Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1996-09-26
1998-05-12
Tsang, Cecilia J.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
530324, 530399, A61K 3800
Patent
active
057505012
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method and composition for treating patients having hepatic decompensation.
2. Description of the Background Art
Hepatic decompensation is liver failure which can result from chronic or chronic active infection of a patient by Hepatitis B virus.
Of several known therapeutic agents which have been proposed for use in the treatment of Hepatitis B, the most extensively evaluated is interferon alpha-2b (hereinafter ".alpha.-interferon"), available commercially as INTRON.RTM. A. Unfortunately, the response rate of chronic Hepatitis B patients to .alpha.-interferon has been less than 50%. With the establishment of liver transplantation as a therapeutic modality for a variety of liver diseases, new expectations were raised for a cure of hepatic decompensation resulting from Hepatitis B infection. Unfortunately after some years of experience with liver transplantation, it is apparent that the rate of reoccurrence of Hepatitis B infection following transplantation is high.
In patients who have undergone liver transplantation wherein Hepatitis B virus DNA was detectable in the patient's serum prior to transplantation, the recurrence of Hepatitis B infection has been virtually universal within one year following transplantation. In view thereof, current medical practice precludes liver transplantation at many transplant centers in patients who have chronic Hepatitis B infection and who are serum positive for Hepatitis B virus DNA.
Treatment with .alpha.-interferon has not been successful in rendering serum of most patients with decompensated chronic Hepatitis B liver disease negative for Hepatitis B virus DNA. In fact, the INTRON.RTM. A label insert warns that .alpha.-interferon is contraindicated for patients exhibiting symptoms of hepatic failure, and may actually increase the risk of clinical decompensation. It is also known that .alpha.-interferon can lead to a level of decompensation which results in death.
In addition to .alpha.-interferon, another drug which has been suggested for treatment of Hepatitis B in patients is Thymosin .alpha..sub.1 ("T.alpha..sub.1 "). However, in view of the published warnings concerning the increased risk of hepatic decompensation when treating Hepatitis B using .alpha.-interferon, there would appear to be a negative motivation to use Thymosin .alpha..sub.1 in patients exhibiting symptoms of decompensated liver disease.
There remains a need in the art for methods of treating patients with hepatic decompensation so as to qualify such patients for liver transplantation.
SUMMARY OF THE INVENTION
In accordance with the present invention a method of treating a Hepatitis B patient having hepatic decompensation comprises administering Hepatitis B virus-reducing amounts of T.alpha..sub.1 to a patient having decompensated liver disease, so as to render said patient serum negative (seronegative) for Hepatitis B virus DNA.
The invention further includes a composition for use in treating a Hepatitis B patient having hepatic decompensation, comprising a pharmaceutical dosage unit containing a Hepatitis B virus-reducing amount of T.alpha..sub.1, which pharmaceutical dosage unit can be administered to Hepatitis B-infected patient having decompensated liver disease, so as to render serum of said patient negative for Hepatitis B virus DNA.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
It has surprisingly been discovered that Thymosin .alpha..sub.1 ("T.alpha..sub.1 ") can render Hepatitis B patients having decompensated liver disease serum negative for Hepatitis B virus DNA, thereby qualifying such patients for liver transplantation. This is surprising since the only approved drug for treatment of Hepatitis B, .alpha.-interferon, is contraindicated for use in patients with decompensated liver disease.
The terms "Thymosin .alpha..sub.1 ", "Thymosin alpha 1" and "T.alpha..sub.1 " as used herein encompass not only native (i.e., naturally occurring) T.alpha..sub.1 but also synthetic T.alpha..sub.1 and recombinant
REFERENCES:
patent: 5308833 (1994-05-01), Scharschmidt
Chretien Paul B.
Mutchnick Milton G.
Alpha 1 Biomedicals, Inc.
The Board of Governors of Wayne State Univ.
Touzeau P. Lynn
Tsang Cecilia J.
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