The FDA ( Food and Drug Administration ) approved Prezista ( Darunavir ), a new drug for adults whose infection with the human immunodeficiency virus ( HIV ) has not responded to treatment with other antiretroviral drugs.

Prezista, a HIV protease inhibitor, is approved to be co-administered with a low-dose of Ritonavir and other active anti-HIV agents.
Ritonavir, a protease inhibitor approved in 1996, slows the breakdown of Prezista in the body thereby increasing the concentration of Prezista.

The accelerated approval is based on evidence from two randomized, controlled studies comparing the safety and effectiveness of a Darunavir -Ritonavir combination with other Ritonavir-boosted protease inhibitor combinations. Patients in both arms of these trials also used other anti-HIV agents ( nucleoside reverse transcriptase inhibitors ) with or without Enfuvirtide ( Fuzeon ), a fusion inhibitor that inhibits the virus from entering the cell.
In these studies, patients on a Darunavir-Ritonavir combination experienced higher rates of reduction of their HIV viral load than patients on other Ritonavir-boosted protease inhibitor combinations.
Seventy percent of treatment-experienced patients achieved a virologic response, improving the treatment outcome, with Darunavir -Ritonavir in combination therapy compared to 21 percent in control group at week 24.

The most common side effects reported by patients on the Darunavir -Ritonavir regimen included diarrhea, nausea, and headache. About seven percent of patients on this combination therapy experienced skin rashes ranging from mild to serious.

The risks and benefits of Darunavir have not been established for adults who have not been previously treated for HIV, or for children.

Prezista and Ritonavir need to be taken with food, and the combination therapy doesn’t have not to be used together with St. John's wort or various other drugs, including certain anticonvulsants, antihistamines, sedatives and a few of the protease inhibitors.

Source: FDA, 2006


XagenaMedicine2006