Gilead's One-Pill HIV Treatment Shows Promise In Late-Stage Trial

Gilead Sciences Inc. (NASDAQ:GILD) on Thursday shared topline results from the Phase 3 ARTISTRY-1 trial.

The open-label trial evaluated the treatment responses of HIV patients who are virologically suppressed switching from a multi-tablet regimen to an investigational single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN).

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In ARTISTRY-1, the once-daily single-tablet regimen of BIC/LEN met the primary success criterion for non-inferiority to baseline multi-tablet antiretroviral therapy regimens.

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

In the trial, BIC/LEN was generally well tolerated, with no significant or new safety concerns identified.

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ARTISTRY-1 is a multicenter Phase 2/3 clinical trial comparing the investigational once-daily combination of bictegravir, a global guidelines-recommended integrase strand transfer inhibitor, and lenacapavir, a first-in-class capsid inhibitor, versus current therapy in people with HIV who are virologically suppressed on complex regimens.

In Phase 3, participants were randomized 2:1 to receive a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg or continue their stable baseline complex regimen.

Key secondary endpoints at week 48 included the proportion of participants with virologic suppression, change in baseline in CD4 cell count, and the proportion of participants with treatment-emergent adverse events (TEAEs).

Further evaluation of this investigational combination includes the double-blind, Phase 3 ARTISTRY-2 trial, which is evaluating the safety and efficacy of switching from BIKTARVY (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg in virologically suppressed people with HIV-1.

Topline data readout for the primary endpoint is anticipated before the end of the year.

GILD Price Action: GILD stock is up 2.97% at $127.07 at publication on Thursday.

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