Topline findings
- Primary endpoint: BIC/LEN single-tablet regimen achieved non-inferiority to participants’ baseline multi-tablet regimens.
- Viral suppression: High rates maintained at week 48, with HIV-1 RNA <50 copies/mL.
- Safety: Treatment-emergent adverse events were consistent with expectations; no new safety signals observed.
- Trial design: Randomized, open-label, 2:1 switch vs. continued multi-drug therapy.
- Next steps: ARTISTRY-2 Phase III trial ongoing, with topline readout expected by year-end.
Gilead has shared positive results from the Phase III ARTISTRY-1 trial (NCT05502341) evaluating an investigational single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) in adults with HIV who are virologically suppressed, and switched from a multi-tablet regimen.1
Single-tablet regimen demonstrates non-inferiority
The BIC/LEN single-tablet regimen met the primary success criterion, demonstrating non-inferiority to baseline multi-tablet antiretroviral therapy regimens.
In a press release, Chloe Orkin, MBE, clinical professor of infection and inequities at Queen Mary University of London, said: “Developing new effective, convenient regimens for those left behind by advances in medical research is necessary to close the unmet HIV treatment gap. 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 trial design
ARTISTRY-1 is a randomized, open-label, multicenter, active-controlled Phase II/III study.
- In the Phase III portion, participants were randomized 2:1 to switch to bictegravir 75 mg/lenacapavir 50 mg or continue their existing multi-drug regimen.
- The primary endpoint assessed the proportion of patients with HIV-1 RNA ≥50 copies/mL at week 48 using the FDA snapshot algorithm.
- Key secondary endpoints at week 48 included rates of virologic suppression (<50 copies/mL), changes in CD4 cell counts, and incidence of treatment-emergent adverse events.
Jared Baeten, MD, PhD, senior vice president, clinical development, virology therapeutic area head, Gilead Sciences, added: “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. 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.”
