Study: Gel Using Anti-HIV Drug, Tenofovir Proves Safe for Women

By Anna Boyd
14:22, February 27th 2008
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Study: Gel Using Anti-HIV Drug, Tenofovir Proves Safe for Women

A gel that uses popular anti-HIV drug, Tenofovir proved to be safe for women to use on a daily basis, a six-month study revealed.

Tenofovir, the active ingredient in the gel, is an antiviral drug called nucleotide reverse transcriptase inhibitor, which acts against HIV by blocking the virus' ability to replicate and grow inside the body.

The study, conducted by researchers at the University of Alabama at Birmingham (UAB) and the University of Pittsburgh, involved 200 sexually active HIV-negative women aging 19 to 50, of whom 64 percent were married.

The researchers found that 80 percent of the women instructed to use the gel within two hours before sex said they followed instructions, and 83 percent instructed to use the gel daily said they had done so in the week prior. There were no differences in liver, blood kidney function between women who used the gel and those who used a placebo. Moreover, there were not signaled genital symptoms such as itching or burning.

“The gel is safe to use, and well tolerated by HIV-negative women. That’s a key message in our findings. This sets the stage for larger studies to see if tenofovir can prevent HIV infection,” said Dr. Craig Hoesley of the University of Alabama at Birmingham.

Women seem to be physically more at risk from AIDS infection than men are. According to the United Nations Agency UNAIDS, women make up for 46 percent of the 33.2 million people infected with the AIDS virus. Women currently protect themselves mainly by relying on male consent to wear a condom. This situation could significantly change if further researches on the gel show women are protected against HIV when using the gel.

The findings represents a real success in the field of microbicides (gels or creams that can be applied vaginally or anally to prevent transmission of the human immunodeficiency virus that causes AIDS). They come a week after a study showed Carraguard, another gel used vaginally, did not protect women from infection.

“Based on what we have learned, we can proceed with greater confidence on a path that will answer whether tenofovir gel and other gels with HIV-specific compounds will be able to prevent sexual transmission of HIV in women when other approaches have failed to do so. It is a critical time for all of us engaged in HIV prevention, and I truly believe we are turning a corner," said Sharon L. Hillier, director of reproductive infectious disease at the University of Pittsburg School of Medicine and co-author of the study in a prepared statement for the Washington Post.

The findings were presented Monday at an international microbicides meeting in New Delhi.

 



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