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| |  HIV Levels Undetectable In Patients Taking Sustiva CHICAGO, IL -- June 5, 1998 -- Six HIV-infected patients taking the DuPont Merck’s investigational drug, Sustiva(TM) (efavirenz), in dual and triple combinations, achieved HIV-RNA levels in plasma and cerebrospinal fluid (CSF) below the level of detection (less than 400 copies/ml). These results were presented by Dr. Karen Tashima and colleagues at The Miriam Hospital, Brown University, Massachusetts General Hospital, Harvard University and DuPont Merck at the eighth annual Neuroscience of HIV Infection, Basic Research and Clinical Frontiers meeting, sponsored by Northwestern University Medical School. CSF drug levels and HIV-RNA were measured in these patients who took Sustiva in a combination either with AZT and 3TC, or with indinavir, for a mean duration of 26 weeks. "We are encouraged that these early results show Sustiva, in combination with other agents, suppresses HIV replication in the CSF,” said Karen Tashima, M.D., assistant professor of medicine, Brown University at The Miriam Hospital. “Since not all antiretrovirals cross the blood-brain barrier, the ability to control viral replication in the CSF will become increasingly critical when constructing durable combination treatment regimes." Efavirenz levels were determined both in the CSF and in the plasma. Efavirenz levels in the CSF achieved a mean concentration of 35.9nM. The CSF concentrations of efavirenz reflected the levels of free drug in the plasma (not bound to plasma proteins). Mean plasma viral load prior to treatment was 53,675 (range 2,985 to 108,778) and was reduced in all six patients to below the level of detection, both in plasma and CSF at the time point studied. HIV-RNA levels were evaluated using the standard Roche Amplicor(TM) HIV assay. Sustiva is currently in development as a once-daily treatment. Sustiva is generally well tolerated; side effects include rash, nausea, dizziness, diarrhea, headache and insomnia. Severe rashes have been reported in fewer than one percent of patients. Pregnant women should not take this new medication unless the benefit to the mother clearly outweighs the potential risk to the fetus.
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