Gilead’s investigational drug combo bic/len could help lower the pill burden in patients with virologically suppressed HIV who are on complex treatment regimens, according to BMO Capital Markets.
A single-tablet combo of Gilead’s bictegravir and lenacapavir—a regimen being called bic/len—can sustain viral suppression in patients with HIV-1 who are on complicated antiretroviral regimens, according to new data issued Thursday.
“Reduced pill burden is on the horizon for HIV patients currently on complex treatment,” analysts at BMO Capital Markets told investors in a Thursday afternoon note. “Bic/Len has the potential to improve the treatment experience where high pill burden and subpar adherence, especially in patients with comorbidities, highlight areas in need of improvement.”
Moreover, bic/len “clears the path for Gilead to further strengthen its existing dominance in the HIV treatment market,” BMO continued.
The pharma’s daily treatment Biktarvy, which contains bictegravir as one of its active ingredients, is currently the “primary treatment” in HIV, according to the analysts. Meanwhile, the FDA in June approved Gilead’s lenacapavir, sold as Yeztugo, as a twice-yearly pre-exposure prophylaxis option. Bic/len combines these two drugs.
Results presented on Thursday come from the ARTISTRY-1 study, a Phase II/III study that compared the single-pill bic/len formulation against current therapy in patients with virologically suppressed HIV who are on complex treatment schedules. Though specific data was not disclosed, Gilead said that bic/len was “statistically non-inferior” to current multi-tablet regimens.
The drug combo was also generally well-tolerated. ARTISTRY-1 did not detect new or significant safety signals.
Bic/len is also presently being tested in the Phase III ARTISTRY-2 study, which assesses the safety and efficacy of switching virologically suppressed patients from Biktarvy to the investigational combo. Topline data for that trial are expected before the end of the year.
In the meantime, Gilead on Thursday indicated that it intends to share ARTISTRY-1 findings with the FDA, as well as present them at a future scientific conference.
While the pharma did not specify note a filing timeline for bic/len, BMO appears to already be looking forward to the product’s market debut, noting on Thursday that “we could see a Bic/Len launch as soon as 2027.”
And looking even farther ahead, the analysts expect “meaningful physician reception and patient uptake” if approved.
“Given Bic/Len’s single-dose formulation, the therapy has the potential to reduce the daily pill burden from two to 11 pills down to a single pill, promoting improved adherence and patient treatment experiences,” they added.
