TORONTO, August 14 /PRNewswire/ --
Additional safety and efficacy data for PREZISTA(TM) (darunavir) 300mg tablets, an anti-HIV medication, will be presented Tuesday, 15 August, at the 16th International AIDS Conference (AIDS 2006) in Toronto, Canada. In an oral presentation, researchers will report data from patients who had reached 48 weeks of treatment in an ad hoc pooled analysis from the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) studies.
The U.S. Food and Drug Administration (FDA) granted marketing approval to PREZISTA, a protease inhibitor formerly known as TMC114, in June 2006. In the U.S., PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/rtv) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. Health Canada also granted conditional approval to PREZISTA on July 28, 2006.
Both the US and Canadian approvals were based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the POWER 1 and POWER 2 studies. In Canada, PREZISTA, co-administered with 100 mg ritonavir and with other antiretroviral agents, is indicated for the treatment of HIV infection in treatment-experienced adult patients who have failed prior antiretroviral therapy.
An application for marketing authorization was filed with the European Agency for the Evaluation of Medicinal Products (EMEA) in January 2006. Applications for approval in several other countries around the world have been submitted or are planned for submission in the coming months.
48-Week Ad Hoc Analysis Findings
The data to be presented are from the patients in POWER 1 and 2 who had reached 48 weeks of treatment at the time of the ad hoc analysis. Among 110 patients who had reached 48 weeks of treatment in the PREZISTA/rtv arm (total n=131) vs. 120 patients who had reached 48 weeks of treatment in the control arm (total n=124), intent-to-treat data will be presented:
- 61 percent vs. 15 percent had a virologic response defined as equal to
or greater than a 1.0 log10 reduction (90 percent reduction) in viral
load from baseline
- 46 percent vs. 10 percent reached undetectable viral load (less than 50
copies/mL)
- CD4+ cell mean increase of 102 cells/mm3 vs.19 cells/mm3 from baseline
Patients enrolled in the POWER 1 and POWER 2 studies had previously been treated with at least one protease inhibitor, one non-nucleoside reverse transcriptase inhibitor (NNRTI) and one nucleoside reverse transcriptase inhibitor (NRTI), had one or more primary protease inhibitor mutations, and were failing a PI-based regimen. Investigator-selected optimised background regimen (OBR) and control protease inhibitors were chosen based on resistance testing and prior treatment history. The OBR consisted of at least two NRTIs with or without enfuvirtide.
Among patients reaching 48 weeks, the most commonly reported adverse events among patients in the PREZISTA/rtv arm vs. control arm were diarrhoea (20 percent vs. 28 percent), nausea (18 percent vs. 13 percent), headache (15 percent vs. 20 percent), nasopharyngitis (14 percent vs. 11 percent) and fatigue (12 percent vs. 17 percent). Discontinuations because of adverse events were 7 percent in the PREZISTA/rtv arm vs. 5 percent in the control arm.
Sharon Walmsley, M.D., of University Health Network, Ontario, Canada, who will be presenting the 48-week PREZISTA data, said, "The sustained efficacy and favourable tolerability profile of PREZISTA provide treatment-experienced HIV patients with an important new treatment option."
Important Safety Information
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
In studies, PREZISTA was generally well tolerated. Mild to moderate rash was seen in 7 percent of patients. Some patients developed severe rash. In clinical studies, 0.3 percent of patients discontinued due to rash. The most common moderate to severe side effects associated with PREZISTA include diarrhoea (2.3 percent), headache (3.8 percent), abdominal pain (2.3 percent), constipation (2.3 percent), and vomiting (1.5 percent). Four percent of patients discontinued treatment due to adverse events. People who are allergic to PREZISTA or any of its ingredients or ritonavir (Norvir) should not take PREZISTA.
There were few relevant drug-drug interactions with other medications commonly used in HIV patient populations, such as other antiretroviral medications, proton pump inhibitors, and H2 receptor antagonists. Patients should talk to their healthcare provider about all the medicines they are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Before taking PREZISTA, patients should tell their healthcare provider if they have any medical conditions, including diabetes, liver problems, haemophilia, or allergy to sulfa medicines and should tell their doctor if they are pregnant or planning to become pregnant, or are nursing. PREZISTA should be used with caution in patients with hepatic impairment.
High blood sugar, diabetes or worsening of diabetes, muscle pain, tenderness or weakness, and increased bleeding in people with haemophilia have been reported in patients taking protease inhibitor medicines like PREZISTA. Changes in body fat have been seen in some patients taking anti-HIV medicines, including loss of fat from legs, arms and face, increased fat in the abdomen and other internal organs, breast enlargement and fatty lumps on the back of the neck. The cause and long-term health effects of these conditions are not known at this time.
Clinical laboratory safety observed in the PREZISTA group was comparable to the control group.
Please see full Product Information for more details.
About PREZISTA
PREZISTA was developed by Tibotec Pharmaceuticals Ltd. In the U.S., it is marketed by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P. In Canada, it is marketed by Tibotec, a division of Janssen-Ortho Inc. Pending regulatory approval, Tibotec, a division of Janssen-Cilag, will commercialise PREZISTA in Europe and other countries
PREZISTA/rtv is currently in Phase III comparative clinical trials in treatment-naïve (ARTEMIS) and less treatment-experienced patients (TITAN) versus Kaletra (lopinavir/ritonavir).
For further information, please visit www.tibotec.com.
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. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec Pharmaceuticals 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 PREZISTA includes access pricing, registration, medical education for appropriate use and voluntary licensing.
About Tibotec
Tibotec, a division of Janssen-Cilag, will bring innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa. This new division was created within the Janssen-Cilag companies in October 2005 to focus on patients' and health care providers' specific needs in this disease domain. The company will also commercialise medicine against other viral diseases in the future.
Janssen-Cilag
(CONTINUA)
