The US Food and Drug Administration (US FDA) has approved lenacapavir, a twice-a-year injection, to prevent HIV infection, a mark shifted from daily pills that could also help control the spread of the epidemic.
Developed by US drugmaker Gilead Sciences, the drug, to be sold under the name Yeztugo, offers six months of protection with just two injections a year — redefining convenience and adherence to HIV regimen.
With 1.3 million new HIV infections globally each year, Yeztugo could accelerate epidemic control, particularly in high-burden countries.
Why it matters
Yeztugo, which got the nod on June 18, is the only FDA-approved HIV prevention option requiring just two injections in a year, a major leap from daily oral pills and monthly injectables.
In large-scale clinical trials, Yeztugo was 100 percent effective in preventing HIV in cisgender women and 96 percent in diverse populations — comparable or superior to existing Pre-Exposure Prophylaxis (PrEP) daily oral therapy such as Truvada.
Daily pill regimens often falter due to stigma, forgetfulness or access issues. Yeztugo’s long-acting profile addresses this gap, especially for vulnerable populations.
The price barrier
The approval has been welcomed by global health organizations, including the World Health Organization (WHO), which is working to expand access and integrate lenacapavir into HIV prevention strategies worldwide.
However, concerns about affordability and equitable access remain.
In the US, Yeztugo is priced at $28,218 (around Rs 24.4 lakh) a person per a year, or $14,109 (Rs 12.2 lakh) for an injection — making it one of the most expensive HIV preventive drugs in the market.
In comparison, generic Truvada costs $200–$500 a year.
Gilead said it is committed to lowering prices in low- and middle-income countries, where generic versions could cost $35–$46 (around Rs 3,000-3,900) a year, or even $25 (Rs 2,1065) a year with scale.
Gilead will supply up to 2 million doses at no profit until generics are available.
When will it be available in India?
Lenacapavir is not yet approved in India. The patent claims of Gilead lenacapavir has been challenged in India and the case is still being heard.
India is home to 3.14 million people living with HIV, according to the National AIDS Control Organisation (NACO). The staggering number makes India a key market for Yeztugo’s global rollout.
In March, Gilead submitted a new medicine application for lenacapavir in several countries, but there is no public confirmation yet of regulatory approval or a launch date for India.
The drug is suitable for populations at risk of HIV, these include female sex worker, men who have sex with men (MSM), drug users and transgender people. Other risk factors include unprotected heterosexual intercourse, low condom use, intravenous drug use, and transfusions with contaminated blood.
Gilead has announced a global access strategy, including voluntary licensing and no-profit supply, to enable broad and rapid access in low- and middle-income countries, which would include India.
In September, Gilead signed voluntary licensing agreements with six generic manufacturers, including Dr Reddy’s Laboratories, Emcure Pharmaceuticals and Hetero from India. These firms will produce and distribute generic lenacapavir across 120 low-income countries, including India, once regulatory approvals are secured.
Currently, first generation antiretroviral combination Tenofovir/Lamivudine/Dolutegravir (TLD) is widely supplied in India at less than $100 a year. The oral PrEP Truvada costs on average Rs 2,000 for 30 tablets. The prices are coming down, due to competition among generic manufacturers, especially in Indian companies.
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