US FDA Approves Breakthrough HIV Prevention Shot Taken Twice a Year

In a major advancement for global HIV prevention, the United States Food and Drug Administration (FDA) has approved Lenacapavir, a long-acting injectable medication developed by Gilead Sciences. Marketed under the name Yeztugo, this twice-yearly injection demonstrated 99.9% efficacy in preventing HIV in Phase 3 trials. The drug offers a revolutionary alternative to daily pills or bimonthly injections currently in use and holds the potential to overcome key barriers such as pill fatigue, stigma, and access-related challenges.

Why in News?

The US FDA approved Lenacapavir for pre-exposure prophylaxis (PrEP) against HIV. Phase 3 trials showed 99.9% of recipients remained HIV-negative with just two injections annually. The drug could significantly improve compliance and reduce stigma associated with HIV prevention. WHO said this may pave the way for faster regulatory approvals and global rollout.

What is Lenacapavir?

• Lenacapavir is an antiretroviral drug that works by binding to the HIV capsid, blocking essential steps in the virus’s replication.
• It is already marketed as Sunlenca for treating HIV in multi-drug resistant patients.
• Now approved as Yeztugo, it is used for prevention (PrEP) of HIV infection.

What is PrEP (Pre-exposure Prophylaxis)?

• PrEP is a medication taken before potential exposure to HIV to prevent infection.

Currently includes,

• Daily oral pills (e.g., Truvada, Descovy)
• Dapivirine vaginal ring
• Cabotegravir injection (taken every 2 months)
• PrEP reduces HIV risk by:
• 99% via sexual contact
• 74% via injection drug use

Who Should Take PrEP?

Recommended for,

• Individuals with HIV-positive partners
• People with multiple or unknown-status sexual partners
• Sex workers
• Users of injectable drugs
• Those at risk of occupational or accidental exposure

Global and Indian Context

In India

• Generic PrEP pills approved
• Cabotegravir is available via license
• Not included in national HIV programme due to high costs
• Lenacapavir costs ~USD 28,218/year — a major affordability barrier

Globally

• Usage remains low, even in the US (only 36% of eligible people use it)

Significance of the Breakthrough

• Ease of use: Only two shots annually increase patient compliance.
• Reduces stigma: Discreet use eliminates visible signs of HIV prevention.

Global implications

• Could become part of WHO’s prequalification list.
• Opens doors to procurement by donor agencies like the Global Fund.

Addresses systemic barriers like,

• Frequent clinic visits
• Daily adherence burden
• Costly treatment interruptions