Gilead Sciences and Merck have announced positive results from a Phase 2 clinical trial investigating a novel combination therapy for HIV. The trial evaluated the effectiveness of weekly oral doses of islatravir, an experimental nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class HIV-1 capsid inhibitor.
The study involved 104 adults with suppressed HIV who were currently on a stable regimen of Biktarvy. Participants were divided into two groups: one group continued taking Biktarvy daily, while the other switched to the once-weekly islatravir and lenacapavir combination.
At the 48-week mark, both groups demonstrated comparably high rates of viral suppression, with 94.2% of the islatravir and lenacapavir group and 92.3% of the Biktarvy group maintaining viral suppression. Notably, no participants in either group had a viral load resurgence above 50 copies/mL, a key indicator of treatment efficacy.
Treatment-related adverse events were generally mild. In the islatravir and lenacapavir groups, the most common side effects were dry mouth and nausea, each experienced by 3.8% of participants. No serious adverse events related to the study drug were reported in either group.
These positive Phase 2 results have led to the advancement of the islatravir and lenacapavir combination therapy to Phase 3 clinical trials. Two Phase 3 studies are currently underway to further evaluate the efficacy and safety of this fixed-dose combination regimen in individuals with suppressed HIV.
This novel once-weekly oral treatment holds significant promise for transforming HIV care. It offers a less frequent dosing regimen compared to daily pills, which could potentially improve adherence, minimize the stigma associated with daily medication, and ultimately contribute to better health outcomes for individuals 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.