New HIV Therapy Approved by FDA
Nov. 5, 2015 -- A new treatment for HIV has been approved by the U.S. Food and Drug Administration.
Genvoya -- a tablet containing the drugs elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide -- can be used to treat HIV-1 infection in adults and children 12 and older weighing at least 77 pounds.
The approval is based on four clinical trials that included a total of 3,171 patients. They showed Genvoya was effective in reducing viral loads and comparable to other treatments, the FDA said.
Genvoya -- made by California-based Gilead Sciences Inc. -- contains a new form of tenofovir not previously approved by the FDA. This new form of tenofovir places lower amounts of drug in the bloodstream, but higher amounts within cells where HIV-1 replicates.
"Today's approval of a fixed dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
The most common side effect associated with Genvoya is nausea. The product carries a Boxed Warning about the possible risk of a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal.
The warning also states that Genvoya is not approved to treat chronic hepatitis B infection.
Genvoya -- a tablet containing the drugs elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide -- can be used to treat HIV-1 infection in adults and children 12 and older weighing at least 77 pounds.
The approval is based on four clinical trials that included a total of 3,171 patients. They showed Genvoya was effective in reducing viral loads and comparable to other treatments, the FDA said.
Genvoya -- made by California-based Gilead Sciences Inc. -- contains a new form of tenofovir not previously approved by the FDA. This new form of tenofovir places lower amounts of drug in the bloodstream, but higher amounts within cells where HIV-1 replicates.
"Today's approval of a fixed dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
The most common side effect associated with Genvoya is nausea. The product carries a Boxed Warning about the possible risk of a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal.
The warning also states that Genvoya is not approved to treat chronic hepatitis B infection.
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