Adefovir Dipivoxil (PREVEON (tm) ): Expanded Access Restrictions Being Eased

After meeting with advocates for people with AIDS, Gilead Sciences has agreed to remove the CD-4 and viral load requirements for entry into the expanded access program for adefovir dipivoxil (brand name PREVEON, formerly called bis-POM PMEA). This and other program changes must be approved by the FDA; but Gilead is already making exceptions under the current program for persons who are able to obtain either DuPont Merck's efavirenz (SUSTIVA (tm) ) or Glaxo Wellcome's abacavir (1592U89), so that they will be able to start two or three new drugs at once, in case of failure of their current treatment.

Adefovir is an antiviral which has shown about a half log median decrease in viral load when used as monotherapy; this is comparable to approved nucleoside analogs, but adefovir may have less viral resistance problem than the other anti-HIV drugs. In laboratory studies, adefovir is also active against many herpes viruses which can be important in HIV disease, including herpes simplex types 1 and 2, CMV, and hepatitis B. It is taken as one tablet once a day. A phase II/III clinical trial is currently underway to determine the best way to use adefovir in combination with other antiretrovirals.

Gilead's proposed modified expanded access program will still require that patients "have failed or be intolerant to combination therapy with at least two commercially available nucleosides and at least one commercially available protease inhibitor. In addition, the treating physician must be unable to construct a viable regimen based on current treatment guidelines and the patient's previous antiretroviral use."

The proposed program may also assign patients at random to either a low dose (60 mg. once a day) or a high dose (120 mg. once a day), in order to collect safety data which may help in the approval of the drug. However this randomization will be voluntary; a doctor who wants the 120 mg. dose for a particular patient can request assignment to that dose.

Gilead has notified physicians who have registered for the adefovir dipivoxil expanded access program about these proposed changes--and that exceptions to the current CD-4 and viral load requirements will be favorably considered for patients starting abacavir or efavirenz.

Note: For more information on either the ongoing clinical trials or the expanded access program, call 800-GILEAD-5.