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In a groundbreaking development for HIV prevention, Gilead Sciences announced today that its innovative twice-yearly injectable HIV capsid inhibitor, lenacapavir (Sunlenca), has demonstrated superior efficacy compared to the widely used daily pre-exposure prophylaxis (PrEP) pill, emtricitabine and tenofovir disoproxil (Truvada). The announcement follows the early results from the PURPOSE 2 phase 3 clinical trial.
The trial data revealed that lenacapavir provided a remarkable 99.9% prevention rate against HIV infection. Among 2,180 participants receiving lenacapavir, only two confirmed cases of HIV were reported, resulting in an incidence rate of 0.10 per 100 person-years. In comparison, the incidence rate for the Truvada group was 0.93 per 100 person-years, with nine new HIV cases among 1,087 individuals. This translates to a 96% relative risk reduction with lenacapavir over Truvada (incidence rate ratio 0.04, p<0.0001). Additionally, lenacapavir was found to be 89% more effective than Truvada (incidence rate ratio 0.11, p=0.00245).
Dr. Onyema Ogbuagu, principal investigator of the PURPOSE 2 trial, expressed enthusiasm about the findings. “The incredible efficacy demonstrated in the PURPOSE 2 trial, coupled with the convenience of a twice-yearly injection, highlights the significant impact lenacapavir could have on global HIV prevention efforts. This breakthrough adds a powerful new tool to our arsenal, bringing us closer to an AIDS-free generation,” said Dr. Ogbuagu, who is also an associate professor of Medicine and Pharmacology at Yale School of Medicine.
The PURPOSE 2 trial included a diverse cohort of participants, including cisgender men, transgender men, transgender women, and gender non-binary individuals across Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States. The trial met its key efficacy endpoints, demonstrating superiority of lenacapavir over both bHIV (the primary comparator) and Truvada (the secondary comparator). Consequently, the Data Monitoring Committee (DMC) recommended halting the blinded phase and offering open-label lenacapavir to all participants.
Both lenacapavir and Truvada were generally well-tolerated, with no new or significant safety concerns reported.
This announcement builds on the success of the PURPOSE 1 trial, which, in June 2024, demonstrated 100% efficacy of lenacapavir in preventing HIV among cisgender women in sub-Saharan Africa. The first trial included over 5,300 participants across South Africa and Uganda.
Gilead CEO Daniel O’Day highlighted the transformative potential of lenacapavir. “With such remarkable outcomes from two phase 3 studies, lenacapavir stands poised to revolutionize HIV prevention and contribute significantly to ending the epidemic,” he stated.
In response to discussions at the International AIDS Society 2024 conference regarding access, Gilead outlined an access strategy focused on high-incidence, low-resource countries. The company is working to expedite regulatory review and approval processes in these regions, including establishing voluntary licensing agreements to provide affordable versions of lenacapavir.
Looking ahead, Gilead plans to continue its regulatory pursuits to make lenacapavir widely available. “With a comprehensive dataset now available, we are committed to collaborating with regulatory, government, public health, and community partners to ensure that twice-yearly lenacapavir can be delivered globally to all who need it,” said O’Day.
This promising advancement underscores a significant milestone in the fight against HIV, offering a potentially game-changing option for those at risk of infection.
