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Published in the Bulletin of Experimental Treatments for AIDS March 1997 issue, by the San Francisco AIDS Foundation. |
Glaxo Wellcome Responds to AIDS Community Concerns about Early Access to 1592by Ronald Baker, PhD In the December 1996 issue, BETA outlined the available data on 1592, the promising new nucleoside analog reverse transcriptase inhibitor drug from Glaxo Wellcome. As a part of its treatment advocacy efforts, the San Francisco AIDS Foundation (SFAF), in collaboration with other community advocacy groups, has called on Glaxo Wellcome to make 1592 available through compassionate use and expanded access programs as soon as possible. Community advocates and activists have formed a 1592 "working group" to represent AIDS community interests concerning the development of this important new drug. One emerging group consensus is that community members expect to have more input than in the past in determining inclusion/exclusion criteria for expanded access programs established by drug companies. Without community oversight, these programs will not reflect the best interests of the patient population. Following a series of meetings and conversations with SFAF and other community groups, Glaxo Wellcome issued the following statement regarding the company's plans for compassionate use and expanded access programs for 1592. SFAF and other groups want Glaxo to start expanded access for 1592 this spring rather than their proposed start-up in the summer. "We appreciate the community's interest in 1592. As the drug enters large-scale clinical studies, we share the community's concern for patients who do not have treatment options. Our goal is to design programs that address the needs of those patients, while we ensure supplies for an ambitious clinical development program and collect safety data in treatment-experienced patients. "For adults, access to 1592 has already begun, or will soon begin, with controlled studies for patients who have had previous nucleoside reverse transcriptase and protease inhibitor therapy, as well as for those with AIDS dementia. Additional studies in a broader patient population, including both adults and children, will begin in April and May. "The first compassionate use of 1592 will be a program for children, which is scheduled to begin within the next 3 months. More details of the pediatric protocol will be released in the coming weeks. "Adult patients with advanced disease (i.e., fewer than 50 CD4 cells/mm3) who have exhausted other treatment options will be able to access 1592 through a compassionate use program scheduled to begin this summer [1997]. Toward the end of the year, based on data from Phase II/III studies, that program will evolve into an expanded access protocol, which will be designed to help Glaxo Wellcome collect additional safety data. "The company will continue to develop its expanded access plans, and more details about the programs will be announced as specific elements are finalized." --- Jennifer McMillan, Director, Health Care Coalitions and Advocacy Relations, Glaxo Wellcome Inc. Page last updated 1 April 1997 |
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