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HIV Patients Get New Treatment Option Genvoya
- Updated: November 7, 2015
The Food and Drug Administration (FDA) has approved a new option for the treatment of HIV-1 infection for adults and pediatric patients 12 years old and older. Genvoya is a a fixed-dose combination tablet used once daily as a complete regimen for treatment.
A Genvoya tablet contains elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide. Tenofovir alafenamide is a new form of the inhibitor that enters the cells where H.I.V. replicates more efficiently, reducing the tenofovir in the bloodstream by 91 percent. This new form of tenofovir has not been previously approved.
Genvoya is marketed by Gilead Sciences based in Foster City, California. The drug is approved for patients who have never taken HIV therapy and HIV-infected adults whose HIV-1 virus is currently suppressed. Patients prescribed the medication must weigh at least 77 pounds (35 kilograms).
More than 3,000 participants enrolled in four clinical trials were evaluated for Genvoya’s safety and efficacy in adults. Participants were randomly assigned to receive Genvoya or another FDA approved HIV treatment, depending on the trial. The results showed efficacy at viral load reduction comparable to the previously approved treatment regimens.
Side effects associated with Genvoya were also examined. The most common side effect reported was nausea. Patients also reported some serious side effects, including new or worsening kidney problems, bone mineral density reduction, fat redistribution, and immune system changes.
Genvoya is not recommended for patients with severe renal impairment. The drug can cause a buildup of lactic acid in the blood and severe liver problems, which can be fatal. Patients with moderate renal impairment can take Genvoya, according to the FDA approval.
It is recommended that patients taking Genvoya be monitored for kidney and bone side effects by their health care providers. The drug may also have drug interactions with a number of other commonly used medications. The FDA does not recommend that Genvoya be given with other antiretroviral products.
The number of people living with HIV has increased over the past decade. According to data from the Centers for Disease Control and Prevention, there are an estimated 1.2 million people living with HIV infection who are ages 13 years and older. In this age range, another 150,000 or more are unaware of their HIV infection. The number of new HIV infections reported annually has remained steady over the past ten years.