Gilead Announces Expanded Access Program for TenofovirGilead 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:
- 18 years or older with diagnosed HIV infection;
- CD4+ T cell count of Viral load >=10,000 copies per milliliter by PCR within the past two months;
- Have failed treatment with at least two protease inhibitors or one protease inhibitor and one non-nucleoside reverse transcriptase inhibitor.