| |
PREZISTA*(TMC114) APPROVED FOR TREATMENT OF HIV BY
HEALTH CANADA
|
| |
| |
This is press announcement from Tibotec
Nearly four times as many treatment-experienced HIV patients receiving PREZISTA in clinical studies achieved an undetectable viral load after 24 weeks
compared to patients treated with other protease inhibitors
TORONTO, ON, August 10, 2006 - Leading into the 16th International AIDS Conference in Toronto, there is a new option for the treatment of Human Immunodeficiency Virus-1 (HIV) in Canada. Tibotec, a division of Janssen-Ortho Inc., announced that Health Canada has approved PREZISTA* (darunavir, also known as TMC114), co-administered with ritonavir and with other antiretroviral agents, for the treatment of HIV in treatment-experienced adult patients who have failed prior antiretroviral therapy.
PREZISTA is approved under Health Canada's Notice of Compliance with Conditions policy that enables physicians and their patients to gain early access to new therapies demonstrating promising evidence of clinical effectiveness and an acceptable benefit/risk profile.1
In clinical studies, PREZISTA, a protease inhibitor (PI), has been shown to decrease the levels of HIV in patients' blood (reduce viral load) and increase levels of healthy, disease-fighting cells (CD4 counts) in treatment-experienced adult patients. In clinical trials, 70 per cent of treatment-experienced patients receiving PREZISTA achieved a reduction in viral load at the 24-week primary endpoint, which was significantly higher when compared to the 21 per cent achieved by patients on the investigator-selected PI.2 Nearly four times as many treatment-experienced patients receiving PREZISTA (45 per cent), achieved an undetectable viral load after 24 weeks, compared with patients taking an investigator-selected PI (12 per cent).2 Additionally, the increase in CD4 counts for patients taking PREZISTA was more than five times that of patients on the investigator-selected PI after 24 weeks (92 cells/mm3 versus 17 cells/mm,3 respectively).2 Treatment-experienced patients were defined as those who had prior treatment with three classes of antiretroviral therapies, including PIs.
"Finding an effective and tolerable therapy for patients with HIV is critical. Many patients who are infected by the virus are now resistant to medication, either because combination therapies were not available when they started their treatment or because they took their medication at irregular times due to side effects," said Dr. Cecile Tremblay, Infectious Disease specialist, Director of CHUM's Research Unit on AIDS, Montreal. "The approval of PREZISTA offers an encouraging new option for patients seeking a treatment that is not only effective but also well-tolerated."
Since the first reports on AIDS in the early '80s, considerable progress has been made with significant improvement in survival rates. HIV/AIDS is becoming more of a manageable chronic illness because of the effectiveness of combining antiretrovirals from different classes in highly active antiretroviral therapy (HAART). However, many challenges still remain. Due to the high mutation and replication rates of HIV, patients develop resistance to most anti-HIV drugs over time. Hence, drugs with improved potency to resistant HIV and a higher genetic barrier to the development of resistance are needed. Sub-optimal drug levels also facilitate the emergence of resistant HIV, making adherence to therapy very important.
"The more options my healthcare providers can offer, the more likely I am to find a treatment program that suits my individual needs," said Brian Finch, a Canadian living with HIV/AIDS. "As a patient who has been living with HIV, and has tried various treatment options since my diagnosis, I am very excited that a treatment like PREZISTA is now available."
ABOUT PREZISTA
PREZISTA is indicated for the treatment of HIV infection in treatment-experienced adult patients who have failed prior antiretroviral therapy. Studies of PREZISTA have established its efficacy in significantly reducing viral load and increasing CD4 counts in this patient population compared with patients taking an investigator-selected PI. The recommended oral dose of PREZISTA tablets is 600mg (two 300mg tablets) twice daily (BID) taken with ritonavir 100mg BID with food. The type of food does not affect the exposure of PREZISTA. In clinical trials, the most common side effect reported during treatment with PREZISTA was nausea. Other common side effects included headache, constipation, abdominal pain, vomiting and fatigue.2
ABOUT HIV/AIDS
Acquired Immune Deficiency Syndrome (AIDS) is an illness caused by a chronic infection with a retrovirus (HIV, Human Immunodeficiency Virus). The breakdown of the immune system resulting from HIV leads to increased susceptibility to other infections and immune disorders. UNAIDS estimates that approximately 40 million people worldwide are currently infected with HIV.
It is estimated that between 2,800 and 5,200 new HIV cases occur in Canada each year, though many of these are not reported right away.3 In Canada, just under 58,000 positive HIV tests had been reported by the end of 2004.4 During a five year period, the number of positive HIV test reports increased by 20 per cent, from 2,111 in 2000 to 2,529 in 2004.5
TIBOTEC - DIVISION OF JANSSEN-ORTHO INC.
Tibotec, a division of Janssen-Ortho Inc., is dedicated to delivering innovative virology therapeutics that improve Canadian patients' survival and quality of life and that address serious unmet healthcare needs.
TIBOTEC PHARMACEUTICALS LTD.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA, USA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec is developing a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access Program for TMC114 includes access, pricing, registration, medical education for appropriate use and voluntary licensing.
* All trademarks used under license.
References:
1. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/noccfs_accfd_2005_e.html , retrieved June 14, 2006.
2. PREZISTA* Product Monograph, Janssen-Ortho Inc., 2006.
3. http://www.avert.org/canstatg.htm, retrieved June 14, 2006.
4. UNAIDS: Joint United Nations Programme on HIV/AIDS, retrieved June 14, 2006; http://www.unaids.org/en/Regions_Countries/Regions/NthAmer_West_Cent_Europe.asp.
5. Public Health Agency of Canada: Canada's Report of HIV/AIDS 2005, retrieved June 14, 2006; http://www.phac-aspc.gc.ca/aids-sida/hiv_aids/report05/2_e.html.
|
|
| |
| |
|
|
|
