Switching to Bictegravir-Lenacapavir Combination Maintains HIV Virologic Suppression in Patients With Complex Regimens

Some individuals with HIV have not had the ability to be on a single-tablet regimen (STR) due to various reasons, including developing treatment resistance, comorbidities, or drug interactions. These challenges often arise in a large group of older patients who have had HIV for many years, points out Chloe Orkin, MD, MSc, professor at Queen Mary University of London.

“In many cases, these are people who were diagnosed early on in the HIV epidemic and they've been through all of the treatment regimens, and therefore, they've developed resistance,” Orkin said. “Many of these people in this situation who are taking complex regimens [CRs] are older, and so far, none of the single-tablet regimens have been suitable for these individuals.”

However, that may be changing, as a new STR option could become available in the near future. At the ongoing Conference on Retroviruses and Opportunistic Infections, investigators presented data from the ARTISTRY-1 phase 3 trial, sponsored by Gilead, which studied the combination of bictegravir/lenacapavir (BIC/LEN) as an STR for individuals who had virological suppression on complex treatment regimens. The study was also published in The Lancet.

Trial Specifics

ARTISTRY-1 included 557 people with HIV who were randomly assigned and treated for almost a year (48 weeks). Study participants were taking, on average, between 2 and 11 antiretroviral tablets daily. There were 371 participants who were switched to BIC/LEN, and 186 continued their CR. Trial results demonstrated that an overwhelmingly large majority of participants were able to maintain virologic suppression, had a similar safety profile, and had no emerging resistance.

“At week 48, an HIV-1 RNA viral load of 50 copies per mL or higher was observed in three (1%) participants receiving bictegravir–lenacapavir and two (1%) receiving a complex regimen (difference −0.3%; 95.002% CI −2.3 to 1.8), meeting the noninferiority margin of 4%,” the investigators wrote.

If the BIC/LEN combination therapy is approved by the US Food and Drug Administration, Orkin, who served as the lead investigator on ARTISTRY-1, believes it will give people who have been on multipill daily regimens a significant alternative.

“It's an exciting new drug in itself, but what it will enable the clinician to do is to look at the people they're looking after and find these people who are still taking twice-daily pills or multiple pills and say to them, ‘Look, for the first time, we've got a regimen that you can take a single tablet,’” Orkin said.

 

Reference
Orkin C, Ruane PJ, Hedgcock M, et al; ARTISTRY-1 Study Group. Switch to single-tablet bictegravir–lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial. Lancet. Published online February 25, 2026. doi:10.1016/S0140-6736(26)00307-7