Method of treating anemia caused by ribavirin treatment of hepatitis C using erythropoietin alpha

Abstract

Claimed and disclosed is a new use for a previously approved drug: erythropoietin. The present invention teaches using Erythropoetin to treat anemia caused by the combined treatment of Ribavirin and alpha-interferon. Erythropoetin has previously been approved for the treatment of anemia caused by cancer chemotherapy, renal failure and HIV. It has not been used for anemia caused by ribavirin. Ribavirin is part of a two-drug regimen now used to treat hepatitis C along with alpha interferon. The principal side effect of ribavirin is a hemolytic anemia. In the past, management of that anemia was done by dose reduction of the ribavirin, sometimes resulting in reversal of part of the anemia. It has become particularly important in light of new data, to maximize the dose of ribavirin given to persons undergoing treatment for hepatitis C to ensure a successful eradication of hepatitis C.

1 . A method for treating hepatitis C in a patient in need thereof comprising administering ribavirin (RBV) or RBV and interferon-alpha (IFN), wherein the improvement comprises administering Erythropoetin (EPO) or a vector that expresses EPO in vivo, concomitantly or sequentially or via co-administration with the RBV or with the RBV and IFN.  
     
     
         2 . A method for treating ribavirin or ribavirin and interferon-alpha induced anemia comprising administering erythropoietin to a patient in need thereof as a liquid preparation subcutaneously, parenterally, intradermally, intramuscularly or intravenously.  
     
     
         3 . A method for treating ribavirin or ribivirn and interferon-alpha induced anemia comprising administering Erythropoetin to a patient in need thereof as a suspension, emulsion, syrup or elixir.  
     
     
         4 . A method for treating hepatitis C (HCV) and for treating ribavirin or ribivirn and interferon-alpha induced anemia employed in treating said HCV in a patient in need thereof by administering erythropoietin to the patient subcutaneously for at least about six months.  
     
     
         5 . A method for treating hepatitis C (HCV) and for treating ribavirin or ribivirn and interferon-alpha induced anemia employed in treating said HCV in a patient in need thereof by administering erythropoietin to the patient subcutaneously for at least about 12.  
     
     
         6 . The method of  claim 4  wherein the hepatitis C is genotype 2 and/or 3.  
     
     
         7 . The method of  claim 5  wherein the hepatitis C genotype 1 and/or 4.  
     
     
         8 . In a method for treating hepatitis C in a patient in need thereof, comprising administering ribavirin and interferon-alpha wherein the improvement comprises co-administering to the patient subcutaneously, at a pre-determined effective amount, an Erythropoetin liquid preparation.  
     
     
         9 . The method for treating hepatitis C comprising administering ribavirin and interferon-alpha wherein the improvement as claimed in  claim 8  comprises administering to patients subcutaneously at a weekly dose of about 10,000 to 70,000 units of erythropoietin.  
     
     
         10 . The method for treating hepatitis C comprising administering ribavirin and interferon-alpha wherein the improvement as claimed in  claim 8  comprises administering to patients subcutaneously at a weekly dose of about 20,000 to 60,000 units of erythropoietin.  
     
     
         11 . The method of  claim 8  wherein the patient is HIV negative.  
     
     
         12 . The method of  claim 9  wherein the patient is HIV positive.  
     
     
         13 . A kit comprising RBV and EPO, or, RBV, EPO and IFN, for at least one co-administration of RBV and EPO or RBV, EPO and IFN; wherein the kit optionally contains instructions for administration and/or devices for administration  
     
     
         14 . The kit of  claim 12  wherein the EPO and IFN are together in the kit.  
     
     
         15 . The kit of  claim 13  wherein the EPO and IFN are in forms so that when co-administered they can be admixed prior thereto and/or they are in an admixed form for co-administration.  
     
     
         16 . A composition comprising EPO and IFN admixed together or in a form for admixture.