– Two-Year Resistance Analysis from CAPELLA Pivotal Trial Reinforces Sunlenca as a Person-Centered Option in Combination with an Optimized Background Regimen –

– Latest Research Highlights the Potential Impact of Lenacapavir on the Future of HIV Clinical Care –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) presented new data today supporting Sunlenca® (lenacapavir) as an important treatment option for adults with multi-drug resistant (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 (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 (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.

“The bar is rightly now set high for the efficacy and safety of HIV treatment across a diverse range of people living with the virus. The next wave of innovation in HIV includes long-acting options that are aiming to help address the differentiated needs and preferences of the diverse range of individuals and communities affected by the epidemic,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “These unmet needs fueled our research teams at Gilead to develop Sunlenca, an innovative treatment option that helps respond to the unmet needs of adults with limited therapy choices. The new findings presented at EACS 2023 demonstrate that Sunlenca has the potential to improve clinical outcomes for adults with HIV who are heavily treatment experienced and also positively impact their health-related quality of life.”

CAPELLA Two-Year Resistance Data

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 (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 (n=10) or an OBR lacking fully active antiretrovirals (n=4), 7 of the 14 participants with Sunlenca resistance resuppressed (HIV-1