes in the form of a virus-killing gel that puts the power of protection in women's hands.
Called microbicides, they are increasingly drawing worldwide attention and funding in light of the distant prospects for an AIDS vaccine and the unwillingness of men in developing countries to use condoms.
"It's just so desperately needed, I can't put words to it," said Stephen Lewis, the United Nations special envoy for HIV/AIDS in Africa and an advocate of microbicide development. "The need for a microbicide has grown with the awareness of women's vulnerability."
A microbicide is a simple-to-use vaginal gel or cream applied prior to sex. Its continuing development will be a major topic at next month's International AIDS Conference in Toronto.
Melinda Gates, who along with husband, Microsoft founder Bill Gates, has invested billions of dollars to fight HIV/AIDS, is also a strong backer of microbicides. So is Graca Machel, a women's rights advocate and wife of South Africa's Nelson Mandela.
Not a single microbicide is on the market now, but momentum is building with the possibility of the first product being available by 2010, potentially saving millions of lives.
Though still four years away, advocates say vaccine researchers have yet to figure out an immune response to the virus, making microbicides the nearest to an HIV-prevention breakthrough that there is.
More than 15,000 women in Africa and India are taking part in clinical trials of five products, one or more of which could soon become a success story.
"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," Lewis said.
Women now account for nearly half of all HIV/AIDS cases worldwide. In Africa, close to 70 per cent of infected people are women, according to UN estimates. Globally, 62 per cent of those aged 15 to 24 living with HIV/AIDS are girls and women.
Lewis recently visited the overcrowded women's ward at Beira General Hospital in Mozambique, where 90 per cent were hospitalized because of acquired immune deficiency syndrome.
"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.
In contrast, across the hall in the men's ward there were empty beds.
"There is just no way we can stop this tidal wave of infections among women without a new preventive option of some kind," said Anna Forbes, deputy director of the Global Campaign for Microbicides.
Researchers attending next month's AIDS conference are calling for an immediate doubling of funding for microbicides — from $160 million to $320 million a year — to help hasten a product to market and keep prospects in the research pipeline, said Zeta Rosenberg, CEO of the International Partnership for Microbicides, which is facilitating research. It's a small sum, advocates say, compared to the $15 billion set aside for the overall response to AIDS in 2006.
Earlier this month, leaders of the G-8 nations, including Canada, called for increased support for microbicide research but stopped short of a specific funding announcement.
"When you think about it, we're 25 years into a fatal pandemic without a woman-controlled prevention tool," said Forbes, an American AIDS activist. "Would that have happened for men? I don't think so."
About 60 microbicide products are now in various stages of research, 14 of which are in early safety studies on women. They come in the form of a gel, cream, sponge, suppository or vaginal ring that acts to block or kill the virus in the vagina during sexual intercourse. Some are also contraceptives.
A highlight at next month's conference will be when researchers present what are expected to be encouraging results of a safety study involving a vaginal ring. Its advantage is two-fold: It uses an anti-HIV drug to combat the virus and can work for more than 30 days.
The beauty of any microbicide is that it is undetectable, so a woman can protect herself without her partner's knowledge or permission.
The reasons for the disproportionate levels of infection among women — some call it the "feminization of AIDS" — are complex:
The physiology of women makes them twice as likely to acquire HIV from men as vice versa and the effect is even more pronounced among adolescent girls. During sex, the vaginal tissue sees more virus, is more easily damaged and there are more target cells.
Women are frequent targets for rape. Of the 250,000 women raped during the Rwandan genocide, about 70 per cent of the survivors were HIV-positive.
Poverty, violence and lack of education are all associated with higher rates of HIV infection, and in many developing countries women have no property rights or economic assets.
Millions of women in developing nations don't have the power to force a husband or boyfriend to use a condom, still the most effective preventive method against infection. As a result, 75 per cent of new infections among African women are acquired from a spouse or regular partner.
The stark statistics highlight the failure of the U.S. administration-backed "ABC" prevention campaign to fight AIDS: to abstain, be faithful or use condoms. When women are getting infected from husbands who are unfaithful, how does monogamy protect them?
Amid the enthusiasm, advocates caution against viewing microbicides as a magic bullet that will empower women overnight. For one thing, the first microbicide is likely to be only partially effective and will have to be applied at least within an hour before sex, Rosenberg said.
The five candidates now in large-scale trials are gels developed in the early to mid-1990s. Carraguard, BufferGel, Savvy, PRO2000, Ushercell (made by the small Canadian firm Polydex) — these are the leading products being tested for their safety and effectiveness in thousands of healthy HIV-negative women, mostly in poor neighbourhoods in Africa and India.
They have shown promise in smaller safety studies to combat HIV and also work against other sexually transmitted diseases like herpes, gonorrhea and chlamydia. Trial participants are given either a placebo or microbicide to use, but they're also given condoms and counselled to urge sex partners to use them.
Based on earlier studies, it's expected they will be between 30 and 60 per cent effective against HIV. Even so, researchers at the London School of Hygiene and Tropical Medicine say a microbicide that is only 60 per cent effective would prevent 2.5 million infections over three years.
More than 5,000 women are enrolled in the three-year Carraguard trials in South Africa and Botswana, trying out the gel to see if it protects against HIV and is safe for long-term use. Developed by the New-York based Population Council and funded by the Bill and Melinda Gates Foundation, the trial should end by mid-2007. Data should be available by the end of next year.
In some communities where the male preference is for a dry, tight vagina to enhance their pleasure during intercourse, women have objected that the gel causes too much wetness. However, other men and women in the same area have said it feels good, Forbes said.
"It makes you wonder if this preference for dryness is really something they endorse or if it's something they're taught they should like," she said.
In Cameroon, a microbicide called the Invisible Condom, funded by the Canadian Institutes of Health Research, is being tested in 450 women as part of a smaller safety study. Results are expected by early 2007, said researcher Dr. Michel Bergeron.
"We're very optimistic," said Bergeron, director of the infectious disease centre at Laval University in Quebec. "From what we've seen, we've had no major side effects up to now."
Bergeron said one of the toughest challenges for microbicide research has been the lack of funding. Pharmaceutical companies have been reluctant to invest in microbicide development, so research has relied on government, a few small companies and charitable organizations like the Gates and Rockefeller foundations.
In 2004, the Canadian government stepped forward and committed $15 million over three years to microbicide research in response to pressure from the Canadian AIDS Society, although advocates say it's time to renew that commitment. And several drug companies recently negotiated licensing arrangements with the International Partnership for Microbicides that allows free access to their HIV drugs.
"Given nobody was initially interested in microbicides except for a few women, I think we've done astonishingly," said Toronto AIDS activist Louise Binder, who says she contracted HIV from her husband years ago. He later died.
Binder said Canadian women, particularly aboriginals and sex-trade workers, would benefit equally as much from a microbicide as women in developing nations. The gay community is also pushing for more research into a rectal microbicide.
One of the biggest challenges will be how to make an effective virus-killing gel available — and affordable — to millions of women in poor nations.
Some companies have already said they will offer their product at subsidized rates, said Manju Chatani, co-ordinator of the African Microbicides Advocacy Group. A coalition of 250 scientists, advocates and policy-makers, the AMAG network is busy preparing men and women on the continent for the moment a product bursts onto the market.
We are convinced it will be affordable, she said.
At least as affordable as a condom
