Gilead has presented updated data for its twice-yearly pre-exposure prophylaxis (PrEP) lenacapavir, which has shown nearly perfect efficacy in two pivotal studies.
The Phase III PURPOSE-2 trial (NCT04925752) enrolled cis- and transgender men, transgender women, and gender non-binary individuals who have sex with partners assigned male at birth. The trial pitted PrEP lenacapavir against standard-of-care once-daily Truvada (emtricitabine + tenofovir disoproxil fumarate).
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New safety data from the trial indicated that lenacapavir was generally well tolerated with few serious adverse events (SAEs) reported. One of the most common AEs was injection site reaction. (ISRs). Among the 15,239 shots administered, 63.4% of the lenacapavir recipients reported subcutaneous nodules, while 56.4% experienced injection site pain.
Other common AEs included sexually transmitted infections such as chlamydia and gonorrhoea. SAEs were reported in 3.3% of participants who received lenacapavir compared to 4% of those who got Truvada.
This builds on efficacy data from the PURPOSE-2 trial previously announced in September, which showed that lenacapavir outperformed once-daily Truvada. There were two HIV cases out of the 2,180 enrolled patients, meaning 99.9% of patients did not acquire HIV. Lenacapavir was 89% more effective than Truvada, and it reduced HIV infections by 96% compared to background HIV incidence (bHIV).
The drug was also evaluated in the PURPOSE-1 trial (NCT04994509), which compared lenacapavir as PrEP to alternative daily PrEP with Truvada or Gilead’s Descovy (emtricitabine and tenofovir alafenamide) in 5,345 HIV-negative, adolescent girls and young women aged 16 to 26 in South Africa and Uganda. The trial demonstrated 100% efficacy in HIV prevention in women. It also demonstrated superior prevention compared with Truvada and Descovy.
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By GlobalDataIn the announcement accompanying the study results, PURPOSE-2 principal investigator and professor of medicine at Emory University Dr. Colleen Kelley said: “These data reinforce that twice-yearly lenacapavir could be a highly effective and potentially game-changing HIV prevention choice that we have long hoped for in our efforts to end the HIV epidemic.”
This news comes days after Gilead pledged its commitment to making its HIV drugs more accessible. The company signed royalty-free licensing agreements with six generic drugmakers to enhance access to lenacapavir. Under the terms of the voluntary agreement, the six companies will manufacture and sell Gilead’s lenacapavir in 120 low- and lower-middle-income countries with high incidences of HIV.
However, the Joint United Nations Programme on HIV/AIDS (UNAIDS) called out Gilead after the announcement for excluding several middle-income countries from the agreements and urged the company to secure further licenses.
Lenacapavir is marketed by Gilead as Sunlenca as an HIV treatment for patients resistant to other medication options. In PURPOSE-1 and 2 it is being trialled as a PrEP medication, a group of drugs that HIV-negative people can take to minimise the risk of contracting HIV. Gilead now plans to use the data from both trials to support a series of global regulatory filings for lenacapavir for PrEP that will begin by the end of 2024.
