Early Access Program Opened For Nucleotide Analogue Tenofovir
February 22, 2001
The makers of the new nucleotide analogue tenofovir have started offering the medication to people living with HIV through a limited early access program. Tenofovir is a compound that looks to be of use for people with resistance to currently available nucloeoside anologue drugs. The early access program is designed to make the medication available to people who have run out of other viable treatment options. To be eligible to participate in the program a person must be at least 18 years old, have a CD4 count at or below 100, and an HIV RNA viral load greater than or equal to 10,000 copies. The program is also limited to those who have had treatment failure with at least two protease inhibitors (PIs) or one PI and one non-nucleoside reverse transcriptase inhibitor (NNRTI). If a person has between 100 and 200 CD4 cells, and has had an AIDS-defining illness in the last 90 days, they may also be eligible. It is hoped that these criteria will be expanded to include more people as the drug gets closer to FDA approval (expected in June).
For more information about the tenofovir early access program in the U.S., call (877) 226-8802, or visit the website http://www.gilead.com/webpage_templates/frame_home.php3. To enroll patients in the program, U.S. physicians should call (800) GILEAD-5. Patients will receive the investigational drug as a once-daily, 300mg tablet.
This article was provided by Seattle Treatment Education Project. It is a part of the publication STEP Ezine.