- Drug: Lenacapavir (brand name Yeztugo).
- Approval: Approved by the US FDA (June 2025) as the first and only twice-yearly (every six months) injectable for Pre-Exposure Prophylaxis (PrEP).
- Efficacy: Showed $\ge 99.9\%$ efficacy in the Phase 3 PURPOSE trials (PURPOSE 1 and PURPOSE 2).
- Mechanism: It is an HIV-1 capsid inhibitor, acting on multiple stages of the viral life cycle.
- Significance:
- Offers a long-acting, low-maintenance alternative to daily oral PrEP pills.
- Expected to dramatically improve global adherence/compliance and reduce stigma.
- Global Access Challenges (Cost):
- High initial price (e.g., ~$28,000 USD or $\sim\text{₹}24$ lakh annually in the US market) currently makes it inaccessible for national programs in India and other Low- and Middle-Income Countries (LMICs).
- Resolution: WHO issued a guideline recommendation (July 2025) and generic manufacturers (including Indian firms like Dr. Reddy’s and Hetero) have signed agreements to supply the drug for as low as $40 per patient per year to LMICs starting around 2027, following regulatory and procurement support from agencies like WHO, Unitaid, and the Gates Foundation.
This makes the drug a transformative tool, pending the successful, affordable rollout in regions with high HIV burdens.
Would you like a brief comparison of Lenacapavir with the other available long-acting PrEP option?