FDA Approves Expanded Use Of ISENTRESS® (raltegravir) In Combination Therapy For Adult Patients With HIV-1 Infection
Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for ISENTRESS®. The broadened indication now includes use in the treatment of adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as in treatment-experienced adult patients. ISENTRESS is used in combination with other antiretroviral (ARV) medicines for the treatment of HIV-1 infection in adult patients. The indication for ISENTRESS is based on analyses of plasma HIV-1 RNA levels through 48 weeks in three double-blind controlled studies. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRT, NRTI, PI) treatment-experienced adults and one was conducted in treatment-naïve adults. The safety and efficacy of ISENTRESS have not been established in pediatric patients. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.
Public Health