Switch to single-tablet bictegravir-lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial - PubMed
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- #HIV treatment
- #clinical trial
- #antiretroviral therapy
- The ARTISTRY-1 trial evaluated the efficacy and safety of switching to a single-tablet regimen (STR) of bictegravir-lenacapavir from complex multi-tablet HIV regimens.
- This was a randomized, open-label, phase 3 non-inferiority trial conducted across 15 countries with 557 participants who were virologically suppressed on complex regimens.
- Participants were assigned (2:1) to either switch to bictegravir-lenacapavir or continue their complex regimen, with the primary outcome being HIV-1 RNA viral load ≥50 copies/mL at week 48.
- Results showed non-inferior efficacy (1% in both groups), no resistance emergence, and similar adverse event rates between the two groups.
- Treatment satisfaction increased among participants who switched to the bictegravir-lenacapavir STR.
- The study concluded that bictegravir-lenacapavir offers a viable and simplified treatment option for people with HIV-1 on complex regimens.