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Integrase inhibitor MK-0518: Merck opens expanded-access program.

On September 11 Merck announced that its worldwide expanded-access program for MK-0518 is now open in the U.S. This program is for "patients who are resistant to at least one drug in all three classes of oral anti-HIV medication, are failing their current regimens, and require a medication to which they may not be resistant."

Patients are ineligible if they are or were in a previous MK-0518 trial, are under 16, are pregnant or breast feeding, have acute hepatitis, or are taking certain medications including phenobarbital, phenytoin, or rifampin. There are other exclusion conditions. This program is for patients unable to participate in the clinical trials.

Because this drug is in the new class of integrase inhibitors, it has an entirely different mechanism of action than previous antiretrovirals. Therefore patients resistant to current medications should not be resistant to it.

For more information on the expanded access program, called Earmrk, visit http://www.earmrk.com.

Comment

This is a very important potential drug, but it must be used in combination with other active antiretrovirals. It is usually a mistake to try a new antiretroviral when no others are working, because of the risk of developing resistance to the new drug as well; if possible, patients should wait until more new drugs are available for use in combination. Merck recommends "that patients failing their current regimen receive at least 2 new antiretroviral medications to which their virus is still sensitive"--including approved drugs still active against that patient's virus.

Fortunately Merck is allowing patients to combine MK-0518 with other experimental antiretrovirals in different companies' expanded access programs, after review and approval.
COPYRIGHT 2006 John S. James
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Author:James, John S.
Publication:AIDS Treatment News
Date:Jul 1, 2006
Words:271
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