Gilead Sciences and Merck (MSD outside the U.S. and Canada) have shared promising Phase 2 clinical study results for their investigational oral combination regimen of islatravir and lenacapavir in virologically suppressed individuals with HIV. These findings, presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI), support the potential of this novel regimen to serve as the first oral weekly HIV treatment, addressing various unmet needs within HIV care, such as adherence and stigma associated with daily medication.
The investigational combination maintained viral suppression (HIV-1 RNA <50 copies/mL) in 94.2% of study participants at 24 weeks. Only one participant exhibited a viral load >50 copies/mL at this time point but achieved viral suppression by Week 30. The pharmacokinetic profiles and potent antiviral activities of islatravir and lenacapavir underscore their development as a once-weekly oral regimen.
In the study, virologically suppressed adults on Biktarvy were either shifted to the investigational regimen or continued their current therapy, showing that a less frequent dosing schedule could retain high rates of HIV suppression, a crucial objective in long-term HIV management.
These data underscore the potential of providing flexible treatment options to cater to individual needs, moving closer to transforming the HIV treatment paradigm by offering a diverse range of dosing schedules that could maximize long-term health outcomes for those living with HIV.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
