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New Interim Results Demonstrate High Response Rate with FUZEON® Plus Darunavir Regardless of Existing Protease Inhibitor Resistance


Roche and Trimeris, Inc. (Nasdaq: TRMS) today announced interim results from BLQ (Below the Level of Quantification), an ongoing study evaluating the use of FUZEON® (enfuvirtide) with the most recently-approved boosted protease inhibitor, darunavir/ritonavir (r), in combination with other anti-HIV drugs. The data, which are being presented at the 4th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Sydney, Australia, show that almost two-thirds (64 percent) of three-class, treatment-experienced patients achieved undetectable HIV (less than 50 copies per mL of blood) at 24 weeks, and that baseline sensitivity to darunavir (the amount of resistance to this protease inhibitor prior to the study) did not appear to influence patient response to the regimen.

FUZEON, co-developed by Roche and Trimeris, is the first and only fusion inhibitor available for the treatment of HIV, while darunavir (Prezista®) is a commercially available, ritonavir-boosted protease inhibitor, marketed by Tibotec Therapeutics. The BLQ study is sponsored by Roche and Trimeris; patients received darunavir predominantly through co-enrollment in the darunavir compassionate use program.

“Previous studies had provided encouraging – but limited – information on the use of enfuvirtide in combination with darunavir/r,” said Edwin DeJesus, M.D., Medical Director, Orlando Immunology Center, Florida. “Given that attaining undetectable HIV of less than 50 copies has become the standard of care even in treatment-experienced patients, it is encouraging that so many patients can achieve this result with enfuvirtide and darunavir/r – two agents widely available to patients and physicians today. Even patients with significant resistance to darunavir responded well to this combination.”


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