Tibotec Data Presented at ICAAC and HIV9 Follow Key Regulatory Approvals for Anti-HIV... (ive adults (those who have never taken H...)

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Tibotec Data Presented at ICAAC and HIV9 Follow Key Regulatory Approvals for Anti-HIV Compounds

Date:11/12/2008

ive adults (those who have never taken HIV medication

before).

- 23 October 2008 - Darunavir received a positive opinion from the

European Medicines Agency's (EMEA) Committee for Medicinal Products for

Human Use (CHMP) to extend the drug's indication to treat human

immunodeficiency virus (HIV-1) infection to include

treatment-experienced adult patients. Darunavir, coadministered with low

dose ritonavir, is currently indicated for the treatment of HIV-1 in

combination with other antiretroviral medicines in highly pre-treated

adult patients who failed more than one regimen containing a protease

inhibitor.

Tibotec Data at ICAAC and HIV9 Data from multiple studies examining the use of darunavir in patients with varying levels of treatment experience were presented at ICAAC and will be presented at HIV9. Highlights include:

- A new analysis of ARTEMIS (AntiRetroviral Therapy with TMC114 Examined

In Naive Subjects), a randomised, controlled, open-label Phase III trial

that compares the 96-week efficacy and safety of darunavir/ritonavir

with lopinavir/ritonavir in treatment-naive adults. ARTEMIS is the first

study to examine darunavir/ritonavir in a once-daily dose in

treatment-naive patients with HIV. These data were presented at ICAAC on

26 October.

- A new analysis of TITAN (TMC114/r In Treatment-experienced patients

Naive to lopinavir), a randomised, controlled, open-label Phase III

study that compares the 96-week efficacy and safety of

darunavir/ritonavir with lopinavir/ritonavir in treatment-experienced,

lopinavir-naive patients. These data will be presented at HIV9 on 13

November.

The ARTEMIS and TITAN studies are ongoing. Darunavir and etravirine were developed by Tibotec Pharmaceuticals, Cork, Ireland. Tibotec, a division of Janssen-Cilag, is responsible for market
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