Method for short-term and long-term drug dosimetry
Methods for the treatment of interferon-response disorders by administration of an interferon alone or in combination with adjunctive therapy are described. The invention encompasses providing to a patient both a formulation of an interferon that is suitable for short-term administration and a formulation of an interferon associated with a sustained release delivery system that is suitable for long-term administration. A principal advantage of the method is that responsiveness to treatment can be ascertained with short-term dosimetric techniques using one formulation of an interferon, which permits the appropriate selection of a dose that is both effective and safe for long-term administration using the second formulation.
1 - 64 . (canceled)
65 . A method of treating an interferon-responsive disorder in a warm-blooded animal, comprising administering to the animal via an internally implanted pump that is not externally programmed an amount of an interferon determined from short-term administration of the same or a different interferon to be suitable to treat the disorder.
66 . The method of claim 65 , wherein administration via the pump and the short-term administration overlap.
67 . The method of claim 65 , wherein administration via the pump and the short-term administration do not overlap.
68 . The method of claim 65 , wherein there is a period of at least a few hours without treatment between administration via the pump and the short-term administration.
69 . The method of claim 65 , wherein there is a period of at least one day without treatment between administration via the pump and the short-term administration.
70 . The method of claim 65 , wherein administration via the pump occurs at least one day subsequent to cessation of the short-term administration.
71 . The method of claim 65 , wherein there is a period of one month or more without treatment between administration via the pump and the short-term administration.
72 . The method of claim 65 , wherein there is a period of six months or more without treatment between administration via the pump and the short-term administration.
73 . The method of claim 65 , wherein there is a period of nine months or more without treatment between administration via the pump and the short-term administration.
74 . The method of claim 65 , wherein there is a period of twelve months or more without treatment between administration via the pump and the short-term administration.
75 . The method of claim 65 , wherein the short-term formulation of interferon is selected from natural or recombinant alpha, beta, consensus, gamma, leukocyte, omega, or tau interferon or versions thereof to which polyethylene glycol or a polyethylene glycol-fatty acid moiety has been attached by covalent or non-covalent bonding, or mixtures thereof.
76 . The method of claim 65 wherein the interferon administered via the pump is selected from naturally occurring or recombinant omega interferon, or versions thereof to which polyethylene glycol or a polyethylene glycol-fatty acid moiety has been attached by covalent or non-covalent bonding, or mixtures thereof.
77 . The method of claim 65 , wherein the interferon-responsive disease is selected from viral hepatitis C, viral hepatitis B, viral hepatitis D, condyloma accuminata, hairy cell leukemia, malignant melanoma, multiple myeloma, follicular lymphoma, non-Hodgkin's lymphoma, cutaneous T-cell lymphoma, chronic myelogenous leukemia, basal cell carcinoma, mycosis fungoides, carcinoid syndrome, superficial bladder cancer, renal cell cancer, colorectal cancer, laryngeal papillomatosis, actinic keratosis, Kaposi's sarcoma, multiple sclerosis, chronic granulomatous disease, pulmonary fibrosis, and tuberculosis.
78 . The method of claim 65 , wherein administration via the pump occurs over a period of at least approximately one month.
79 . The method of claim 65 , wherein administration via the pump occurs over a period of at least approximately a quarter year.
80 . The method of claim 65 , wherein administration via the pump occurs over a period of approximately a year.
81 . A method for individualizing doses of an interferon in the treatment of interferon responsive disorders in a warm-blooded animal, comprising administering to an individual animal via an internally implanted pump that is not externally programmed an amount of an interferon determined from short-term administration of the same or a different interferon in a plurality of animals to be suitable to treat the disorder.
82 . The method of claim 81 , wherein the short-term formulation of interferon is selected from natural or recombinant alpha, beta, consensus, gamma, leukocyte, omega, or tau interferon or versions thereof to which polyethylene glycol or a polyethylene glycol-fatty acid moiety has been attached by covalent or non-covalent bonding, or mixtures thereof
83 . The method of claim 81 wherein the interferon administered via the pump is selected from naturally occurring or recombinant omega interferon, or versions thereof to which polyethylene glycol or a polyethylene glycol-fatty acid moiety has been attached by covalent or non-covalent bonding, or mixtures thereof.
84 . The method of claim 81 , wherein the interferon-responsive disease is selected from viral hepatitis C, viral hepatitis B, viral hepatitis D, condyloma accuminata, hairy cell leukemia, malignant melanoma, multiple myeloma, follicular lymphoma, non-Hodgkin's lymphoma, cutaneous T-cell lymphoma, chronic myelogenous leukemia, basal cell carcinoma, mycosis fungoides, carcinoid syndrome, superficial bladder cancer, renal cell cancer, colorectal cancer, laryngeal papillomatosis, actinic keratosis, Kaposi's sarcoma, multiple sclerosis, chronic granulomatous disease, pulmonary fibrosis, and tuberculosis.