Gilead reports its investigational single tablet of bictegravir and lenacapavir was efficacious in people with HIV who are virologically suppressed who switched from taking multi-tablet regimens. The company says its phase 3 study results will form the basis for its future regulatory submissions.
Today, Gilead announced positive topline results showing that its investigational, combination therapy, bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN), was non-inferior as compared with study participants’ existing multi-tablet antiretroviral regimens at Week 48. The results come from the company's phase 3 ARTISTRY-1 trial that evaluated the once-daily single-tablet regimen of (BIC/LEN) in adults living with HIV who were virologically suppressed.
“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," Chloe Orkin, MBE, clinical professor of Infection and Inequities at Queen Mary University of London, said in a statement. "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.”
According to the study's findings, the single-tablet regimen was generally well tolerated, with no new or significant safety concerns reported.
People living with HIV who are on complex regimens often face challenges such as high pill burden, complex adherence requirements, and reduced quality of life due to factors like preexisting resistance, tolerability, or drug interactions. In ARTISTRY-1, participants were taking between 2 and 11 pills per day, and nearly 40% required more than one daily dosing at baseline. Transitioning to a single-tablet regimen could simplify HIV care and improve daily treatment adherence.
The investigational single-tablet regimen of bictegravir/lenacapavir met its primary endpoint of non-inferiority versus multi-tablet HIV therapies in ARTISTRY-1.
Participants taking up to 11 pills daily achieved comparable viral suppression with one pill a day, potentially simplifying treatment for those on complex regimens.
Gilead plans regulatory submissions for ARTISTRY-1 data and anticipates Phase 3 ARTISTRY-2 results later this year.
The ARTISTRY-1 study is a multicenter phase 2/3 clinical trial comparing the investigational once-daily combination of bictegravir and lenacapavir, vs 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).
Gilead is also conducting its double-blind phase 3 ARTISTRY-2 trial, which evaluates switching from bictegravir, emtricitabine & tenofovir alafenamide (Biktarvy) to BIC/LEN in virologically suppressed individuals. Topline data from ARTISTRY-2 are expected before the end of 2025.
Bictegravir and lenacapavir in combination remain investigational and are not yet approved anywhere globally. Their safety and efficacy as a fixed-dose combination have not been established.
Bictegravir is an integrase strand transfer inhibitor (INSTI) with a high barrier to resistance. INSTIs are a class of antiviral agents that target the viral integrase. Bictegravir is used only in combination with other antiretroviral agents in the treatment of HIV.
Lenacapavir is approved in multiple countries as pre-exposure prophylaxis to reduce the risk of HIV, and the agent is also approved infor the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.
The company 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.
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