Gilead Sciences Inc. (NASDAQ:GILD) announced promising results from its Phase 3 ARTISTRY-1 trial, which evaluates a new single-tablet regimen for HIV treatment. The trial focused on patients who are already virologically suppressed and switched from a multi-tablet regimen to the investigational combination of bictegravir 75 mg and lenacapavir 50 mg (BIC/LEN).
The once-daily treatment met its primary endpoint for non-inferiority compared to existing multi-tablet antiretroviral therapies. Specifically, the primary efficacy measure assessed the percentage of participants with HIV-1 RNA levels of 50 copies/mL or more at Week 48, as determined by the FDA snapshot algorithm. These results indicate that the new regimen is as effective as traditional treatments.
Trial Overview and Results
In the ARTISTRY-1 trial, which is multicenter and open-label, the participants were randomized in a 2:1 ratio to receive either the fixed-dose combination of BIC/LEN or to continue their established treatment regimens. The trial demonstrated that BIC/LEN was generally well tolerated, with no significant new safety concerns arising during the study.
Key secondary endpoints at Week 48 included the proportion of participants achieving virologic suppression, the change in CD4 cell counts from baseline, and the occurrence of treatment-emergent adverse events (TEAEs). Preliminary findings indicated a positive response among those who switched to the new single-tablet regimen.
Further evaluation of the BIC/LEN combination is underway in the double-blind Phase 3 ARTISTRY-2 trial. This study aims to assess the safety and efficacy of switching from BIKTARVY (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) to the new fixed-dose combination in virologically suppressed individuals with HIV-1. Data on the primary endpoint from this trial is expected to be released by the end of the year.
Market Impact and Future Outlook
Following the announcement, Gilead’s shares experienced a notable increase, rising by 2.97% to reach $127.07. This uptick reflects investor optimism regarding the potential of BIC/LEN to revolutionize HIV treatment by simplifying regimens for patients who are already managing their condition effectively.
As the trial progresses and more data becomes available, Gilead continues to enhance its position in the competitive landscape of HIV treatment. The findings from the ARTISTRY-1 trial could pave the way for broader adoption of this single-tablet regimen, ultimately improving patient adherence and outcomes.
Gilead’s commitment to innovation in HIV therapy remains strong, and the results from these clinical trials will be crucial in shaping the future of treatment for millions affected by the virus worldwide.
