By IDSE News Staff
The FDA granted a new indication to emtricitabine-tenofovir alafenamide (Descovy, Gilead; FTC/TAF) for use as pre-exposure prophylaxis (PrEP).
FTC/TAF for PrEP is indicated to reduce the risk for sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are HIV-negative and at risk for sexually acquired HIV, excluding individuals at risk from receptive vaginal sex.
The advisory panel that reviewed the data did not support a recommendation for women because the members felt there was not enough data to support that indication.
The approval of a PrEP indication for FTC/TAF, taken once daily with or without food in patients weighing at least 35 kg, is based on data from the DISCOVER trial, a multiyear, global phase 3 registrational clinical trial that evaluated the safety and efficacy of FTC/TAF for PrEP compared with that of current approved PrEP treatment—emtricitabine-tenofovir disoproxil fumarate (Truvada, Gilead; F/TDF)—in reducing the risk for acquiring HIV-1 infection. Enrollment included more than 5,300 adult cisgender men who have sex with men or transgender women (TGW) who have sex with men.
The primary efficacy end point of DISCOVER was the incidence of documented HIV infection per 100 person-years after all participants had a follow-up of at least 48 weeks and at least half had 96 weeks of follow-up. These data, which were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI), included 5,387 individuals who were randomized 1:1 to receive either FTC/TAF or F/TDF. Among the 2,694 participants (4,370 person-years) who were at risk for HIV-1 infection and received once-daily FTC/TAF, seven HIV-1 infections (HIV-1 incidence, 0.16/100 person-years) were reported. Among the 2,693 participants (4,386 person-years) who were at risk for HIV-1 infection and received F/TDF, 15 HIV infections (0.34/100 person-years) were reported.
Results from the DISCOVER trial demonstrated that FTC/TAF achieved noninferiority to F/TDF in study participants who were at risk for HIV acquisition. Efficacy was strongly correlated with adherence to daily dosing.
Additionally, statistically significant advantages were observed with respect to all six prespecified secondary end points for both renal and bone laboratory parameters in patients receiving FTC/TAF compared with F/TDF.
“Today, because of landmark biomedical and scientific research advances, there are unprecedented opportunities to significantly reduce new HIV infections,” said Edwin DeJesus, MD, FACP, FIDSA, the medical director of Orlando Immunology Center, in Florida. “Descovy for PrEP offers health care 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.”
The most common adverse reaction in people without HIV who were taking FTC/TAF for PrEP was diarrhea.
According to the CDC, 38,739 people received an HIV diagnosis in the United States in 2017. The plan to end the HIV epidemic in America seeks to provide the country’s hardest-hit communities with additional expertise, technology and resources required to address the HIV epidemic. The aim is to reduce new infections by 75% in the next five years and by 90% in the next 10 years, averting more than 250,000 HIV infections in that timespan.
PrEP is an HIV prevention method in which people who do not have HIV take daily medication to reduce their risk for contracting HIV if they are exposed to the virus. FTC/TAF for PrEP should be used as part of a comprehensive strategy, including adherence to daily administration and safer sex practices, including condom use, to reduce the risk for sexually acquired infections.
“PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection,” said Jeffrey Murray, MD, MPH, the deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “This approval provides more prevention options for certain patients at risk for acquiring HIV and helps further efforts by the FDA and the Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections.”
There is a boxed warning for individuals who take FTC/TAF who also have hepatitis B virus (HBV) to be aware of a risk for exacerbations of HBV in those who discontinue products with emtricitabine or tenofovir disproxil fumarate, and which may occur in individuals who discontinue FTC/TAF. FTC/TAF for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status and should only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating use and at least every three months during use.
FTC/TAF was FDA approved in 2016 in combination with other antiretroviral drugs to treat HIV-1 infection in adults and pediatric patients. The FDA approved the supplemental New Drug Application for Descovy under a priority review designation.
Gilead offers the Gilead Advancing Access program to help address affordability challenges and to help continue to ensure that cost is not a barrier to people in the United States who need the company’s medication. Information about Gilead’s support programs is available on the Gilead Advancing Access website.