Tibotec, a division of Janssen-Ortho, has announced that Health Canada has approved Prezista for use in treatment-naive adults, dosed once daily in combination with other antiretroviral agents.
The new indication for Prezista includes a new tablet strength of 400mg to support the recommended dosing regimen. Prezista, dosed at 600mg twice daily, co-administered with 100mg ritonavir twice daily, is already approved in treatment-experienced patients. In treatment naive adults, Prezista will be dosed at 800mg once daily, co-administered with 100mg ritonavir once daily and with other antiretroviral agents.
As a result of the new indication, Prezista is now indicated for the treatment of human immunodeficiency virus infection, regardless of treatment history. The new indication for Prezista was based on data from the pivotal randomized, controlled, open-label Phase III HIV trial.
Anita Rachlis, professor of department of medicine and division of infectious diseases for Sunnybrook Health Sciences Center at University of Toronto, said: With the introduction of Prezista in Canada two years ago, the medical community welcomed a well-tolerated and effective option for treatment-experienced patients living with HIV. It’s encouraging that now we can offer Prezista as part of combination therapy to an even broader patient population who may benefit from the treatment.