Efavirenz (Sustiva (tm) ) Expanded Access Now to 400 CD4
On December 17 the DuPont Merck Pharmaceutical Company announced more flexible eligibility criteria for expanded access to efavirenz (Sustiva, also known as DMP-266). Now, U.S. patients who have ever had a CD4 count under 400 can be eligible; before, they had to have a count of less than 50 within the last 90 days. (In Europe, entry criteria will be similarly changed in the first quarter of 1998.)Efavirenz "must be used in combination with and initiated at the same time as at least one other marketed or investigational antiretroviral which the patient has not previously taken. Sustiva is not recommended as monotherapy. Patients are now eligible for this program if at any time they have had a CD4 cell count of less than 400 cells/mm3, they are failing or intolerant to their current treatment regimen, and their physician is unable to assemble a treatment combination without Sustiva that is likely to produce a sustained reduction of virus in the blood.
"DuPont Merck believes that patients who have failed non-nucleoside reverse transcriptase inhibitors are less likely to benefit from Sustiva because of a common mutation (K103N).
"Physicians and patients may call 1-800-998-6854 for more information on inclusion criteria and materials for investigator and patient enrollment in the Sustiva Expanded Access Program."
