Isentress (raltegravir) is a medication that falls under the class of medications called HIV integrase strand transfer inhibitors that works by slowing the spread of HIV in the body. In the October 2007 this medication was approved only for adults suffering from HIV, this medication was under the FDA’s accelerated approval program which allows the agency to approve a particular medication to treat a grave disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patient suffering from the disease.
In order to confirm the drugs clinical benefit the company will be required to submit a n additional clinical information on the medication.
“Many young children and adolescents are living with HIV and this approval provides an important additional option for their treatment,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Isentress is a oral medication that can be consumed twice everyday and can be consumed with or without food, this medication in a pill form is also available in various other forms such as a chewable tablet. Because the two tablet formulations are not interchangeable, the chewable form is only approved for use in children ages 2 to 11.
A single, multi-center clinical trial of 96 children and adolescents ages 2-18 years with HIV-1 infection evaluated the safety and effectiveness of Isentress. These patients previously received treatment for HIV-1 infection. After 24 weeks of treatment with Isentress, 53 percent of these patients had an undetectable amount of HIV in their blood. Like any other medication isentress also has a few side effects that can be easily taken care of and can be cured in a short span of time. Isentress pill is meant only for slowing down the spread of HIV infection, it does not cure this disease. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.
Isentress is a product manufactured by Whitehouse Station, N.J.-based Merck & Co., Inc.