Health Canada Approves PREZISTA* Once Daily as Part of Combination Therapy for
Treatment-Naive Adults with HIV-1
- Approval based on pivotal ARTEMIS study that demonstrated 84 percent of patients taking PREZISTA in
combination with ritonavir reached an undetectable viral load at 48 weeks -
TORONTO, April 7 /CNW/ - Tibotec, a division of Janssen-Ortho Inc., announced today that Health Canada has approved
PREZISTA* (darunavir) for use in treatment-naive adults (those who have never taken HIV medication before), dosed once
daily in combination with other antiretroviral agents. The new indication for PREZISTA includes a new tablet strength of 400 mg
to support the recommended dosing regimen.
PREZISTA, dosed at 600 mg twice daily, co-administered with 100 mg ritonavir twice daily, is already approved in treatment-
experienced patients. In treatment naive adults, PREZISTA will be dosed at 800 mg (two 400 mg tablets) once daily, co-
administered with 100 mg ritonavir once daily and with other antiretroviral agents. As a result of the new indication, PREZISTA
is now indicated for the treatment of human immunodeficiency virus (HIV-1) infection, regardless of treatment history.
"With the introduction of PREZISTA in Canada two years ago, the medical community welcomed a well-tolerated and effective
option for treatment-experienced patients living with HIV. It's encouraging that now we can offer PREZISTA as part of
combination therapy to an even broader patient population who may benefit from the treatment," said Dr. Anita Rachlis,
Professor, Department of Medicine and Division of Infectious Diseases, Sunnybrook Health Sciences Center, University of
The new indication for PREZISTA was based on data from the pivotal ARTEMIS trial. In this randomized, controlled, open-label
Phase 3 study, 84 per cent of treatment-naive HIV-1 infected adults taking PREZISTA/ritonavir 800 mg/100 mg once daily with
TRUVADA® reached an undetectable viral load ((less than)50 copies/mL) at week 48, compared with 78 per cent of patients
taking KALETRA® (lopinavir/ritonavir) 800 mg/200 mg once daily (or 400 mg/100 mg twice daily) with TRUVADA. The study
demonstrated non-inferiority of PREZISTA/ritonavir compared to KALETRA®. The mean difference in response between the
treatment groups was statistically significant.(i)
In treatment-naive adult patients, the most common side effects ((greater than or equal to) 2 per cent) of at least moderate
intensity ((greater than or equal to) Grade 2) in the PREZISTA/ritonavir arm were diarrhea (6 per cent), headache (5 per cent),
abdominal pain (4 per cent), nausea (3 per cent), vomiting (2 per cent), and rash (2 per cent).(ii)
Since the first reports on AIDS in the early 1980s, 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, several challenges still remain.
Many patients cannot tolerate the side effects experienced with existing medications. In the ARTEMIS study, diarrhea was
among the most common adverse events. Moderate to severe treatment-related diarrhea occurred less frequently in patients
treated with PREZISTA/ritonavir, compared to KALETRA®.(iii)
Eric Johnston was diagnosed with HIV at the age of 34, and is a member of the Board of Directors of the Canadian AIDS
Society. "For many years, an HIV diagnosis was a death sentence - but as more effective treatment options become available,
hope for patients grows. Finding an effective and well-tolerated treatment, like I found with PREZISTA, has allowed me to live
my life as normally as possible," said Mr. Johnston.
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 33 million people worldwide were infected with HIV in
2007.(iv) It is estimated that between 2,300 and 4,500 new HIV infections occurred in Canada in 2005 compared with 2,100 to
4,000 in 2002.(v) In Canada, there were an estimated 78,000 people living with HIV infection by the end of 2007.(vi)
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 health care 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
* All trademark rights used under license.
(i) Ortiz R, DeJesus E, Khanlou H et al. Efficacy and safety of once-
daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-
naive HIV-1-infected patients at week 48.
(iv) UNAIDS/WHO AIDS epidemic update 2007,http://data.unaids.org/pub/EPISlides/2007/2007_epiupdate_en.pdf, retrieved
February 26, 2009.
(v) Public Health Agency of Canada, http://www.phac-aspc.gc.ca/aids-sida/publication/epi/pdf/epi2007_e.pdf, Retrieved March
(vi) AIDS epidemic update 2008. 1-362. 2008. UNAIDS / WHO (World Health Organization).