The European Commission (E.C.) has approved Janssen/Cilag International’s 100mg/ml oral suspension of Prezista (darunavir), and the use of darunavir co-administered with low dose ritonavir, for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral therapy (ART)-experienced pediatric patients age three and above, weighing at least 15kg. The drug must be taken in combination with other ARTs.
The approval is based on a 48-week analysis of ARIEL, a phase II, open-label trial to evaluate pharmacokinetics, safety, tolerability and antiviral activity of darunavir in combination with low dose ritonavir in treatment-experienced HIV-1 infected children from three to less than six years of age.
"This approval is exciting news for young children with HIV, as there is a significant and often overlooked need in the availability of specifically formulated antiretroviral therapies for this patient population. An oral suspension that makes it easier for children with HIV to take their treatment as prescribed is very important for this group, who must maintain a lifetime of daily therapy to prevent the progression of HIV to AIDS," said Dr. Avy Volari of the Chris Hani Baragwanath Hospital in South Africa, and lead author of the ARIEL study.
Long-term durability of treatment is an important issue for young children living with HIV, which can be affected by challenges in adherence to therapy. Strict adherence to treatment regimens and dosing schedules is crucial to prevent virological failure and the development of drug resistance. Currently, one in eight children and adolescents with HIV in Europe experience virological failure of three drug classes within five years, which can severely limit treatment options into adolescence and adulthood.
The E.C. also recommended approval of the darunavir 100 mg/ml oral suspension for use in patients who are unable to swallow tablets, providing an additional way to receive treatment.