Gilead single tablet regimen of Bictegravir, Lenacapavir for HIV-1 meets primary endpoint in Phase 3 trial
Foster City: Gilead Sciences has 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.”
ARTISTRY-1 (NCT05502341) is a multicenter Phase 2/3 clinical trial comparing the investigational once-daily combination of bictegravir, a global guidelines-recommended integrase strand transfer inhibitor, and lenacapavir, a first-in-class capsid inhibitor, versus current therapy in people with HIV who are virologically suppressed on complex regimens. In Phase 3, participants were randomized 2:1 to receive a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg or continue their stable baseline complex regimen. The primary endpoint was the proportion of patients with HIV-1 RNA ≥50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm. Key secondary endpoints at week 48 included the proportion of participants with virologic suppression (HIV viral load <50 copies/mL per US FDA Snapshot), change in baseline in CD4 cell count and the proportion of participants with treatment-emergent adverse events (TEAEs).
“People living with HIV who are on complex antiretroviral treatment regimens may experience pill burden, adherence challenges and difficulties with the long-term management of HIV,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “Gilead developed the first single-tablet complete regimen for the treatment of HIV in 2006. Today, innovative single-tablet regimens are still needed to help suit people’s needs, modernizing treatment while helping to sustain viral suppression. By reducing the multi-tablet burden, we hope to improve health outcomes while expanding options.”
Further evaluation of this investigational combination includes the double-blind, Phase 3 ARTISTRY-2 (NCT06333808) trial which is evaluating the safety and efficacy of switching from BIKTARVY (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg in virologically suppressed people with HIV-1. A topline data readout for the primary endpoint is anticipated before the end of the year.
Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established in combination.
There is currently no cure for HIV or AIDS.
