Gilead's Descovy Receives FDA Advisory Committee Support for Use as HIV PrEP Therapy

Aug 09, 2019 09:59 CST Updated 09:59

Gilead Sciences

Antiviral Drug Developer

FDA

U.S. Food and Drug Administration

Today, Gilead Sciences announced that the U.S. Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 2 in support of Descovy as pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection among men who have sex with men and transgender women.

AIDS is an infectious disease caused by HIV infection. The development of modern antiretroviral drugs and the rise of “cocktail therapy” have enabled patients with HIV to achieve long-term control of the condition and attain a life expectancy comparable to that of the general population. Recent studies have found that taking antiretroviral medications before exposure can reduce the risk of HIV infection. This preventive approach is known as pre-exposure prophylaxis (PrEP).

Descovy (F/TAF), a fixed-dose combination tablet composed of emtricitabine and tenofovir alafenamide developed by Gilead Sciences, Inc., has been approved for the treatment of HIV/AIDS. The potential of Descovy as pre-exposure prophylaxis (PrEP) has been validated in the DISCOVER trial.

▲Brief Introduction to the DISCOVER Trial Design (Image Source: Reference [2])

In the DISCOVER trial, Descovy was compared with the approved PrEP regimen Truvada (F/TDF) to evaluate whether its efficacy in reducing HIV risk met the non-inferiority criteria. The results showed that the average annual HIV incidence rate was 0.16 per 100 person-years in the Descovy group, compared to 0.34 per 100 person-years in the Truvada group. Descovy demonstrated non-inferiority to Truvada. Furthermore, Descovy exhibited significantly better safety profiles regarding bone mineral density and renal function than Truvada.

References:

[1] Gilead Sciences Statement on U.S. Food and Drug Administration Advisory Committee’s Recommendation on Descovy for PrEP™. Retrieved Aug 8, 2019, from https://www.businesswire.com/news/home/20190807005917/en

[2] Gilead Sciences Q4 2018 Earning Results. Retrieved February 5, 2019, from http://investors.gilead.com/static-files/d37c8017-5ae2-40d1-b8e3-371604c33341

*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.

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