Background
A combination of bictegravir (BIC), an integrase strand transfer inhibitor, and lenacapavir (LEN), a first-in-class capsid inhibitor, could optimize treatment in people with HIV-1 (PWH) who are virologically suppressed (VS) and are otherwise unable to take a single tablet regimen (STR). ARTISTRY-1 (NCT05502341) is a randomized, open-label, multicenter Phase 2/3 study of BIC+LEN in PWH who are VS on a complex regimen (CR). Efficacy and safety outcomes from Phase 2 through Week (W) 24 and W48 have been presented; we report longer-term data through W96.
Methods
In Phase 2, PWH on a CR (≥6 months prior to screening) were randomized to once-daily oral BIC 75 mg + LEN (25 mg or 50 mg) or to continue CR. After the end of the randomized treatment visit, participants were invited to enter the extension and received once-daily BIC 75 mg/LEN 50 mg STR. This analysis includes data from those who were originally randomized to BIC 75 mg + LEN 50 mg and continued into the extension. Outcomes included the proportion of participants with HIV-1 RNA <50 copies/mL (missing=excluded [M=E]), change in CD4 cell count, and incidence of adverse events (AEs).
Results
Overall, 52 PWH were originally randomized to BIC 75 mg + LEN 50 mg; 47 continued into the extension. At baseline, median (range) age was 62 (34-76) years; 13% were female, 31% were Black, and 17% were Hispanic or Latine. At baseline, participants were taking a median (range) of 3 (2-9) tablets per day; 42% were taking tablets twice daily; 71% were taking a protease inhibitor. At W96, 96% (45/47) of participants had HIV-1 RNA <50 copies/mL (M=E); CD4 counts were similar to baseline (Table). BIC+LEN was generally well tolerated (Table). AEs were reported in 47 (90%) participants and were mostly Grade 1-2. Drug-related AEs (DRAEs) occurred in 3 (6%) participants, with 1 participant discontinuing BIC+LEN due to a DRAE (vomiting). No serious DRAEs were reported. There was 1 death (coronary artery disease), which was deemed unrelated to study treatment.
Conclusions
BIC+LEN maintained high levels of virologic suppression through W96 and was generally well tolerated. Based on these results, a BIC/LEN STR is being assessed in PWH who are VS on CR in the Phase 3 portion of ARTISTRY-1.
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