Gilead has released new phase 3 data from its ARTISTRY‑1 and ARTISTRY‑2 trials assessing treatment responses in adults with HIV who are virologically suppressed, including those switching from complex multi‑tablet regimens or a global guideline‑recommended single‑tablet option.
The findings, presented at the 33rd Conference on Retroviruses and Opportunistic Infections in 2026, showed that switching to bictegravir 75 mg/lenacapavir 50 mg was effective in maintaining viral suppression. According to Gilead, the efficacy of the investigational combination was comparable both to complex multi‑tablet antiretroviral regimens and to treatment with Biktarvy. The ARTISTRY‑1 results were also featured in an oral presentation and published simultaneously in The Lancet.
Gilead said: “While the advent of single‑tablet regimens has transformed the outlook for many people living with HIV, some people living with the virus cannot take available single‑tablet combinations due to viral resistance, medication intolerance, or contraindications, resulting in a demand for novel treatment options that better meet people’s needs and preferences.”
The company explained: “The ARTISTRY data demonstrate the potential of BIC/LEN to expand HIV treatment options for adults with virological suppression, combining the durability of bictegravir, a global guideline‑recommended integrase strand transfer inhibitor with a high barrier to resistance, and lenacapavir, a first‑in‑class capsid inhibitor with no overlapping resistance to other existing drug classes.”
At week 48, ARTISTRY‑1 showed that 0.8% of participants receiving the investigational combination had HIV‑1 RNA ≥ 50 copies/mL, compared with 1.1% of those who remained on complex multi‑tablet regimens. ARTISTRY‑2 found that 1.3% of participants on the investigational therapy had HIV‑1 RNA ≥ 50 copies/mL, compared with 1.0% of those who stayed on Biktarvy. Both trials reported that the combination was generally well tolerated with no significant or new safety concerns.
Gilead plans to file the phase 3 results with regulators in the near future. The company noted that bictegravir and lenacapavir in combination remain investigational and are not approved anywhere globally.
