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

Inactive Publication Date: 2005-08-11
DIETERICH DOUGLAS T
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0023] It is an object of the present invention to provide a new use of Erythropoetin (“EPO”) to treat an anti-anemia condition caused by the combination treatment of ribavirin and interferon-alpha. It is another object of the present invention

Problems solved by technology

There can be either an inadequate production of EPO or a lack of response to EPO by the bone marrow.
This anemia can be severe and even life threatening, particularly in people with heart disease.
When interferon is administered with ribavirin, however, it blocks the normal response of the bone marrow to respond to the anemia and the reticulocyte response is blunted.
It is also an important global problem with as many as 50 million people afflicted with hepatitis C worldwide.
Such high doses of ribavirin cause a substantial increase of almost 50% in the incidence of anemia.
The normal management of this would be to reduce the ribavirin dose and thereby reduce the efficacy of the interferon/ribavirin combination therapy.
However, this would defeat the purpose of the hepatitis C treatment.
. . Despite the mean trends the variability of these data was high, suggesting that it would not be possible to establish a concentration range below which hemolysis would not occur, or above which anem

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Example

Example 1

[0059] In an open-label, prospective pilot study, 56 subjects with chronic HCV infection were treated with both RBV and IFN-α. Eighteen subjects with anemia (hemoglobin 2 g / dl) and reduced exercise tolerance following IFN-α / RBV initiation were treated with Epoetin alpha (up to 40,000 units per week subcutaneously). Remaining nonanemic subjects (38 / 56) who did not receive Epoetin alpha served as a control group. The two groups were followed for means of 25.3 and 21.2 weeks, respectively. At baseline, mean hemoglobin levels were not significantly different in the subjects who received epoetin alpha compared to those who did not receive the medication (14.3 g / dl vs. 15.1 g / dL, n.s.). At the time of epoetin alpha initiation, the mean hemoglobin level declined 25.4% (to 10.6 g / dL) in the group receiving this treatment. At the last study visit, mean hemoglobin levels were 12.7 g / dL among patients receiving epoetin alpha vs. 13.0 g / dL among controls (difference n.s.) reflecting a...

Example

Example 2

[0060] A study of interferon alone and interferon plus ribavirin for hepatitis C in HIV-infected patients was performed. Ten patients received interferon alone and 11 received the combination treatment of interferon alpha and ribavirin. Median liver biopsy fibrosis score for both groups was 2.1. In the interferon alone group, at 3 months, there was no change in HCV RNA, CD4 dropped from a median of 190 to 186 cells / ml and HIV RNA dropped from a median of 1500 copies per ml to less than 400. At the same time point, 3 months, in the combination group, the HCV RNA dropped from 3.2 million to less than about 600 copies / ml. CD4 cells dropped from a median of 544 to 237, but percentage CD4 cells did not change. The main adverse event was anemia which occurred in 5 / 21(23.8%). This was treated with erythropoietin 40,000 units weekly when the hemoglobin declined to to 10 g / dl. This treatment resulted in a rise in hemoglobin to 12.7 g / dl after a median of 4 weeks treatment. This was...

Example

Example 3

[0062] Fifty-six chronically HCV-infected (>90 days) subjects who were treated with IFN-α (3 million units TIW) and RBV (1000 mg / d for subjects 75 kg) were entered into an open-label, pilot, prospective study at several centers. Subjects were excluded if they were infected with the human immunodeficiency virus type-i or had a history of anemia, chronic renal disease, or coronary artery disease. RBV doses were adjusted by treating physicians as clinically indicated throughout the study.

[0063] Following INF-α / RBV initiation, subjects with new-onset anemia (hemoglobin 2 g / dL decrease in hemoglobin) or a decrease in hemoglobin accompanied by decreased exercise tolerance (providers' impressions) received epoetin alpha (up to 40,000 units per week, subcutaneously). Subjects who did not become anemic and who did not receive epoetin alpha served as a control group.

[0064] After initiation of epoetin alpha therapy, subjects were evaluated at a 2-week interval for 8 weeks and every...

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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.

Description

FIELD OF THE INVENTION [0001] The present invention is directed to a new use for Erythropoetin (“EPO”), such as EPO alpha, for treating hepatitis C and / or anemia caused by hepatitis C treatment. Accordingly, the invention involves using EPO with hepatitis C treatment, such as Ribavirin (“RBV”) and / or interferon such as alpha-interferon (“α-IFN” or “IFN”); and thus, the invention pertains to methods involving administration of EPO, RBV and α-IFN, or EPO and RBV, and compositions and kits containing EPO, RBV and α-IFN or EPO and RBV. [0002] Various documents are cited herein, e.g., in the text and / or in a reference section. There is no admission that any of the various documents cited in this text are prior art as to the present invention. Any document having as an author or inventor person or persons named as an inventor herein is a document that is not by another as to the inventive entity herein. All documents cited in this text (“herein cited documents”) and all documents cited or...

Claims

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Application Information

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IPC IPC(8): A61K38/18A61K38/21
CPCA61K38/1816A61K38/212A61K31/7056A61K2300/00
Inventor DIETERICH, DOUGLAS T.
Owner DIETERICH DOUGLAS T
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