Gilead Moves Closer to Filing Novel HIV Combo After Second Phase 3 Win

Gilead Moves Closer to Filing Novel HIV Combo After Second Phase 3 Win

By, Admin 17 December 2025

Gilead Sciences is accelerating toward regulatory submissions for its next-generation HIV treatment after another late-stage clinical success.

ARTISTRY-2 Confirms Noninferiority to Biktarvy

In the Phase 3 ARTISTRY-2 trial, Gilead’s single-tablet regimen of bictegravir + lenacapavir (BIC/LEN) matched the efficacy of its blockbuster HIV drug Biktarvy.

Key details:

  • Study enrolled adults with HIV who were already virologically suppressed on Biktarvy
  • Patients were randomized 2:1 to switch to BIC/LEN or continue Biktarvy
  • Primary endpoint: HIV-1 RNA ≥50 copies/mL at Week 48

The BIC/LEN regimen met the primary endpoint and was noninferior to Biktarvy.

Safety and Tolerability Remain Strong

Gilead reported that the investigational combination was generally well tolerated, with no unexpected safety concerns at the topline level.

“These data support the potential of BIC/LEN as a meaningful additional treatment option,” said Dr. Jared Baeten, SVP, Clinical Development, Gilead Sciences.

Momentum Builds After ARTISTRY-1

This result follows a positive topline readout from ARTISTRY-1, announced last month.

  • ARTISTRY-1 enrolled patients switching from complex, multi-tablet HIV regimens
  • ARTISTRY-2 focused on patients stable on Biktarvy

Together, the two studies support BIC/LEN as a simpler, durable option for virologically suppressed adults.

What Comes Next?

Gilead plans to:

  • Present full Phase 3 data from ARTISTRY-1 and ARTISTRY-2 in 2026
  • Submit the combined dataset for regulatory approval

If approved, BIC/LEN could expand treatment choices for long-term HIV maintenance therapy, especially for patients seeking regimen optimization without sacrificing viral control.

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