Topline findings
- Major endpoint: BIC/LEN single-tablet routine achieved non-inferiority to members’ baseline multi-tablet regimens.
- Viral suppression: Excessive charges maintained at week 48, with HIV-1 RNA <50 copies/mL.
- Security: Remedy-emergent adversarial occasions have been in step with expectations; no new security alerts noticed.
- Trial design: Randomized, open-label, 2:1 change vs. continued multi-drug remedy.
- Subsequent steps: ARTISTRY-2 Part III trial ongoing, with topline readout anticipated by year-end.
Gilead has shared constructive outcomes from the Part III ARTISTRY-1 trial (NCT05502341) evaluating an investigational single-tablet routine of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) in adults with HIV who’re virologically suppressed, and switched from a multi-tablet routine.1
Single-tablet routine demonstrates non-inferiority
The BIC/LEN single-tablet routine met the first success criterion, demonstrating non-inferiority to baseline multi-tablet antiretroviral remedy regimens.
In a press launch, Chloe Orkin, MBE, medical professor of an infection and inequities at Queen Mary College of London, stated: “Creating new efficient, handy regimens for these left behind by advances in medical analysis is important to shut the unmet HIV therapy hole. These ARTISTRY-1 trial outcomes reveal {that a} mixture routine of bictegravir and lenacapavir maintains viral suppression in individuals residing with HIV who would in any other case must take a posh multi-tablet routine. The findings are vital for these individuals, a lot of whom have lived with HIV for many years and who’ve medical comorbidities of growing older and thus take many different drugs as effectively.”
ARTISTRY-1 trial design
ARTISTRY-1 is a randomized, open-label, multicenter, active-controlled Part II/III examine.
- Within the Part III portion, members have been randomized 2:1 to change to bictegravir 75 mg/lenacapavir 50 mg or proceed their current multi-drug routine.
- The first endpoint assessed the proportion of sufferers with HIV-1 RNA ≥50 copies/mL at week 48 utilizing the FDA snapshot algorithm.
- Key secondary endpoints at week 48 included charges of virologic suppression (<50 copies/mL), adjustments in CD4 cell counts, and incidence of treatment-emergent adversarial occasions.
Jared Baeten, MD, PhD, senior vice chairman, medical improvement, virology therapeutic space head, Gilead Sciences, added: “Individuals residing with HIV who’re on complicated antiretroviral therapy regimens could expertise capsule burden, adherence challenges and difficulties with the long-term administration of HIV. Gilead developed the primary single-tablet full routine for the therapy of HIV in 2006. At present, progressive single-tablet regimens are nonetheless wanted to assist go well with individuals’s wants, modernizing therapy whereas serving to to maintain viral suppression. By lowering the multi-tablet burden, we hope to enhance well being outcomes whereas increasing choices.”
Further analysis in ARTISTRY-2 trial
Along with ARTISTRY-1, Gilead is evaluating this investigational mixture within the Part III ARTISTRY-2 trial (NCT06333808).
ARTISTRY-2 is a double-blind, multicenter, randomized, active-controlled examine assessing the security and efficacy of switching from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, to a fixed-dose mixture of bictegravir 75 mg/lenacapavir 50 mg in virologically suppressed members with HIV-1. Gilead is anticipating a topline knowledge readout for the first endpoints of this trial earlier than the top of the 12 months.
Earlier Part II knowledge of lenacapavir algonside Merck’s islatravir
In October 2024, Part II trial (NCT05052996)
Outcomes confirmed:
- At 48 weeks, 94.2% of members on islatravir + lenacapavir maintained viral suppression, with no members reaching HIV-1 RNA ≥50 copies/mL.
- Comparable viral suppression was noticed in members persevering with Biktarvy (92.3%), additionally with no circumstances ≥50 copies/mL.
- Remedy-related adversarial occasions (TRAEs) occurred in 19.2% of the islatravir + lenacapavir group versus 5.8% within the Biktarvy group.
- Commonest TRAEs have been dry mouth (3.8%) and nausea (3.8%).
- No grade 3 or 4 TRAEs associated to review medication have been reported in both cohort.
In an organization assertion from the time, Baeten stated: “The way forward for HIV therapy is person-centered, with long-acting choices tailor-made to assist meet the wants and preferences of individuals affected by HIV. There is no such thing as a ‘one measurement suits all’ strategy. The complexities of HIV care require placing individuals first within the improvement of biomedical improvements as we maintain striving to supply choices for all these residing with HIV.”
References
1. Gilead’s Investigational Single-Pill Routine of Bictegravir and Lenacapavir for HIV-1 Remedy Meets Major Endpoint in Part 3 ARTISTRY-1 Trial. Information launch. Gilead. November 13, 2025. Accessed November 13, 2025.
2. Gilead and Merck Announce Part 2 Information Displaying a Remedy Swap to an Investigational Oral As soon as-Weekly Mixture Routine of Islatravir and Lenacapavir Maintained Viral Suppression in Adults at Week 48. Information launch. Gilead. October 19, 2024. Accessed November 13, 2025.
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