Gilead Sciences and Merck have announced new Phase 3 trial results showing their investigational once-weekly oral HIV treatment regimen maintained high levels of viral suppression among adults who switched from existing daily antiretroviral therapies.
The companies said results from the ISLEND-1 and ISLEND-2 studies showed the combination of islatravir 2 mg and lenacapavir 300 mg (ISL/LEN) met its primary goal at Week 48, demonstrating noninferiority to current standard treatment options.
If approved, ISL/LEN could become the first complete once-weekly oral single-tablet HIV treatment option, offering an alternative to daily medication for people living with HIV.
"Once-daily, combination, single-tablet antiretroviral therapy is the cornerstone of HIV treatment today. However, the treatment landscape is evolving,” said Jürgen Rockstroh, Department of Medicine University Hospital Bonn, Germany.
“Long-acting therapies provide an alternative to daily pills. The ISLEND-1 study results show the potential of ISL/LEN as the first once-weekly oral single-tablet treatment option.”
Trial results show sustained viral suppression
In the ISLEND-1 trial, adults who switched from BIKTARVY to ISL/LEN maintained viral suppression at rates comparable to those who continued daily treatment.
At Week 48, no participants who switched to ISL/LEN had HIV-1 RNA levels of 50 copies/mL or higher, compared with one participant (0.3%) who remained on BIKTARVY, according to the U.S. FDA-defined snapshot algorithm.
ISLEND-2 trial, ISL/LEN also performed comparably with standard-of-care daily oral HIV regimens. Researchers reported that 0.3% of participants receiving ISL/LEN had HIV-1 RNA levels of 50 copies/mL or higher, compared with 1.3% of participants who continued their existing therapies.
“Single tablet regimens have transformed the outlook for millions of people living with HIV,” said Amy Colson, Research Director at Community Resource Initiative and Medical Director of the Zinberg Clinic at Cambridge Health Alliance.
“Having a treatment option with once weekly dosing can expand choice to help address individual needs and preferences. The 48-week findings provide the evidence for ISL/LEN as the potential first once-weekly oral treatment option to help support long-term treatment needs and be responsive to the preferences of people living with HIV.”
The investigational treatment combines Merck’s islatravir, a next-generation nucleoside analog designed to block HIV replication through multiple mechanisms, with Gilead’s lenacapavir, a first-in-class capsid inhibitor that targets multiple stages of the HIV lifecycle.
The companies said the properties of both medicines allow them to be combined into a once-weekly oral tablet.
Islatravir and lenacapavir remain investigational and are not approved for use.
“There is currently no cure for HIV or AIDS,” the companies noted.
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