With a second late-stage trial win for its investigational HIV combo in the books, Gilead Sciences is moving full steam ahead toward regulatory filings for the novel HIV regimen.
In Gilead's Artistry-2 study, the company's single-tablet regimen of bictegravir and lenacapavir matched up to Gilead's own megablockbuster HIV medicine Biktarvy when assessing patients' treatment responses, Gilead said in a Dec. 15 release. The trial enrolled adults with HIV who had achieved virologic suppression on Biktarvy and randomized them 2-1 to either switch to the novel regimen or continue receiving Biktarvy.
In top-line results shared Monday, Gilead said the bictegravir 75-mg/lenacapavir 50-mg regimen was noninferior to Biktarvy, meeting the trial's primary endpoint. The primary endpoint looked at the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48. The investigational combo was generally well tolerated, Gilead added.
“These data support the potential of BIC/LEN as a meaningful additional treatment option for adults with HIV who are virologically suppressed," Gilead's Jared Baeten, M.D., Ph.D., senior vice president of clinical development and virology therapeutic area head, said in a statement. "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.”
The news comes about a month after Gilead reported a top-line win in the Artistry-1 study. The trials were similar in design, but Artistry-1 enrolled patients who were on complex multi-tablet regimens at baseline.
Bictegravir, an integrase strand transfer inhibitor, is one of the three active ingredients in Biktarvy, alongside the antivirals emtricitabine and tenofovir alafenamide. Lenacapavir is a capsid inhibitor used in the company's long-acting HIV treatment Sunlenca and its twice-yearly PrEP drug Yeztugo.
When Gilead reported the Artistry-1 win, Citi analyst Geoffrey Meacham, Ph.D., wrote that the novel regimen "targets a key unmet need within the HIV market (~6-8%), who are not candidates for the standard-of-care" drug Biktarvy. Thus, the combo could allow Gilead to expand its reach in HIV without "cannibalizing its flagship product," Meacham wrote.
In the wake of the Artistry-2 readout, Meacham explained in a note to clients that the novel offering could find use in the "Biktarvy switch market."
"Indeed, today's positive results will enable Gilead to position the combo strategically and retain patients who might otherwise switch to other 2 drug regimen," Meacham wrote. "Overall the positive results across both ARTISTRY (1&2) trials will allow Gilead to provide a simplified 2-drug regimen and provide an alternative for the specific market segments that prefer fewer medications."
Meacham's team is projecting 2030 sales of $630 million for the combo product. After planned filings next year, Gilead could launch the drug in 2027, the analyst wrote.