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Saturday, June 30, 2012

Four-in-One AIDS Drug Gets the OK in Clinical Trial


A potential new once-daily HIV treatment is as safe and effective as traditional combination therapies, according to two clinical trials reported on Friday. Researchers tested Quad - an experimental pill made by Gilead Sciences and comprising emtricitabine (FTC), tenofovir (TDF), elvitegravir, and a booster called cobicistat - against two other treatment combinations.

In the first study, Quad was matched against the three-in-one pill Atripla, which has been a standard HIV therapy since 2006. After 48 weeks, 88 percent of patients taking Quad had undetectable viral loads, compared with 84 percent of Atripla patients. Side effects were infrequent among the North American trial’s 700 participants. Mild nausea was the most common adverse event for Quad patients, and the Atripla group was more likely to experience dizziness, unusual dreams or insomnia, and skin rashes.

The second trial compared Quad with a widely recommended therapy, ritonavir-boosted atazanavir, FTC, and TDF. After 48 weeks, 90 percent taking Quad had undetectable viral loads, compared with 87 percent of those who took the other combination. Just 3.7 percent of patients taking Quad had to stop because of side effects, compared with 5.1 percent of those taking the other drug combination. However, reported kidney complications were relatively higher in the Quad group. The trial involved 708 patients at study sites in Australia, North America, and Europe.

In May, a Food and Drug Advisory panel recommended the agency approve Quad for previously untreated adult patients with HIV. The agency’s decision is expected by August.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

TOGETHER WE REMAIN STRONG!