Evotaz Receives Expanded Indication to Treat HIV

July 31, 2020 – The U.S. FDA has approved an expanded indication for Evotaz® (atazanavir/cobicistat) oral tablets, manufactured by Bristol-Myers Squibb, to include its use in combination with other retroviral agents to treat HIV-1 infection in pediatric patients who weigh at least 35kg (77 pounds). Previously, Evotaz was approved only for use in adults.

HIV infection in children and adolescents is rare in the United States. Children under 13 years of age usually contract the virus from their mother during pregnancy, birth, or breastfeeding. Most adolescents in the U.S. who have HIV contract it through sexual transmission. Antiretroviral agents help suppress the virus, which can slow the disease’s progression and prevent complications.

In a clinical study of pediatric patients whose HIV was virologically suppressed on other medications, 93% remained virologically suppressed on Evotaz. Recommended dosing for both pediatric and adult patients is one tablet taken with food once daily. Patient renal function should be tested prior to treatment. Evotaz is not recommended for use in treatment-experienced patients who have end-stage renal disease and are on hemodialysis. It is also not recommended for use in patients who have any degree of hepatic impairment. The use of Evotaz in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions.

The product first received FDA approval in 2015.