FOSTER CITY, U.S.A – Gilead Sciences, Inc. (Nasdaq: GILD) has announced that Yeztugo® (Lenacapavir), the company’s injectable HIV-1 capsid inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) as pre-exposure prophylaxis (PrEP) to lower the risk of sexually acquired HIV in adults and adolescents weighing at least 35 kg.
Y News understands that this makes it the first and only twice-yearly option available in the U.S. for those who need or desire PrEP. According to data, 99.9% of individuals in the Phase 3 PURPOSE 1 and PURPOSE 2 studies who were given Yeztugo continued to be HIV negative.
“This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences.
Daniel further said that Lenacapavir is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention.
“Gilead scientists have made it their life’s work to end HIV, and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality,” Daniel added.
What caused the low uptake of PrEP across various demographics
Y News has learnt that Gilead also created the first PrEP drug, which was authorised in the United States in 2012. However, according to data from the Centres for Disease Control and Prevention (CDC), just roughly one in three (36%) Americans who satisfied the CDC’s eligibility requirements for PrEP were prescribed a form of the medication in 2022, the most recent year for which data is available.
According to CDC data, PrEP use is currently below rates that could stop the virus from spreading at the population level in all U.S. demographics, with specific gaps for women, Black/African American and Hispanic/Latino individuals, and those living in the U.S. South.
Additionally, data indicate that low uptake of PrEP across various demographics is caused by several difficulties, such as adherence issues, stigma, and a lack of knowledge about available PrEP alternatives among consumers and healthcare providers.
The fact that more than 100 people were diagnosed with HIV every day in the United States in 2023 highlights the possible implications of this low uptake, adherence, and access.
“Yeztugo could be the transformative PrEP option we’ve been waiting for—offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,” said Carlos del Rio, MD, Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and Co-Director of the Emory Center for AIDS Research in Atlanta.
How UNAIDS boss Director Winnie Byanyima reacted to the new drug
According to Carlos, a twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face.
“We also know that, in research, many people who need or want PrEP prefer less frequent dosing,” Carlos stated.
While reacting to the medical breakthrough, United Nations Programme on HIV/AIDS (UNAIDS) Executive Director Winnie Byanyima disclosed that the most infected people across Africa are young girls and young women.
“They are infected because they do not control sex. If they have sex with a man or a boy, they may not be able to insist on protection while having sex. Or they may not even be able to insist on turning the request down. So, they are the most infected,” said Byanyima.
Why sex workers should embrace the new injectable HIV-1 capsid inhibitor
The Ugandan-born academician observed that the injection is the solution for them because they don’t know how best to protect themselves.
“They can get this injection and rest assured that whatever happens will be okay with them. The most affected are the sex workers. A sex worker may sleep with 8 men in a day. So, if she is infected, then it means that she is spreading the disease,” Byanyima added.
To keep sex workers safe, Byanyima indicated that the new injection would be the best solution.
“She gets her injection every six months; whatever she is doing, she is not transmitting. So, we need it here. Gilead Sciences is going to sell the drug at USD 28,000 (Sh3.6 million) per person per year, which is out of reach for us,” lamented Byanyima.
Meanwhile, Y News knows that Yeztugo received FDA approval under Priority Review. Additionally, in October 2024, Yeztugo was granted Breakthrough Therapy Designation, which is intended to expedite the development and review of new drugs that may demonstrate substantial improvement over available therapy.
