Gilead Sciences and Merck & Co. have reported positive phase 3 results for a combined weekly HIV pill, positioning the two-drug regimen as a potential rival to existing daily and long-acting therapies.
Data from two trials, Islend-1 and Islend-2, showed that a once-weekly, single-tablet combination of Gilead's lenacapavir and Merck's islatravir, referred to as ISL/LEN, matched the viral suppression achieved by daily treatments including Gilead's Biktarvy, according to Fierce Pharma.
In Islend-1, which enrolled 607 people already virally suppressed on Biktarvy, reportedly none of those switched to the weekly pill had detectable HIV at 50 copies/mL or more by week 48, compared with one participant (0.3%) who remained on Biktarvy. Islend-2, involving 626 participants stable on various daily regimens, found similarly low rates of virological failure between the weekly pill and standard treatment arms at 48 weeks.
The findings are due to be presented at the 26th International AIDS Conference in Rio de Janeiro. Both trials reported broadly comparable safety profiles between ISL/LEN and daily oral comparators, with treatment-related serious adverse events and discontinuations low across all arms.
The results carry added significance given that some Merck islatravir studies were placed on a US Food and Drug Administration clinical hold in 2021 after high-dose use was linked to declines in lymphocyte and CD4 counts, the outlet noted.
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Researchers said no meaningful between-group differences in lymphocyte counts emerged in the Islend trials at week 48.
Jared Baeten, Gilead's clinical development lead in virology, told Fierce Pharma that adherence remained one of the biggest hurdles in HIV care, saying cutting pill-taking from daily to weekly could ease that burden considerably for many patients.
The weekly pill would join a treatment landscape that already includes GSK's Cabenuva, a long-acting injectable dosed monthly or every two months.
Baeten said pill-based options would still appeal to patients wary of injections, even as some prefer longer-acting formulations.
Gilead is separately pursuing extended dosing intervals of its own, testing lenacapavir alongside two broadly neutralising antibodies in its Daybreak programme with the goal of eventually matching six-month dosing.
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