Gilead, Merck announce Phase 2 data on islatravir-lenacapavir combination

Gilead Sciences (GILD) and Merck (MRK) announced results from the Phase 2 clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class capsid inhibitor. These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections, or CROI. Prior to the late-breaker oral presentation, the key findings were featured in a CROI press conference. At 24 weeks, the novel investigational combination maintained a high rate of viral suppression, which is a secondary endpoint of the study. Results of the primary endpoint showed that one participant treated with islatravir and lenacapavir had a viral load of greater than50 copies/mL at Week 24; the participant later suppressed on islatravir and lenacapavir at Week 30. “The potent antiviral activities, along with pharmacokinetic profiles of islatravir and lenacapavir, support their development as an investigational once-weekly oral combination regimen. Single-tablet daily oral therapies have helped to transform HIV care, but options that allow for less frequent dosing have the potential to address adherence, stigma and other challenges faced by some individuals taking daily oral antiretroviral therapy,” the companies stated.