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FDA Approves Gilead’s HIV Therapy, Descovy

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Descovy

Descovy is to be used in combination with other antiretroviral drugs, but is not indicated for use as a prophylactic to reduce the risk of HIV infection.

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April 6, 2016 | by Sarah Massey, M.Sc.

The US Food and Drug Administration (FDA) has approved Gilead’s third therapy – called Descovy – for the treatment of patients with HIV-1. Descovy is to be used in combination with other antiretroviral drugs, but is not indicated for use as a prophylactic to reduce the risk of HIV infection.

Tenofovir alafenamide (TAF) is the active ingredient in Descovy, along with Gilead’s other HIV therapies, Genvoya and Odefsey. According to a statement released by Gilead, TAF is a tenofivir prodrug that’s shown higher antiviral efficacy compared to the companies older HIV drug, Viread (tenofovir disoproxil TDF).

In a Phase III clinical trial, patients taking TAF scored better on biomarker-based measures of renal and bone safety, compared to those taking TDF. In addition, TAF is able to be administered at a much lower dose due to its ability to efficiently enter HIV-infected cells.



“As the first new HIV treatment backbone approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care,” said Dr. Norbert Bischofberger, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “As part of a single tablet regimen or partnered with a third agent, the components of Descovy offer patients a simple and effective combination with a safety profile that has the potential to improve health.”

“With today’s approval, Gilead is now able to offer patients and providers in the United States a range of options from our TAF-based portfolio, which is designed to help address the diverse needs of HIV patients worldwide,” said Bischofberger. Descovy has also received approval from the European Medicines Agency (EMA).

The drug does carry a boxed warning about the risk of lactic acidosis, along with severe liver problems. Descovy is a combination drug, with both TAF and emtricitabine – a compound that interferes with viral replication – taken in a single pill.


Keywords: FDA, HIV, Clinical Trial


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