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.
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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.
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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).
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By GlobalDataIt 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.
