Sign in Subscribe
Biological products industry

FDA Approves Groundbreaking HIV Prevention Drug Lenacapavir

Strategic Insights

— 2 min read

The Food and Drug Administration has approved a new, twice-a-year injectable HIV prevention medication, lenacapavir, which has been shown to be highly effective in preventing new infections. The medication, which will be marketed as Yeztugo, offers a more convenient alternative to existing daily HIV prevention pills, which have adherence rates as low as 50% to 55%. Clinical trials have demonstrated that lenacapavir is 100% effective in preventing HIV infections among women and adolescent girls in sub-Saharan Africa and Uganda, and 96% effective in lowering HIV infection rates among cisgender men and gender-diverse people in the U.S., Argentina, Brazil, Mexico, Peru, South Africa, and Thailand.

Key Takeaways:

  • Lenacapavir, marketed as Yeztugo, is a twice-a-year injectable HIV prevention medication approved by the FDA, with an annual price of $28,218 or $14,109 per injection.
  • The medication has been shown to be 100% effective in preventing HIV infections among women and adolescent girls in sub-Saharan Africa and Uganda, and 96% effective in lowering HIV infection rates among cisgender men and gender-diverse people in several countries.
  • Existing daily HIV prevention pills, such as Truvada and Descovy, have adherence rates as low as 50% to 55%, highlighting the need for more convenient and effective alternatives.
  • Insurers will likely cover the cost of lenacapavir, with Gilead working with insurers, healthcare systems, and other payers to ensure broad insurance coverage.
  • The U.S. Preventive Services Task Force has assigned an "A" rating for PrEP medications, including lenacapavir, when prescribed to adolescents and adults at increased risk of HIV.
  • Activists warn that insurers have charged copays or other cost sharing for required laboratory tests and medical visits associated with PrEP medications.

Statistics:

  • 1 million new HIV cases occur globally every year, according to the World Health Organization.
  • About 10 million people worldwide need to take PrEP to meet global HIV prevention goals, but only 2.5 million take the medication.
  • More than 39,000 U.S. residents were diagnosed with HIV in 2023, with over 4,700 deaths attributed to the virus.
  • Men account for nearly 80% of new HIV cases, with gay and bisexual men being disproportionately affected.
  • White patients are more likely to take PrEP than Black or Latino patients, despite being less likely to get infected with HIV.

Sources:

  • FDA approval of lenacapavir (Gilead)
  • Study on lenacapavir's effectiveness among women and adolescent girls in sub-Saharan Africa and Uganda (Journal of Acquired Immune Deficiency Syndromes)
  • Study on lenacapavir's effectiveness among cisgender men and gender-diverse people in several countries (New England Journal of Medicine)
  • U.S. Preventive Services Task Force recommendation on PrEP medications (USPSTF)
  • GoodRx analysis on out-of-pocket costs for uninsured patients taking Truvada and Descovy (GoodRx)
  • Centers for Disease Control and Prevention data on HIV cases and deaths in the U.S. (CDC)
  • World Health Organization data on global HIV cases and PrEP use (WHO)

Read more