Sunday, April 12, 2009
Health Canada approves Prezista for treatment-naive adults with HIV-1
Tibotec, a division of Janssen-Ortho Inc., announced 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 Toronto.
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.
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).
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, diarrhoea was among the most common adverse events. Moderate to severe treatment-related diarrhoea occurred less frequently in patients treated with Prezista/ritonavir, compared to Kaletra.
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 Johnston.
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.