Gilead’s HIV treatment meets primary trial endpoint
Esme Needham | December 16, 2025 | News story | Research and Development | Gilead, HIV/AIDS
Gilead has announced positive topline results from its phase 3 ARTISTRY-2 trial, which evaluated a combination of bictegravir and lenacapavir (bic/len) in virologically suppressed adults with HIV.
Trial participants switched from Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) to bic/len, which is taken once daily as a tablet. The trial found that bic/len was statistically non-inferior to Biktarvy.
The bic/len combination was found to be well tolerated by participants, with no significant or new safety concerns.
Bictegravir is an integrase strand transfer inhibitor with a high barrier to resistance, while lenacapavir is a capsid inhibitor with no overlapping resistance to other existing drug classes. A simple, single-tablet regimen combining the two drugs could offer hope for patients with HIV, sustaining virologic suppression and expanding treatment options.
The ARTISTRY-2 results will be combined with findings from the phase 3 ARTISTRY-1 trial, topline results of which were released in November 2025. These results showed that bic/len was well-tolerated and statistically non-inferior to multi-tablet antiretroviral regimens. The combined results of the two trials will form the basis of future regulatory submissions.
“The HIV treatment landscape is evolving. As a collective HIV community, we must look to the future of tailored treatments to meet the needs and preferences of people affected by HIV,” said Jared Baeten, senior vice president, clinical development, virology therapeutic area head at Gilead. “This data supports the potential of bic/len as a meaningful additional treatment option for adults with HIV who are virologically suppressed.”
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