Gilead announced that its Phase 3 ARTISTRY‑1 study of the once‑daily bictegravir/lenacapavir (BIC/LEN) single‑tablet regimen met the primary non‑inferiority endpoint, with 48‑week virologic suppression rates meeting the FDA snapshot criteria and no new safety signals identified.
The open‑label trial enrolled adults whose HIV was already virologically suppressed and who switched from complex multi‑tablet regimens to the single‑tablet BIC/LEN. The study demonstrated that the new regimen maintained viral suppression at week 48, with a tolerability profile comparable to existing therapies.
By delivering a single‑tablet option that incorporates lenacapavir—a first‑in‑class capsid inhibitor with long‑acting potential—Gilead expands its HIV portfolio into a format that can improve patient adherence and reduce pill burden. The result positions the product for regulatory submission and potential market entry, aligning with the company’s strategy to offer convenient, long‑acting treatment options.
Gilead plans to file the data with the U.S. Food and Drug Administration and to present the findings at a forthcoming scientific congress. Successful regulatory approval would add a new, high‑margin product to Gilead’s HIV franchise and could capture market share from competitors pursuing long‑acting or single‑tablet therapies.
The ARTISTRY‑1 outcome comes at a time when the HIV market is intensifying around long‑acting injectables and simplified regimens. Gilead’s ability to combine a proven integrase inhibitor with a novel capsid inhibitor in a single tablet could give it a competitive edge, especially if the product demonstrates sustained efficacy and safety in a broader patient population.
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