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Gilead Sciences, Inc. (NASDAQ:GILD) today announced positive topline results from the Phase 3 ARTISTRY-1 trial. The open-label trial evaluated the treatment responses of adults with HIV who are virologically suppressed switching from a multi-tablet regimen to an investigational single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN). BIC/LEN efficacy was found to be statistically non-inferior to multi-tablet regimens. Gilead plans to file the Phase 3 data from the ARTISTRY trials with regulatory authorities and submit the detailed findings for presentation at a future scientific congress.
In ARTISTRY-1, the once-daily single-tablet regimen of BIC/LEN met the primary success criterion for non-inferiority to baseline multi-tablet antiretroviral therapy regimens. The primary efficacy endpoint was the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48, defined by the FDA snapshot algorithm. In the trial, BIC/LEN was generally well tolerated, with no significant or new safety concerns identified.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. At baseline, participants enrolled in ARTISTRY-1 were taking between 2 and 11 pills per day for their HIV treatment, with ~40% taking their antiretrovirals more than once a day.
"Developing new effective, convenient regimens for those left behind by advances in medical research is necessary to close the unmet HIV treatment gap," said Chloe Orkin, MBE, Clinical Professor of Infection and Inequities at Queen Mary University of London. "These ARTISTRY-1 trial results demonstrate that a combination regimen of bictegravir and lenacapavir maintains viral suppression in people living with HIV who would otherwise have to take a complex multi-tablet regimen. The findings are significant for those people, many of whom have lived with HIV for decades and who have medical comorbidities of aging and thus take many other medications as well."
Posted In: GILD
