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| Ontario government demonstrates leadership in HIV/AIDS treatment
PREZISTA™ (darunavir), new antiretroviral drug to treat HIV/AIDS, reimbursed in Ontario | |||
| 16 May 2007
, Toronto, ON
: People living with HIV/AIDS across Ontario have a new option today with news that PREZISTA™ (darunavir) is now listed on the Ontario Drug Benefit Formulary (ODBF). PREZISTA™, a protease inhibitor (PI) co-administeredwith ritonavirand with other antiretroviral agents, is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in treatment-experienced adult patients who have failed prior antiretroviral therapy. Through the Facilitated Access Mechanism of the Ontario Drug Benefit Programs Branch, patients who have failed at least two PIs will be eligible for access to PREZISTA™. PREZISTA™ is marketed by Tibotec, a division of Janssen-Ortho Inc. The listing of PREZISTA™ on the ODBF represents an important new option. "This is terrific news for people living with this challenging disease," said Yves Brunet, an Ottawa resident diagnosed with HIV/AIDS in 1986. "As a patient who is experiencing success using PREZISTA™ as part of my treatment regimen, I believe that reimbursement by the Ontario government brings a new option to others like me and is a positive step towards ensuring more people living with HIV/AIDS have access to this treatment." Tibotec, a division of Janssen-Ortho Inc., is pleased with the quick and timely decision of the Ministry of Health, as the announcement comes soon after PREZISTA™ was granted approval in July of 2006, just prior to the 16th International AIDS Conference in Toronto. PREZISTA™ received approval under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. This policy 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 PREZISTA™ is the first NOC/c medication in Canada to receive a positive recommendation by the Common Drug Review (CDR) on first review. The CDR is a national reimbursement review body that conducts objective, rigorous reviews of the clinical and cost effectiveness of new drugs, and provides formulary listing recommendations to the publicly funded drug plans in Canada (with the exception of Québec).2 "PREZISTA™ is an important development for patients who have failed prior HIV therapies. It decreases the levels of HIV and increases healthy, disease-fighting immune cells in patients' blood while maintaining a high level of tolerability," said Dr. Sharon Walmsley, senior scientist, Division of Clinical Investigation & Human Physiology, Toronto General Research Institute. "Given the ODBF has recognized thesignificant therapeutic value of PREZISTA™, and approved it on the provincial formulary, more patients with HIV/AIDS in Ontario will be able to benefit from this treatment." 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 600 mg (two 300 mg tablets) twice daily (BID) taken with ritonavir 100 mg 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 diarrhea, headache, constipation, abdominal pain, vomiting and fatigue.3 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 2,300 and 4,500 new HIV cases occur in Canada each year, though many of these are not reported right away.4 In Canada, just under 58,000 positive HIV tests had been reported by the end of 2004.5 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 2004.6 About Tibotec, a 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 health care needs. About 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. References: 1 www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/fs-fi/noccfs_accfd_2005_e.html, retrieved May 03, 2007. 2 www.cadth.ca/index.php/en/cdr, retrieved May 07, 2007. 3 PREZISTA™ Product Monograph, Janssen-Ortho Inc., 2006. 4 www.avert.org/canstatg.htm, retrieved May 03, 2007. 5 UNAIDS: Joint United Nations Programme on HIV/AIDS, retrieved June 14, 2006; www.unaids.org/en/Regions_Countries/Regions/NthAmer_West_Cent_Europe.asp. 6 Public Health Agency of Canada: Canada’s Report of HIV/AIDS 2005, retrieved May 03, 2007; www.phac-aspc.gc.ca/aids-sida/publication/reports/report05/2_e.html. |
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