FDA approves twice-yearly injectable PrEP

The Food and Drug Administration on June 18 approved a twice-yearly injectable HIV prevention shot, representing another key development in a years-long effort to deliver another option in the fight against HIV/AIDS. The approval comes more than three years after cabotegravir, which is offered by ViiV Healthcare under the name Apretude, was approved as an injectable form of PrEP that is administered every other month. In recent years, studies have yielded promising results surrounding the effectiveness of the injectable form of PrEP. The latest approval involves using lenacapavir, by Gilead, which will label it under the brand name Yeztugo. It has been more than a decade since Gilead's Truvada pill was first approved for HIV prevention in 2012. Another oral option, Descovy, was approved in 2019. However, it has been a challenge for some people to take the pill on a daily basis, and there have been longstanding racial disparities. While Apretude is used by 21,000 Americans, the daily pills are taken by 500,000 Americans, according to the New York Times. The new approval, however, prompted questions about affordability as well as concerns about funding cuts from the Trump administration, which has proposed steep cuts to the Centers for Disease Control and Prevention's (CDC) HIV prevention efforts in the upcoming fiscal year. In recent weeks, the Trump administration terminated a $258 million program tasked with searching for an HIV vaccine and paused a separate program to search for a vaccine made by Moderna, according to the New York Times. In late May, the Times reported that the Trump administration withheld funds owed to states and territories for HIV prevention. PrEP4All, which fights for greater access to HIV prevention medication and seeks a national PrEP program for uninsured and underinsured populations, said in a written statement that the FDA's approval was a "welcome development," but also said "the path to access is more perilous than ever for the communities in greatest need of PrEP, and it is far from clear that innovation will triumph over the expensive price Gilead has set for lenacapavir coupled with active efforts by the Trump administration and Congressional Republicans to dismantle HIV prevention and healthcare systems in America." The New York Times, citing Gilead, reported that Lenacapavir will be priced at $28,218. Gilead is making the case that many people would not have to pay for it because it would be covered by insurance or through patient assistance programs. However, legal issues could also complicate the future of PrEP: Earlier this year, the Supreme Court said it would hear an appeal in a case surrounding the legality of the US Preventive Services Task Force, which makes determinations surrounding which drugs should require coverage under the Affordable Care Act. Carl Schmid, the executive director of the HIV+Hepatitis Policy Institute, said the new drug would reduce HIV infections "if people are aware of it and payers, including private insurers, cover it without cost-sharing as a preventive service." "Private insurers and employers must also immediately cover Yeztugo as a required preventive service, which means that PrEP users should not face any cost-sharing or utilization management barriers. Despite a Grade ‘A’ rating from the USPSTF for PrEP, and supporting federal guidance, PrEP users are still being subjected to unlawful copays and prior authorization. At a time when there is such an emphasis on prevention to avert chronic diseases, we call on federal and state regulators to step up enforcement of the ACA preventive services requirement."