Methods for treating, ameliorating or preventing infections using drug and vaccination combination treatment

Inventors

Borody, Thomas Julius

Assignees

Topelia Aust Ltd Acn 652 771 670 • Topelia Aust Ltd 652 771 670 • Centre for Digestive Diseases Pty Ltd

Abstract

In alternative embodiments, provided are methods for treating, ameliorating, decreasing the chances of having any adverse effects from, decreasing the severity of adverse effects from, or preventing an infection by administration of an antibiotic and/or an anti-viral drugs and a vaccine directed to a causative agent of the infection and/or an attenuated and/or a live, viable or infectious causative agent of the infection. In alternative embodiments, the infection is bacterial or viral. In alternative embodiments, the viral infection is a coronavirus infection such a Covid-19 infection. In alternative embodiments, methods as provide herein prevent or decrease the prevalence or severity of “vaccine breakthrough infections” after vaccination, where external mutants of COVID-19 infect patients in spite of the fact that they have undergone immunization, for example, to prevent a mutant or variant COVID-19 infection. In alternative embodiments, an antiviral combination administered in coordination with a vaccine comprises PF-07321332 or PAXLOVID™ and/or ritonavir, or ivermectin, doxycycline and a zinc or a zinc salt. In alternative embodiments, methods as provided herein are used to prevent in vivo mutations of such mutant infectious agent to enhance the efficacy of an administered vaccination; in other words, methods as provided herein are used to prevent in vivo replication of an acquired viral mutant or variant infectious agent, and thus also prevents ongoing mutations of the viral infectious agent because using the combination antiviral co-therapy where there is no replication of infectious agent and so there is no possible further mutation of the infectious agent.

Core Innovation

The invention provides a method for treating, ameliorating, decreasing the chances of having any adverse effects from, and decreasing the severity of adverse effects from a coronavirus infection. The method comprises administering an anti-viral drug combination and administering a live, inactivated or attenuated causative agent of the infection. The anti-viral drug combination is capable of killing the causative agent of the infection, or inhibiting the ability of the causative agent to replicate, become infectious, or cause pathology in a subject or an individual in need thereof.

The anti-viral drug combination comprises a specified compound having a shown structure and molecular weight and/or ritonavir, and a drug combination comprising ivermectin, doxycycline, and zinc. At least one dosage of the anti-viral drug combination is administered 1 or more days before, or on the day of, and/or 1 or more days after a first dose of the live, inactivated or attenuated causative agent. This scheduling links the antiviral regimen to the first dose of the causative agent used for treatment or prevention.

The disclosed method includes embodiments where the infection is COVID-19 or a COVID-19 variant infection, and the causative agent is live, inactivated or attenuated. The disclosure also includes additional refinements involving immunoglobulin measurement and testing (IgM, IgG, and/or IgA) after administration of the live, inactivated or attenuated causative agent, with a second or additional dosage based on measured immunoglobulin levels or at stated post-administration time windows. The method also includes formulations and administration in various dosage forms for the named antiviral components.

Claims Coverage

The independent claim clm-00001 defines a coordinated treatment/amelioration approach using an anti-viral drug combination together with a live, inactivated or attenuated causative agent, with anti-viral dosing scheduled around the first dose. The independent claim includes three main inventive feature groupings.

Overall claim coverage centers on the combination of an anti-viral regimen having the specified composition with administration of a live, inactivated or attenuated causative agent, wherein anti-viral dosing is given before, on, or after the first dose of the causative agent.

Stated Advantages

Documented Applications