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FDA Approves New Once-a-Day HIV Pill

Update Date: Nov 07, 2015 10:11 AM EST
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The U.S. Food and Drug Administration (FDA) has approved a new HIV pill that will make taking medications easier for HIV positive patients. The incurable infection, HIV (human immunodeficiency virus) leads to AIDS.

The pill, which is an updated version of an older pill named Stribild, contains four HIV drugs, which include elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. Unlike the old version, Genvoya was designed to reduce toxic side effects. Stribild, which also contains four drugs, used a different formulation of tenofovir.

"Genvoya contains a new form of tenofovir that has not been previously approved. This new form of tenofovir provides lower levels of drug in the bloodstream, but higher levels within the cells where HIV-1 replicates," the FDA explained in a statement. "Genvoya appears to be associated with less kidney toxicity and decreases in bone density than previously approved tenofovir-containing regimens based on laboratory measures."

Side effects from this new drug include kidney damage, reduced bone density, severe liver complications and lactic acid buildup in the blood. The drug will be sold with a black box warning, which is the highest warning label that the FDA has.

The FDA examined the results from four late-stage studies before deciding to approve the drug. The studies involved 3,171 patients.

"While exceptional progress has been made in the field of HIV, there is still a need for new treatment options that may help improve the health of people as they grow older with the disease," Gilead Sciences Inc. CEO John C. Martin said.

Genyova is made by Gilead Sciences Inc. The company has listed the yearly price for the drug at $31,362. There will be financial assistance for patients who cannot afford it.

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