Combining islatravir/lenacapavir could provide alternative to daily antiretroviral therapy for virologically suppressed patients with HIV.
New phase III data has demonstrated the potential for Gilead and MSD’s islatravir/lenacapavir (ISL/LEN) to be the first once-weekly oral single-tablet regimen to treat HIV.
It combines Merck’s islatravir, a next-generation nucleoside analogy with distinct mechanisms of action and Gilead’s lenacapavir, a first-in-class capsid inhibitor.
The combination treatment targets multiple stages of HIV-1 replication. As an alternative to daily antiretroviral therapy, if authorised, ISL/LEN would improve convenience and adherence for virologically suppressed patients.
In both Phase III ISLEND-1 and ISLEND-2 trials, ISL/LEN met the primary efficacy endpoint at Week 48, demonstrating non-inferiority and a comparable safety profile to daily antiretroviral therapy.
Dr Jared Baeten, Senior Vice President, Clinical Development and Virology Therapeutic Area Head, Gilead Sciences, said: “Long-acting oral therapies represent a new wave of transformational innovation in HIV drug development, with the potential to reshape the landscape of care.
“Innovative oral HIV treatment options that allow for less frequent dosing may make a meaningful difference in the lives of people living with the virus, potentially offering more flexibility and discretion.”
“[This] novel once-weekly oral regimen of islatravir and lenacapavir, if approved, would represent the first of its kind with less frequent dosing and further expand options for people living with HIV”
Dr Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer at Merck Research Laboratories
Dr Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer at Merck Research Laboratories, added: “By advancing this investigational novel once-weekly oral regimen of islatravir and lenacapavir, we aim to bring forward a new long-acting oral option that, if approved, would represent the first of its kind with less frequent dosing and further expand options for people living with HIV.”
Gilead and MSD plans to present findings from the Phase III ISLEND at a future scientific congress.
Alongside GSK and MSD, ViiV Healthcare is also advancing long‑acting treatment for HIV. The firm shared positive 12-month data from its Phase IIb EMBRACE trial for long-acting, broadly neutralising antibody (bNAb) lotivibart (N6LS) at CROI 2026.
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