Prezcobix HIV Indication Expanded to Include Pediatric Patients

July 31, 2020 – The U.S. FDA has approved an expanded indication for Prezcobix® (darunavir/cobicistat) oral tablets, manufactured by Janssen Pharmaceuticals. The product is now indicated to treat HIV-1 infection in treatment-naïve and treatment-experienced pediatric patients who weigh at least 40kg (88 pounds) and have no darunavir resistance-associated substitutions. Previously, Prezcobix was only approved for use in adults.

Although rare in pediatric patients in the United States, HIV can occur in both children and adolescents. Children under the age of 13 usually contract the infection from their mothers during pregnancy, birth, or breastfeeding, while adolescents typically are infected via sexual transmission. Antiretroviral medication can suppress the virus to help prevent disease complications and progression. However, HIV can become resistant to treatment with these medications, meaning not all patients will benefit from the same treatment regimen.

In a clinical study of pediatric patients already virologically suppressed on antiretroviral medication, 86% remained virologically suppressed when switched to Prezcobix. Recommended dosing for adults and pediatric patients is one tablet taken once daily with food. HIV genotypic testing is recommended prior to treatment for treatment-experienced patients, as well as an assessment of creatinine clearance.

Prezcobix first received FDA approval in 2015.