Public Release: 

Extensive Phase II Data Of Amprenavir (141W94/VX-478) To Be Presented

Vertex Pharmaceuticals

Amprenavir's emerging profile is of a highly potent drug, well-tolerated in two-, three-, and four-drug combinations. Among the data being reported that support this view, we direct you to the following key presentations:

  • First results of amprenavir used in double protease inhibitor (PI) combinations. Preliminary dual PI combination data shows high potency and a rapid antiviral effect (80% of patients with undetectable virus at 4 weeks), with good tolerability, in patients who have previously taken reverse transcriptase inhibitors. We expect 16-week data will be presented, showing a sustained antiviral effect as measured by the percentage of patients with undetectable virus. Data will be presented at the conference by Dr. Joseph Eron from University of North Carolina on Monday, February 2 at 10:30AM.
  • Extended results of amprenavir in combination with 1592, an experimental reverse transcriptase inhibitor. This two-drug, twice daily combination showed a rapid and potent antiviral effect (13 of 17 patients evaluated had undetectable virus at 4 weeks, and 12 of 12 evaluated at 8 weeks had undetectable virus). We expect that 16 week-data will be presented, documenting a sustained antiviral effect. The author of this poster exhibit, which will be presented on Tuesday, February 3, is Dr. Pierre Bart of Lausanne, Switzerland.

A second study being presented describes 1592/amprenavir therapy in the context of other 1592/PI treatment possibilities. Available four week data confirms the rapid and potent antiviral effect of 1592 and amprenavir. Longer term data that demonstrates amprenavir's potency compared with other 1592/PI regimens will be the subject of an oral presentation given by Dr. John Mellors of the University of Pittsburgh Medical Center on Monday, February 2, at 10:30AM. Amprenavir is currently being evaluated in pivotal Phase III clinical trials with development partner Glaxo Wellcome. A U.S. new drug application (NDA) filing is expected later in 1998. An NDA is required for marketing approval.


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