PrEP is an HIV prevention method designed to reduce the risk of getting HIV in people, who do not have HIV but are exposed to the virus
Image: The FDA approved the supplemental New Drug Application (sNDA) for Descovy. Photo: Courtesy of Steve Buissinne from Pixabay.
US-based biotechnology company Gilead Sciences has secured the US Food and Drug Administration (FDA) approval for its Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg tablets), with a pre-exposure prophylaxis (PrEP) indication.
Descovy is aimed at HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, in HIV-negative adults and adolescents weighing at least 35kg, and at-risk for sexually acquired HIV.
The drug is not indicated for individuals at risk of infection from receptive vaginal sex, as the effectiveness in the particular population has not been evaluated.
Gilead Sciences chairman and chief executive officer Daniel O’Day said: “Descovy for PrEP provides a new HIV prevention option that matches Truvada’s high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time.
“This is a reflection of Gilead’s continued commitment to addressing the evolving needs of people living with or at risk for HIV and to driving innovation across the HIV care continuum.”
The trial demonstrated that Descovy and Truvada reduces the risk of acquiring HIV-1 infection
PrEP is an HIV prevention method designed to reduce the risk of getting HIV in people, who do not have HIV but are exposed to the virus, by taking medicine on a daily basis.
Descovy for PrEP is intended to be used as part of a broad strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually acquired infections.
DISCOVER, a randomised, double-blind multinational trial has been conducted to evaluate the safety and efficacy of Descovy for PrEP, in 5,387 HIV-negative men and transgender women who have sex with men and were at risk of HIV-1 infection.
The study compared Descovy with Truvada (emtricitabine, tenofovir disoproxil fumarate, 200 mg/300 mg), and a daily fixed dose combination of the two drugs was approved to prevent the sexual acquisition of HIV participants.
In addition, the individuals without HIV, taking Descovy for PrEP, have faced diarrhea as the most common adverse reaction.
FDA centre for drug evaluation and research antiviral products division deputy director Jeffrey Murray said: “PrEP drugs are highly effective when taken as indicated in the drug labelling and can prevent HIV infection.
“This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the U.S. Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections.”