Gilead announces start of early access program for investigational anti-HIV agent tenofovir DF in United States and France
Programs to Begin in Germany, Italy, Spain and the United Kingdom upon Regulatory Clearance
Gilead Sciences, Inc. have announced the initiation of a limited expanded access program to provide tenofovir disoproxil fumarate (tenofovir DF) to people with advanced human immunodeficiency virus (HIV) infection in the United States and multiple countries in the European Union. Regulatory review has been concluded and programs are open for registration in the United States and France. Early access programs will be initiated in Germany, Italy, Spain and the United Kingdom as regulatory approvals are obtained. Tenofovir DF is an investigational reverse transcriptase inhibitor, dosed as a single tablet once daily, currently being evaluated in combination with other agents in multinational Phase III clinical studies as a potential treatment for HIV infection. Expanded access programs are part of an effort by the U.S. Food and Drug Administration (FDA), European regulatory agencies and the pharmaceutical industry to make investigational drugs available during the later stages of clinical development for the treatment of serious or life-threatening diseases. “Patients with advanced HIV disease can rapidly run out of viable treatment options and often rely upon access to experimental therapies, said James Rooney, MD, Vice President of Clinical Research and leader of the worldwide Tenofovir DF Early Access Program at Gilead. “Initiating this limited program is our first step toward providing patients in greatest medical need with access to tenofovir DF.
The U.S. program will make tenofovir DF available to patients at least 18 years of age with HIV infection who have had a CD4 count less than or equal to 100 cells/mm 3 and an HIV RNA level of greater than or equal to 10,000 copies/mL by PCR within the past two months. Patients must also have failed treatment with at least two protease inhibitors (PIs) or one PI and one non-nucleoside analogue reverse transcriptase inhibitor. Additionally, patients with a CD4 cell count between 100 cells/mm 3 and 200 cells/mm 3 and an AIDS- defining opportunistic infection within the last 90 days may also be eligible. The U.S. program was designed with input from HIV patient advocates and representatives of HIV/AIDS community organizations. The viral load and CD4 cell count entry criteria for the U.S. program were established to insure that patients with the most advanced disease and in greatest need of a new antiretroviral therapy would have priority access during the initial stages of the program.
The French program will make tenofovir DF available to patients through an Authorisation Temporaire d’Utilisation de Cohorte. Design of early access programs in the European Union varies from country to country, according to specific regulatory guidelines. Patients will receive tenofovir DF 300 mg dosed as a single tablet once daily. Gilead will advise physicians to include, in addition to tenofovir DF, at least one new antiretroviral agent that has not been previously administered to their patients.
Gilead intends to submit the NDA to the U.S. FDA and the Marketing Authorisation Application to the European Medicines Evaluation Agency for tenofovir DF in mid-year 2001.
For more information regarding the tenofovir DF early access program or to request registration materials, physicians in the United States may call 1-800-GILEAD-5 and those within Europe may call +33-1-44-90-34-46.