The study used five validated scoring tools that assessed health-related quality of life components, in which participants reported favourable scores at Week 52 and consistent results throughout the study
A product image of Gilead’s Sunlenca. (Credit: Business Wire)
Gilead Sciences has announced new data including patient-reported outcomes (PRO) from the Phase 2/3 CAPELLA trial that supports the efficacy, safety, and tolerability profile of lenacapavir (Sunlenca) in people with HIV.
Lenacapavir is said to be the first long-acting injectable HIV treatment medication administered twice yearly.
The results support the role of lenacapavir as a person-centric therapy and its potential impact on the future of coordinated HIV clinical care.
In the CAPELLA study, the participants reported favourable scores at Week 52 and consistent results over the course of the study. The study used five validated scoring tools that assessed health-related quality of life components, including physical and mental health.
According to separate analyses from the Phase 2/3 CAPELLA and Phase 2 CALIBRATE trials, weekly oral lenacapavir when combined with an OBR resulted in high rates of virologic suppression.
It also led to high, efficacious concentrations of the HIV treatment in the participant’s blood when the administration of subcutaneous Sunlenca was halted.
Gilead Sciences HIV Clinical Development VP Jared Baeten said: “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 optimise HIV treatment, people’s experience and insights are at the centre.”
In December last year, the US Food and Drug Administration (FDA) cleared Sunlenca in combination with other antiretrovirals to treat type 1 HIV in heavily treatment-experienced adults with multi-drug resistant infection.
In a separate development, Gilead extended its partnership with Cognizant with a five-year service agreement worth $800m.
Under the agreement, Cognizant will handle Gilead’s global IT infrastructure, platforms, applications and advanced analytics, and lead programmes designed to accelerate its digital transformation.
The deal will enable the pharmaceutical firm to optimise different parts of its operations to reduce the time to market various medicines.