Results From Six Pivotal Tibotec Trials, Including Head-To-Head Data, Presented At The 11th European AIDS Conference

Main Category: HIV / AIDS
Also Included In: Pharma Industry / Biotech Industry;  Pharmacy / Pharmacist
Article Date: 25 Oct 2007 - 18:00 PDT

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Data from six pivotal trials investigating Tibotec HIV compounds will be presented at the 11th European AIDS Conference (EACS) in Madrid from 24-27 October 2007. Results from these and other studies examining PREZISTA™ (darunavir), the company's protease inhibitor (PI), and two of its investigational next-generation non-nucleoside reverse transcriptase inhibitors (NNRTIs), TMC125 and TMC278, will be featured in 21 abstracts, including two oral presentations and 19 posters.

"The breadth of Tibotec data presented at EACS demonstrates our progress in delivering new HIV treatments that address drug resistance and minimize treatment failure," said Brian Woodfall, Senior Director, Global Clinical Development, Tibotec. "Through our passion for science and innovation, we are committed to meeting the needs of people with HIV."

PREZISTA

Data from multiple studies examining the use of darunavir in patients with varying levels of treatment experience will be presented at EACS. Highlights include:

ARTEMIS - ARTEMIS (AntiRetroviral Therapy with TMC114 ExaMined In Naïve Subjects) is a randomised, controlled, open-label Phase III trial that compares the 48-week efficacy and safety of darunavir/ritonavir with Kaletra®1 (lopinavir/ritonavir) in treatment-naïve adults. It is the first study to examine darunavir/ritonavir in a once-daily dose in treatment-naïve patients with HIV. A new sub-analysis of ARTEMIS will be presented in a late-breaking oral session on 26 October.

TITAN - TITAN (TMC114/r In Treatment-experienced pAtients Naïve to lopinavir) is a randomised, controlled, open-label Phase III study that compares the 48-week efficacy and safety of darunavir/ritonavir with lopinavir/ritonavir in treatment-experienced patients. Multiple sub-analyses of TITAN will be presented as posters at EACS, and one oral presentation on the pharmacokinetics of darunavir/ritonavir will be presented on 24 October.

The ARTEMIS and TITAN studies are ongoing. Submissions of the data to the European Agency for the Evaluation of Medicinal Products (EMEA) and regulatory authorities in other areas are part of a post-marketing commitment for darunavir.

POWER - The 96-week safety and efficacy results from the Phase IIb POWER 1, 2 and 3 studies will be presented in three posters at EACS. These trials, upon which the approval of darunavir was based, examine the safety and efficacy of darunavir/ritonavir compared with an investigator-selected PI in treatment-experienced patients.

TMC125

Results from five studies on TMC125 will be presented at EACS. Highlights include:

DUET - DUET-1 and DUET-2 are pivotal, ongoing Phase III studies that examine the efficacy, safety and tolerability of TMC125 in treatment-experienced patients with documented resistance to NNRTIs. Pooled results from a 24-week analysis of the two studies will be presented during poster sessions on 24 October. The DUET studies are the basis of an application for marketing authorization of TMC125 to the EMEA, which was submitted in July 2007.

The expanded access program (EAP) for TMC125 is open in a number of European countries, the United States, Canada and Australia.

TMC278

Data on TMC278 also will be presented at EACS, including a 48-week primary analysis of an ongoing, Phase IIb study comparing the efficacy of TMC278 with efavirenz in treatment-naïve patients. In addition, a sub-analysis of this study compares lipid parameters of TMC278 with efavirenz.

In addition to its HIV portfolio, Tibotec is developing other breakthrough therapies that combat life-threatening infections, including hepatitis C and tuberculosis.

About PREZISTA

Darunavir, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor (PI). The use of darunavir/ritonavir in treatment-naïve patients and the once-a-day dose have not been approved at this time.

Tibotec has received approval for darunavir in several areas including the European Union, the United States, and Canada, among others, and applications for approval also have been submitted or are planned for submission in many other countries.

Important Safety Information

In the registrational studies, darunavir was generally well tolerated versus the investigator selected PIs. The majority of the adverse reactions reported during treatment with darunavir co-administered with 100 mg ritonavir twice daily were mild to moderate in severity. The most frequently reported moderate to severe adverse reactions of at least grade 2 severity were diarrhoea (2.6%), vomiting (2.2%) and hypertriglyceridaemia (2.0%).

The most commonly reported adverse reactions of any grade were nausea (7.2%), diarrhoea (6.6%) and headache (3.3%). Skin rash can also appear but this is usually mild to moderate. One percent of patients discontinued treatment due to adverse events.

People who are allergic to darunavir or any of its ingredients, or ritonavir should not take darunavir. Before taking darunavir, patients should tell their doctor 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. Darunavir should not be used in patients with severe liver problems.

There were some relevant drug-drug interactions with other medications commonly used in HIV patient populations, such as other antiretroviral medications. Patients should talk to their healthcare provider about all the medicines they are taking or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Darunavir does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

http://www.PREZISTA.com

About Tibotec

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.

Tibotec, a division of Janssen-Cilag, delivers innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa. This 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 to combat other viral diseases in the future.

PREZISTA abstracts being presented at EACS:

ARTEMIS - Efficacy and safety of Lopinavir (BID vs QD) and Darunavir (QD) in Antiretroviral-naïve Patients
Abstract # / type: Oral Session
Date / time / location: Friday, 26 October, 10:30 AM-12:30 PM, Auditorium B
Presenter: J Van Lunzen

Effect of Extrinsic and Intrinsic Factors on the Pharmacokinetics of Darunavir/ritonavir (DRV/r) in HIV-1 Patients: Results of a Randomized, Controlled, Phase III study (TITAN)
Abstract # / type: Oral Session
Date / time / location: Thursday, 25 October, 2:00-4:00 PM, Room A
Presenter: V J Sekar

Pharmacokinetic/pharmacodynamic (PK/PD) analyses of darunavir in the TITAN study
Abstract # / type: Poster
Date / time / location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: V J Sekar

Tolerability of darunavir/r versus lopinavir/r in lopinavir/r-naïve, treatment-experienced, hepatitis B or C co-infected patients in TITAN
Abstract # / type: Poster
Date / time / location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: D Banhegyi

Lower virologic failure (VF) rate and mutations development during treatment with darunavir/ritonavir (DRV/r) compared with lopinavir/ritonavir (LPV/r) in treatment-experienced patients: TITAN 48-week resistance analysis
Abstract # / type: Poster
Date / time / location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: S De Meyer

Efficacy of darunavir/ritonavir in treatment-experienced HIV-1-infected patients at 96 weeks in the POWER 1 and 2 trials
Abstract # / type: Poster
Date / time / location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: A Pozniak

Safety and tolerability of darunavir/ritonavir in treatment-experienced HIV-1-infected patients at 96 weeks in the POWER 1, 2 and 3 trials
Abstract # / type: Poster
Date / time / location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: P Yeni

Efficacy Analysis of Darunavir/r in Treatment-experienced POWER 3 Patients at Week 96
Abstract # / type: Poster
Date / time / location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: K Arasteh

Analysis of the cost of full virological suppression for highly treatment experienced, HIV infected patients in the POWER trials in different European healthcare settings
Abstract # / type: Poster
Date / time / location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: A Hill

Effect of Baseline Factors on Virologic Response to Darunavir/r (DRV/r) and Lopinavir/r (LPV/r) at Week 48 in TITAN
Abstract # / type: Poster
Date / time / location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: D Berger

TMC125 abstracts being presented at EACS:

Pooled 24-Week Results of DUET-1 and -2: Efficacy of TMC125 in Treatment-Experienced HIV-1-Infected Patients
Abstract # / type: Poster
Date/Time/Location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: C Katlama

Pooled 24-Week Results of DUET-1 and -2: TMC125 (Etravirine; ETR) Safety and Tolerability in Treatment-Experienced, HIV-1-Infected Patients
Abstract # / type: Poster
Date/Time/Location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: G Di Perri

Impact of Baseline NNRTI Mutations on the Virological Response to TMC125 (Etravirine; ETR) in the DUET-1 and DUET-2 Phase III Clinical Trials
Abstract # / type: Poster
Date/Time/Location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: J Vingerhoets

No pharmacokinetic interaction between TMC125 and paroxetine in HIV-negative volunteers Abstract # / type: Poster
Date/Time/Location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: M Schöller-Gyüre

Thorough QT Trial with Etravirine (TMC125) at Two Dose Regimens in HIV-Negative Volunteers Abstract # / type: Poster
Date/Time/Location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: M Peeters

An Open, Randomized, Two Period, Crossover Study in 2 Cohorts to Investigate the Effect of Steady State TMC125 and the Combination of TMC125 / Darunavir / Ritonavir on the Steady State Pharmacokinetics of Oral Maraviroc in Healthy Subjects
Abstract # / type: Poster
Date/Time/Location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: J Davis

Impact of TMC125, a next-generation NNRTI, on clinical outcomes (AIDS-defining illnesses and deaths): 24-week findings from a planned pooled analysis of the DUET studies
Abstract # / type: Poster
Date/Time/Location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: JM Gatell

Health-related quality of life (HRQL) as measured by the Functional Assessment of HIV Infection (FAHI) questionnaire in treatment-experienced HIV-1 infected subjects: results from the pooled DUET trials (TMC125 compared to placebo as part of antiretroviral therapy (ART))
Abstract # / type: Poster
Date/Time/Location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: K Peeters

TMC278 abstracts being presented at EACS:

TMC278, a next-generation NNRTI, demonstrates potent and sustained efficacy in ARV-naïve patients: Week 48 primary analysis of study TMC278-C204
Abstract # / type: Poster
Date/Time/Location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: P Yeni

TMC278, an investigational, NNRTI, has a potential benefit on lipid parameters compared with efavirenz in ARV-naïve patients
Abstract # / type: Poster
Date/Time/Location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: A Pozniak

The pharmacokinetic interaction between atorvastatin and TMC278, a next generation non-nucleoside reverse transcriptase inhibitor (NNRTI), in HIV-negative volunteers
Abstract # / type: Poster
Date/Time/Location: Thursday, 25 October & Friday, 26 October, 12:00-2:00 PM, 3rd floor of the conference venue
Presenter: RPG Van Heeswijk

1 Kaletra® (lopinavir/ritonavir) is a trademark owned by Abbott Laboratories

http://www.PREZISTA.com