European Commission Approves PREZISTA® (Darunavir) 800mg Tablet Once A Day Reducing The Number Of Pills Taken By People Living With HIV

Date: Jan-17-2013Janssen R&D Ireland has announced that the European Commission (EC) has approved a
new PREZISTA(R) (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-naive patients with no darunavir resistance-associated
mutations[i].[1] 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[2] 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.[2]

"Strict adherence to treatment regimens is crucial to prevent virological failure and
the development of drug resistance when treating HIV," said Brian Woodfall, 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."

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.