Janssen Therapeutics, division of Janssen Products, LP, has received the US Food and Drug Administration (FDA) approval for a new 800mg tablet of Prezista (darunavir) for once daily oral administration for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations. Prezista is always taken with and at the same time as ritonavir with food and in combination with other HIV medicines.
The new tablet strength will allow patients taking Prezista once daily to reduce the number of Prezista tablets by half, taking one 800mg tablet instead of two 400mg tablets once a day with ritonavir 100mg and other antiretroviral medications.
The 800mg tablet is expected to be available shortly. Janssen plans to discontinue the Prezista 400mg tablet, which will become obsolete as a result of the introduction of the 800mg tablet. To help physicians and patients transition to the new tablet, Janssen will provide educational materials about the new tablet to pharmacies. Prezista 800mg tablets will be added to medicines covered by the Janssen Therapeutics Patient Savings Program as well as those covered by the Johnson & Johnson Patient Assistance Foundation.
"The single 800mg tablet provides an option for a reduced pill burden and reflects our ongoing commitment to offer more treatment options for the diverse population of people living with HIV," said Bryan Baugh, medical director at Janssen Therapeutics.
Prezista (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors. Prezista is always taken with and at the same time as ritonavir (Norvir), in combination with other HIV medicines for the treatment of HIV infection in adults. Prezista should also be taken with food.