Published on 16 January 2013
European commission approves PREZISTA®
Janssen R&D Ireland has announced 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.(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.”
It is estimated that currently there are 34.5 million people living with HIV globally, with 2.5 million people becoming newly infected each year.(3) Thanks to significant advances in treatment for HIV over the past 30 years a diagnosis for these people is no longer a death sentence. Yet, data shows that after eight months of treatment only 65% of patients will achieve 100% compliance.(4) Missing doses can allow drug levels in the blood to fall which could allow viral replication to occur and greatly increase the risk of resistance emerging.(5)
- PREZISTA 800 mg. Summary of Product Characteristics, 2012.
- Janssen data on file.
- World Health Organization. Global summary of the AIDS epidemic. Available at URL: http://www.who.int/hiv/data/2012_epi_core_en.png . Last accessed December 3, 2012.
- Mannheimer S, Friedland G, Matts J, et al. The consistency of adherence to antiretroviral therapy predicts biologic outcomes for human immunodeficiency virus-infected persons in clinical trials. Clinical Infectious Diseases. 2002; 34:1115-1121.
- Aids Map. Adherence. Available at URL: http://www.aidsmap.com/Adherence/page/1730785/. Last accessed December 3, 2012.