Twice-yearly HIV prevention drug 'lenacapavir' demonstrates 100% efficacy in preventing HIV in Phase III clinical trial
Lenacapavir, developed by
Gilead's Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention
https://www.gilead.com/news-and-press/press-room/press-releases/2024/6/gileads-twiceyearly-lenacapavir-demonstrated-100-efficacy-and-superiority-to-daily-truvada-for-hiv-prevention
Watch out, GSK. Gilead's twice-yearly PrEP drug shows 100% efficacy for HIV prevention | Fierce Pharma
https://www.fiercepharma.com/pharma/watch-out-gsk-gileads-twice-yearly-prep-drug-shows-100-efficacy-hiv-prevention
Lenacapavir, a twice-yearly HIV prevention drug developed by Gilead Sciences, is available as both an oral and subcutaneous drug. Lenacapavir has demonstrated 100% efficacy in preventing HIV in cisgender women. Lenacapavir achieved superior results in key efficacy endpoints, including superiority and background incidence, against Truvada , an HIV prevention drug that requires oral administration once daily. In response to these results, an independent data monitoring committee recommended that Gilead Sciences discontinue the blinded phase of the study and provide lenacapavir to all subjects in an open-label setting.
'Lenacapavir's 100% efficacy in reducing HIV infection demonstrates its potential as an important new tool to help prevent HIV,' said Mehrdat Parsy, MD, Chief Medical Officer, Gilead Sciences. 'We look forward to receiving further results from our ongoing clinical trial program and continuing to advance our goal of ending the HIV epidemic for all people around the world.'
In a Phase 3 clinical trial, Gilead Sciences evaluated the safety and efficacy of lenacapavir twice-yearly, Descovy once-daily, or Truvata once-daily for pre-exposure prophylaxis (PrEP) in more than 5,300 cisgender women and girls ages 16-25 years old at 25 sites in South Africa and three sites in Uganda. Participants were treated with lenacapavir, Descovy, and Truvata in a 2:2:1 ratio.
Of the 2,134 women who received lenacapavir, 0 were infected with HIV, compared with 16 of the women who received Truvata (1,068) and 39 of the women who received Descovy (2,136). Lenacapavir, which only needs to be administered twice a year, performed better than Truvata, which must be administered once daily. Lenacapavir was generally well tolerated, and no significant or new safety concerns were identified.
'Approval of twice-yearly lenacapavir for PrEP could provide an important new HIV prevention option that fits into the lives of many people around the world who could benefit from PrEP, particularly cisgender women,' said Dr. Linda Gayle Becker, director of the Desmond Tutu HIV Centre at the University of Cape Town in South Africa and former president of the International AIDS Society. 'While traditional HIV prevention options have been shown to be highly effective when taken as prescribed, twice-yearly lenacapavir for PrEP could help address the stigma and discrimination some people may face when taking or storing oral PrEP pills. It may also help increase adherence and retention on PrEP, given the twice-yearly dosing schedule.'
Going forward, Gilead Sciences plans to evaluate the effectiveness of lenacapavir in cisgender men who have sex with men, transgender men, transgender women, and non-binary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.
Based on this and future data, Gilead Sciences plans to seek approval of lenacapavir from the US regulatory authority, the Food and Drug Administration (FDA).
According to estimates by biopharmaceutical company GSK, the PrEP market is expected to more than double in size by 2031, reaching around £4-5 billion (approximately 800-1 trillion yen). Of this, long-acting injectables account for around 80% of the market value, so 'lenacapavir is likely well positioned to capture a significant share of the PrEP market,' said Salim Said, an analyst at investment bank William Blair & Company.
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