Gilead Sciences has secured the US Food and Drug Administration (FDA) approval for Descovy in pre-exposure prophylaxis (PrEP) to mitigate the risk of sexually acquired HIV-1 infection.
The drug is indicated for PrEP in men and transgender women weighing at least 35kg. PrEP is an approach for preventing HIV, where HIV-negative individuals take medicine daily to reduce the risk of infection upon exposure to the virus.
Descovy comprises 200mg emtricitabine and 25mg tenofovir alafenamide. In 2016, the drug received FDA approval to treat HIV-1 infected adults and paediatric patients in combination with other antiretroviral drugs.
The latest approval for PrEP indication comes from results obtained during the Phase III DISCOVER clinical trial, which compared the safety and efficacy of Descovy to that of Truvada in 5,387 adult cisgender men or transgender women who have sex with men.
Truvada is also the company’s medicine indicated for PrEP to reduce the risk of sexually acquired HIV-1.
The primary efficacy endpoint was the incidence of HIV infection per 100 person-years after the follow-up of all participants for at least 48 weeks and follow-up of a minimum of 50% participants for 96 weeks.
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Of the 2,694 participants who were at HIV-1 infection risk and treated with Descovy, seven went on to develop the infection, compared to 15 out of the 2,693 participants treated with Truvada.
In addition to the non-inferiority to Truvada, Descovy demonstrated statistically significant advantages on all pre-specified secondary endpoints across renal and bone laboratory parameters.
Gilead Sciences chairman and CEO 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.”
Descovy comes with a boxed warning for the risk of acute hepatitis B exacerbation after treatment. It also has a warning for drug resistance risk with PrEP use in undiagnosed early HIV-1 infection.