San Diego, CA, September 27, 1998 - Clinical investigators today presented Phase III clinical trial data for the HIV protease inhibitor Agenerase` (amprenavir) which suggest that the drug may be potent and generally well-tolerated in combination with Epivir" (lamivudine) also known as 3TC", and Retrovir" (zidovudine; AZT). These data, presented at a late-breaker slide session at the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) support the role of Agenerase in front-line combination antiretroviral therapy.
An as-treated analysis of interim 16 week data showed that 88% of patients taking triple therapy with Agenerase+Epivir+Retrovir achieved viral load below the limit of detection of standard assays (<400 copies/mL), compared to 19% of patients taking Epivir+Retrovir alone. An additional analysis showed that 59% of patients receiving this regimen achieved viral load below the limit of detection of an investigational ultrasensitive assay1 (<50 copies). An as-treated analysis evaluates only those patients who remain on study medication through the entire study period.
"In this trial, Agenerase appears to provide a significant amount of virus suppression when given in combination with two reverse transcriptase inhibitors," said Dr. Jeffrey Goodgame, M.D., lead investigator for the study and Associate Professor at the University of Central Florida. "Data generated in smaller studies have supported the potential clinical utility of Agenerase in a number of different regimens, including dual protease inhibitor combinations."
Agenerase (formerly known as 141W94 or VX-478) is a second-generation protease
inhibitor that is now being made available in the United States to certain
patients through an early access program. Phase III data presented today are
intended to support applications to be submitted later in the fall by Vertex's
partner Glaxo Wellcome for approval to market Agenerase in the United States
and the European
Contact: Michael Partridge