Overview
- ARTISTRY‑1 found non‑inferior efficacy at 48 weeks, with about 96% of switchers maintaining viral suppression and FDA Snapshot virologic failure of 0.8% versus 1.1% on complex regimens.
- The randomized, open‑label trial enrolled 557 adults across 15 countries (2:1 switch versus continue), with a median age of 60 years, a median 28 years on therapy, and high rates of historical resistance and comorbidities.
- Participants who switched reported higher treatment satisfaction, and lipid measures improved, addressing cardiovascular risk factors common in this older cohort.
- Safety was generally acceptable with no new signals reported; six participants discontinued the investigational pill for adverse events and five deaths in that arm were deemed unrelated to study drug.
- Supportive ARTISTRY‑2 data showed similarly low virologic failure versus Biktarvy, and longer‑term and blinded Phase III follow‑up studies are underway as the combination remains investigational.