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Title: Etravirine Suppresses HIV Viral Load With or Without Raltegravir or Darunavir Combination: Presented at AIDS 2008
URL: http://www.pslgroup.com/dg/2276A6.htm
Doctor's Guide
August 7, 2008

By Ed Susman

MEXICO CITY -- August 7, 2008 -- More than 60% of patients infected with human immunodeficiency virus (HIV) who were previously treated with antiretroviral therapies were able to suppress the virus to undetectable levels with the new non-nucleoside reverse transcriptase inhibitor etravirine, according to trial data presented here at the 17th International AIDS Conference (AIDS 2008).

Researchers added that this efficacy could be achieved with etravirine alone or in combination with the potent protease inhibitor darunavir or the integrase inhibitor raltegravir.

In reporting the results of the TMC125-C214 trial here at a poster presentation August 5, William Towner, MD, HIV/AIDS Research Treatment Program, Kaiser Permanente-Infectious Diseases, Los Angeles, California, said the trial was designed to provide early-access treatment to a racially diverse population who were experiencing inadequate viral suppression on their current regimen. About 20% of the 1,675 subjects in this substudy analysis were black, and about 15% were Hispanic; 60% were Caucasian.

At 24 weeks, Dr. Towner observed the following results:

· 66% of the 140 patients on etravirine plus optimised background therapy prescribed by the clinician achieved an undetectable viral load using a less than 75 copy/mL assay

· 66% of the 486 patients on etravirine, raltegravir, darunavir, and optimised background therapy achieved undetectable viral loads

· 65% of the 234 patients on etravirine, raltegravir, and optimised background therapy achieved undetectable viral levels

· 62% of the 338 patients on etravirine, darunavir, and optimised background therapy achieved undetectable viral levels

· 65% of 1,198 patients on etravirine alone and optimised background therapy achieved an undetectable viral load at 24 weeks

"The results suggest that etravirine [plus] the appropriate selection of the background regimen was an effective treatment approach in this treatment-experienced patient population," Dr. Towner concluded.

"The reported rates of serious adverse events and discontinuations due to adverse events were low and similar across the subgroups," he added.

Subjects in this study averaged 47 years of age; approximately 90% were male.

Funding for this study was sponsored by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., Yardley, Pennsylvania.


[Presentation title: Efficacy, Safety and Tolerability of Etravirine With and Without Darunavir and/or Raltegravir in Treatment-Experienced Patients: Preliminary Analysis of TMC125-C214 Early Access Program in the US. Abstract TUPE0066]

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