Trial reportAIDS (London, England)2026
Baseline and week 48 resistance analysis in participants receiving bictegravir + lenacapavir in the phase 2 ARTISTRY-1 study.
Trial report in AIDS (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
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Who cites it
1 citing paper in PubMed.
- Resistance Analysis of Weekly Islatravir Plus Lenacapavir in People With HIV at 48 Weeks.Journal of acquired immune deficiency syndromes (1999) · 2026Trial
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundARTISTRY-1 is an operationally seamless Phase 2/3 study evaluating the safety and efficacy of once-daily oral lenacapavir (LEN) + bictegravir (BIC) in virologically suppressed participants without known integrase strand-transfer inhibitor (INSTI) resistance, compared to a complex multi-tablet regimen.
methodsBaseline HIV-1 resistance-associated mutations (RAMs) were assessed via historical genotypic reports (HGR) and proviral DNA genotyping (GenoSure Archive, Monogram Biosciences). The impact of baseline RAMs on Week 48 efficacy in the Phase 2 part of the study was evaluated. Post-baseline genotypic and phenotypic resistance was assessed in participants with confirmed virologic rebound (HIV-1 RNA ≥50 copies/ml; analyzed if ≥200 copies/ml).
resultsBaseline HIV-1 genotypic data from HGR and/or proviral DNA analyses were available for 98% (125/128) of participants. RAMs for nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and protease inhibitors (PIs) were found in 81%, 65%, and 46% of participants, respectively; 11% had primary INSTI RAMs by proviral DNA genotyping. Baseline RAMs had no impact on Week 48 efficacy. One participant with baseline resistance to NRTIs, NNRTIs, and PIs, and detectable baseline viral load met the criteria for resistance testing. A novel capsid polymorphism (N74T) emerged in this individual, with no impact on LEN susceptibility.
conclusionsDespite high frequencies of baseline resistance, substantial rates of viral suppression were maintained through Week 48 and no on-treatment resistance to study drugs was detected. These findings support the development of once-daily BIC+LEN STR to improve and optimize treatment options in individuals on complex ART.
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