Method for short-term and long-term drug dosimetry

Abstract

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.

Description

CROSS-REFERENCE [0001] This application claims benefit under 35 U.S.C. § 119(e) of U.S. provisional application 06 / 245,883 filed Nov. 3, 2000. The provisional application is incorporated herein in its entirety.FIELD OF THE INVENTION [0002] This invention relates to a method and a kit for treating disorders, especially interferon-responsive disorders in warm-blooded animals and a method for individualizing doses of a drug, e.g. an interferon, in treating such disorders. It further relates to a method for preparing a long-term dosage for treating such disorders. BACKGROUND OF THE INVENTION [0003] Introduction [0004] Long-term delivery of drugs using a device that provides a constant delivery of a drug over time has significant advantages over delivery of a drug by regular injections or even oral delivery. One advantage is that the patient may avoid “peak-related” adverse effects. Another advantage is that the patient may avoid “trough-related” ineffective therapy. Another advantage is...

AI Technical Summary

Benefits of technology

[0024] I have now invented an approach that addresses the problems in the prior art in the long-term use of a drug, e.g. an interferon, for the treatment of disease of warm-blooded animals that require long term administration to treat the disease or condition, e.g. one that is interferon-responsive.

[0025] My invention maximizes the probability of delivering an effective dose of a drug, such as an interferon, to a warm-blooded animal with, e.g. an interferon-responsive disease or condition and further maximizes the chances of delivering a safe dose of the drug, such that the dose is minimally toxic and therefore tolerated by the recipient.

[0026] My invention further facilitates the selection of a safe, tolerated and effective dosage of a drug, e.g. an interferon, to be delivered to a warm-blooded animal

Problems solved by technology

However, one disadvantage of long-term, constant-rate delivery of drugs is that there has not been an easy way to adjust doses for an individual patient in a given population of patients having a disease.

These current antiviral therapeutics are, however, not without limitations.

In addition, a significant fraction of patients whose disease does respond initially do not have a sustained response after drug therapy has ceased.

Among those patients who fail to respond to alpha interferon, the majority also fail to respond to subsequent treatment with consensus interferon.

Furthermore, not all patients can tolerate therapy with an interferon, whether alone or in combination with an adjunctive therapeutic agent, because of adverse side effects.

Moreover, certain patients who have been characterized initially as “resistant” to alpha interferon appear to respond to alpha interferon when a second or subsequent course of therapy is given, suggesting that the patient may have been inadequately treated during the earlier course of therapy or otherwise not truly resistant.

Inadequate treatment can easily occur if the initial duration of treatment is too brief or the dose for a particular patient is too low, leading to misleading or false conclusions regarding viral resistance.

Problems with Short-Term Administration

In addition, whether used as monotherapies or as part of combination therapies, currently available injectable interferons are inconvenient for patients to administer over a long period of time.

Nonetheless, there is still a significant risk of peaks in drug concentration in blood or tissues (occurring immediately after or early in the dosing cycle) and troughs (occurring just before the next dose is to be administered).

This phenomenon can be particularly troublesome with an interferon formulated for short-ter

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