On February 1 Gilead Sciences announced a much-enlarged expanded access program for tenofovir DF (tenofovir disoproxil fumarate), a potentially important new drug which is now in a phase III clinical trial with over 500 treatment-experienced patients (averaging more than five years of HIV treatment before beginning this trial). The new pre-approval program is limited to "patients who have failed commercially available antiretroviral treatment regimens, have limited treatment options and are at risk for disease progression." It is now open in the U.S. and France, and will soon begin in Germany, Italy, Spain, and the United Kingdom. Gilead hopes to apply for marketing approval for tenofovir DF in mid-2001 in both the U.S. and Europe, and the drug has been designated for fast-track evaluation by the U.S. FDA.
Criteria for U.S. Program
"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/mm3
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 analog reverse transcriptase inhibitor. Additionally, patients with a CD4 cell count between 100 cells/mm3
and 200 cells/mm3
and an AIDS-defining opportunistic infection within the last 90 days may also be eligible."
"Physicians will be required to evaluate patients at baseline and after one month on therapy, then every two months until drug discontinuation or study termination following the protocol guidelines. Data collection is limited to the report of serious adverse events, and no specific laboratory testing is required except as indicated for standard medical care."
The drug is taken as one pill per day -- and patients should also be taking at least one other new antiretroviral.
Phase III Results
On February 20 Gilead released 24-week results from the ongoing phase III trial in treatment-experienced patients. Those randomly assigned to tenofovir had a 0.6 log decrease in viral load, compared to a negligible change in those taking placebo. Both the tenofovir and placebo arms had the same dropout rate, 6% -- indicating a good safety profile at the 24-week time point. (This trial will run for 48 weeks.)
The drug is also being tested in a separate phase III trial in treatment-naive patients.
For More Information
For more information about the tenofovir DF expanded access program in the U.S., and for physicians to request registration materials, call 1-800-GILEAD-5 (1-800-445-3235) between 8 a.m. and 6 p.m. Monday through Friday Eastern time. For the European program, call 33-1-44-90-34-46.
ISSN # 1052-4207
Copyright 2001 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.
Back to the AIDS Treatment News February 23, 2001 contents page.