Gilead Announces Expanded Access Program for Tenofovir
Gilead Sciences, Inc. has announced a limited expanded access program for tenofovir disoproxil fumarate, an investigational nucleotide analog used in combination with other antiretrovirals and currently being tested in phase III studies, for the treatment of people with advanced HIV. Programs in the United States and France are open for enrollment, and programs in Germany, Italy, Spain and the United Kingdom will open as soon as the company receives regulatory approvals. The expanded access programs are a joint effort between regulatory agencies and pharmaceutical companies to provide patients with serious or life-threatening diseases access to experimental drugs that are in the final stages of testing. The tenofovir program will accept patients who meet the following qualifications:
Patients who have CD4+ T cell counts between 100 cells/mm3 and 200 cells/mm3 and an AIDS-defining opportunistic infection within the last 90 days may also be eligible. Patients will receive a daily single 300 mg tablet of tenofovir, and physicians will be advised to prescribe at least one new antiretroviral drug that the patient has not previously taken. Gilead plans to submit to the FDA a new drug application for tenofovir in mid-2001. For more information regarding the program, contact Gilead at
1-800-445-3235 (Gilead release, 1/31).
This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.