Gilead Sciences has developed an industry-leading HIV portfolio in recent years with its megablockbuster daily treatment Biktarvy and its new long-acting pre-exposure prophylaxis (PrEP) medicine Yeztugo. Now, the company is finding success in combining two of the active ingredients in those products.
Gilead's investigational single-tablet HIV regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) has prevailed in a phase 3 trial, the company announced Thursday.
The open-label trial assessed responses to the investigational regimen in adults with HIV who were virologically suppressed on a complex multi-tablet regimen. The trial randomized patients 2 to 1 to either switch to the investigational once-daily tablet or stay on their existing regimens.
In the Artistry-1 study, the efficacy of switching to BIC/LEN was "found to be statistically non-inferior" compared with staying on baseline multi-tablet regimens, Gilead said. The trial's primary endpoint looked at the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48.
The trial forms part of the company's late-stage push for the BIC/LEN program, and the positive results will be submitted to regulators and submitted for presentation at future medical conferences, the drugmaker said.
The company has not yet reported a top-line readout for the other phase 3 trial in the program, Artistry-2. That study is testing responses to the investigational tablet in those who were already virologically suppressed on Biktarvy; it's due for a top-line readout by the end of the year, Gilead said Thursday.
People who are on complex regimens for HIV haven't been able to benefit from single-tablet regimens due to a range of reasons such as resistance to drugs, tolerability and drug-drug interactions, Gilead noted. The promise of the BIC/LEN program is that it could offer a new option for people who remain on complex multi-tablet regimens.
In Artistry-1, patients were taking between 2 and 11 pills per day at baseline, Gilead said.
“Developing new effective, convenient regimens for those left behind by advances in medical research is necessary to close the unmet HIV treatment gap,” Chloe Orkin, professor of infection and inequities at Queen Mary University of London, said in a statement.
For people who are currently on multi-tablet HIV regimens, many of whom are also on medicines for other conditions, the findings are "significant," Orkin added.
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.
The investigational therapy “targets a key unmet need within the HIV market (~6-8%), who are not candidates for the standard-of-care" drug Biktarvy, Citi analyst Geoffrey Meacham wrote in a note to clients on Thursday.
With this treatment, Gilead could expand its reach in the HIV market without “cannibalizing its flagship product,” Meacham wrote.
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