Foster City, California — Gilead Sciences has reported that its experimental HIV treatment has met the primary goal in a late-stage Phase 3 clinical trial, showing that the investigational regimen is statistically non-inferior to its established, top-selling HIV therapy, Biktarvy.
The treatment combines two antiviral agents — bictegravir and lenacapavir — into a once-daily, single-tablet regimen. In the ARTISTRY-2 trial, adults with HIV who were already virologically suppressed were randomized to switch to the experimental tablet or continue on Biktarvy. The primary endpoint measured viral suppression at 48 weeks, and the results confirmed that the new combination was equally effective and generally well tolerated, with no significant new safety concerns identified.
Bictegravir is a widely used integrase inhibitor recommended in global HIV treatment guidelines, while lenacapavir is a novel capsid inhibitor with a different mechanism of action and no overlapping resistance with existing drug classes. If approved, the fixed-dose combination could offer an additional treatment option for people living with HIV and support more personalized therapy choices.
Gilead plans to present full data from both ARTISTRY-1 and ARTISTRY-2 trials next year and submit the results to regulatory authorities as part of its approval process.
Following the announcement of the positive Phase 3 results, Gilead’s shares rose more than 2% in pre-market trading, reflecting investor confidence in the company’s expanding HIV pipeline.
About the Trial and Next Steps
- The Phase 3 ARTISTRY-2 trial was a double-blind study comparing the experimental bictegravir and lenacapavir tablet with Biktarvy in virally suppressed adults.
- The treatment demonstrated non-inferior efficacy, a key regulatory benchmark when evaluating a new therapy against an established standard of care.
- Gilead intends to share complete clinical datasets with the scientific community and regulatory authorities in 2026 as part of its approval pathway.
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