Gilead’s Phase 3 ARTISTRY‑2 trial met its primary endpoint, showing that the fixed‑dose combination of bictegravir and lenacapavir (BIC/LEN) was non‑inferior to the current standard BIKTARVY in maintaining viral suppression at 48 weeks in adults who were already virologically suppressed.
The trial enrolled 1,200 adults across 30 sites worldwide, all of whom had been on BIKTARVY for at least 12 months. The primary endpoint was the proportion of participants with HIV RNA <50 copies/mL at week 48. BIC/LEN achieved 94.5% suppression versus 95.2% for BIKTARVY, meeting the pre‑specified non‑inferiority margin of 10 percentage points. Safety data were comparable, with no new safety signals.
The results give Gilead a new single‑tablet regimen that could be offered to patients who are stable on BIKTARVY but seek a different mechanism of action or a longer‑acting option. By adding BIC/LEN to its HIV portfolio, Gilead can deepen its market share in the 1‑tablet segment, potentially capturing patients who prefer a regimen that includes a capsid inhibitor and may reduce the risk of resistance.
Jared Baeten, senior vice president of clinical development, said, "These data support the potential of BIC/LEN as a meaningful additional treatment option for adults with HIV who are virologically suppressed. We look forward to sharing the full Phase 3 data from the ARTISTRY‑1 and ARTISTRY‑2 trials next year and submitting these data for regulatory approval." External experts echoed the enthusiasm, noting that the combination offers a novel therapeutic approach that could broaden treatment options.
The announcement was well received by investors, reflecting confidence in Gilead’s continued leadership in HIV therapy and the potential for future revenue growth from a new product that could complement its existing BIKTARVY line.
Gilead plans to file the Phase 3 results with regulatory authorities in the coming months and expects the new regimen to enter the market once approval is obtained, positioning the company to sustain its dominant presence in the HIV market.
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