Revolutionary HIV Drug Lenacapavir Achieves Breakthrough Status for PrEP, Promises Global Impact

December 20, 2024
Revolutionary HIV Drug Lenacapavir Achieves Breakthrough Status for PrEP, Promises Global Impact
  • Lenacapavir is approved in the US and other countries for treating adults with drug-resistant HIV, demonstrating near-complete efficacy as a pre-exposure prophylaxis (PrEP) in clinical trials.

  • The FDA has granted lenacapavir breakthrough therapy designation, which accelerates its development and review for PrEP use.

  • In clinical trials, lenacapavir showed remarkable results, with none of the 2,138 women in the PURPOSE 1 trial contracting HIV, and only two out of 2,179 participants becoming infected in the PURPOSE 2 trial, indicating over 99% success.

  • The treatment's twice-yearly injection schedule offers a significant advantage over daily oral PrEP, making it more appealing for individuals at risk.

  • Dr. John Nkengasong emphasized the importance of lenacapavir in reducing the 1.3 million new annual HIV infections, highlighting its potential to transform prevention efforts.

  • An estimated two million people in countries supported by PEPFAR and the Global Fund, including Kenya, are expected to gain access to lenacapavir over the next three years, pending necessary regulatory approvals.

  • In October 2024, Gilead announced non-exclusive licensing agreements with six companies to produce generic lenacapavir in 120 low and lower-middle-income countries.

  • Peter Sands from the Global Fund noted collaborative efforts to ensure affordable access to lenacapavir for high-risk populations, while Chris Hohn stressed the need for timely availability for communities in need.

  • The World Health Organization has a history of recommending various PrEP options, including tenofovir disoproxil fumarate in 2015, the dapivirine ring in 2021, and cabotegravir in 2022.

  • Global regulatory submissions for lenacapavir are anticipated to begin by the end of 2024, bolstered by the positive trial data.

Summary based on 1 source


Get a daily email with more Medicine stories

Source

More Stories