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to Section One | to Arts & Entertainment
posted Friday, November 6, 2015 - Volume 43 Issue 45
FDA approves new HIV drug designed to reduce side effects
Section One
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FDA approves new HIV drug designed to reduce side effects

by Mike Andrew - SGN Staff Writer

The U.S. Food and Drug Administration (FDA) approved a new HIV drug on November 5.

The drug, to be marketed under the trade name Genvoya, is manufactured by Gilead Sciences, the maker of Truvada. The drug is a novel form of tenofovir, one of the ingredients of Truvada.

Genvoya is designed to be taken as a single tablet per day aimed at HIV-1, for use by adults who previously have not been treated or those whose HIV-1 infection is currently suppressed by other antiretroviral drugs.

This new form of tenofovir provides lower levels of the drug in the bloodstream but higher levels within the cells where HIV-1 replicates.

It was developed to help reduce some side effects of already-existing antiretrovirals. Genvoya appears to be associated with less kidney toxicity and loss of bone density than previously approved tenofovir-based drugs.

Genoyva is not without its own dangers, however. The treatment will carry a warning label citing possible buildup of lactic acid in the blood and severe liver problems. Genoyva is also not recommended for patients with chronic hepatitis B.

Nevertheless, the drug is being hailed as an improvement in treatment for some HIV patients.

'As the HIV patient population ages, there is an increased risk for development of age- and treatment-related comorbidities, including low bone mineral density and renal impairment,' Dr. David Wohl told Business Wire. 'This is due to the combination of HIV infection, antiretroviral treatments and the natural aging process.

'Given its demonstrated efficacy and safety profile, Genvoya represents an important new treatment option for a range of patients who are either new to therapy or who choose to switch treatments.'

Wohl is an associate professor of medicine, in the Division of Infectious Diseases at the University of North Carolina at Chapel Hill, and is the lead author of the Genvoya study.

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