Gilead Sciences has announced positive topline results from its phase 3 ARTISTRY-2 trial evaluating an investigational fixed-dose combination of bictegravir 75 mg and lenacapavir 50 mg (BIC/LEN) in adults with HIV who were virologically suppressed on bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets (B/F/TAF; Biktarvy). The multicenter, double-blind study met its primary end point, showing that switching to BIC/LEN was statistically noninferior to continuing B/F/TAF in maintaining viral suppression at week 48.1
“The findings from ARTISTRY-2 provide evidence that the investigational combination of bictegravir—a standard-of-care integrase strand transfer inhibitor—and lenacapavir—a novel capsid inhibitor—has a comparable efficacy profile to a global guideline-recommended treatment regimen, demonstrating potential to expand current HIV treatment options,” Eric Meissner, MD, PhD, associate professor, director of HIV and hepatitis patient care and research, Medical University of South Carolina, said in a statement. 1
About the Study
The ARTISTRY-2 study enrolled participants who were stable on B/F/TAF and randomly assigned them in a 2:1 ratio to switch to BIC/LEN or remain on their existing regimen. The primary efficacy end point was the proportion of participants with HIV-1 RNA ≥50 copies/mL at week 48, while key secondary end points included rates of virologic suppression below 50 copies/mL, changes in CD4 cell count, and treatment-emergent adverse events. The investigational regimen was generally well tolerated, with no significant or new safety concerns identified.1
The BIC/LEN regimen combines bictegravir, a guideline-recommended integrase strand transfer inhibitor with a high barrier to resistance, and lenacapavir, a first-in-class capsid inhibitor with no overlapping resistance to existing antiretroviral drug classes.1
