Gilead Sciences Inc. (GILD) delivered positive news Monday, announcing that its experimental two-drug HIV tablet hit the mark in a late-stage clinical trial. The big question: could fewer drugs do the same job?
Turns out, yes. The Phase 3 ARTISTRY-2 trial evaluated adults with HIV who had already achieved viral suppression and were switched from Biktarvy—Gilead's current three-drug combination of bictegravir, emtricitabine, and tenofovir alafenamide—to an investigational fixed-dose combination of just bictegravir and lenacapavir (BIC/LEN).
The new two-drug combo proved statistically non-inferior to the existing three-drug standard. In medical trial speak, that means it worked just as well without being demonstrably worse. The company plans to submit these Phase 3 results to regulatory authorities and present detailed findings at an upcoming scientific conference.
Breaking Down the Trial Results
ARTISTRY-2 tested whether the once-daily single tablet regimen of BIC/LEN could maintain viral suppression as effectively as Biktarvy. The primary measure of success was straightforward: what percentage of participants had HIV-1 RNA levels of 50 copies/mL or higher at the 48-week mark? Lower viral loads mean the treatment is working.
The BIC/LEN combination cleared that hurdle, meeting the primary success criterion for non-inferiority. Beyond efficacy, the safety profile looked encouraging. The novel combination was generally well tolerated, and researchers didn't identify any significant or new safety concerns during the trial.
These ARTISTRY-2 results won't stand alone. Gilead plans to combine them with findings from the Phase 3 ARTISTRY-1 trial for its regulatory submissions. That earlier trial, which reported topline results in November 2025, showed that BIC/LEN was well tolerated and statistically non-inferior to multi-tablet antiretroviral regimens.
Why This Combination Matters
The science behind the pairing is compelling. The investigational regimen brings together bictegravir, an integrase strand transfer inhibitor recommended in global guidelines with a high barrier to resistance, and lenacapavir, a capsid inhibitor that represents an entirely different mechanism of action.
That last point is particularly important. Lenacapavir has no overlapping resistance to other existing drug classes, which means it attacks HIV in a way that doesn't compete with or duplicate other treatments. For patients who've developed resistance to earlier therapies, that's potentially a game changer.
If approved, a single-tablet regimen combining these two drugs could reshape HIV treatment options. The goal isn't just simplification for its own sake—it's about giving people living with HIV more ways to maintain virologic suppression over the long term. Fewer pills can mean better adherence, and better adherence means better outcomes.
Gilead shares were essentially flat Monday, trading up 0.04% at $120.45.