American biopharmaceutical company Gilead Sciences has secured approval from the US Food and Drug Administration (FDA) for Descovy (emtricitabine 200mg/tenofovir alafenamide 25mg, F/TAF) to treat patients with HIV.

Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients 12 years of age and older.

It is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high-risk.

Gilead Sciences chief scientific officer Norbert Bischofberger said: "As the first new HIV treatment backbone approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care. 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."

The approval allows Gilead to offer a range of options from its TAF based-portfolio in the US, which is designed to help address the diverse needs of HIV patients worldwide.

"The components of Descovy offer patients a simple and effective combination with a safety profile that has the potential to improve health."

TAF is a novel targeted prodrug of tenofovir that is said to have demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate, TDF).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

It has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents.

TAF can be given at a much lower dose as it enters cells, including those that are HIV-infected, more efficiently than TDF.

Approval of Descovy is based on two pivotal Phase III studies (Studies 104 and 111) in which the F/TAF-based regimen met its primary objective of non-inferiority compared to a F/TDF-based regimen.

It is also supported by a Phase III study (Study 109) that evaluated the F/TAF-based regimen (administered as Genvoya) among virologically suppressed adult patients who switched from F/TDF-based regimens.

Image: Scanning electron micrograph of HIV-1 budding (in green) from cultured lymphocyte. Photo: courtesy of C Goldsmith.