1592U89 Expanded Access Announced

Today, Glaxo Wellcome announced the first compassionate use programs of 1592U89 for children and adults. The program for children will begin first within the next three months. More details will be released in coming weeks. The adult program is scheduled to begin this summer for individuals with advanced disease (CD4 below 50) who have exhausted other treatment options. Toward the end of the year, based on data from phase II/III studies, the program will evolve into an expanded access protocol designed to help Glaxo Wellcome collect additional safety data.

Additional details will be forthcoming from Glaxo Wellcome. NATAP's recently printed newsletter contains an editorial about expanded access and 1592U89. We will mail you a copy if you contact us.

I know our community is anxious to hear about this development; there are important considerations regarding the use of all new drugs including 1592. Simply adding a new drug onto one's current therapy may not be the best use of that new drug for an individual. In my editorial, I discuss at length important considerations regarding this concern.