Henry Gabelnick has been working on microbicides for over 20 years. Last week, at the International AIDS Conference in Vienna, a research team including the executive director of CONRAD, a division of the Obstetrics and Gynecology Department at Eastern Virginia Medical School in Norfolk, made headline news around the world for its research on a vaginal gel that promises a breakthrough in slowing the spread of both the genital herpes virus and HIV/AIDS.

Over the next 20 years, it's estimated that it could prevent 1.1 million cases and prevent 800,000 deaths in South Africa alone.

Since 1986, Gabelnick's research with CONRAD, which stands for Contraceptive Research and Development, has morphed primarily into HIV prevention. The most recent groundbreaking study was conducted with 900 women in South Africa divided between a rural community and an urban community. "That's where the HIV is. It's one of the worst places. We're looking at it in heterosexuals," Gabelnick said in a phone interview from Vienna. "This gel is for vaginal use by women." (According to U.N. statistics, women account for 60 percent of HIV cases in sub-Saharan Africa.) It's the first study of an HIV-prevention method controlled by women to show success. Several studies with other populations are ongoing to compare daily use of the gel compared with oral use as a pre-exposure prophylactic, says Gabelnick.

The gel contains tenofovir, an anti-retroviral which stops the replication of the virus. In the study, which took place over 30 months, there was a reduction in infection of 39 percent among occasional users and a 54 percent reduction by those who used the gel 80 percent of the time. The gel, licensed by California-based Gilead Sciences in 2006, must be applied before and after intercourse for full effect. One-third of the women in the study reported that their partners were unaware of its use.

Gabelnick believes that the efficacy could be much higher than the study's results. "The women didn't use it all the time," he says, especially towards the end of the 30-month study. "I think they just got tired of it. They were hearing the same message every month, 'be careful,' 'use condoms,' etc. – but they still wanted the health care that came with the study and the reimbursement for their time." He cites an efficacy of 50 percent in the first year and 47 percent over 18 months, followed by a drop in the last few months. He emphasizes that there was no sign of resistance to the drug over time and that side effects were minimal.

Each dose in the study cost 32 cents, of which the applicator and packaging accounted for 30 cents. Gabelnick's hope is that larger-scale production will reduce costs further. Researchers are also looking at developing a re-usable applicator, getting the gel into a toothpaste-style tube, and using other delivery systems, such as the vaginal ring.

Researchers are pursuing FDA approval for the gel on two counts. "It's better if a drug is approved where it's developed so they don't think we're trying to foist off something that's not good enough for us," says Gabelnick, noting that the study was largely funded by the U.S. Agency for International Development. Also, he says, for domestic use, it promises to reduce the transmission of herpes infections by 50 percent or more.

Though he can't set a timeline for its approval, Gabelnick says the researchers are "working as fast as we can with the South African government to set up public/private partnerships to be ready. We're working to get it in place for capacity production with no delay once the regulatory authorities approve it."

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