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AIDS Action Committee Encouraged By New Pre-Exposure Prophylaxis Study

Posted Nov 23 2010 4:56pm

Gilead pillBOSTON, November 23, 2010—Results published today from a National Institute of Health clinical trial shows that taking a once-a-day anti-HIV pill  can reduce the risk of HIV infection by 44 percent in gay and bisexual men, transgender women who have sex with men.

Half of the participants in the clinical trial were given a daily pill containing two anti-retroviral drugs (ARVs), emtricitabine and tenofovir. Both drugs are already widely available in the ARV combination pill Truvada, which is commonly prescribed in HIV treatment. The other half of the trial participants were given a placebo pill.

Participants were tested for HIV monthly, and received risk-reduction counseling, condoms, and management of any sexually-transmitted infections. During the trial period, 64 people in the placebo group became infected with HIV, while only 36 people in the group receiving the daily anti-retroviral pill did.

“This is the most exciting news in prevention science since the Mother-to-Child-Transmission studies,” said Mike Wong M.D., Assistant Professor of Medicine at Harvard Medical School, on staff in the Division of Infectious Diseases at the Beth Israel Deaconess Medical Center, and Chairman of AIDS Action Committee’s Board of Directors. “For the first time, we can do something in addition to behavior modification or Post-Exposure Prophylactics (PEP) to reduce HIV transmission in populations where the risk exists. This will make an enormous impact on reducing HIV transmission in addition to other proven methods of reducing infection such as routinized testing, getting HIV positive patients into care, and needle exchange programs.”

Wong cautioned that further study was needed to determine why the daily ARV pill did not work for those who were taking the pill and still became infected with HIV, and added that researchers will need to watch for emerging resistance to the combination pill. There was also a significant variance in HIV infection rates among participants who took the pill 90 percent of the days they were enrolled in the study, and those who took it less than 90 percent. Those with adherence rates of 90 percent and above saw their risk of becoming infected with HIV drop 73 percent; those who took the pills less than 90 percent of the time saw their risk of HIV infection reduced by just 21 percent.

“This is tremendous news. We need further study on women and heterosexual men, as well as real world data on the regimen’s efficacy as it becomes commonly prescribed. But this is a very exciting development in the struggle to end the transmission of HIV,” said Rebecca Haag, President and CEO of AIDS Action Committee. “It’s also encouraging that over the course of the clinical trial, participants actually decreased their risky behavior, which is consistent with what AIDS Action has found with clients receiving regular risk-reduction counseling and coaching.”

The clinical trial, called the Pre-exposure Prophylaxis Initiative, involved 2,499 HIV-negative individuals age 18 to 67. Trial sites were set up in six countries, with two sites in the United States, including one at Boston’s Fenway Health.

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