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 breast feeding Pediatrics The provision of a neonate and infant with liquified lacteal products 'on tap'; lactation and BF–≥ 6 months before age 20 is associated with a relative risk of 0. , have acute hepatitis acute hepatitis Clinical medicine Liver inflammation of abrupt onset, which may be due to a viral infection–eg HAV or toxins Clinical Low-grade fever, anorexia, N&V, fatigue, malaise, headache, photophobia, pharyngitis, cough; later, dark urine, light , or are taking certain medications including phenobarbital phenobarbital /phe·no·bar·bi·tal/ (fe?no-bahr´bi-tal) a long-acting barbiturate, used as the base or sodium salt as a sedative, hypnotic, and anticonvulsant. phe·no·bar·bi·tal n. , phenytoin phenytoin /phen·y·to·in/ (fen´i-toin?) an anticonvulsant used in the control of various kinds of epilepsy and of seizures associated with neurosurgery. phen·y·to·in n. , or rifampin rifampin (rĭfăm`pĭn), antibiotic used in the treatment of tuberculosis. It is also used to eliminate the meningococcus microorganism from carriers and to treat leprosy, or Hansen's disease. . 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 Expanded access refers to the inclusion of patients in a clinical trial for a new therapeutic treatment or chemical entity, where those patients would not satisfy the enrolment criteria for the scientific study in progress. 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. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion