Raltegravir, an antiretroviral medication that delays the spread of HIV infection provides a new method to treat HIV in children and adolescents. The drug was recently approved (December 21, 2011) by the Food and Drug Administration (FDA) for use with other antiretroviral drugs to treat children and teenagers between 2 to18 years of age with the disease. Raltegravir is part of a class of medications called HIV integrase inhibitors and was approved by the FDA for adults in 2007.
In a national multi-centered human trial that investigated the safety and effectiveness of raltegravir in HIV-infected children and teenagers funded by the National Institute of Health’s National Institute of Allergy and Infectious Diseases, Dr. Sharon Nachman (Associate Dean for Research and Professor of Pediatrics, Stony Brook University School of Medicine, and lead researcher and Study Chair) and her team enrolled 95 patients previously treated with a regimen of other HIV medications prior to raltegravir aged between 2 to 18 years to participate in the study. 53% of participants had an undetectable amount of HIV in their blood 24 weeks after receiving raltegravir treatment.
Dr. Nachman explains:
“Raltegravir is an important new option for children with HIV. The trial shows it has an excellent efficacy profile in children with HIV who have failed other regimens and is also effective against the virus regardless where the child lives around the world. The data also shows no significant toxicities or interactions with other HIV medications.”
For younger patients, raltegravir is given in a chewable form, while children and adolescents receive raltegravir in a pill that can be taken twice daily, with or without food. Furthermore, Dr. Nachman highlights that as well as the medication being an important new option for children and teenagers, the formulations available may help increase patient compliance as they are more convenient.
According to the FDA, the most prevalent adverse effects of taking raltegravir include headache and insomnia. The frequency of these adverse effects is similar in children and adults.
Dr. Nachman states that the investigation of using raltegravir to treat children and teenagers with the disease will continue and that each participant will be followed for 5 years. During the follow-up period, the team will continue to assess raltegravir’s efficacy and any long-term complications in study participants.
The investigation is the first to provide pediatric data on the use of raltegravir in children and adolescents between 2 to 18 years of age. Patients are enrolled through Stony Brook and other study locations across the country. According to Dr. Nachman, one of the next steps to advance the investigation is to assess a novel baby formulation.
Written by Grace Rattue