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Title: Etravirine Approved in the European Union for HIV Combination Therapy
URL: http://www.pslgroup.com/dg/22A322.htm
Doctor's Guide
August 29, 2008

CORK, Ireland -- August 29, 2008 -- The European Medicines Agency (EMEA) has granted marketing authorisation for the non-nucleoside reverse transcriptase inhibitor (NNRTI) etravirine (Intelence).

"NNRTIs have been trusted by physicians and used in antiretroviral therapy for more than a decade, but NNRTI resistance has limited the use of this important class of HIV medication," said Christine Katlama, AIDS Clinical Research Unit, Department of Infectious Diseases, Pitié-Salpêtrière Hospital, Paris, France.

"[Etravirine] extends the NNRTI class to thousands of treatment-experienced patients in Europe who have NNRTI-resistant virus, providing them with the potential to suppress their virus to undetectable levels -- the ultimate treatment goal."

This indication is based on week 24 analyses from 2 randomised, double-blind, placebo-controlled phase 3 trials in highly treatment-experienced patients with viral strains harbouring mutations of resistance to NNRTIs and protease inhibitors.

Etravirine was investigated in combination with an optimised background regimen that included darunavir/ritonavir.

The data showed that significantly more patients in the etravirine arm achieved undetectable viral load (<50 copies/mL) compared with placebo (58.9% vs 41.1%, P < .0001).

Etravirine was generally safe and well tolerated. Rash, generally mild to moderate, was the most common adverse event of moderate intensity or greater (>=grade 2) compared with placebo (9% vs 3.2%).

SOURCE: Johnson & Johnson

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