This shot prevents HIV with 100% success—and it's finally approved
What's the story
The US Food and Drug Administration (FDA) has approved a new HIV prevention injection, Yeztugo.
The drug's active ingredient is lenacapavir, which was developed by American biopharmaceutical company Gilead Sciences.
The innovative treatment only requires two injections a year for protection against HIV infection.
This is a major departure from the current daily pills or monthly injections used for the same purpose.
Effectiveness
Yeztugo's efficacy and advantages over daily oral therapies
Yeztugo has shown remarkable effectiveness in preventing HIV infection, with a 100% success rate in cisgender women and 96% in diverse populations.
This is comparable or even better than existing daily oral therapies like Truvada.
The long-acting nature of Yeztugo could help overcome challenges faced by daily pill regimens, such as stigma, forgetfulness, or access issues.
Pricing
Yeztugo's cost in US and expected price in India
Despite its potential, the high cost of Yeztugo remains a major concern.
In the US, it costs $28,218 (roughly ₹24 lakh) per year or $14,109 for an injection. This makes it one of the most expensive HIV preventive drugs on the market.
However, Gilead is working to lower prices in low- and middle-income countries where generic versions could cost between $35-$46 (nearly ₹3,000-3,900) annually.
Indian market
Approval status in India and at-risk populations
Yeztugo is not yet approved in India, where 3.14 million people are living with HIV.
Gilead has filed a new medicine application for lenacapavir in multiple countries but there is no public confirmation of approval or launch date for India.
The drug doesn't treat existing infections. It is meant for populations at risk of HIV, including female sex workers, men who have sex with men (MSM), drug users and transgender people.
Distribution plan
Global access strategy for low-and middle-income countries
Gilead has announced a global access strategy, including voluntary licensing and no-profit supply, to ensure rapid access in low- and middle-income countries.
The company has signed voluntary licensing agreements with six generic manufacturers, including India's Dr Reddy's Laboratories, Emcure Pharmaceuticals and Hetero.
These companies will manufacture and distribute generic lenacapavir in 120 low-income countries, including India, once regulatory approvals are obtained.