Infectious Disease Advisor news story
Results of a phase 3, noninferiority trial support bictegravir plus lenacapavir (BIC/LEN) as an effective single-tablet antiretroviral therapy (ART) for virologically suppressed patients with HIV-1 infection. These study findings were published in The Lancet HIV.
Reducing the complexity of ART with single-tablet formulations has improved treatment adherence, clinical outcomes, quality of life, and patient satisfaction. The trial ARTISTRY-1 found that switching to single-tablet BIC/LEN was noninferior to remaining on complex ART.
Researchers conducted a double-blind, randomized, controlled, phase 3, noninferiority trial (ARTISTRY-2; ClinicalTrials.gov Identifier: NCT06333808) to assess the noninferiority of single-tablet BIC/LEN relative to single-tablet bictegravir plus emtricitabine and tenofovir alafenamide (BIC/FTC/TAF). People with HIV (PWH; N=574) who had viral suppression on single-tablet BIC/FTC/TAF were recruited in 14 countries in 2024. The participants were randomly assigned 2:1 to either switch to 75-50 mg BIC/LEN or continue using 50-200-25 mg BIC/FTC/TAF for 48 weeks. The primary outcome was the proportion of individuals with HIV-1 RNA of at least 50 copies/mL at week 48. Noninferiority was defined as a margin of 4%.
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Source : Infectious Disease Advisor
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