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Twice-Yearly Injection Approved for HIV Prevention
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The FDA’s approval of lenacapavir marks a turning point in HIV prevention, but challenges remain in ensuring global access.
The U.S.Food and Drug Governance (FDA) granted approval on June 18 to the first medication designed to prevent HIV that requires administration only twice annually. Individuals at high risk of contracting HIV now have the option of receiving an injection-known as lenacapavir and marketed as Yeztugo-just once every six months.
This approval signifies a major advancement in the ongoing battle against HIV and holds the potential to reshape the course of the epidemic. While existing anti-HIV treatments have been instrumental in helping millions achieve undetectable viral loads, preventing transmission, and enabling HIV-negative individuals to maintain their status through pre-exposure prophylaxis (PrEP), the reliance on daily pills often leads to adherence challenges, impacting overall effectiveness.
Data from two studies conducted by Gilead, the developer of lenacapavir, demonstrated that the drug exhibited a 96% effectiveness rate in preventing HIV acquisition among cisgender women compared to daily oral PrEP. Among men who have sex with men and gender-diverse individuals, the drug demonstrated 100% effectiveness.
“Lenacapavir used by itself for prevention is a huge breakthrough,” said Dr. David Ho,professor of microbiology,immunology,and medicine at Columbia University,a pioneer of combination anti-HIV therapies. “Its potential is great in curtailing the epidemic.”
Though, advocacy groups and global AIDS organizations have voiced concerns regarding the full realization of this potential, citing recent cutbacks in U.S.-funded programs dedicated to HIV treatment and prevention on a global scale.
From Treatment to Prevention
“lenacapavir used by itself for prevention is a huge breakthrough. Its potential is great in curtailing the epidemic.”
Lenacapavir initially received FDA approval in 2022 for the treatment of individuals with HIV who have developed resistance to multiple other drugs.
Frequently Asked Questions About Lenacapavir
How dose lenacapavir work to prevent HIV?
lenacapavir is a capsid inhibitor that interferes with the HIV virus’s ability to infect new cells by disrupting its protein shell. This prevents the virus from replicating and spreading within the body.
Who is lenacapavir for?
Lenacapavir is approved for individuals at high risk of HIV infection. It provides an option to daily oral prep medications, particularly beneficial for those who may struggle with adherence.
How often is lenacapavir administered?
Lenacapavir is administered as an injection once every six months, making it a long-acting PrEP option.
