Single-Tablet Bictegravir/Lenacapavir Regimen Demonstrates High Efficacy in HIV-1 Treatment Switch
FOSTER CITY, Calif. – November 16, 2025 – A new single-tablet regimen combining bictegravir and lenacapavir has met its primary endpoint in the Phase 3 ARTISTRY-1 trial, offering a promising new option for individuals living with HIV-1. Announced November 13, 2025, by Gilead Sciences, the results indicate the investigational treatment is effective for patients switching from a complex HIV regimen.
The findings represent a importent step forward in HIV treatment, potentially simplifying medication for individuals with multidrug-resistant HIV or those experiencing intolerance to their current therapies.Approximately 1.2 million people in the U.S.are living with HIV,and manny face challenges with long-term treatment adherence due to complex regimens and potential side effects. Prosperous implementation of this single-tablet option could improve patient outcomes and quality of life, while also reducing the burden of managing HIV. Further analysis and potential regulatory submissions are anticipated in the coming months.
The ARTISTRY-1 trial evaluated the efficacy and safety of switching to daily bictegravir plus lenacapavir in participants already on a stable HIV treatment regimen. Published in clinical Infectious Diseases on April 2025, data from a Phase 2 study (ARTISTRY-1) by Mounzer et al. showed similar promising results, paving the way for the larger Phase 3 trial. The Phase 3 trial’s primary endpoint was the proportion of participants achieving and maintaining an undetectable viral load at week 48.
Detailed results from the Phase 3 ARTISTRY-1 trial were not promptly available, but Gilead’s news release confirms the regimen demonstrated statistically significant efficacy.The study involved multiple centers and a randomized, open-label design. More details can be found at https://www.gilead.com/news/news-details/2025/gileads-investigational-single-tablet-regimen-of-bictegravir-and-lenacapavir-for-hiv-1-treatment-meets-primary-endpoint-in-phase-3-artistry-1-trial.
