Descovy FDA approval : Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) has been approved by the US Food and Drug Administration for HIV Pre-Exposure Prophylaxis (PrEP) or in other words prevention of HIV infection..
PrEP is defined as an HIV prevention method in which medicine is taken everyday before an HIV-negative person may be exposed to the virus via sex to help cut down the risk of infection. As per the Centers for Disease Control and Prevention (CDC), PrEP is highly effective at lowering the risk of HIV infection in at-risk populations.
Descovy for PrEP has been indicated to lower the risk of sexually acquired HIV 1 infection in adult and adolescent patients who are than 35kg weight, who are HIV-negative, and are prone to sexually acquired HIV with the exclusion of people at-risk from receptive vaginal sex.
The drug’s effectiveness for PrEP in individuals prone to HIV-1 from receptive vaginal sex has not been established.
Daniel O’Day – Chairman and CEO of Gilead Sciences, commenting on Descovy FDA approval, 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.”
Descovy FDA approval has been given on the basis of data from the phase 3 DISCOVER clinical trial that assessed the safety and efficacy of Descovy for PrEP in comparison to Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP in lowering the risk of acquiring HIV-1 infection.
Enrollment for the DISCOVER clinical trial consisted of 5,300 plus adult cisgender men who have sex with men or transgender women (TGW), who have sex with men.
The DISCOVER clinical trial’s primary endpoint was the incidence of documented HIV infection per 100 person-years after all participants had follow-up of 48 or more weeks and 96 or more weeks of follow-up.
Among the 2,694 participants who were prone to HIV-1 infection and were given once-daily Descovy, seven HIV-1 infections were recorded. Among the 2,693 participants in the Truvada arm, who were at risk of HIV-1 infection, 15 HIV infections (0.34/100 PY) were reported.
The DISCOVER clinical trial showed that Descovy achieved non-inferiority to Truvada in the participants who were prone to HIV acquisition.
Apart from that, statistically significant advantages were observed with respect to all six pre-specified secondary endpoints for renal as well as bone laboratory parameters in patients subjected to Descovy compared to those in the Truvada arm.
Edwin DeJesus – Orlando Immunology Center Medical Director said: “Today, because of landmark biomedical and scientific research advances, there are unprecedented opportunities to significantly reduce new HIV infections”
“Descovy for PrEP offers healthcare providers and appropriate people at risk for HIV an additional biomedical prevention option with a demonstrated improvement in bone and renal safety parameters as compared to Truvada.”
Descovy cannot be used for preventing other sexually transmitted infections or for the cure of HIV infection or AIDS.