USFDA approves first HIV prevention shot needing only two doses a year

Even after decades of medical progress, HIV continues to infect thousands globally each day, according to estimates by the World Health Organization. In a major breakthrough, the US Food and Drug Administration (FDA) on Thursday approved lenacapavir, a long-acting injectable drug that offers near-complete protection against HIV with just two doses a year.
Lenacapavir, developed by Gilead Sciences and marketed under the brand name Yeztugo, is the world's first twice-yearly HIV prevention shot. It could transform pre-exposure prophylaxis (PrEP) options, particularly for those who struggle with daily medication adherence due to stigma, access issues, or lifestyle factors.
How does lenacapavir work?
Lenacapavir is a capsid inhibitor, a class of drugs that blocks the protein shell (capsid) the HIV virus needs to replicate. Unlike oral PrEP pills that must be taken daily, lenacapavir is administered as an injection once every six months, providing a discreet and highly effective method of prevention.
How effective is lenacapavir against HIV?
In two large-scale clinical trials conducted by Gilead:
The first trial involved over 2,000 women in sub-Saharan Africa and showed a 100 per cent reduction in HIV infections, outperforming the daily oral PrEP pill Truvada.
The second trial, involving over 2,000 men and gender-diverse individuals, reported only two infections, yielding a 99.9 per cent prevention rate.
'This medicine only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention,' said Daniel O'Day, Chairman and CEO of Gilead Sciences. 'With the FDA approval of Yeztugo, we are one step closer to ending HIV.'
Is lenacapavir safe?
Clinical trials report that lenacapavir is well tolerated, with mild injection site reactions being the most common side effect. No serious safety concerns have emerged, making it a viable long-term option for prevention.
Who stands to benefit the most?
The twice-yearly dosing offers particular promise for:
Young women
LGBTQ+ individuals
People in remote or underserved regions
Public health experts say it will improve adherence and reduce infection rates in communities often left behind by daily-pill-based prevention strategies.
When will lenacapavir be available outside the US?
While the FDA has cleared the drug, approvals in other countries are still pending. Applications are under review in Europe, Australia, Canada, South Africa, Brazil, and Latin America. The World Health Organization is expected to release global guidance on July 14 during the International AIDS Conference in Kigali.
How much will Yeztugo cost?
Gilead has yet to announce the price of Yeztugo. However, analysts estimate that the US launch could cost up to $25,000 per year. Currently, lenacapavir is priced at $39,000 annually for HIV treatment use, though prices are expected to fall for prevention.
Advocacy groups such as UNAIDS and Unitaid are calling for significant price reductions in low- and middle-income countries. Generic manufacturing is being explored, with estimates suggesting a potential price of $25–$46 per year if Gilead grants licences.
What's the HIV situation in India?
According to the National AIDS Control Organisation (NACO), an estimated 2.4 million people were living with HIV in India in 2021. That year, 41,970 AIDS-related deaths were recorded, underscoring the ongoing public health challenge.

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