Merck to continue clinical studies of once-daily Isentress
Isentress is currently administered to patients with HIV twice daily in 400-milligram doses as part of a larger treatment program. Merck will move forward with phase three clinical studies early next year on once-daily Isentress that would be administered each day in an 800-milligram dose.
Previous studies showed that the once-daily dose was inferior to the twice-daily dose. Once-daily doses achieved viral suppression in 83 percent of patients at 48 weeks. The twice-daily dose, meanwhile, achieved 89 percent viral suppression at 48 weeks.
"We previously studied once daily Isentress in a combination regimen, and in that study, the once-daily formulation did not meet the non-inferiority endpoint," Merck Vice-President of Global Clinical Development, Infectious Disease and Vaccines Dr. Jeff Chodakewitz said. "The data we are presenting at the EACS, as well as other currently available data, provide a strong scientific basis to continue our investigational work toward a once-daily dosing regimen."
When administered in an HIV treatment regimen, Isentress slows the insertion of HIV-1 DNA into a patient's DNA through the integrase enzyme. That blocks the virus's ability to replicate and infect new cells.