2006-08-14

Analysis Provides Additional Data for PREZISTA as Part of HIV Combination Therapy


Toronto (ots/PRNewswire) -

Additional safety and efficacy data for PREZISTA(TM) (darunavir)300mg tablets, an anti-HIV medication, will be presented Tuesday, 15August, at the 16th International AIDS Conference (AIDS 2006) inToronto, Canada. In an oral presentation, researchers will reportdata from patients who had reached 48 weeks of treatment in an ad hocpooled analysis from the TMC114-C213 (POWER 1) and TMC114-C202 (POWER2) studies.

The U.S. Food and Drug Administration (FDA) granted marketingapproval to PREZISTA, a protease inhibitor formerly known as TMC114,in June 2006. In the U.S., PREZISTA, co-administered with 100 mgritonavir (PREZISTA/rtv) and with other antiretroviral agents, isindicated 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 proteaseinhibitor. Health Canada also granted conditional approval toPREZISTA on July 28, 2006.

Both the US and Canadian approvals were based on the 24-weekanalysis of HIV viral load and CD4+ cell counts from the pooledanalysis of the POWER 1 and POWER 2 studies. In Canada, PREZISTA,co-administered with 100 mg ritonavir and with other antiretroviralagents, is indicated for the treatment of HIV infection intreatment-experienced adult patients who have failed priorantiretroviral therapy.

An application for marketing authorization was filed with theEuropean Agency for the Evaluation of Medicinal Products (EMEA) inJanuary 2006. Applications for approval in several other countriesaround the world have been submitted or are planned for submission inthe coming months.

48-Week Ad Hoc Analysis Findings

The data to be presented are from the patients in POWER 1 and 2who had reached 48 weeks of treatment at the time of the ad hocanalysis. Among 110 patients who had reached 48 weeks of treatment inthe PREZISTA/rtv arm (total n=131) vs. 120 patients who had reached48 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 hadpreviously been treated with at least one protease inhibitor, onenon-nucleoside reverse transcriptase inhibitor (NNRTI) and onenucleoside reverse transcriptase inhibitor (NRTI), had one or moreprimary protease inhibitor mutations, and were failing a PI-basedregimen. Investigator-selected optimised background regimen (OBR) andcontrol protease inhibitors were chosen based on resistance testingand prior treatment history. The OBR consisted of at least two NRTIswith or without enfuvirtide.

Among patients reaching 48 weeks, the most commonly reportedadverse events among patients in the PREZISTA/rtv arm vs. control armwere diarrhoea (20 percent vs. 28 percent), nausea (18 percent vs. 13percent), headache (15 percent vs. 20 percent), nasopharyngitis (14percent vs. 11 percent) and fatigue (12 percent vs. 17 percent).Discontinuations because of adverse events were 7 percent in thePREZISTA/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, "Thesustained efficacy and favourable tolerability profile of PREZISTAprovide treatment-experienced HIV patients with an important newtreatment option."

Important Safety Information

PREZISTA does not cure HIV infection or AIDS, and does not preventpassing HIV to others.

In studies, PREZISTA was generally well tolerated. Mild tomoderate rash was seen in 7 percent of patients. Some patientsdeveloped severe rash. In clinical studies, 0.3 percent of patientsdiscontinued due to rash. The most common moderate to severe sideeffects 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 patientsdiscontinued treatment due to adverse events. People who are allergicto PREZISTA or any of its ingredients or ritonavir (Norvir) shouldnot take PREZISTA.

There were few relevant drug-drug interactions with othermedications commonly used in HIV patient populations, such as otherantiretroviral medications, proton pump inhibitors, and H2 receptorantagonists. Patients should talk to their healthcare provider aboutall the medicines they are taking or plan to take, includingprescription and nonprescription medicines, vitamins, and herbalsupplements.

Before taking PREZISTA, patients should tell their healthcareprovider if they have any medical conditions, including diabetes,liver problems, haemophilia, or allergy to sulfa medicines and shouldtell their doctor if they are pregnant or planning to becomepregnant, or are nursing. PREZISTA should be used with caution inpatients with hepatic impairment.

High blood sugar, diabetes or worsening of diabetes, muscle pain,tenderness or weakness, and increased bleeding in people withhaemophilia have been reported in patients taking protease inhibitormedicines like PREZISTA. Changes in body fat have been seen in somepatients taking anti-HIV medicines, including loss of fat from legs,arms and face, increased fat in the abdomen and other internalorgans, breast enlargement and fatty lumps on the back of the neck.The cause and long-term health effects of these conditions are notknown at this time.

Clinical laboratory safety observed in the PREZISTA group wascomparable to the control group.

Please see full Product Information for more details.

About PREZISTA

PREZISTA was developed by Tibotec Pharmaceuticals Ltd. In theU.S., it is marketed by Tibotec Therapeutics, a division of OrthoBiotech Products, L.P. In Canada, it is marketed by Tibotec, adivision of Janssen-Ortho Inc. Pending regulatory approval, Tibotec,a division of Janssen-Cilag, will commercialise PREZISTA in Europeand other countries

PREZISTA/rtv is currently in Phase III comparative clinical trialsin 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 apharmaceutical research and development company. The Company's mainresearch and development facilities are in Mechelen, Belgium withoffices in Yardley, PA. Tibotec is dedicated to the discovery anddevelopment of innovative HIV/AIDS drugs and anti-infectives fordiseases of high unmet medical need.

Tibotec Pharmaceuticals is developing a Global Access Program tofacilitate access to its antiretrovirals for patients living withHIV/AIDS in developing countries. The Global Access Program forPREZISTA includes access pricing, registration, medical education forappropriate use and voluntary licensing.

About Tibotec

Tibotec, a division of Janssen-Cilag, will bring innovativeproducts for HIV/AIDS to patients in Europe, the Middle East andAfrica. This new division was created within the Janssen-Cilagcompanies in October 2005 to focus on patients' and health careproviders' specific needs in this disease domain. The company willalso commercialise medicine against other viral diseases in thefuture.

Janssen-Cilag

Janssen-Cilag is a leader in traditional and biological medicinesfor disorders such as in gastroenterology, women's health, mentalhealth and neurology as well as for pain, oncology, haematology andnephrology.

Contact: Kellie McLaughlin, mobile +1-609-468-8356

Web site: http://www.tibotec.com

ots Originaltext: Tibotec Pharmaceuticals Ltd.Im Internet recherchierbar: http://www.presseportal.de

Contact:Kellie McLaughlin, mobile +1-609-468-8356

Tibotec Pharmaceuticals Ltd.

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Analysis Provides Additional Data for PREZISTA as Part of HIV Combination Therapy

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