The results of ARTISTRY-2 will be combined with the findings from the Phase 3 ARTISTRY-1 (NCT05502341) trial to form the basis of regulatory submissions. Top-line results from the ARTISTRY-1 trial announced in November 2025 showed that the investigational combination of BIC/LEN was well tolerated and statistically non-inferior to multi-tablet antiretroviral regimens.
People living with HIV-1 on complex regimens are unable to benefit from guideline-recommended STRs due to reasons of pre-existing resistance, tolerability and drug-drug interactions, and therefore may face challenges such as high pill burden, complicated adherence, and reduced quality of life. A single-tablet regimen combining bictegravir and lenacapavir could offer a new medication option with convenient dosing for people living with HIV treated with complex regimens.
