Gilead presents new data on lenacapavir

Gilead Sciences presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the Phase 2/3 CAPELLA trial. These latest findings underscore the role of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its transformative potential impact on the future of coordinated HIV clinical care. The data were presented at the 12th International AIDS Society (IAS) Conference on HIV Science (IAS 2023), taking place July 23-26 in Brisbane, Australia. Using five validated scoring instruments measuring health-related quality of life components including physical and mental health, CAPELLA participants (n=64/72) reported favorable scores at Week 52 and with relative consistency over the time period. These reflect values that are similar to that of the general U.S. population. Separate analyses from the Phase 2/3 CAPELLA and Phase 2 CALIBRATE trials showed weekly oral lenacapavir, when paired with an OBR, led to high rates of virologic suppression and high, efficacious concentrations of lenacapavir in the blood in study participants when the administration of subcutaneous lenacapavir was interrupted. “Understanding potential real-world use of novel HIV options is essential to helping ensure they have the greatest potential impact,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “The patient-reported outcome data presented at IAS 2023 provide deep insight into the tolerability of lenacapavir, and the oral bridging data helps demonstrate how twice-yearly lenacapavir can fit into people’s lives. As we continue development of lenacapavir-based options with the goal to optimize HIV treatment, people’s experience and insights are at the center.”