FDA Approves Yeztugo: A Breakthrough Twice-Yearly Injection for HIV Prevention
The FDA's approval of Yeztugo, a twice-yearly injection for HIV prevention, marks a significant milestone amid ongoing challenges in HIV prevention efforts.
FDA Approves “Breakthrough” HIV Drug
Mother Jones
FDA Approves a Twice-Yearly Shot to Prevent HIV
TIME Magazine
FDA approves first HIV prevention injection - Washington Examiner
Washington Examiner
FDA approves the world's only twice-a-year shot to prevent HIV
Associated Press
Overview
- The FDA has approved Yeztugo, the first twice-yearly injection for HIV prevention, which offers a convenient alternative to daily pills.
- Lenacapavir, the active ingredient in Yeztugo, can reduce HIV infection rates by 96% in high-risk populations, including men and women.
- Despite the approval, budget cuts from the Trump administration may impact HIV prevention efforts and access to treatment for patients.
- In 2022, approximately 31,800 new HIV infections were reported in the U.S., highlighting the urgent need for effective prevention methods.
- Yeztugo's high cost, with an annual list price exceeding $28,000, may hinder access for many Americans despite its potential benefits.
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Analysis
Center-leaning sources frame the FDA approval of lenacapavir as a significant advancement in HIV prevention, emphasizing its convenience and effectiveness compared to existing treatments. However, they also highlight potential barriers, such as cost and previous funding cuts, reflecting a cautious optimism about its impact on public health.
The twice-yearly injection provides a more convenient option for HIV prevention compared to daily pill regimens like Truvada.
The cost of Yeztugo may pose a barrier to accessing the medication, which will be sold under a different name for prevention purposes.
Lenacapavir targets the virus's capsid protein to prevent replication for six months, making it the longest-lasting preventive option available.
The FDA and U.S. have approved the world's only twice-a-year shot for HIV prevention.
Only a small percentage of Americans who could benefit from PrEP are currently using it.
The FDA approved lenacapavir as a twice-yearly injection for HIV prevention, marking a significant milestone in HIV prevention efforts.
Articles (11)
"…The historic arrival of lenacapavir (aka Yeztugo) as a form of PrEP makes now a uniquely bad time to walk away from HIV research and aid."
Mother Jones·6d·"…The long-acting nature of lenacapavir represents a new direction for anti-HIV drugs that could make preventing infections more tenable and accessible to more people."
TIME Magazine·6d·"…The hope is the medication could accelerate the stubbornly slow decline of HIV transmission in the United States."
NBC News·6d·"…The U.S. has approved the world’s only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions."
Chicago Sun-Times·6d·"…The FDA's decision makes lenacapavir available today in the U.S., which sees about 31,000 of the 1.3 million new HIV infections each year worldwide."
NPR·6d·"…Giving people the option of a twice-a-year injectable is "a game changer, not only for the United States, but around the world," said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute."
USA TODAY·6d·"…The U.S. has approved the world’s only twice-a-year shot to prevent HIV, which could protect millions."
ABC News·6d·"…The approval of lenacapavir represents a significant advancement in the fight against HIV, although concerns remain about the impact of funding cuts on vaccine research."
CBS News·6d·"…Lenacapavir’s six-month protection makes it the longest-lasting type, an option that could attract people wary of more frequent doctor visits or stigma from daily pills."
Associated Press·6d·"…The U.S. has approved the world’s only twice-a-year shot to prevent HIV, which could protect millions."
Boston Herald·6d·"…The Food and Drug Administration on Wednesday granted approval for Gilead Sciences’ twice-yearly injectable HIV prevention medication, a milestone that the company and some epidemiologists have said could be a monumental step toward ending the decadeslong HIV/AIDS epidemic."
Washington Examiner·6d·FAQ
Yeztugo is a twice-yearly injectable medication containing lenacapavir, which acts as an HIV-1 capsid inhibitor to prevent sexually acquired HIV infections in adults and adolescents.
Clinical trials demonstrated that lenacapavir reduced HIV infections by up to 96% in high-risk populations, with some studies showing a 100% reduction among trial participants receiving the drug.
The high cost of Yeztugo, with an annual list price exceeding $28,000, combined with budget cuts to HIV prevention programs from previous administrations, may hinder patient access and impact overall prevention efforts.
Yeztugo is approved for use as pre-exposure prophylaxis (PrEP) in adults and adolescents at high risk of sexually acquired HIV infection, including both men and women.
Yeztugo offers a more convenient alternative to daily oral PrEP pills by requiring only two injections per year, which could improve adherence and help reduce new HIV infections.
History
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