Gilead's New Four-in-One HIV Pill, Genvoya, Wins US Approval
Source: ABC
Federal regulators have approved a new four-in-one combination pill to treat HIV, the virus that causes AIDS.
The Food and Drug Administration on Thursday approved sales of Genvoya from Gilead Sciences Inc., the top maker of HIV medicines.
The once-a-day pill combines three existing Gilead HIV drugs — Vitekta, Tybost and Emtriva — with a new version of tenofovir, the active ingredient in Gilead's widely used Viread. A chemical cousin, called tenofovir alafenamide, gets more of the drug into cells where HIV copies itself, reducing drug levels in the bloodstream and with that, side effects including kidney damage and reduced bone density.
However, patients taking the drug should be monitored for those side effects. In addition, fatal side effects including severe liver problems and a dangerous buildup of lactic acid in the blood are possible, so the drug carries a so-called black box warning, the FDA's strongest. Genvoya can also cause redistribution of fat in the body and changes in the immune system, and can interact with a number of commonly used medicines.
Gilead, based in Foster City, California, said the annual list price for Genvoya will be $31,362, about the same as for its older four-in-one HIV drug, Stribild. The company offers financial assistance to patients unable to afford that.
Read more: http://abcnews.go.com/Business/wireStory/gileads-hiv-pill-genvoya-wins-us-approval-35006087
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