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Los Angeles – www.news.nurse.com – Tenofovir gel could protect against HIV during anal sex just as it does during vaginal sex, according to an early-phase study presented at the 18th Conference on Retroviruses and Opportunistic Infections in Boston.
The vaginal gel formulation might not be ideal for rectal use, so researchers have modified the gel and are testing it in another study.
“We are very encouraged about these findings that indicate applying tenofovir gel topically to the rectum could be a promising approach to HIV prevention,” said researcher Peter Anton, MD, professor of medicine and director of the Center for Prevention Research at the University of California, Los Angeles,who led the study with Ian McGowan, MD, PhD, co-principal investigator of the Microbicide Trials Network (MTN) and professor of medicine at the University of Pittsburgh.
“These are early results, but help set the stage for current and future trials of rectal microbicides and the development of a rectal-specific formulation of tenofovir gel,” said McGowan, who is leading the second study of the new gel formulation.
Most microbicide research thus far has focused on products to prevent HIV during vaginal sex, even though the risk of infection from unprotected anal sex could be 20 times greater.
The study tested two products, tenofovir gel and oral tenofovir, in 18 sexually abstinent, HIV-negative men and women. To gauge whether any actual protection was provided by the drug given in the different regimens — single oral, single gel and seven-day gel (or placebo) — researchers took small biopsies from the rectal lining of the participants using sigmoidoscopy. They sent the tissue samples directly to the laboratory and exposed them to HIV to determine how well study products protected the tissue from infection.
The researchers found that HIV was significantly inhibited in tissue samples from participants who used tenofovir gel daily for one week compared to tissue from participants who used the placebo gel. While a slight anti-viral effect was noted in tissue from participants who received a single dose of tenofovir gel, the finding was not statistically significant. The single dose of oral tenofovir did not provide any protection against HIV in rectal tissue samples.
According to self-reports, only 25% of men and women who had used the tenofovir gel said they liked it. However, when asked whether they would consider using the product in the future, 75% of these participants reported a high likelihood. Two of the 12 participants who received tenofovir gel reported severe gastrointestinal side effects, including diarrhea and lower abdominal cramps.
