Bictegravir-lenacapavir STR maintains viral suppression: Phase 3 ARTISTRY-2 findings

As people age with HIV, there is a need to expand treatment options that help ensure virologic suppression is maintained over time. If approved, the investigational single-tablet treatment regimen combining bictegravir and lenacapavir (BIC/LEN) could provide another meaningful treatment option for adults with HIV who are virologically suppressed.

Q. What were the key findings from the study, and how should clinicians interpret the results when considering treatment switches in stable patients?

ARTISTRY-2 was designed to evaluate the treatment responses of adults with HIV who are virologically suppressed switching from B/F/TAF, a global guideline-recommended single-tablet treatment regimen, to a once-daily, single-dose combination of BIC/LEN. This is an important distinction from ARTISTRY-1, which is comparing BIC/LEN to complex multi-drug regimens.

At CROI 2026, new detailed efficacy and safety data were presented through 48 weeks of treatment. The presented data build on the topline ARTISTRY-2 results that were announced in December and show that BIC/LEN demonstrated non-inferiority to B/F/TAF in maintaining viral suppression over a 48-week period in individuals who were already suppressed on B/F/TAF prior to study enrolment. Additionally, Gilead announced that no significant or novel safety concerns were identified with either treatment.

Results from the ARTISTRY-2 trial presented at CROI 2026 demonstrate the potential of BIC/LEN to broaden current HIV treatment options, since BIC/LEN demonstrated comparable efficacy to B/F/TAF. BIC/LEN was non-inferior to B/F/TAF in maintaining virologic suppression through Week 48, with 1.3% of participants receiving BIC/LEN having HIV-1 RNA ≥50 copies/mL (as determined by the US FDA-defined snapshot algorithm) compared to 1.0% who remained on B/F/TAF. Through 48 weeks, CD4 cell count remained stable in both treatment groups and switching to BIC/LEN had no significant impact on weight, with BMI remaining stable in both treatment groups.

Q. Given the comparable safety and tolerability profiles between the two regimens, what factors should guide clinicians when deciding whether to switch patients from B/F/TAF to BIC/LEN?

If approved, BIC/LEN would be an important addition to the HIV treatment landscape. People living with HIV whose treatment currently consists of multiple daily pills due to viral resistance could be eligible to switch to BIC/LEN, which would reduce their daily pill burden. This is the scenario being evaluated in the ARTISTRY-1 study.

BIC/LEN could also provide an alternative option for people whose current treatment, whether it is a multi-pill or single-pill regimen, may benefit from a switch based on their provider’s judgement and through shared decision-making.

Q. How do these findings position BIC/LEN within the evolving HIV treatment landscape, particularly in terms of long-term management and expanding options for virologically suppressed individuals?

The findings from ARTISTRY-2 support the potential of the BIC/LEN regimen to expand the range of single-tablet antiretroviral treatments available to people living with HIV. With efficacy shown to be comparable to a guideline-recommended therapy, we look forward to the prospect of having another meaningful treatment option for adults with HIV who are virologically suppressed.

Q. What were the most important therapeutic and treatment updates presented at CROI 2026?

It was encouraging to see the many research groups and multiple companies continuing to explore and develop new daily and long-acting treatments for both HIV treatment and prevention, as well as updates on the multiple strategies and ongoing work targeting the HIV reservoir as part of HIV cure research.