June 29, 2012
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.
[PNU editor's note: The studies, "Co-Formulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Versus Co-Formulated Efavirenz, Emtricitabine, and Tenofovir for Initial Treatment of HIV-1 Infection: A Randomized, Double-Blind, Phase 3 Trial, Analysis of Results After 48 Weeks" and "Co-Formulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Co-Formulated Emtricitabine and Tenofovir Disoproxil Fumarate for Initial Treatment of HIV-1 Infection: A Randomized, Double-Blind, Phase 3, Non-Inferiority Trial," were published in the Lancet (2012;9835:2439-2448 and 2429-2438, respectively).]