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posted Friday, July 23, 2010 - Volume 38 Issue 30
New gel may cut women's HIV infections in half
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New gel may cut women's HIV infections in half

by Mike Andrew - SGN Staff Writer

A new microbicidal gel may cut HIV infections among women by more than 50%, according to a study published July 19 in the journal Science.

The gel containing Viread, the commercial name for tenofovir, was the first successful 'pre-exposure prophylaxis' product after 20 years of research and six previous failures.

The study included 889 women in the South African coastal city of Durban and a remote rural village. Half the women used the tenofovir gel and half used a placebo gel.

Among the 445 women who applied the tenofovir gel before and after sex, there were 39% fewer HIV infections overall than among those who used the placebo.

There were 54% fewer infections among those who used the gel more than 80% of the time and a 28% reduction among those who used it least.

Women who used the gel also got an added benefit: protection from genital herpes, or HSV-2 - a disease that increases susceptibility to HIV infection.

Women who used the gel had a 51% reduction in new herpes infections, according to Dr. Salim Abdool Karim, director of the Centre for the AIDS Programme of Research in South Africa (CAPRISA), which coordinated the study.

"Boy, have we been doing the happy dance," Dr. Karim said.

Dr. Anthony Fauci of the U.S. National Institutes of Health said, "It's the first time we've ever seen any microbicide give a positive result that you could say was statistically significant."

"It's a game-changing trial," said Mitchell Warren, executive director of the New York-based AIDS Vaccine Advocacy Coalition. "At last, here is now proof of concept that we can use a microbicide against HIV. It's a transformative moment in prevention science."

In sub-Saharan Africa 60% of HIV infections occur among women, who often feel they are not able to resist the demands of their partners for unprotected sex.

A reliable and easy-to-apply medication that women could use on their own might significantly reduce rates of new infection.

"We are giving hope to women," said Michel Sidibe, the executive director of the World Health Organization's UNAIDS program. "For the first time, we have seen results for a woman-initiated and controlled HIV prevention option."

The gel could "help us break the trajectory of the AIDS epidemic," he said.

The gel was developed by Conrad, a nonprofit organization based in Arlington, Virginia. Conrad is funded by the US and South African governments. The gel's active ingredient was obtained under a royalty-free license from Gilead, the world's biggest maker of AIDS medicines.

Researchers are also testing Viread and Gilead's Truvada as a means of blocking the virus in Gay men and I.V. drug users.

A product could be ready as early as 2013 if the results are confirmed by a second study, known as "Voice," that is now enrolling participants, Warren said.

Gilead will not participate in marketing the product in developing nations, said its Chairman Howard Jaffe. It is still "an open question" as to whether the company markets it in the U.S. and Europe, he said.

"We're not in the business of doing vaginal or rectal gels," Jaffe said. "I've always believed that it's easier to pop a pill than it is to apply a gel."

Gilead's top three drugs, which all rely on Viread as a key ingredient, are given to 85% of newly diagnosed AIDS patients in the U.S.

Gels could be made more marketable by emphasizing their ability to increase sexual pleasure, Karim said in a conference call with reporters.

"The future is going to involve making this gel something that is part of the sex act - that enhances sex, even," said Karim.

Karim said the gel in the trial "is a simple cylindrical white plastic tube. There is no color, no design, nothing. Even Coke would have gone bankrupt if they took this approach in marketing their product."

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