Roche, Trimeris phase 3 study data shows immune system benefits of Fuzeon HIV fusion inhibitor

By Lisa Kerner

Charlotte, N.C., June 26 - Roche and Trimeris, Inc. said results from their TORO phase 3 studies demonstrate continued CD4 cell increases in some patients who continued with Fuzeon (enfuvirtide)-based regimens, despite virologic failure and Fuzeon resistance.

Complete CD4 cell count data for up to 96 weeks following virologic failure was available for 134 patients.

Patients either maintained CD4 cell gains or exhibited statistically significant and clinically meaningful increases in CD4 cell counts over 48 weeks of additional Fuzeon therapy despite virological rebound.

Adverse events associated with Fuzeon include injection site reactions, bacterial pneumonia, hypersensitivity, diarrhea, nausea and fatigue.

Co-developed by Roche and Trimeris, Fuzeon is the first HIV fusion inhibitor, according to a company news release.

Unlike other HIV drugs, Fuzeon works outside the CD4 cell, blocking HIV from entering the human immune cell. Fuzeon is administered by one 90 mg subcutaneous injection twice daily.

Data from the TORO studies were presented at the 15th International HIV Drug Resistance Workshop in Spain.

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, a research-oriented health care group.

Trimeris is a biopharmaceutical company located in Morrisville, N.C., specializing in novel therapeutic agents for the treatment of viral disease.

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