Gilead and Merck’s Investigational HIV Combo Shows Promising Long-Term Viral Suppression in Phase 2 Trial

Efficacy:
The investigational combination of islatravir and lenacapavir, developed by Gilead Sciences and Merck & Co., maintained a high rate of viral suppression (94.2%) in virologically suppressed adults at 48 weeks in a Phase 2 clinical trial.

Clinical Trial:
The open-label, active-controlled trial (NCT05052996) involved 104 adults who were randomly assigned to either receive the once-weekly islatravir and lenacapavir regimen or continue with daily Biktarvy.

Safety and Tolerability:
The combination was found to be safe and well-tolerated, with no clinically significant decreases in CD4 cells and total lymphocytes observed. Mild to moderate adverse events were more common in the islatravir plus lenacapavir group but did not lead to significant discontinuations.

Future Development:
The promising results have led to the advancement of this combination into Phase 3 clinical trials, potentially paving the way for the first weekly oral HIV treatment.

Innovative Approach:
This once-weekly regimen aims to address adherence challenges and stigma associated with daily oral antiretroviral therapy, offering a more flexible and patient-centered approach to HIV treatment.