AMPRENAVIR EXPANDED ACCESS PROGRAM ANNOUNCED TODAY
Glaxo Wellcome announced today (9/21) that the amprenavir expanded access program is starting for both adults and children (>4 yrs). You or your doctor can call-
1-800-248-9757 immediately to receive information about enrollment. You or your doctor can call to give the company your doctor's name and address. On Sept 28 they will send out expanded access program binders explaining the program. As soon as a person is enrolled in the program drug will be sent out. The company is submitting their NDA to the FDA for accelerated approval in October. Review and approval can take usually from 3-6 months, meaning approval will not come sooner than January 1999.
The program is uniquely offering 3 options for accessing amprenair-
1. Individuals experiencing adverse side effects from their current PI regimen such as lipodystrophy or elevated lipids but are not failing their current PI regimen can enroll in this option. The purpose is to try and collect data to determine the effect of amprenavir on these side effects
2. Option 2 provides amprenavir to individuals who have failed a PI regimen. In this option, participants will have the choice of one of the following treatment regimens-
Option 1 - amprenavir+a second PI+abacavir+NNRTI+NRTI(s)
New or recycled NRTIs ca be used
Option 2 - amprenavir+abacavir+NNRTI+NRTI(s)
Recycled NRTIs can be used
Option 1 - amprenavir+a second PI+abacavir+NRTIs (new or recycled NRTIs ok)
Option 2 - amprenavir+abacavir+NRTIs (new or recycled)
3. This option provides amprenavir on an open-label basis to individuals failing
current therapy, failed a PI previously, and need amprenavir to create a viable treatment regimen.
Regardless of which option is selected patients need to have received prior treatment with at least 1 PI in addition to fulfilling other criteria-
Each of the 3 options may have different entry requirements. Additional information can be obtained by calling the 800 number above.