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Drug approval

US Approves Twice-Yearly Injection for HIV Prevention: A Breakthrough in Expanding Options for People at Risk of HIV Infection

Strategic Insights

— 2 min read

The US Food and Drug Administration has approved lenacapavir, an injectable drug that offers long-lasting protection against HIV infection. This new treatment marks a significant advancement in expanding prevention options for people at risk of HIV infection, offering a convenient and highly effective alternative to daily pills.

Key Takeaways:

  • Lenacapavir is administered once every six months, providing long-lasting protection against HIV infection.
  • The drug works by attacking HIV's protective shell, stopping the virus from copying itself at multiple stages.
  • People using lenacapavir take pills for a short time before or after the injection to ensure they are protected while the injection starts working.
  • Discretion is an important factor, as people receiving long-acting medicines do not need to carry pills or explain them to others.
  • Lenacapavir is highly effective in preventing HIV, but it does not offer protection from other sexually transmitted infections (STIs), so using condoms and getting regular screening for STIs remains important.
  • Two breakthrough HIV cases in the second pivotal study of lenacapavir were linked to a virus mutation that made it resistant to the drug, highlighting the need for regular check-ups.
  • Most people do not experience serious side-effects when using long-acting lenacapavir for prevention, with mild discomfort at the injection site being the most common side-effect.
  • A few people have reported feeling nauseous, but this is uncommon.
  • The drug can interact with some other medicines, so it must only be used under medical supervision.
  • The price of lenacapavir will be a significant factor in its global roll-out, with an estimated price of around US$28,000 per year in the US.
  • Generic manufacturers supplying low- and middle-income countries could make lenacapavir for as little as US$25 a year if it were made in large enough quantities.
  • Researchers have estimated that a once-yearly version of the drug could be available in the future.

Statistics:

  • Lenacapavir is administered once every six months.
  • The drug has an estimated price of around US$28,000 per year in the US.
  • Generic manufacturers could make lenacapavir for as little as US$25 a year if it were made in large enough quantities.
  • Most people do not experience serious side-effects when using long-acting lenacapavir for prevention.
  • Mild discomfort at the injection site is the most common side-effect.
  • A few people have reported feeling nauseous, but this is uncommon.
  • Two breakthrough HIV cases in the second pivotal study of lenacapavir were linked to a virus mutation that made it resistant to the drug.

Sources:

  • The Conversation -- UK -- By Andrew Owen, Molecular and Clinical Pharmacology, University of Liverpool
  • US approves twice-yearly injection for HIV prevention -- what you need to know about lenacapavir -- https://theconversation.com/us-approves-twice-yearly-injection-for-hiv-prevention-what-you-need-to-know-about-lenacapavir-259467

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