Immunotherapy for chronic hepatitis C virus infection
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IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-039/29
A61K-045/00
C12N-001/00
C12N-001/19
출원번호
US-0119760
(2009-09-18)
등록번호
US-8728489
(2014-05-20)
국제출원번호
PCT/US2009/057535
(2009-09-18)
§371/§102 date
20110630
(20110630)
국제공개번호
WO2010/033841
(2010-03-25)
발명자
/ 주소
Apelian, David
Duke, Richard C.
Franzusoff, Alex
출원인 / 주소
GlobeImmune, Inc.
대리인 / 주소
Sheridan Ross P.C.
인용정보
피인용 횟수 :
0인용 특허 :
50
초록▼
Disclosed are uses of immunotherapeutic compositions in combination with Standard of Care (SOC), or interferon therapy combined with anti-viral therapy, for the improved treatment of chronic hepatitis C virus (HCV) infection and related conditions, including liver function. The compositions, kits an
Disclosed are uses of immunotherapeutic compositions in combination with Standard of Care (SOC), or interferon therapy combined with anti-viral therapy, for the improved treatment of chronic hepatitis C virus (HCV) infection and related conditions, including liver function. The compositions, kits and uses of the invention, as compared to the use of SOC therapy alone: improves the rate of early response to therapy as measured by early virologic markers (e.g., RVR and EVR), enlarges the pool of patients who will have sustained responses to therapy over the long term, offers shortened courses of therapy for certain patients, enables “rescue” of patients who are non-responders or intolerant to SOC therapy, improves liver function and/or reduces liver damage in patients, and enables the personalization of HCV therapy for a patient, which can result in dose sparing, improved patient compliance, reduced side effects, and improved long term therapeutic outcomes.
대표청구항▼
1. A method to increase the frequency of rapid virologic responses (RVR) and/or early virologic responses (EVR/cEVR) in a population of subjects chronically infected with hepatitis C virus (HCV), as compared to RVR and EVR/cEVR in a population of subjects chronically infected with HCV and treated on
1. A method to increase the frequency of rapid virologic responses (RVR) and/or early virologic responses (EVR/cEVR) in a population of subjects chronically infected with hepatitis C virus (HCV), as compared to RVR and EVR/cEVR in a population of subjects chronically infected with HCV and treated only with combination interferon and anti-viral therapy, the method comprising administering to the population of subjects an immunotherapeutic composition comprising a yeast vehicle expressing at least one HCV antigen or immunogenic domain thereof that elicits a T cell-mediated immune response against one or more HCV antigens in combination with interferon and an anti-viral compound. 2. The method of claim 1, wherein the immunotherapeutic composition is first administered at least 12 weeks prior to the first administration of the combination of interferon and the anti-viral compound. 3. A method to increase the number of complete responders in a population of subjects chronically infected with hepatitis C virus (HCV), as compared to the number of complete responders in a population of subjects chronically infected with HCV that is treated only with interferon and anti-viral therapy, the method comprising administering to the population of subjects an immunotherapeutic composition comprising a yeast vehicle expressing at least one HCV antigen or immunogenic domain thereof that elicits a T cell-mediated immune response against one or more HCV antigens in combination with interferon and an anti-viral compound. 4. The method of claim 3, wherein the immunotherapeutic composition is first administered at least 12 weeks prior to the first administration of the combination of interferon and the anti-viral compound. 5. A method to treat a subject who is chronically infected with HCV, comprising: a) administering an immunotherapeutic composition comprising a yeast vehicle expressing at least one HCV antigen or immunogenic domain thereof that elicits a T cell-mediated immune response against one or more HCV antigens to the subject for at least 4 to 12 weeks, followed by administering interferon and anti-viral concurrently with continued administration of the immunotherapeutic composition;b) determining the rapid virologic response (RVR) of the subject at about 4 weeks after the first administration of interferon and anti-viral compound; andc) reducing the dosage and/or frequency of one or both of the interferon or anti-viral compound in subjects with an RVR that is statistically significantly greater or strongly trending toward greater than the expected RVR of a subject treated with a combination of interferon and the anti-viral compound alone. 6. A method to continue treatment of a chronically HCV-infected subject who is predicted to fail combination interferon-anti-viral compound therapy, comprising administering to the subject an immunotherapeutic composition comprising a yeast vehicle expressing at least one HCV antigen or immunogenic domain thereof that elicits a T cell-mediated immune response against one or more HCV antigens. 7. The method of claim 6, wherein the subject continues receiving combination interferon-anti-viral compound therapy during the period of time in which the immunotherapeutic composition is administered. 8. A method to treat chronic hepatitis C virus (HCV) infection, comprising administering to a subject who is naïve to any prior interferon-based treatment for HCV an immunotherapeutic composition comprising a yeast vehicle expressing at least one HCV antigen or immunogenic domain thereof, and further administering to the subject one or both of at least one interferon and at least one anti-viral compound; wherein the immunotherapeutic composition elicits a T cell-mediated immune response against one or more HCV antigens; andwherein the interferon and anti-viral compound are first administered at least 4 weeks after the immunotherapeutic composition is first administered. 9. The method of claim 8, wherein additional doses of the immunotherapeutic composition are administered during the same period as the administration of the interferon and the anti-viral compound. 10. The method of claim 8, wherein the immunotherapeutic composition is administered weekly for five weeks, followed by monthly administration. 11. The method of claim 8, wherein the subject is naïve to any prior interferon-based treatment for HCV and has a high viral titer at baseline (>600,000 IU/ml HCV RNA levels). 12. The method of claim 8, wherein the interferon is pegylated interferon-α. 13. The method of claim 8, wherein the anti-viral compound is ribavirin or a functional analog thereof. 14. The method of claim 8, wherein the anti-viral compound is an NS3 protease inhibitor. 15. The method of claim 8, wherein the method decreases liver damage in the subject. 16. The method of claim 8, wherein the yeast vehicle is a whole yeast. 17. The method of claim 8, wherein the yeast vehicle is from Saccharomyces. 18. The method of claim 8, wherein the immunotherapeutic composition comprises an HCV NS3-Core fusion protein comprising HCV sequences, wherein the HCV sequences consist of an HCV NS3 protease sequence or at least one immunogenic domain thereof linked to an HCV Core sequence or at least one immunogenic domain thereof, wherein the HCV NS3 protease sequence lacks the catalytic domain of a natural HCV NS3 protease, wherein the composition elicits an HCV NS3-specific immune response and an HCV Core-specific immune response. 19. The method of claim 18, wherein the fusion protein consists of SEQ ID NO:2.
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이 특허에 인용된 특허 (50)
Paliard, Xavier; Houghton, Michael; Selby, Mark, Activation of HCV-specific T cells.
Houghton Michael (Danville CA) Choo Qui-Lim (El Cerrito CA) Kuo George (San Francisco CA), Combinations of hepatitis C virus (HCV) antigens for use in immunoassays for anti-HCV antibodies.
Sablon,Erwin; Van Broekhoven,Annie; Bosman,Fons; Depla,Erik; Deschamps,Geert, Constructs and methods for expression of recombinant HCV envelope proteins.
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