Merck receives FDA approval of new HIV-1 treatment
Merck has announced that the U.S. Food and Drug Administration (FDA) has approved ISENTRESS® HD, a new 1200 mg once-daily dose of the company’s integrase inhibitor, ISENTRESS® (raltegravir), to be administered orally as two 600 mg film-coated tablets with or without food, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults, and pediatric patients weighing at least 40 kg, who are treatment-naïve or whose virus has been suppressed on an initial regimen of ISENTRESS 400 mg given twice daily.
“ISENTRESS has been used as a component of treatment regimens for patients diagnosed with HIV-1 for almost a decade,” said Dr. Michael S. Saag, associate dean for global health, and director of the Center for AIDS Research at the University of Alabama at Birmingham School of Medicine. “The addition of a convenient once-daily version with a comparable efficacy and safety profile at 48 weeks to the existing twice-daily version of ISENTRESS provides physicians with a new therapeutic option for some patients with HIV-1 infection.”
ISENTRESS and ISENTRESS HD do not cure HIV-1 infection or AIDS.