Claims for Patent: 6,347,633

Summary for Patent: 6,347,633

Title:	Treatment of hepatitis C using hyperthermia
Abstract:	The invention provides a method of treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce or eliminate the patient\'s viral load of HCV.
Inventor(s):	Groth; Karl Emil (St. Paul, MN), Kelly; Theodore Charles (Minnetonka, MN), Westerbeck; Todd L. (Burnsville, MN), Blick; Gary (Stamford, CT)
Assignee:	First Circle Medical, Inc. (Minneapolis, MN)
Application Number:	09/484,360
Patent Claims:	1. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce the patient's viral load of HCV by 30 percent or more three months after the core temperature has been raised and returned to normal said at least one time, and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time. 2. The method of claim 1, wherein the core temperature of the patient is raised and returned to normal one time. 3. The method of claim 1, wherein the core temperature of the patient is raised and returned to normal two or more times. 4. The method of claim 1, wherein the core temperature is raised by circulating the patient's blood from the patient, through an extracorporeal blood flow circuit, and back to the patient, wherein the blood returned to the patient has been heated within the blood flow circuit to an elevated temperature range. 5. The method of claim 4, wherein the patient's blood is circulated from the patient through a blood vessel and returned to the patient through a blood vessel. 6. The method of claim 4, wherein the patient's blood is circulated from the patient through a vein and returned to the patient through a vein. 7. The method of claim 4, wherein the patient's blood is circulated from the patient through an artery and returned to the patient through a vein. 8. The method of claim 1, wherein the core temperature is raised by inserting a heating element into the patient and wherein the heating element heats the patient's blood. 9. The method of claim 8, wherein the heating element is inserted into a blood vessel of the patient. 10. The method of claim 1, wherein the core temperature is raised to a temperature range of from 38 to 48.degree. C. 11. The method of claim 1, wherein the core temperature is raised to a temperature range of from 38 to 44.degree. C. 12. The method of claim 1, wherein the core temperature is raised to a temperature range of from 41.8 to 42.2.degree. C. 13. The method of claim 10, wherein the core temperature is measured rectally. 14. The method of claim 10, 11, or 12, wherein the core temperature is raised for a period of from 2 minutes to sixteen hours. 15. The method of claim 10, 11, or 12, wherein the core temperature is raised for a period of from one-half to three hours. 16. The method of claim 10, 11, or 12, wherein the core temperature is raised for a period of from one to two hours. 17. The method of claim 10, 11, or 12, wherein the core temperature is raised for a period of from 80 to 100 minutes. 18. The method of claim 1, 4, or 8, wherein the patient's viral load of HCV is determined at least once before the core temperature has been raised said at least one time. 19. The method of claim 1, 4, or 8, wherein the patient's viral load of HCV is determined at least two different times after the core temperature has been raised and returned to normal said at least one time. 20. The method of claim 1, 4, or 8, wherein the patient's viral load of HCV is reduced by 50 percent or more three months after the core temperature has been raised and returned to normal said at least one time. 21. The method of claim 1, 4, or 8, wherein the patient's viral load of HCV is reduced by 75 percent or more three months after the core temperature has been raised and returned to normal said at least one time. 22. The method of claim 1, 4, or 8, wherein the patient's viral load of HCV is reduced by 90 percent or more three months after the core temperature has been raised and returned to normal said at least one time. 23. The method of claim 1, 4, or 8, wherein the patient's viral load of HCV is reduced by 95 percent or more three months after the core temperature has been raised and returned to normal said at least one time. 24. The method of claim 1, further comprising treating the patient with a pharmaceutical indicated for hepatitis C. 25. The method of claim 24, wherein the patient is treated with a single pharmaceutical indicated for treating hepatitis C. 26. The method of claim 24, wherein the patient is treated with two or more pharmaceuticals indicated for treating hepatitis C. 27. The method of claim 24, wherein the pharmaceutical is administered before raising the core temperature of the patient said at least one time. 28. The method of claim 24, wherein the pharmaceutical is administered while the core temperature of the patient is raised. 29. The method of claim 24, wherein the pharmaceutical is administered after the core temperature of the patient has been raised and returned to normal said at least one time. 30. The method of claim 24, wherein the pharmaceutical is administered: (i) before raising the core temperature of the patient said at least one time; (ii) while the core temperature of the patient is raised; (iii) after the core temperature of the patient has been raised and returned to normal said at least one time; or (iv) combinations thereof. 31. The method of claim 24, wherein the pharmaceutical is administered before raising the core temperature of the patient said at least one time, while the core temperature of the patient is raised, and after the core temperature of the patient has been raised and returned to normal said at least one time. 32. The method of claim 24, wherein the pharmaceutical is selected from interferons, protease inhibitors, cytokines, or any combination of antiviral drugs. 33. The method of claim 24, wherein the pharmaceutical is selected from ribavirin, lamivudine, interferon alfacon-1, interferon alfa-2a, interferon alfa-2b, interferon-alfa-n1, thymosin alpha-1, interleukin-2, interferon alpha-n3, ketoprofen, interferon beta-1a, interferon gamma-1b, interleukin-12, histamine dihydrochloride, thymalfasin, zidovudine, didanosine, zalcitabine, stavudine, abacavar, nevirapine, delaviridine, efavirenz, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, or combinations thereof. 34. The method of claim 24, wherein the pharmaceutical is selected from an interferon, ribavirin, or lamivudine. 35. The method of claim 24, wherein the pharmaceutical is an alpha interferon. 36. The method of claim 1, 4, or 8, wherein the patient has an acute HCV infection. 37. The method of claim 1, 4, or 8, wherein the patient has a chronic HCV infection. 38. The method of claim 1, 4, or 8, wherein the patient is co-infected with a pathogen. 39. The method of claim 38, wherein the pathogen is a virus. 40. The method of claim 39, wherein the virus is a heat labile virus. 41. The method of claim 40, wherein the heat labile virus is selected from herpesviruses, hepadnaviruses, togaviruses, flaviviruses, coronaviruses, rhabdoviruses, filoviruses, paramyxoviruses, othomyxoviruses, bunyaviruses, arenaviruses, or retroviruses. 42. The method of claim 40, wherein the heat labile virus is selected from HIV, hepatitis B virus, Ebstein-Barr virus, cytomegalovirus, or varicella-zoster virus. 43. The method of claim 38, wherein the pathogen is a spirochete or bacterium. 44. The method of claim 43, wherein the pathogen is a spirochete selected from the genus treponema, borrelia, or leptospira. 45. The method of claim 43, wherein the pathogen is a spirochete selected from Treponema pallidum, Treponema pertenue, Treponema carateum, Treponema pallidum endemicum, Borrelia burgdorferi, Borrelia hermsii, or Leptospira interrogans. 46. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce the patient's viral load of HCV to less than the sensitivity level of a branched DNA signal amplification test three months after the core temperature has been raised and returned to normal said at least one time, and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time. 47. The method of claim 46, wherein the core temperature is raised by circulating the patient's blood from the patient, through an extracorporeal blood flow circuit, and back to the patient, wherein the blood returned to the patient has been heated within the blood flow circuit to an elevated temperature range. 48. The method of claim 46, wherein the core temperature is raised by inserting a heating element into the patient and wherein the heating element heats the patient's blood. 49. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce the patient's viral load of HCV is reduced to less than the sensitivity level of a reverse transcriptase-polymerase chain reaction test three months after the core temperature has been raised and returned to normal said at least one time, and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time. 50. The method of claim 49, wherein the core temperature is raised by circulating the patient's blood from the patient, through an extracorporeal blood flow circuit, and back to the patient, wherein the blood returned to the patient has been heated within the blood flow circuit to an elevated temperature range. 51. The method of claim 49, wherein the core temperature is raised by inserting a heating element into the patient and wherein the heating element heats the patient's blood. 52. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce the patient's viral load of HCV by 30 percent or more one month after the core temperature has been raised and returned to normal said at least one time, and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time. 53. The method of claim 52, wherein the core temperature is raised by circulating the patient's blood from the patient, through an extracorporeal blood flow circuit, and back to the patient, wherein the blood returned to the patient has been heated within the blood flow circuit to an elevated temperature range. 54. The method of claim 52, wherein the core temperature is raised by inserting a heating element into the patient and wherein the heating element heats the patient's blood. 55. The method of claim 52, 53, or 54, wherein the patient's viral load of HCV is reduced by 50 percent or more one month after the core temperature has been raised and returned to normal said at least one time. 56. The method of claim 52, 53, or 54, wherein the patient's viral load of HCV is reduced by 75 percent or more one month after the core temperature has been raised and returned to normal said at least one time. 57. The method of claim 52, 53, or 54, wherein the patient's viral load of HCV is reduced by 90 percent or more one month after the core temperature has been raised and returned to normal said at least one time. 58. The method of claim 52, 53, or 54, wherein the patient's viral load of HCV is reduced by 95 percent or more one month after the core temperature has been raised and returned to normal said at least one time. 59. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce the patient's viral load of HCV to less than the sensitivity level of a branched DNA signal amplification test one month after the core temperature has been raised and returned to normal said at least one times and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time. 60. The method of claim 54, wherein the core temperature is raised by circulating the patient's blood from the patient, through an extracorporeal blood flow circuit, and back to the patient, wherein the blood returned to the patient has been heated within the blood flow circuit to an elevated temperature range. 61. The method of claim 54, wherein the core temperature is raised by inserting a heating element into the patient and wherein the heating element heats the patient's blood. 62. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce the patient's viral load of HCV to less than the sensitivity level of a reverse transcriptase-polymerase chain reaction test one month after the core temperature has been raised and returned to normal said at least one time, and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time. 63. The method of claim 62, wherein the core temperature is raised by circulating the patient's blood from the patient, through an extracorporeal blood flow circuit, and back to the patient, wherein the blood returned to the patient has been heated within the blood flow circuit to an elevated temperature range. 64. The method of claim 62, wherein the core temperature is raised by inserting a heating element into the patient and wherein the heating element heats the patient's blood. 65. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce the patient's viral load of HCV by 30 percent or more three months after the core temperature has been raised and returned to normal said at least one time, wherein the patient is co-infected with HIV, and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time. 66. The method of claim 65, wherein the core temperature of the patient is raised and returned to normal one time. 67. The method of claim 65, wherein the core temperature of the patient is raised and returned to normal two or more times. 68. The method of claim 65, wherein the core temperature is raised to a temperature range of from 38 to 44.degree. C. 69. The method of claim 65, wherein the core temperature is raised to a temperature range of from 41.8 to 42.2.degree. C. 70. The method of claim 65, wherein the core temperature is raised by circulating the patient's blood from the patient, through an extracorporeal blood flow circuit, and back to the patient, wherein the blood returned to the patient has been heated within the blood flow circuit to an elevated temperature range. 71. The method of claim 70, wherein the patient's blood is circulated from the patient through a blood vessel and returned to the patient through a blood vessel. 72. The method of claim 70, wherein the patient's blood is circulated from the patient through a vein and returned to the patient through a vein. 73. The method of claim 70, wherein the patient's blood is circulated from the patient through an artery and returned to the patient through a vein. 74. The method of claim 65, wherein the core temperature is raised by inserting a heating element into the patient and wherein the heating element heats the patient's blood. 75. The method of claim 74, wherein the heating element is inserted into a blood vessel of the patient. 76. The method of claim 65, 70, or 74, wherein the patient's viral load of HCV is determined at least once before the core temperature has been raised said at least one time. 77. The method of claim 65, 70, or 74, wherein the patient's viral load of HCV is determined at least two different times after the core temperature has been raised and returned to normal said at least one time. 78. The method of claim 65, 70, or 74, wherein the patient's viral load of HCV is reduced by 50 percent or more three months after the core temperature has been raised and returned to normal said at least one time. 79. The method of claim 65, 70, or 74, wherein the patient's viral load of HCV is reduced by 75 percent or more three months after the core temperature has been raised and returned to normal said at least one time. 80. The method of claim 65, 70, or 74, wherein the patient's viral load of HCV is reduced by 90 percent or more three months after the core temperature has been raised and returned to normal said at least one time. 81. The method of claim 65, 70, or 74, wherein the patient's viral load of HCV is reduced by 95 percent or more three months after the core temperature has been raised and returned to normal said at least one time. 82. The method of claim 65, wherein the core temperature is raised to a temperature range of from 38 to 48.degree. C. 83. The method of claim 82, wherein the core temperature is measured rectally. 84. The method of claim 82, 68, or 69, wherein the core temperature is raised for a period of from 2 minutes to sixteen hours. 85. The method of claim 82, 68, or 69, wherein the core temperature is raised for a period of from one-half to three hours. 86. The method of claim 82, 68, or 69, wherein the core temperature is raised for a period of from one to two hours. 87. The method of claim 82, 68, or 69, wherein the core temperature is raised for a period of from 80 to 100 minutes. 88. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce the patient's viral load of HCV to less than the sensitivity level of a branched DNA signal amplification test three months after the core temperature has been raised and returned to normal said at least one time, wherein the patient is co-infected with HIV, and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time. 89. The method of claim 88, wherein the core temperature is raised by circulating the patient's blood from the patient, through an extracorporeal blood flow circuit, and back to the patient, wherein the blood returned to the patient has been heated within the blood flow circuit to an elevated temperature range. 90. The method of claim 88, wherein the core temperature is raised by inserting a heating element into the patient and wherein the heating element heats the patient's blood. 91. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce the patient's viral load of HCV to less than the sensitivity level of a reverse transcriptase-polymerase chain reaction test three months after the core temperature has been raised and returned to normal said at least one time, wherein the patient is co-infected with HIV, and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time. 92. The method of claim 91, wherein the core temperature is raised by circulating the patient's blood from the patient, through an extracorporeal blood flow circuit, and back to the patient, wherein the blood returned to the patient has been heated within the blood flow circuit to an elevated temperature range. 93. The method of claim 91, wherein the core temperature is raised by inserting a heating element into the patient and wherein the heating element heats the patient's blood. 94. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce the patient's viral load of HCV by 30 percent or more one month after the core temperature has been raised and returned to normal said at least one time, wherein the patient is co-infected with HIV, and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time. 95. The method of claim 94, wherein the core temperature is raised by circulating the patient's blood from the patient, through an extracorporeal blood flow circuit, and back to the patient, wherein the blood returned to the patient has been heated within the blood flow circuit to an elevated temperature range. 96. The method of claim 94, wherein the core temperature is raised by inserting a heating element into the patient and wherein the heating element heats the patient's blood. 97. The method of claim 94, 95, or 96, wherein the patient's viral load of HCV is reduced by 50 percent or more one month after the core temperature has been raised and returned to normal said at least one time. 98. The method of claim 94, 95, or 96, wherein the patient's viral load of HCV is reduced by 75 percent or more one month after the core temperature has been raised and returned to normal said at least one time. 99. The method of claim 94, 95, or 96, wherein the patient's viral load of HCV is reduced by 90 percent or more one month after the core temperature has been raised and returned to normal said at least one time. 100. The method of claim 94, 95, or 96, wherein the patient's viral load of HCV is reduced by 95 percent or more one month after the core temperature has been raised and returned to normal said at least one time. 101. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce the patient's viral load of HCV to less than the sensitivity level of a branched DNA signal amplification test one month after the core temperature has been raised and returned to normal said at least one time, wherein the patient is co-infected with HIV, and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time. 102. The method of claim 101, wherein the core temperature is raised by circulating the patient's blood from the patient, through an extracorporeal blood flow circuit, and back to the patient, wherein the blood returned to the patient has been heated within the blood flow circuit to an elevated temperature range. 103. The method of claim 101, wherein the core temperature is raised by inserting a heating element into the patient and wherein the heating element heats the patient's blood. 104. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce the patient's viral load of HCV to less than the sensitivity level of a reverse transcriptase-polymerase chain reaction test one month after the core temperature has been raised and returned to normal said at least one time, wherein the patient is co-infected with HIV, and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time. 105. The method of claim 104, wherein the core temperature is raised by circulating the patient's blood from the patient, through an extracorporeal blood flow circuit, and back to the patient, wherein the blood returned to the patient has been heated within the blood flow circuit to an elevated temperature range. 106. The method of claim 104, wherein the core temperature is raised by inserting a heating element into the patient and wherein the heating element heats the patient's blood. 107. A method for treating a patient infected with hepatitis C virus (HCV) comprising raising the core temperature of the patient and then returning the core temperature of the patient to normal at least one time, wherein the core temperature is raised to a temperature range and a duration sufficient to reduce or eliminate the patient's viral load of HCV, further comprising treating the patient with a pharmaceutical indicated for hepatitis C, wherein the pharmaceutical is administered before raising the core temperature of the patient said at least one time, while the core temperature of the patient is raised, and after the core temperature of the patient has been raised and returned to normal said at least one time, and wherein the patient's viral load of HCV is determined at least once after the core temperature has been raised and returned to normal said at least one time.

Details for Patent 6,347,633

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132	06/04/1986		2039-02-26
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2039-02-26
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2039-02-26
Biogen Inc.	AVONEX	interferon beta-1a	For Injection	103628	05/17/1996		2039-02-26
Biogen Inc.	AVONEX	interferon beta-1a	Injection	103628	05/28/2003		2039-02-26
Biogen Inc.	AVONEX	interferon beta-1a	Injection	103628	02/27/2012		2039-02-26