Novel single-tablet BIC/LEN noninferior to standard of care in PWH

A single-tablet regimen (STR) combining bictegravir and lenacapavir (BIC/LEN) was noninferior to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in maintaining virologic suppression among people with HIV (PWH) who are virologically suppressed, according to the ARTISTRY-2 trial presented at CROI 2026.

“STRs have transformed the HIV treatment landscape and are associated with significant benefits, including improved clinical outcomes, adherence, and quality of life for PWH,” said lead author Associate Professor Eric Meissner from the Medical University of South Carolina in Charleston, South Carolina, US.

“A novel BIC/LEN could expand treatment options for PWH with virologic suppression,” he noted.

The phase III ARTISTRY-2 trial involved 574 PWH (mean age 35.7 years, 19.3 percent female), all of whom were virologically suppressed on B/F/TAF and were randomized in a 2:1 ratio to switch to BIC/LEN (75/50 mg; n=383) or to continue on B/F/TAF (n=191), with both treatments administered as once-daily STRs.

At week 48, only 1.3 percent of patients who switched to BIC/LEN and 1 percent of those who continued on B/F/TAF had HIV-1 RNA ≥50 copies/mL (as per the US FDA snapshot), the study’s primary endpoint, with a percentage difference of 0.3 percent that was within the noninferiority margin of 4 percent. [CROI 2026, abstract 513]

This result indicated that “BIC/LEN was noninferior to B/F/TAF in maintaining virologic suppression,” said Meissner.

Majority of the participants in both groups maintained virologic suppression (HIV-1 RNA <50 copies/mL) at week 48 (93.5 percent [BIC/LEN] and 90.6 percent [B/F/TAF]).

The median CD4 cell count from baseline to week 48 remained stable in both treatment groups.

Additionally, of the two patients in each treatment group who met the criteria for a resistance analysis, one patient on BIC/LEN and both patients on B/F/TAF showed no treatment-emergent resistance through week 48.

Of note, there was only one case of isolated R263K integrase substitution in the BIC/LEN group, who remain phenotypically susceptible to BIC.

In terms of safety, the rates of adverse events (AEs) and drug-related AEs were comparable between the BIC/LEN and B/F/TAF groups (75.2 percent vs 73.8 percent and 10.4 percent vs 12 percent, respectively).

Diarrhoea (8.1 percent), nasopharyngitis (7.8 percent), and upper respiratory tract infection (7.6 percent) were the most common AEs reported in the BIC/LEN arm.

BIC/LEN was generally well tolerated, with no serious drug-related AEs observed, and grade ≥3 drug-related AEs (9.9 percent [BIC/LEN] vs 7.9 percent [B/F/TAF]) or AEs leading to treatment discontinuation were infrequent (1.6 percent in each group).

“[Overall, switching to] a novel STR of BIC/LEN maintained high levels of virologic suppression at week 48 and was noninferior to standard-of-care treatment with B/F/TAF in PWH with virologic suppression,” said Meissner.

The results of the ARTISTRY-2 trial align with findings from the ARTISTRY-1 study, which demonstrated the noninferiority of BIC/LEN STR compared with complex multi-tablet regimens in maintaining virologic suppression, and support the use of a novel BIC/LEN STR to expand treatment options for PWH with virologic suppression, he added.