3TC Expanded Access Program: New Requirement for CD4 Less Than 100


The expanded access program for 3TC has in the past required a
CD4 count of under 300. But due to the greatly increased
demand for the drug after reports of good results with the
combination of 3TC and AZT, Glaxo was unable to manufacture
enough, and announced on April 3 that it was limiting
enrollment to 350 new patients per week, and starting a
waiting list. At that time, 800 or more per week had been
enrolling. Enough supplies for everyone should be available in
the fall of this year.

On April 24 Glaxo announced two other changes in the program.
It changed the entry criterion to require a CD4 count of less
than 100 (instead of 300). And it is requiring physicians to
provide a copy of the lab slip to verify the CD4 count.

Glaxo made this change after hearing from community
representatives that, if there is not enough of the drug for
everyone, those with more advanced disease should have
priority. However, a cutoff at a CD4 of 100 was not what was
agreed in those meetings. Now there is discussion of a waiting
lists for those with counts from 100 to 300, so that they can
receive the drug immediately when it becomes available.