Gilead's Experimental Combo Tablet For HIV Treatment Hits Primary Goal

Gilead Sciences Inc. (NASDAQ:GILD) on Monday shared topline results from the Phase 3 ARTISTRY-2 trial.

The trial evaluated the treatment responses of adults with HIV who are virologically suppressed, switching from Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide, B/F/TAF) to a fixed-dose combination of bictegravir/lenacapavir (BIC/LEN).

BIC/LEN efficacy was found to be statistically non-inferior to Biktarvy.

Gilead plans to file the Phase 3 results from the ARTISTRY trials with regulatory authorities and submit the detailed findings for presentation at a future scientific congress.

Also Read: Merck’s Investigational Two-Drug Regime Matches Gilead’s Three-Drug Tablet For HIV Treatment

Trial Data

In ARTISTRY-2, the once-daily single tablet regimen of BIC/LEN met the primary success criterion for non-inferiority to Biktarvy.

The primary efficacy endpoint was the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48.

The novel combination of BIC/LEN was generally well tolerated, with no significant or new safety concerns identified during the trial.

The results of ARTISTRY-2 will be combined with the findings from the Phase 3 ARTISTRY-1 trial to form the basis of regulatory submissions.

Topline results from the ARTISTRY-1 trial announced in November 2025 showed that the investigational combination of BIC/LEN was well tolerated and statistically non-inferior to multi-tablet antiretroviral regimens.

What Next?

The company on Monday said the investigational regimen combines bictegravir, a global guidelines-recommended integrase strand transfer inhibitor with a high barrier to resistance, and lenacapavir, a capsid inhibitor with no overlapping resistance to other existing drug classes.

A single-tablet regimen combining bictegravir and lenacapavir would potentially further transform the treatment landscape, expanding options to enable people with HIV to sustain virologic suppression.

GILD Price Action: Gilead Sciences shares were up 0.04% at $120.45 at the time of publication on Monday, according to Benzinga Pro data.

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