Efavirenz (SUSTIVA [tm]) Expanded Access Begins October 1

On September 15 DuPont Merck announced an expanded access program to provide efavirenz (SUSTIVA [tm], formerly DMP 266) to "patients failing on, or intolerant to, their current regimen, and who in the judgment of their physician have no other appropriate treatment options available" (this and later quotes are from a physician's brochure describing the program). Because of limited drug supply for the next three months, the program is currently open only to those who have had a CD4 count less than or equal to 50, within the last 90 days.

Efavirenz "must be used with at least one or more antiviral drugs to which the patient has had no prior exposure. At least one other drug must be changed in a failing regimen if SUSTIVA is added. Optimally, when possible, the failing regimen should be changed entirely. If a patient is intolerant to an existing antiviral drug and the viral load is undetectable, SUSTIVA may be substituted for the agent that is not tolerated." For this program, patients must be at least 13, not be "hospitalized for any reason and/or being treated for an acute, serious life-threatening condition such as Pneumocystis carinii pneumonia or sepsis, or requiring IV antibiotics or chemotherapeutic agents." Other exclusions include concomitant use of terfenadine, astemizole, or cisapride, use of NNRTIs within 14 days of beginning this program, certain abnormal lab values, and pregnant or breastfeeding women.

Importantly, patients in this program may also be receiving experimental medications through other expanded-access programs. In fact, DuPont Merck, Glaxo Wellcome, and Gilead are working together to facilitate joint enrollment (for efavirenz, 1592, and adefovir) for appropriate patients, so that patients who are unable to use the approved treatments can start more than one new drug at the same time.

While the drug will be provided for free, patients or their insurance must pay for the CD4 and blood-chemistry tests required to qualify for the efavirenz program, and for any other expenses.

For more information, patients or physicians can call the SUSTIVA Expanded Access Program, 1-800-998-6854, 8 a.m. to 6 p.m. Eastern time, Monday through Friday.

Note: The generic name is pronounced EF-AH-VIR-ENZ, and the trade name is pronounced SUS-TEE-VAH.