Promising Hepatitus C Treatment

DALLAS, Oct 30, 2000 /PRNewswire via COMTEX/ -- Of the nearly four million Americans who suffer from hepatitis C, an estimated one million cannot begin or must discontinue treatment with the current standard of care due to thrombocytopenia (low platelet levels). Preliminary research presented today at the American Association for the Study of Liver Diseases annual meeting suggests that these patients can begin or continue treatment at full dosage and without interruption when also treated with the platelet growth factor Interleukin-11 (Oprelvekin, marketed under the brand name Neumega(R)).

      This first-of-its kind study, conducted at Georgetown University Hospital, used the platelet growth factor to prevent severe thrombocytopenia and in all cases, platelets increased to safe levels, thereby allowing completion of full-dose therapy with Interferon and Ribavirin.

      "In medicine, we are always looking for new ways to use existing therapies," said Dr. Vinod Rustgi, medical director of liver transplantation at Georgetown University Hospital and lead investigator of the study. "These preliminary findings show that Neumega''s ability to avoid low platelet counts and prevent stable platelet counts from diving in chemotherapy patients may also enable more hepatitis C patients to start treatment and maintain it safely."

      The study involved four patients with chronic hepatitis C, a disease caused by the hepatitis C virus that can lead to inflammation of the liver. In two cases, Neumega was used to correct therapy-induced thrombocytopenia, and in the other two cases it was started before antiviral therapy to prevent further decreases in platelet counts. All study participants responded favorably to Neumega treatment and experienced improved platelet levels.

      "By its nature, hepatitis C puts patients at risk for thrombocytopenia," said Dr. William Ershler, a hematologist on the research team and director of the Institute for Advanced Studies in Aging & Geriatric Medicine. "We''re encouraged by these findings and look forward to exploring IL-11''s potential role in the long-term management of this devastating disease."

      Neumega is a platelet growth factor that can help prevent low platelet counts caused by chemotherapy. Platelets are disk-shaped blood cells that tend to stick to uneven or damaged parts of blood vessels and prevent severe bleeding. Formed in the bone marrow, platelet production can be decreased by myelosuppressive drugs. Neumega is a growth factor (protein) that stimulates the bone marrow to make normal platelets, helping to maintain platelet counts, which may minimize the possibility of having to change myelosuppressive drug dosing or timing.

      Neumega is currently approved by the U.S. Food and Drug Administration for patients undergoing myelosuppressive chemotherapy at high risk of severe thrombocytopenia. Neumega is manufactured and marketed by Wyeth(R)/ Genetics Institute(R), divisions of American Home Products.

      In randomized studies, most adverse events associated with Neumega were mild or moderate in severity, associated with fluid retention and reversible after discontinuation of dosing. The most common adverse events associated with Neumega included peripheral edema, dyspnea, tachycardia, and conjunctival redness. Neumega should be used with caution in patients with congestive heart failure (CHF), at risk of developing CHF, or with a history of heart failure.

      The Institute for Advanced Studies in Aging & Geriatric Medicine is a non- profit biomedical research and educational organization that unites researchers, educators, and clinicians to accelerate the pace of discovery in the multi-faceted field of human aging. The work of the Institute is carried out by world health leaders, both in basic research and prevention. The Institute is the first non-governmental organization to receive the designation of Official Collaborating Center for Health of the Elderly from the World Health Organization.

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