The US Food and Drug Administration has finally approved Lenacapavir. This is a new injectable HIV drug, providing protection for up to six months in a single dose. The Science journal calls this 'breakthrough of the year', which represents groundbreaking advancement in efforts for the prevention and treatment of HIV/AIDS around the globe.

Key Highlights
1. A Breakthrough Approval:

• California-based Gilead Sciences developed Lenacapavir, an HIV-1 capsid inhibitor that can be administered via subcutaneous injection every six months.

• The drug was almost flawless in clinical trials, as it effectively prevented HIV infections in cisgender men, transgender people, and gender-diverse individuals.

2. Clinical Success:

• In the case of African adolescent girls and young women, a 100% efficacy rate was achieved in preventing new infections.

• Another international phase III study showed a 99.9% success rate among gender-diverse populations, further solidifying its capacity to change the landscape of HIV prevention.

3. Revolutionary Promise

• According to the WHO, LEN boasts benefits over daily oral PrEP, including overcoming drawbacks such as stigma, pill burden, and variable medication access.

• Experts, such as infectious disease specialist Linda-Gail Bekker, stress that widespread access and adoption will be key.

Why It Matters:

• Despite decades of medical advances, more than one million new individuals are infected with HIV yearly.

• Lenacapavir may be the first medicine proven to decrease the annualized rate of global infection substantially and accelerate the effort towards making HIV/AIDS a relatively rare, treatable infection.

Challenges and Perspectives:

• The widespread adoption of lenacapavir into HIV prevention will depend on whether it is accessible and affordable and in demand.

• Application for approval as preexposure prophylaxis or PrEP is expected for mid-2025.

Expert Opinion:

• Science journal underlines the importance of lenacapavir in a series of biomedical breakthroughs that propel HIV/AIDS prevention forward.

• WHO reports that oral PrEP is effective, but lenacapavir, administered every six months, provides an essential advantage for populations facing challenges with adherence.

This approval by the FDA marks a giant leap in the battle against HIV/AIDS. As it awaits the mass acceptance that comes with efficient delivery and access, this innovative injectable drug is closer to bringing an end to the global HIV epidemic.