Systemic administration of NAC as an adjunct in the treatment of bioterror exposures such as anthrax, smallpox or radiation and for vaccination prophylaxis, and use in combination with DHEA for the treatment of smallpox and other viruses

Abstract

The invention is for the combination and related methods of N-acetyl-cysteine oral, inhaled, or intravenous, or glutathione inhaled or intravenous, generally in combination with antibiotic and/or antiviral therapy to ameliorate the toxic effects of infection with materials used in Bioterror incidents such as Bacillus anthracis and smallpox virus, and alternatively, upon exposure to radiation, during testing, and vaccination, as treatment prior to treatment with antibiotic or antiviral therapy to ameliorate the toxic effects of infection and exposure with these organisms.

What is claimed is:  
     
         1 . A combination for ameliorating the effects of exposure to a bacterial bioterror weapon, such as Bacillus Anthracis, comprising: 
 in a pharmaceutically acceptable carrier, at least one therapeutic dose of NAC and a therapeutic dose of at least one antibiotic to said bacterial bioterror weapon.    
     
     
         2 . The combination according to  claim 1 , further comprising: 
 a therapeutic dose of Selenium.    
     
     
         3 . The claim according to  claim 2 , further comprising: 
 a therapeutic dose of DHEA.    
     
     
         4 . A combination for prophylaxis of an impending bacterial bioterror weapon comprising: 
 in a pharmaceutically acceptable carrier, a therapeutic dose of NAC and a prophylactic dose of at least one general antibiotic to said impending bacterial bioterror weapon.    
     
     
         5 . The combination according to  claim 4 , further comprising: 
 a therapeutic dose of Selenium.    
     
     
         6 . The claim according to  claim 5 , further comprising: 
 a therapeutic dose of DHEA.    
     
     
         7 . The combination according to  claim 4 , further comprising: 
 said at least one general antibiotic being selected from the group of Penicillins such as Penicillin, Ampicillin, Nafcillin, or Piperacillin, Beta-lactamase inhibitors such as Aztreonam, Imipenem, Ampicillin/sulbactam (Augmentum) or Pipercillin/tazobactam, or a subgroup including Beta-lactams such as Ceftriaxone, Cefuroxime, Quinolones such as Ciprofloxacin, Ofloxacin, Gatifloxacin or Trovafloxacin, Tetracyclines such as Tetracycline, Doxycycline, or Minocycline, and Macrolides such as Erythromycin, Clarithromycin, or Azithromycin.    
     
     
         8 . The claim according to  claim 7 , further comprising: 
 a therapeutic dose of Selenium.    
     
     
         9 . The claim according to  claim 8 , further comprising: 
 a therapeutic dose of DHEA.    
     
     
         10 . A combination for ameliorating the effects of exposure to a viral bioterror weapon, such as smallpox, comprising: 
 in a pharmaceutically acceptable carrier, a therapeutic dose of NAC and a therapeutic dose of at least one antiviral agent to said viral bioterror weapon.    
     
     
         11 . The combination according to  claim 10 , further comprising: 
 a therapeutic dose of Selenium.    
     
     
         12 . The claim according to  claim 11 , further comprising: 
 a therapeutic dose of DHEA.    
     
     
         13 . A combination for prophylaxis of an impending viral bioterror weapon comprising: 
 in a pharmaceutically acceptable carrier, a therapeutic dose of NAC and a prophylactic dose of at least one general antiviral agent to said impending viral bioterror weapon.    
     
     
         14 . The combination according to  claim 13 , further comprising: 
 a therapeutic dose of Selenium.    
     
     
         15 . The claim according to  claim 14 , further comprising: 
 a therapeutic dose of DHEA.    
     
     
         16 . The combination according to  claim 13 , further comprising: 
 said at least one general antiviral agent being selected from the group of cidofovir, Broad spectrum antivirals such as the Triazole carboxamine, Ribavirin, protease inhibitors such as Saquinavir, Ritonavir, Indinavir, and Nelfinavir, tricyclic amines such as Amantadine and Rimantadine, Meuraminic acid mimetics such as Relenza and Tamiflu, small cyclics such as Pleconaril, Nucleoside analogues such as Vidarabine, Acyclovir, Gancyclovir, valganciclovir, Nucleoside Reverse transcriptase inhibitors such as Zidovudine (AZT), Didanosine (dd1), Zaocaitabine (ddC), Stravudine (d4T), and Lamivudine (3TC), and Non-Nucleoside Reverse transcriptase inhibitors such as Nevirapine and Delaviridine,    
     
     
         17 . The claim according to  claim 16 , further comprising: 
 a therapeutic dose of Selenium.    
     
     
         18 . The claim according to  claim 17 , further comprising: 
 a therapeutic dose of DHEA.    
     
     
         19 . A combination for ameliorating the side effects of a vaccine against a bioterror weapon or disease more generally, comprising: 
 in a pharmaceutically acceptable carrier, said vaccine, and a therapeutic dose of NAC.    
     
     
         20 . The combination according to  claim 19 , further comprising: 
 said therapeutic dose of NAC being selected from the group of water soluble NAC compounds.    
     
     
         21 . The claim according to  claim 20 , further comprising: 
 a therapeutic dose of Selenium.    
     
     
         22 . The claim according to  claim 21 , further comprising: 
 a therapeutic dose of DHEA.    
     
     
         23 . A combination for prophylaxis of an impending potential combined viral and bacterial bioterror weapon comprising: 
 in a pharmaceutically acceptable carrier, a therapeutic dose of NAC, a prophylactic dose of at least one general antiviral agent, and a prophylactic dose of at least one general antibiotic.    
     
     
         24 . The combination according to  claim 23 , further comprising: 
 a therapeutic dose of Selenium.    
     
     
         25 . The claim according to  claim 24 , further comprising: 
 a therapeutic dose of DHEA.    
     
     
         26 . The combination according to  claim 23 , further comprising: 
 said at least one general antiviral agent being selected from the group of cidofovir, Broad spectrum antivirals such as the Triazole carboxamine, Ribavirin, protease inhibitors such as Saquinavir, Ritonavir, Indinavir, and Nelfinavir, tricyclic amines such as Amantadine and Rimantadine, Meuraminic acid mimetics such as Relenza and Tamiflu, small cyclics such as Pleconaril, Nucleoside analogues such as Vidarabine, Acyclovir, Gancyclovir, valganciclovir, Nucleoside Reverse transcriptase inhibitors such as Zidovudine (AZT), Didanosine (dd1), Zaocaitabine (ddC), Stravudine (d4T), and Lamivudine (3TC), and Non- Nucleoside Reverse transcriptase inhibitors such as Nevirapine and Delaviridine;    and said at least one general antibiotic being selected from the group of_Penicillins such as Penicillin, Ampicillin, Nafcillin, or Piperacillin, Beta-lactamase inhibitors such as Aztreonam, Imipenem, Ampicillin/sulbactam (Augmentum) or Pipercillin/tazobactam, or a subgroup including Beta-lactams such as Ceftriaxone, Cefuroxime, Quinolones such as Ciprofloxacin, Ofloxacin, Gatifloxacin or Trovafloxacin, Tetracyclines such as Tetracycline, Doxycycline, or Minocycline, and Macrolides such as Erythromycin, Clarithromycin, or Azithromycin.    
     
     
         27 . The claim according to  claim 26 , further comprising: 
 a therapeutic dose of Selenium.    
     
     
         28 . The claim according to  claim 27 , further comprising: 
 a therapeutic dose of DHEA.    
     
     
         29 . A method of ameliorating the effects of exposure to a bacterial bioterror weapon such as Bacillus Anthracis comprising the following steps: 
 administering in a pharmaceutically acceptable carrier at least one therapeutic dose of NAC; and    administering at least one therapeutic dose of at least one antibiotic to said bacterial bioterror weapon.    
     
     
         30 . The method according to  claim 29 , further comprising the additional step: 
 administering a therapeutic dose of selenium.    
     
     
         31 . The method according to  claim 30 , further comprising the additional step: 
 administering a therapeutic dose of DHEA.    
     
     
         32 . A method of prophylaxis of impending exposure to a bacterial bioterror weapon such as Bacillus Anthracis comprising the following steps: 
 administering in a pharmaceutically acceptable carrier a course of therapeutic doses of NAC; and    administering a course of prophylactic doses of at least one antibiotic to said bacterial bioterror weapon.    
     
     
         33 . The method according to  claim 32 , further comprising the additional step: 
 administering a therapeutic dose of selenium.    
     
     
         34 . The method according to  claim 33 , further comprising the additional step: 
 administering a therapeutic dose of DHEA.    
     
     
         35 . The method according to  claim 32 , further comprising: 
 selecting said at least one general antibiotic from the group of Penicillins such as Penicillin, Ampicillin, Nafcillin, or Piperacillin, Beta-lactamase inhibitors such as Aztreonam, Imipenem, Ampicillin/sulbactam (Augmentum) or Pipercillin/tazobactam, or a subgroup including Beta-lactams such as Ceftriaxone, Cefuroxime, Quinolones such as Ciprofloxacin, Ofloxacin, Gatifloxacin or Trovafloxacin, Tetracyclines such as Tetracycline, Doxycycline, or Minocycline, and Macrolides such as Erythromycin, Clarithromycin, or Azithromycin.    
     
     
         36 . The method according to  claim 34 , further comprising the additional step: 
 administering a therapeutic dose of selenium.    
     
     
         37 . The method according to  claim 35 , further comprising the additional step: 
 administering a therapeutic dose of DHEA.    
     
     
         38 . A method of ameliorating the effects of exposure to a viral bioterror weapon such as smallpox comprising the following steps: 
 administering in a pharmaceutically acceptable carrier at least one therapeutic dose of NAC; and    administering at least one therapeutic dose of at least one antiviral agent to said viral bioterror weapon.    
     
     
         39 . The method according to  claim 37 , further comprising the additional step: 
 administering a therapeutic dose of selenium.    
     
     
         40 . The method according to  claim 38 , further comprising the additional step: 
 administering a therapeutic dose of DHEA.    
     
     
         41 . A method of prophylaxis of impending exposure to a viral bioterror weapon such as smallpox comprising the following steps: 
 administering in a pharmaceutically acceptable carrier a course of therapeutic doses of NAC; and    administering a course of prophylactic doses of at least one general antiviral agent to said viral bioterror weapon.    
     
     
         42 . The method according to  claim 41 , further comprising the additional step: 
 administering a therapeutic dose of selenium.    
     
     
         43 . The method according to  claim 42 , further comprising the additional step: 
 administering a therapeutic dose of DHEA.    
     
     
         44 . The method according to  claim 41 , further comprising: 
 selecting said at least one general antiviral agent from the group of cidofovir, Broad spectrum antivirals such as the Triazole carboxamine, Ribavirin, protease inhibitors such as Saquinavir, Ritonavir, Indinavir, and Nelfinavir, tricyclic amines such as Amantadine and Rimantadine, Meuraminic acid mimetics such as Relenza and Tamiflu, small cyclics such as Pleconaril, Nucleoside analogues such as Vidarabine, Acyclovir, Gancyclovir, valganciclovir, Nucleoside Reverse transcriptase inhibitors such as Zidovudine (AZT), Didanosine (dd1), Zaocaitabine (ddC), Stravudine (d4T), and Lamivudine (3TC), and Non-Nucleoside Reverse transcriptase inhibitors such as Nevirapine and Delaviridine,    
     
     
         45 . The method according to  claim 44 , further comprising the additional step: 
 administering a therapeutic dose of selenium.    
     
     
         46 . The method according to  claim 45 , further comprising the additional step: 
 administering a therapeutic dose of DHEA.    
     
     
         47 . A method of ameliorating the side effects of a vaccine against a bioterror weapon or disease more generally, comprising the following steps: 
 administering in a pharmaceutically acceptable carrier a course of therapeutic doses of NAC prior to administration of said vaccine;    administering said vaccine;    continuing said administration of a course of therapeutic does of NAC subsequent to administration of said vaccine at least until any potential side effects of said vaccine are attenuated.    
     
     
         48 . The method according to  claim 47 , further comprising the additional step: 
 administering a therapeutic dose of selenium.    
     
     
         49 . The method according to  claim 48 , further comprising the additional step: 
 administering a therapeutic dose of DHEA.    
     
     
         50 . A method of ameliorating the side effects of a vaccine against a bioterror weapon or disease more generally, comprising the following steps: 
 administering said vaccine;    administering in a pharmaceutically acceptable carrier a therapeutic dose of NAC contemporaneously to administration of said vaccine.    
     
     
         51 . The method according to  claim 50 , further comprising the additional step: 
 continuing said administration of a course of therapeutic doses of NAC subsequent to administration of said vaccine at least until any potential side effects of said vaccine are attenuated.    
     
     
         52 . The method according to  claim 51 , further comprising: 
 said therapeutic dose of NAC being selected from the group of water soluble NAC compounds.    
     
     
         53 . The method according to  claim 52 , further comprising the additional step: 
 administering a therapeutic dose of selenium.    
     
     
         54 . The method according to  claim 53 , further comprising the additional step: 
 administering a therapeutic dose of DHEA.    
     
     
         55 . A method of prophylaxis of impending exposure to an impending potential combined viral and bacterial bioterror weapon comprising the following steps: 
 administering in a pharmaceutically acceptable carrier a course of therapeutic doses of NAC; and    administering a course of prophylactic doses of at least one general antibiotic; and    administering a course of prophylactic doses of at least one general antiviral agent.    
     
     
         56 . The method according to  claim 55 , further comprising the additional step: 
 administering a therapeutic dose of selenium.    
     
     
         57 . The method according to  claim 56 , further comprising the additional step: 
 administering a therapeutic dose of DHEA.    
     
     
         58 . The method according to  claim 57 , further comprising: 
 selecting said at least one general antiviral agent from the group of cidofovir, Broad spectrum antivirals such as the Triazole carboxamine, Ribavirin, protease inhibitors such as Saquinavir, Ritonavir, Indinavir, and Nelfinavir, tricyclic amines such as Amantadine and Rimantadine, Meuraminic acid mimetics such as Relenza and Tamiflu, small cyclics such as Pleconaril, Nucleoside analogues such as Vidarabine, Acyclovir, Gancyclovir, valganciclovir, Nucleoside Reverse transcriptase inhibitors such as Zidovudine (AZT), Didanosine (dd1), Zaocaitabine (ddC), Stravudine (d4T), and Lamivudine (3TC), and Non-Nucleoside Reverse transcriptase inhibitors such as Nevirapine and Delaviridine;    and selecting at least one general antibiotic from the group of Penicillins such as Penicillin, Ampicillin, Nafcillin, or Piperacillin, Beta-lactamase inhibitors such as Aztreonam, Imipenem, Ampicillin/sulbactam (Augmentum) or Pipercillin/tazobactam, or a subgroup including Beta-lactams such as Ceftriaxone, Cefuroxime, Quinolones such as Ciprofloxacin, Ofloxacin, Gatifloxacin or Trovafloxacin, Tetracyclines such as Tetracycline, Doxycycline, or Minocycline, and Macrolides such as Erythromycin, Clarithromycin, or Azithromycin.    
     
     
         59 . The method according to  claim 58 , further comprising the additional step: 
 administering a therapeutic dose of selenium.    
     
     
         60 . The method according to  claim 59 , further comprising the additional step: 
 administering a therapeutic dose of DHEA.    
     
     
         61 . A method of ameliorating radiation damage, comprising the following step: 
 administering a therapeutic dose of NAC.    
     
     
         62 . The method according to  claim 61 , further comprising the additional step: 
 administering a therapeutic dose of selenium.    
     
     
         63 . The method according to  claim 62 , further comprising the additional step: 
 administering a therapeutic dose of DHEA.