HRP20110637T1 - Metoda liječenja pacijenata sa hepatitisom c - Google Patents

Metoda liječenja pacijenata sa hepatitisom c Download PDF

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HRP20110637T1
HRP20110637T1 HR20110637T HRP20110637T HRP20110637T1 HR P20110637 T1 HRP20110637 T1 HR P20110637T1 HR 20110637 T HR20110637 T HR 20110637T HR P20110637 T HRP20110637 T HR P20110637T HR P20110637 T1 HRP20110637 T1 HR P20110637T1
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K. Albrecht Janice
A. Brass Clifford
Orville Ii Ralston Robert
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Schering Corporation
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4965Non-condensed pyrazines
    • A61K31/497Non-condensed pyrazines containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • A61K38/212IFN-alpha
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/20Antivirals for DNA viruses
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/576Immunoassay; Biospecific binding assay; Materials therefor for hepatitis
    • G01N33/5767Immunoassay; Biospecific binding assay; Materials therefor for hepatitis non-A, non-B hepatitis
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/52Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract

Kompozicija koja sadrži najmanje jedan spoj - inhibitor HCV proteaze, naznačena time, što je izabran između spojeva koja imaju formulu: ii izomera spomenutih spojeva, za primjenu u metodi liječenja pacijenta koji ima hepatitis C infekciju, a koji nije prethodno liječen ili koji je recidivirao iz negativnog HCV statusa i onda je bio liječen ribavirinom i interferonom tokom uvodnog perioda, pri čemu ova metoda sadrži korak (i) na kraju spomenutog uvodnog perioda davanje kombinacije ribavirina, interferona i spoja - inhibitora HCV proteaze tokom drugog perioda liječenja koji ima dovoljno dugo trajanje da se ostvari prisustvo virusa koje se ne može detektirati primjenom HCV-RNK testa. Patent sadrži još 19 patentnih zahtjeva.

Claims (20)

1. Kompozicija koja sadrži najmanje jedan spoj - inhibitor HCV proteaze, naznačena time, što je izabran između spojeva koja imaju formulu: [image] [image] [image] [image] [image] [image] i [image] i izomera spomenutih spojeva, za primjenu u metodi liječenja pacijenta koji ima hepatitis C infekciju, a koji nije prethodno liječen ili koji je recidivirao iz negativnog HCV statusa i onda je bio liječen ribavirinom i interferonom tokom uvodnog perioda, pri čemu ova metoda sadrži korak (i) na kraju spomenutog uvodnog perioda davanje kombinacije ribavirina, interferona i spoja - inhibitora HCV proteaze tokom drugog perioda liječenja koji ima dovoljno dugo trajanje da se ostvari prisustvo virusa koje se ne može detektirati primjenom HCV-RNK testa.
2. Kompozicija koja sadrži interferon, naznačena time što se koristi za primjenu u metodi liječenja pacijenta koji ima hepatitis C infekciju, a koji nije prethodno liječen ili koji je recidivirao iz negativnog HCV statusa i onda je bio liječen ribavirinom i interferonom tokom uvodnog perioda, pri čemu ova metoda sadrži korake (a) davanje kombinacije ribavirina i interferona tokom uvodnog perioda; (b) na kraju spomenutog uvodnog perioda davanje kombinacije ribavirina, interferona i najmanje jednog spoja - inhibitora HCV proteaze tokom drugog perioda liječenja koji traje dovoljno dugo da se ostvari prisustvo virusa koje se ne može detektirati primjenom HCV-RNK testa, pri čemu je spoj - inhibitor HCV proteaze izabran između spojeva koji imaju formulu: [image] [image] [image] [image] [image] [image] i [image] i izomera spomenutih spojeva.
3. Kompozicija za primjenu prema bilo kojem od zahtjeva 1-2, naznačena time što je interferon koji se daje tokom uvodnog perioda i/ili drugog perioda liječenja pegilirani interferon alfa ili fuzija između humanog serumskog albumina i interferona alfa.
4. Kompozicija za primjenu prema zahtjevu 3, naznačena time, što je interferon koji se daje tokom uvodnog perioda i/ili drugog perioda liječenja peginterferon alfa-2b i količina koja se daje je od 0,5 mikrograma/kg tjelesne težine pacijenta do 1,5 mikrograma/kg tjelesne težine pacijenta po rasporedu davanja jednom tjedno.
5. Kompozicija za primjenu prema bilo kojem od prethodnih zahtjeva, naznačena time što je spoj - inhibitor HCV proteaze spoj Formule Ia (boceprevir).
6. Kompozicija za primjenu prema zahtjevu 5, naznačena time što je količina boceprevira koja se daje 800 mg u intervalima od 7 sati do 9 sati.
7. Kompozicija za primjenu prema bilo kojem od prethodnih zahtjeva, naznačena time, što je spoj - inhibitor HCV proteaze spoj Formule III.
8. Kompozicija za primjenu prema bilo kojem od zahtjeva 1 do 7, naznačena time što je količina ribavirina koja se daje od 10 mg/kg tjelesne težine pacijenta do 20 mg/kg tjelesne težine pacijenta dnevno.
9. Kompozicija za primjenu prema zahtjevu 8, naznačena time što je količina ribavirina koja se daje i tokom uvodnog perioda, i tokom drugog perioda liječenja 16 mg/kg tjelesne težine pacijenta podijeljena na dva dijela koja se daju u razmaku od 12 sati.
10. Kompozicija za primjenu prema bilo kojem od zahtjeva 1 do 9, naznačena time što čemu uvodni period traje od 2 tjedna do 17 tjedena.
11. Kompozicija za primjenu prema zahtjevu 10, naznačena time što uvodni period traje četiri tjedna.
12. Kompozicija za primjenu prema zahtjevu 11, naznačena time što drugi period liječenja traje od 12 tjedna do 28 tjedana.
13. Kompozicija za primjenu prema zahtjevu 10, naznačena time što drugi period liječenja traje dovoljno dugo da se ostvari trajni virološki odgovor.
14. Kompozicija za primjenu prema bilo kojem od zahtjeva 1 do 13, naznačena time što pacijent nije prethodno liječen.
15. Kompozicija za primjenu prema bilo kojem od zahtjeva 1 do 13, naznačena time što pacijent nije reagirao na prethodno liječenje interferonom alfa i ribavirinom.
16. Kompozicija za primjenu prema bilo kojem od zahtjeva 1 do 13, naznačena time što je pacijent recidivirao poslije prethodnog tretmana interferonom alfa i ribavirinom.
17. Kompozicija za primjenu prema bilo kojem od zahtjeva 1 do 16, naznačen time što je pacijent inficiran genotipom 1 HCV.
18. Kompozicija za primjenu prema bilo kojem od zahtjeva 1-2, naznačena time što je spoj - inhibitor HCV proteaze spoj Formule Ia (boceprevir) i količina koja se daje je 800 mg u intervalima od 7 sati do 9 sati, a interferon je peginterferon alfa-2b i količina koja se daje je 1,5 mikrograma/kg tjelesne težine pacijenta po rasporedu davanja jednom tjedno i količina ribavirina koja se daje je 16 mg/kg tjelesne težine pacijenta dnevno podijeljena u dva dijela koja se daju u razmaku od 12 sati.
19. Kompozicija za primjenu prema bilo kojem od zahtjeva 1 do 18, naznačena time što je na kraju uvodnog perioda kod pacijenta došlo do pada virusnog opterećenja od 2 log ili većeg.
20. Kompozicija za primjenu prema zahtjevu 18, naznačena time što je prije uvodnog perioda pacijent imao virusno opterećenje >600.000 IU/mL HCV.
HR20110637T 2007-09-14 2011-09-07 Metoda liječenja pacijenata sa hepatitisom c HRP20110637T1 (hr)

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US99375307P 2007-09-14 2007-09-14
US99876207P 2007-10-12 2007-10-12
US149407P 2007-10-30 2007-10-30
PCT/US2008/010626 WO2009038663A1 (en) 2007-09-14 2008-09-11 Method of treating hepatitis c patients

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US (1) US20100226885A1 (hr)
EP (2) EP2061513B1 (hr)
JP (1) JP2010539165A (hr)
CN (1) CN101883590A (hr)
AT (1) ATE519503T1 (hr)
AU (1) AU2008301981A1 (hr)
CA (1) CA2699280A1 (hr)
CY (1) CY1112116T1 (hr)
DK (1) DK2061513T3 (hr)
ES (1) ES2369321T3 (hr)
HK (1) HK1129315A1 (hr)
HR (1) HRP20110637T1 (hr)
MX (1) MX2010002909A (hr)
NZ (1) NZ583825A (hr)
PL (1) PL2061513T3 (hr)
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US8841275B2 (en) 2010-11-30 2014-09-23 Gilead Pharmasset Llc 2′-spiro-nucleosides and derivatives thereof useful for treating hepatitis C virus and dengue virus infections
EP2704570A4 (en) * 2011-05-04 2015-02-18 Merck Sharp & Dohme ACTIVE SUBSTANCES, PHARMACEUTICAL COMPOSITIONS AND METHOD FOR THE PRODUCTION THEREOF
SI2709613T2 (sl) 2011-09-16 2020-12-31 Gilead Pharmasset LLC c/o Gilead Sciences, Inc. Postopki za zdravljenje HCV
GB2506086A (en) 2011-10-21 2014-03-19 Abbvie Inc Methods for treating HCV comprising at least two direct acting antiviral agent, ribavirin but not interferon
CA2811250C (en) 2011-10-21 2015-08-11 Abbvie Inc. Methods for treating hcv
US8466159B2 (en) 2011-10-21 2013-06-18 Abbvie Inc. Methods for treating HCV
US8492386B2 (en) 2011-10-21 2013-07-23 Abbvie Inc. Methods for treating HCV
AU2012332827A1 (en) 2011-10-31 2014-05-15 Gilead Pharmasset Llc Methods and compositions for treating hepatitis C virus
AU2012346217B2 (en) * 2011-11-29 2016-02-04 Gilead Pharmasset Llc Compositions and methods for treating hepatitis C virus
US8889159B2 (en) 2011-11-29 2014-11-18 Gilead Pharmasset Llc Compositions and methods for treating hepatitis C virus
WO2013116592A1 (en) 2012-02-01 2013-08-08 Kadmon Pharmaceuticals, Llc Once daily treatment of hepatitis c with ribavirin and taribavirin
SG11201506021XA (en) 2013-01-31 2015-08-28 Gilead Pharmasset Llc Combination formulation of two antiviral compounds
US11192914B2 (en) 2016-04-28 2021-12-07 Emory University Alkyne containing nucleotide and nucleoside therapeutic compositions and uses related thereto

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WO2000037110A2 (en) * 1998-12-18 2000-06-29 Schering Corporation Ribavirin-pegylated interferon alfa induction hcv combination therapy
US6824768B2 (en) * 1998-12-18 2004-11-30 Schering Corporation Ribavirin-pegylated interferon alfa induction HCV combination therapy
WO2000051631A2 (en) * 1999-03-02 2000-09-08 Schering Corporation Pegylated alpha interferon for hiv therapy
PL206255B1 (pl) * 2000-07-21 2010-07-30 Dendreon Corporationdendreon Corporation Inhibitor proteazy wirusa zapalenia wątroby C, zawierająca go kompozycja farmaceutyczna i zastosowanie inhibitora do wytwarzania leku do leczenia chorób związanych z HCV oraz zastosowanie do wytwarzania kompozycji do stosowania w kombinowanej terapii
SV2003000617A (es) 2000-08-31 2003-01-13 Lilly Co Eli Inhibidores de la proteasa peptidomimetica ref. x-14912m
PT1730110E (pt) 2004-02-27 2010-09-14 Schering Corp Compostos de enxofre como inibidores de serina-protease ns3 do vírus da hepatite c
WO2006016930A2 (en) * 2004-05-14 2006-02-16 Intermune, Inc. Methods for treating hcv infection
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AU2009256623A1 (en) * 2008-06-10 2009-12-17 Janssen Pharmaceutica Nv Telaprevir dosing regimen

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ATE519503T1 (de) 2011-08-15
EP2489369A1 (en) 2012-08-22
AU2008301981A1 (en) 2009-03-26
PT2061513E (pt) 2011-10-17
US20100226885A1 (en) 2010-09-09
CA2699280A1 (en) 2009-03-26
EP2061513B1 (en) 2011-08-10
PL2061513T3 (pl) 2011-12-30
CY1112116T1 (el) 2015-11-04
MX2010002909A (es) 2010-03-30
SI2061513T1 (sl) 2011-11-30
DK2061513T3 (da) 2011-11-21
HK1129315A1 (en) 2009-11-27
ES2369321T3 (es) 2011-11-29
JP2010539165A (ja) 2010-12-16
WO2009038663A1 (en) 2009-03-26
CN101883590A (zh) 2010-11-10
EP2061513A1 (en) 2009-05-27
NZ583825A (en) 2012-06-29

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