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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).
Gilead is already making exceptions under the current program for persons who are able to obtain either DuPont Merck's efavirenz (SUSTIVA) 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.
Note: For more information on either the ongoing clinical trials or the expanded access program, call 800-GILEAD-5.
Editor's Note: from AIDS Treatment News
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