November 19, 2002
New test data for the AIDS drug Fuzeon (T-20), presented at an AIDS conference in Scotland Monday, show the drug is most effective in patients still benefiting from at least two other medications. The new results support those from a previous trial, issued Sept. 30, showing that the earlier Fuzeon is prescribed, the more effective it is. However, the drug must be injected twice daily and the price -- which some analysts expect will cost $12,000 or more for a year's supply -- is unprecedented. Even so, Fuzeon makers Trimeris and Roche cautioned that the initial demand could exceed supply. Trimeris and Roche have submitted an application to the Food and Drug Administration seeking approval of the drug. The FDA is expected to act on the application by mid-March.
The latest test involved about 500 AIDS patients in Europe and Australia who took Fuzeon in conjunction with a combination of other drugs optimized to fit their individual needs. The test data showed that patients who took Fuzeon reduced the level of HIV in their blood by 98 percent when they were taking at least two other AIDS drugs that also were effective against their virus. Patients whose virus had developed resistance to all of the drugs they were taking other than Fuzeon reduced the level of HIV by 89 percent. Fuzeon was effective in both scenarios, but was most effective when patients still had other viable drug options.
Patients who took Fuzeon in clinical trials reported that the injections had little or no impact on their lives. But the patients who participated are viewed as highly motivated because they already had developed multiple drug resistance. Dr. Lynne Smiley, senior vice president of clinical research at Trimeris, said Trimeris and Roche are interested in researching how effective Fuzeon can be when prescribed soon after the initial diagnosis -- but they will not do so until there is ample supply for advanced patients.
News & Observer (Raleigh, N.C.)
11.19.02; David Ranii