FDA Approves the Fixed-Dose Combination Tablet Genvoya to Treat HIV Infection

The U.S. Food and Drug Administration (FDA) approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

FDA notes:

Genvoya is approved for use in HIV-infected adults and children ages 12 years and older weighing at least 35 kilograms (77 pounds) who have never taken HIV therapy (treatment-naïve) and HIV-infected adults whose HIV-1 virus is currently suppressed. While Genvoya is not recommended for patients with severe renal impairment, those with moderate renal impairment can take Genvoya. 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. It was developed to help reduce some drug side effects. Genvoya appears to be associated with less kidney toxicity and decreases in bone density than previously approved tenofovir containing regimens based on laboratory measures.

For more information, view the FDA press release.

About Alyssa Kitlas

Alyssa Kitlas serves as a Program Analyst on NACCHO's HIV, STI, and Viral Hepatitis team. Her work includes projects on HIV, STI, and Viral Hepatitis prevention and care. Twitter: @AlyssaKitlas

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