FRIDAY, JUNE 22, 2018

Merck to continue clinical studies of once-daily Isentress

Merck & Co. announced plans on Wednesday to continue clinical studies of once-daily Isentress, an integrase inhibitor used in the treatment of HIV, at the 14th annual European AIDS Clinical Society Conference in Brussels, Belgium.

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.