Method of treating viral infections

A virus infection, ribavirin technology, applied in antiviral agents, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve problems such as side effects, achieve stable dose delivery rate, and avoid systemic side effects.

Inactive Publication Date: 2006-09-20
HOWARD J SMITH & ASSOC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0010] These serious side effects have been found to occur predominantly with combination therapy

Method used

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  • Method of treating viral infections

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Experimental program
Comparison scheme
Effect test

Embodiment A

[0094] The combination therapy of the present invention may be administered in the following clinical regimens.

[0095] Treatment options: Patients with chronic hepatitis C can receive 3 million IU of Intron A (interferon alfa-2b) parenterally once a week in combination with ribavirin at an oral dose of 350 mg / day. Synthetic polymers to form extended release dosage forms. Any study has two phases, the first phase lasts at least 28 weeks and compares the therapeutic effects of a liver-selective formulation of ribavirin with a conventional formulation given as a systemic formulation. The second phase of the study may be conducted in one or several subgroups of patients, with treatment lasting 68 weeks or longer, to ensure continuation of the treatment effect.

[0096] It is expected that use of lower doses of ribavirin (less than 400 mg / day or less than 6 mg / kg / day) combined with concentrations of ribavirin in the liver and portal circulation will substantially reduce side eff...

Embodiment B

[0098] Combination treatments of the present invention may be administered in the following clinical regimens.

[0099] Treatment options: Patients with chronic hepatitis C can receive 3 million IU of Intron A (interferon alpha-2b) parenterally once a week in combination with ribavirin at an oral dose of 600 mg / day. Synthetic polymers to form extended release dosage forms. Any study has two phases, the first phase lasts at least 28 weeks and compares the therapeutic effects of a liver-selective formulation of ribavirin with a conventional formulation given as a systemic formulation. Phase 2 studies in a subgroup or subgroups of patients, with treatment durations of 48 weeks or longer, are needed to ensure persistence of treatment effect.

[0100] It is expected that ribavirin administered in sustained release dosage form at higher doses will produce a more complete or rapid therapeutic response with fewer side effects than conventional or systemic doses.

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Abstract

A method of pharmaceutical therapy comprising the co-administration of any form of interferon or any derivative thereof with a low dose of ribavirin (less than 400 mg / day or less than 6 mg / kg / day), or related compound, where the ribavirin or related compound provides a clinically effective blood level in the portal circulation but a less than clinically effective blood level in the peripheral circulation, to thereby provide a systemic effect of interferon throughout the body but a selective effect of ribavirin in the liver. The method also provides for the co-administration of any form of interferon or any derivative thereof with a high dose of ribavirin (preferably from 400-800 mg / day), or related compound, where the ribavirin or related compound is administered as a slow-release formulation such that it also provides a sustained virologic response in a patient and reduced side effects. The method also provides for the co-administration of an antioxidant or other membrane protective agent with both the interferon and ribavirin such that the hepatoprotective activity of the antioxidant or other membrane protective agent complements the virucidal effect of the interferon and ribavirin. The antioxidant or other membrane protective agent may be administered as a systemic or a low-dose, slow-release, liver-selective formulation.

Description

[0001] The method involves the combined use of ribavirin and interferon for the treatment of viral infections such as hepatitis C infection. Background technique [0002] Hepatitis C is a chronic form of viral hepatitis caused by the hepatitis C virus (HCV). As a viral infection, it is a systemic disease; however, the primary site of cellular damage and viral replication is the liver. The virus is transmitted by blood transfusion and various transcutaneous routes including self-injection and contact of damaged skin or membranes with an infectious agent. [0003] The clinical features of the disease include periods of acute hepatitis followed by chronic hepatitis in 50-70% of cases. For most patients (80% or more) with chronic hepatitis C, the disease is relatively benign, with chronic fatigue lasting 20 or more years. Up to 20% of patients eventually develop cirrhosis, with an increased incidence of primary liver cancer. [0004] The immediate cause of liver injury is the d...

Claims

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Application Information

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IPC IPC(8): A61K38/21A61K31/7056A61K31/7052A61P31/12A61K45/06
CPCA61K31/7056A61K45/06A61K38/212A61K38/21A61P31/12A61P43/00A61K2300/00
Inventor H·J·史密斯
Owner HOWARD J SMITH & ASSOC
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