Gilead announces new Sunlenca data from CAPELLA trial

Gilead presented new data supporting Sunlenca as an important treatment option for adults with multi-drug resistant, or MDR, HIV who have extensive treatment history. These findings highlight the significance of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its potential to help transform the future of coordinated HIV clinical care. The data were presented at the 19th European AIDS Conference, or EACS 2023, in Warsaw, Poland, from October 18-21. The latest results include two-year data from the Phase 2/3 CAPELLA trial, which demonstrate that resistance to Sunlenca occurred in a minority of participants and only among those with inadequate adherence to their optimized background regimen, or OBR, or without fully active antiretrovirals as part of their OBR. Furthermore, a survey of healthcare professionals and coordinators conducting the CAPELLA trial reveal positive perceptions of Sunlenca, suggesting its potential to help improve clinical outcomes and health-related quality of life for adults who are heavily treatment experienced. CAPELLA is an ongoing Phase 2/3 study evaluating the safety and effectiveness of Sunlenca in combination with other antiretrovirals as an optimized background regimen, or OBR, for people with multi-drug resistant HIV who are heavily treatment experienced. CAPELLA investigators enrolled 72 participants with advanced HIV disease. Of the 27 participants who met the resistance analysis criteria, 13 did not develop resistance to Sunlenca. Fourteen participants developed Sunlenca resistance-associated mutations; importantly, all 14 either had inadequate adherence to their OBR or an OBR lacking fully active antiretrovirals, 7 of the 14 participants with Sunlenca resistance resuppressed upon re-adherence to their OBR or with OBR change. These findings emphasize the importance of including more than one fully active agent whenever possible when creating a treatment regimen for people with multi-drug resistant HIV who have limited therapy options. In an additional survey conducted amongst 25 CAPELLA healthcare professionals and study coordinators, the majority of respondents believed Sunlenca would be easy to integrate into real-world clinical practice. Respondents reported that Sunlenca has strong potential to improve clinical outcomes and health-related quality of life for heavily treatment-experienced adults. All respondents perceived that injection site reactions did not affect participants’ willingness to continue Sunlenca treatment. Lenacapavir is being developed as a foundation for future HIV therapies. The goal is to offer both long-acting oral and injectable options with various dosing frequencies in combination with other antiretroviral agents for treatment or as a single agent for prevention. This approach aims to help address the individual needs and preferences of people with HIV and people who would benefit from pre-exposure prophylaxis, or PrEP. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Sunlenca is approved in Australia, Canada, the European Union, Israel, Japan, Switzerland, the United Arab Emirates, the United Kingdom or the United States for the treatment of people with multi-drug resistant HIV in combination with other antiretrovirals.