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Publication Number
US-RE47404-E1
Publication Date
2019-05-28
Expiration Date
Abstract
The present disclosure relates to methods for treating viral hepatitis, compounds useful in the treatment of viral hepatitis, and pharmaceutical compositions comprising such compounds. In one embodiment, pharmaceutical compositions comprising nitazoxanide, tizoxanide, or derivatives and/or mixtures thereof are provided, as well as methods of treating hepatitis C using such compositions.
Core Innovation
The patent describes methods for treating hepatitis C by administering nitazoxanide, tizoxanide, or a mixture thereof, with the stated aim of reducing serum hepatitis C virus RNA to undetectable levels. One method administers the compound alone, whereas another pretreats the patient with the compound before administering interferon. Specific amounts and treatment periods are [procedural detail omitted for safety]. The disclosure also describes pharmaceutical compositions and combinations with additional biologically active agents.
The reported content describes antiviral activity for nitazoxanide or tizoxanide combinations and enhanced interferon activity following nitazoxanide pretreatment. Clinical study results demonstrate undetectable serum HCV RNA among virologic responders and sustained virologic responses in a subset of patients. Because the background section is omitted from the provided text, the specific problem identified in that section is not explicitly described in patent.
Claims Coverage
The claims identify two independent claims reciting two inventive features directed to hepatitis C treatment.
Treatment with nitazoxanide or tizoxanide
The claim covers treating a patient suffering from hepatitis C with nitazoxanide, tizoxanide, or a mixture thereof, to reduce serum hepatitis C virus RNA to undetectable levels. Specific amounts and treatment periods are [procedural detail omitted for safety].
Pretreatment followed by interferon
The claim covers pretreating a patient suffering from hepatitis C with nitazoxanide, tizoxanide, or a mixture thereof, followed by administration of interferon, directed to reducing serum hepatitis C virus RNA to undetectable levels. Specific amounts and treatment periods are [procedural detail omitted for safety].
The independent claims cover administration of nitazoxanide or tizoxanide to reduce serum HCV RNA and sequential treatment wherein administration of either compound precedes interferon administration.
Stated Advantages
The claimed methods are stated to reduce serum hepatitis C virus RNA to undetectable levels.
Documented Applications
Treatment of patients suffering from hepatitis C using nitazoxanide, tizoxanide, or a mixture thereof, including administration followed by interferon.
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