Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
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).
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05502341 (An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens), which is not on this map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens
Who cites it
7 citing papers in PubMed.
- Baseline and week 48 resistance analysis in participants receiving bictegravir + lenacapavir in the phase 2 ARTISTRY-1 study.AIDS (London, England) · 2026Trial
- Efficacy and Safety of Bictegravir Plus Lenacapavir: 48-Week Outcomes in People With HIV-1 Who Are Virologically Suppressed on Complex Antiretroviral Regimens at Baseline.Open forum infectious diseases · 2025Trial
- Occult hepatitis B and risk of reactivation following switch to non-hepatitis B virus-active antiretroviral therapy in people with HIV.AIDS (London, England) · 2026Review
- Tenofovir, Interferon Pathways, and Mucosal Immunity: Implications for People Living With HIV.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026Review
- Block-and-Lock Approaches for HIV Cure: Mechanistic Insights, Challenges, and Emerging Role of CPSF6.International journal of molecular sciences · 2026Review
- New Advances in Anti-HIV-1 Strategies Targeting the Assembly and Stability of Capsid Protein.International journal of molecular sciences · 2025Review
- The Complex Interactions Between HIV-1 and Human Host Cell Genome: From Molecular Mechanisms to Clinical Practice.International journal of molecular sciences · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundComplex 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).
methodsARTISTRY-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.
resultsOverall, 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.
conclusionsThese 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.
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