Gilead says Quad pill suppresses HIV at 48 weeks
Gilead Sciences Inc said 48-week data from a mid-stage trial of its closely watched four-medicine
HIV pill known as the "Quad" show the drug works as well as the company's widely used Atripla
three-drug tablet.
Analysts said the findings met expectations and the company's shares inched up by just a fraction.
Gilead began in April a large pivotal-stage trial of the Quad drug, which combines experimental integrase inhibitor elvitegravir and a "boosting agent" called cobicistat with its older HIV drugs, Emtriva and Viread.
Most of the company's current HIV drug sales come from Atripla -- which is composed of Emtriva, known generically as emtricitabine, Viread, or tenofovir, and Bristol-Myers Squibb Co's Sustiva, also known as efavirenz.
After 48 weeks of treatment in the Quad-Atripla study, 90 percent of patients taking the Quad achieved target reductions in levels of HIV in the blood, known as viral load, compared with 83 percent of those who received Atripla -- matching earlier 24-week results from the trial.
Gilead said safety, tolerability and discontinuation rates were similar between both arms of the study. But fewer central nervous system problems, including abnormal dreams or nightmares, dizziness and anxiety occurred in patients receiving the Quad compared to those treated with Atripla, it said.
Three patients discontinued treatment in each arm of the study, but only one, an Atripla patient, dropped out due to an adverse side effect, which was thoughts of suicide.
Two cases of serious side effects were reported among Quad patients -- pneumonia and anogenital warts, and two among Atripla patients -- B-cell lymphoma and low levels of white blood cells.
Gilead is also studying cobicistat as a stand-alone boosting agent for other antiretroviral medications.
In a separate trial, the booster, used in combination with Bristol-Myers' Reyataz and Gilead's Truvada reduced the virus to undetectable levels in 82 percent of patients, compared with 86 percent of patients treated with a booster called Norvir, which is made by Abbott Laboratories (ABT.N).
Results from the trials were presented on Monday at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Boston.
BMO Capital Markets analyst Jason Zhang said Gilead's release added little to trial details released several weeks ago by the conference organizers.
Shares of Gilead were up 5 cents at $34.44 in midday trading on the Nasdaq exchange.
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