NYMC Faculty Publications
Efficacy and Safety of Switching to Daily Bictegravir Plus Lenacapavir From a Complex HIV Treatment Regimen: A Randomized, Open-Label, Multicenter Phase 2 Study (ARTISTRY-1)
Author Type(s)
Faculty
DOI
10.1093/cid/ciae522
Journal Title
Clinical Infectious Diseases
First Page
881
Last Page
888
Document Type
Article
Publication Date
4-15-2025
Department
Medicine
Keywords
antiretroviral therapy, bictegravir, efficacy, lenacapavir, safety
Disciplines
Medicine and Health Sciences
Abstract
Background: Complex antiretroviral therapy (ART) regimens, such as those requiring multiple tablets, several doses per day, or both, can negatively affect quality of life and treatment adherence among people with human immunodeficiency virus (HIV). Methods: ARTISTRY-1 is a phase 2/3, operationally seamless, randomized, open-label, multicenter, active-controlled study (GS-US-621-6289; NCT05502341). Phase 2 of the study enrolled adults with plasma HIV-1 RNA <50 copies/mL receiving a complex ART regimen for ≥6 months. Efficacy and safety outcomes were evaluated after a switch to bictegravir (BIC) (75-mg) + lenacapavir (LEN) (25- or 50-mg) regimens, compared with continuing on a complex ART regimen through 24 weeks. Results: Overall, 128 participants were assigned randomly to begin BIC 75 mg + LEN 25 mg (n = 51) or BIC 75 mg + LEN 50 mg (n = 52) or continue on their complex ART regimen (n = 25). At week 24, HIV-1 RNA was ≥50 copies/mL in 0 of 51, 1 of 52 (1.9%), and 0 of 25 participants in the 3 groups, respectively. CD4 cell counts and percentages remained stable through week 24; the median change from baseline in CD4 cell count (interquartile range) was 18 (-39 to 70), -16 (-80 to 93), and 42 (-36 to 90) cells/μL, respectively. There were no study discontinuations due to a serious adverse event through week 24. Both BIC + LEN dosing regimens were well tolerated, with similar safety profiles observed between groups. Conclusions: These data support the continued evaluation of the combination of BIC and LEN to optimize treatment in people with HIV and virologic suppression who are receiving complex ART regimens.
Recommended Citation
Mounzer, K., Slim, J., Ramgopal, M., Hedgcock, M., Bloch, M., Santana, J., Mendes, I., Guo, Y., Arora, P., Montezuma-Rusca, J., Sklar, P., Baeten, J., & Segal-Maurer, S. (2025). Efficacy and Safety of Switching to Daily Bictegravir Plus Lenacapavir From a Complex HIV Treatment Regimen: A Randomized, Open-Label, Multicenter Phase 2 Study (ARTISTRY-1). Clinical Infectious Diseases, 80 (4), 881-888. https://doi.org/10.1093/cid/ciae522
