Global pharma powerhouse Gilead Sciences has announced that its investigational HIV treatment, a once-daily combination of bictegravir 75 mg and lenacapavir 50 mg (BIC/LEN), met its primary goal in the Phase 3 ARTISTRY-2 trial. 

 

The study found BIC/LEN to be statistically non-inferior to BIKTARVY, Gilead’s current standard-of-care therapy.

 

The double-blind, multicenter trial evaluated adults with HIV who were virologically suppressed and switched from BIKTARVY to BIC/LEN. The primary endpoint measured the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48 using the FDA snapshot algorithm. 

 

According to Gilead, the investigational regimen was generally well tolerated, with no significant new safety concerns.

 

The novel combination pairs bictegravir, a widely recommended integrase strand transfer inhibitor, with lenacapavir, a first-in-class capsid inhibitor that has no overlapping resistance with existing HIV drugs. 

 

Gilead said the single-tablet regimen “could potentially further transform the treatment landscape, expanding options to enable people with HIV to sustain virologic suppression while taking one of the latest advances in HIV drug development.”

 

“Recent breakthroughs in medical research have led to the approval of new treatments that can help people with HIV sustain viral suppression, facilitating improved health outcomes while also helping to reduce spread of the virus,” said Eric Meissner, Associate Professor and Director of HIV and Hepatitis Patient Care and Research at the Medical University of South Carolina. 

 

“The findings from ARTISTRY-2 provide evidence that the investigational combination of bictegravir—a standard-of-care integrase strand transfer inhibitor—and lenacapavir—a novel capsid inhibitor—has a comparable efficacy profile to a global guideline-recommended treatment regimen, demonstrating potential to expand current HIV treatment options.”

 

Jared Baeten, Senior Vice President of Clinical Development at Gilead, emphasized the broader implications: “The HIV treatment landscape is evolving. As a collective HIV community, we must look to the future of tailored treatments to meet the needs and preferences of people affected by HIV. 

 

"These data support the potential of BIC/LEN as a meaningful additional treatment option for adults with HIV who are virologically suppressed. We look forward to sharing the full Phase 3 data from the ARTISTRY-1 and ARTISTRY-2 trials next year and submitting these data for regulatory approval.”