Gilead Sciences, Inc. today announced positive topline results from its Phase 3 ARTISTRY-2 trial, confirming that its investigational single-tablet regimen (STR) of bictegravir and lenacapavir (BIC/LEN) is statistically non-inferior to BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, B/F/TAF) in maintaining viral suppression in adults with HIV-1.
The positive data from ARTISTRY-2, alongside previously announced results from the ARTISTRY-1 trial, are expected to form the basis of regulatory submissions, paving the way for a potential new, innovative treatment option for people living with HIV.
Trial Results and Primary Endpoint
The ARTISTRY-2 trial was a double-blind, multicenter, randomized, active-controlled study evaluating the safety and efficacy of switching from the existing standard-of-care BIKTARVY to the investigational fixed-dose combination of bictegravir (75 mg) and lenacapavir (50 mg).
The study successfully met its primary efficacy endpoint, demonstrating that switching to the once-daily BIC/LEN STR was statistically non-inferior to remaining on BIKTARVY in terms of the proportion of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48, as defined by the FDA snapshot algorithm. The BIC/LEN regimen maintained high rates of virologic suppression comparable to BIKTARVY.
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A Novel Combination for Long-Term Management
The investigational regimen pairs two potent and distinct antiretroviral agents:
- Bictegravir (BIC): A global guideline-recommended integrase strand transfer inhibitor known for its high barrier to resistance.
- Lenacapavir (LEN): A first-in-class capsid inhibitor that works by blocking multiple stages of the HIV-1 lifecycle and has no known overlapping resistance with existing drug classes.
This combination aims to further simplify and modernize HIV treatment. By combining these two mechanisms into a single, daily tablet, Gilead intends to expand treatment options for individuals looking to sustain virologic suppression.
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Safety and Regulatory Outlook
In terms of safety, the novel combination was generally well tolerated, and no significant or new safety concerns were identified during the trial. Key secondary endpoints, which included rates of virologic suppression below 50 copies/mL and changes in CD4 cell count, were also analyzed.
The positive results from both ARTISTRY-1 (which studied a switch from complex multi-tablet regimens) and ARTISTRY-2 (a switch from BIKTARVY) will collectively be submitted to regulatory authorities globally. Gilead also plans to submit detailed findings from the trials for presentation at a future scientific congress.
This drug program continues Gilead’s legacy in developing single-tablet complete regimens for HIV treatment, which began in 2006, and signifies a key step in providing more convenient and effective options tailored to the diverse needs of people living with HIV.
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