January 16, 2013
In the news release, "European Commission Approves PREZISTA® (darunavir) 800 mg Tablet Once a Day Reducing the Number of Pills Taken by People Living With HIV" issued on
16 Jan 2013
, by Janssen R&D Ireland over PR Newswire, please be advised that the first note following paragraph three has been corrected to read "i. ART-experienced adults with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l." Complete corrected release follows:
Janssen R&D Ireland announced today that the European Commission (EC) has approved a new PREZISTA® (darunavir) 800mg tablet allowing people living with HIV to take one darunavir tablet once a day. Darunavir is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced and treatment-naïve patients with no darunavir resistance-associated mutations
Darunavir is always taken in combination with ritonavir and other HIV medicines together with food. This new tablet strength has been developed to allow patients taking darunavir once daily to reduce the number of darunavir tablets by half.
The approval is based on study C176
which evaluated the 400 mg tablet formulation versus the 800 mg formulation. One hundred and twenty eight healthy volunteers, were included in this study and received treatment under fasting (n=83) or under fed conditions (n=45). The results of this study show that the rate and extent of absorption were similar between intake of a single 800 mg dose of darunavir formulated as one 800 mg tablet or two 400 mg tablets.
"Strict adherence to treatment regimens is crucial to prevent virological failure and the development of drug resistance when treating HIV," said
, Vice President, Medical Affairs, Janssen EMEA. "This single 800 mg tablet formulation is a direct reflection of the ongoing commitment of Janssen to further develop treatment options for people living with HIV. With this approval we are providing an alternative solution and a reduced pill burden which should make it easier for patients to manage their treatment on a day-by-day basis and keep their HIV at undetectable levels."