WO2000037110A3 - Ribavirin-pegylated interferon alfa induction hcv combination therapy - Google Patents

Ribavirin-pegylated interferon alfa induction hcv combination therapy Download PDF

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Publication number
WO2000037110A3
WO2000037110A3 PCT/US1999/027935 US9927935W WO0037110A3 WO 2000037110 A3 WO2000037110 A3 WO 2000037110A3 US 9927935 W US9927935 W US 9927935W WO 0037110 A3 WO0037110 A3 WO 0037110A3
Authority
WO
WIPO (PCT)
Prior art keywords
ribavirin
pegylated interferon
treatment time
effective amount
rna
Prior art date
Application number
PCT/US1999/027935
Other languages
French (fr)
Other versions
WO2000037110A2 (en
Inventor
Paul W Glue
Janice K Albrecht
Original Assignee
Schering Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Schering Corp filed Critical Schering Corp
Priority to JP2000589220A priority Critical patent/JP2003507322A/en
Priority to AU21570/00A priority patent/AU2157000A/en
Priority to EP99965894A priority patent/EP1140143A2/en
Priority to CA002354536A priority patent/CA2354536A1/en
Publication of WO2000037110A2 publication Critical patent/WO2000037110A2/en
Publication of WO2000037110A3 publication Critical patent/WO2000037110A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A61K38/212—IFN-alpha
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Virology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Communicable Diseases (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The use of ribavirin and interferon alpha for the manufacture of pharmaceutical compositions for treating a patient having chronic hepatitis C infection, e.g., a patient having HCV genotype 1, 2 or 3, to eradicate detectable HCV-RNA by a method comprising administering an effective amount of ribavirin in association with an effective amount of pegylated interferon alpha, characterised in that treating patients having chronic hepatitis C infections is effected in two treatment time periods: (a) a first treatment time period of at least 20 to 30 wherein a therapeutically effective amount of ribavirin and a therapeutically effective induction dosing amount of pegylated interferon-alfa, e.g., pegylated interferon-alfa-2b sufficient to at least substantially lower, and preferably to eradicate, detectable HCV-RNA, are administered; and (b) a second treatment time period of at least 20 to 30 weeks wherein a therapeutically effective amount of ribavirin and a therapeutically effective amount of pegylated interferon-alfa are administered sufficient to maintian no detectable HCV-RNA for at least 20-30 weeks are administered after the end of the first treatment time period and to maintain no detectable HCV-RNA for at least 24 weeks after the end of the second treatment time period is disclosed.
PCT/US1999/027935 1998-12-18 1999-12-16 Ribavirin-pegylated interferon alfa induction hcv combination therapy WO2000037110A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2000589220A JP2003507322A (en) 1998-12-18 1999-12-16 Ribavirin-PEGylated interferon-α-induced HCV combination therapy
AU21570/00A AU2157000A (en) 1998-12-18 1999-12-16 Ribavirin-pegylated interferon alfa induction hcv combination therapy
EP99965894A EP1140143A2 (en) 1998-12-18 1999-12-16 Ribavirin-pegylated interferon alfa induction hcv combination therapy
CA002354536A CA2354536A1 (en) 1998-12-18 1999-12-16 Ribavirin-pegylated interferon alfa induction hcv combination therapy

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US21587698A 1998-12-18 1998-12-18
US09/215,876 1998-12-18

Publications (2)

Publication Number Publication Date
WO2000037110A2 WO2000037110A2 (en) 2000-06-29
WO2000037110A3 true WO2000037110A3 (en) 2000-09-14

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/027935 WO2000037110A2 (en) 1998-12-18 1999-12-16 Ribavirin-pegylated interferon alfa induction hcv combination therapy

Country Status (7)

Country Link
EP (1) EP1140143A2 (en)
JP (1) JP2003507322A (en)
AR (1) AR021876A1 (en)
AU (1) AU2157000A (en)
CA (1) CA2354536A1 (en)
PE (1) PE20001369A1 (en)
WO (1) WO2000037110A2 (en)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7365057B2 (en) 2002-06-28 2008-04-29 Idenix Pharmaceuticals, Inc. Modified 2′ and 3′-nucleoside prodrugs for treating Flavivridae infections
US7625875B2 (en) 2002-06-28 2009-12-01 Idenix Pharmaceuticals, Inc. 2′ and 3′-nucleoside prodrugs for treating Flaviviridae infections
US7824851B2 (en) 2002-11-15 2010-11-02 Idenix Pharmaceuticals, Inc. 2′-branched nucleosides and Flaviviridae mutation
US8481713B2 (en) 2004-07-21 2013-07-09 Gilead Pharmasset Llc Preparation of alkyl-substituted 2-deoxy-2-fluoro-D-ribofuranosyl pyrimidines and purines and their derivatives
US8492539B2 (en) 2004-09-14 2013-07-23 Gilead Pharmasset Llc Preparation of 2′-fluoro-2′-alkyl-substituted or other optionally substituted ribofuranosyl pyrimidines and purines and their derivatives
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
US8957046B2 (en) 2007-03-30 2015-02-17 Gilead Pharmasset Llc Nucleoside phosphoramidate prodrugs
US9045520B2 (en) 2008-12-23 2015-06-02 Gilead Pharmasset Llc Synthesis of purine nucleosides
US9393256B2 (en) 2011-09-16 2016-07-19 Gilead Pharmasset Llc Methods for treating HCV
US9549941B2 (en) 2011-11-29 2017-01-24 Gilead Pharmasset Llc Compositions and methods for treating hepatitis C virus
US12121529B2 (en) 2023-11-16 2024-10-22 Gilead Sciences, Inc. Nucleoside phosphoramidate prodrugs

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY164523A (en) 2000-05-23 2017-12-29 Univ Degli Studi Cagliari Methods and compositions for treating hepatitis c virus
NZ547204A (en) 2000-05-26 2008-01-31 Idenix Cayman Ltd Methods and compositions for treating flaviviruses and pestiviruses
CN100448993C (en) * 2000-06-30 2009-01-07 津莫吉尼蒂克斯公司 Interferon-like protein zcyto 21
ES2275711T3 (en) * 2000-08-07 2007-06-16 Sciclone Pharmaceuticals, Inc. TREATMENT OF HEPATITIS C WITH TIMOSINE, INTERFERON AND RIBAVIRINE.
US7208167B2 (en) 2000-08-07 2007-04-24 Sciclone Pharmaceuticals, Inc. Treatment of hepatitis C with thymosin and peptide combination therapy
BR0114636A (en) * 2000-10-18 2004-02-10 Schering Corp Pegylated interferon-alpha / ribavirin hcv combination therapy
CN100482684C (en) 2001-04-20 2009-04-29 津莫吉尼蒂克斯公司 Cytokine protein family
US7910313B2 (en) 2001-04-20 2011-03-22 Zymogenetics, Inc. Cytokine protein family
PT1523489E (en) 2002-06-28 2014-06-24 Centre Nat Rech Scient Modified 2' and 3' -nucleoside produgs for treating flaviridae infections
PL3521297T3 (en) 2003-05-30 2022-04-04 Gilead Pharmasset Llc Modified fluorinated nucleoside analogues
RU2371195C2 (en) * 2003-08-13 2009-10-27 Говард Дж. Смит Энд Эссошиэйтс Пти Лтд Method of virus infection treatment
PT2061513E (en) * 2007-09-14 2011-10-17 Schering Corp Method of treating hepatitis c patients
TW200946541A (en) 2008-03-27 2009-11-16 Idenix Pharmaceuticals Inc Solid forms of an anti-HIV phosphoindole compound
EP2376514A2 (en) 2008-12-23 2011-10-19 Pharmasset, Inc. Nucleoside analogs
NZ593648A (en) 2008-12-23 2013-09-27 Gilead Pharmasset Llc Nucleoside phosphoramidates
US9198907B2 (en) 2009-04-06 2015-12-01 Ptc Therapeutics, Inc. Combinations of a HCV inhibitor such as bicyclic pyrrole derivatives and a therapeutic agent
US8618076B2 (en) 2009-05-20 2013-12-31 Gilead Pharmasset Llc Nucleoside phosphoramidates
TWI583692B (en) 2009-05-20 2017-05-21 基利法瑪席特有限責任公司 Nucleoside phosphoramidates
KR101715981B1 (en) 2010-03-31 2017-03-13 길리애드 파마셋 엘엘씨 Nucleoside phosphoramidates
DE112012003510T5 (en) 2011-10-21 2015-03-19 Abbvie Inc. Method for the treatment of HCV comprising at least two direct-acting antiviral agents, ribavirin but not interferon
GB2506085A (en) 2011-10-21 2014-03-19 Abbvie Inc Combination treatment (eg with ABT-072 or ABT-333) of DAAS for use in treating HCV
US8492386B2 (en) 2011-10-21 2013-07-23 Abbvie Inc. Methods for treating HCV
US8466159B2 (en) 2011-10-21 2013-06-18 Abbvie Inc. Methods for treating HCV
SI2950786T1 (en) 2013-01-31 2020-03-31 Gilead Pharmasset Llc Combination formulation of two antiviral compounds
ES2900570T3 (en) 2013-08-27 2022-03-17 Gilead Pharmasset Llc Combination formulation of two antiviral compounds
JP7129703B2 (en) 2016-04-28 2022-09-02 エモリー ユニバーシティー Alkyne-Containing Nucleotide and Nucleoside Therapeutic Compositions and Uses Associated Therewith

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0707855A2 (en) * 1995-05-19 1996-04-24 Schering Corporation Combination therapy for chronic hepatitis C infection
WO1998048840A1 (en) * 1997-04-29 1998-11-05 Schering Corporation Polyethylene glycol-interferon alpha conjugates for therapy of infection
EP0903148A2 (en) * 1997-09-21 1999-03-24 Schering Corporation Combination therapy for eradicating detectable HCV-RNA in patients having chronic hepatitis C infection
EP0956861A1 (en) * 1998-05-15 1999-11-17 Schering Corporation Combination therapy comprising ribavirin and interferon alpha in antiviral treatment naive patients having chronic hepatitis c infection

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0707855A2 (en) * 1995-05-19 1996-04-24 Schering Corporation Combination therapy for chronic hepatitis C infection
WO1998048840A1 (en) * 1997-04-29 1998-11-05 Schering Corporation Polyethylene glycol-interferon alpha conjugates for therapy of infection
EP0903148A2 (en) * 1997-09-21 1999-03-24 Schering Corporation Combination therapy for eradicating detectable HCV-RNA in patients having chronic hepatitis C infection
EP0956861A1 (en) * 1998-05-15 1999-11-17 Schering Corporation Combination therapy comprising ribavirin and interferon alpha in antiviral treatment naive patients having chronic hepatitis c infection

Non-Patent Citations (6)

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Title
ALGRANATI N.E. ET AL.: "A BRANCHED METHOXY 40 KDA POLYETHYLENE GLYCOL (PEG) MOIETY OPTIMIZES THE PHARMACOKINETICS (PK) OF PEGINTERFERON ALPHA-2A (PEG-IFN) AND MAY XPLAIN ITS ENHANCED EFFICACY IN CHRONIC HEPATITIS", HEPATOLOGY (SUPPLEMENT), vol. 30, no. 4(2), October 1999 (1999-10-01), USA, pages 190A, XP002138616 *
JAYANT TALWALKAR ET AL.: "COMBINATION THERAPY WITH INTERFERON-ALFA-2B (INTRON-A) AND RIBAVIRIN (REBETOL) IN CHRONIC HEPATITIS C PATIENTS PREVIOUSLY RELAPSING OR NOT RESPONSING TO INTERFERON", HEPATOLOGY (SUPPLEMENT), vol. 30, no. 4(2), October 1999 (1999-10-01), USA, pages 197A, XP002138615 *
M.SULKOWSKI ET AL.: "COMBINATION THERAPY WITH PEGINTERFERON ALPHA-2A (PEG-IFN) AND RIBAVIRIN IN THE TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C (CHC)", HEPATOLOGY (SUPPLEMENT), vol. 30, no. 4(2), October 1999 (1999-10-01), USA, pages 197A, XP002138614 *
MITCHELL SCHIFFMAN MITCHELL ET AL.: "CONTROLLE, RANDOMIZED, MULTICENTER, DESCENDING DOSE PHASE II TRIAL OF PEGYLATED INTERFERON ALPHA-2A (PEG) VS STANDARD INTERFERON ALPHA-2A (IFN)FOR TREATMENT OF CHRONIC HEPATITIS C", GASTROENTEROLOGY, vol. 116, no. 4(2), April 1999 (1999-04-01), USA, pages 1275, XP002138617 *
P. GLUE ET AL.: "A DOSE-RANGING STUDY OF PEG-INTRON AND RIBAVIRIN IN CHRONIC HEPATITIS C. SAFETY, EFFICACY AND VIROLOGIC RATIONALE", HEPATOLOGY (SUPPLEMENT), vol. 30, no. 4(2), October 1999 (1999-10-01), USA, pages 303A, XP002138613 *
REICHARD O. ET AL.: "RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF INTERFERON ALPHA-2B WITH AND WITHOUT RIBAVIRIN FOR CHRONIC HEPATITIS C", LANCET, vol. 351, no. 9096, 10 January 1998 (1998-01-10), UK, pages 83 - 87, XP002110247 *

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7365057B2 (en) 2002-06-28 2008-04-29 Idenix Pharmaceuticals, Inc. Modified 2′ and 3′-nucleoside prodrugs for treating Flavivridae infections
US7384924B2 (en) 2002-06-28 2008-06-10 Idenix Pharmaceuticals, Inc. Modified 2′ and 3′-nucleoside prodrugs for treating Flaviviridae infections
US7547704B2 (en) 2002-06-28 2009-06-16 Idenix Pharmaceuticals, Inc. Modified 2′ and 3′-nucleoside prodrugs for treating Flaviviridae infections
US7608600B2 (en) 2002-06-28 2009-10-27 Idenix Pharmaceuticals, Inc. Modified 2′ and 3′-nucleoside prodrugs for treating Flaviviridae infections
US7625875B2 (en) 2002-06-28 2009-12-01 Idenix Pharmaceuticals, Inc. 2′ and 3′-nucleoside prodrugs for treating Flaviviridae infections
US7635689B2 (en) 2002-06-28 2009-12-22 Idenix Pharmaceuticals, Inc. Modified 2′ and 3′-nucleoside prodrugs for treating Flaviviridae infections
US7662798B2 (en) 2002-06-28 2010-02-16 Idenix Pharmaceuticals, Inc. 2′ and 3′-nucleoside prodrugs for treating Flaviviridae infections
US7824851B2 (en) 2002-11-15 2010-11-02 Idenix Pharmaceuticals, Inc. 2′-branched nucleosides and Flaviviridae mutation
US8481713B2 (en) 2004-07-21 2013-07-09 Gilead Pharmasset Llc Preparation of alkyl-substituted 2-deoxy-2-fluoro-D-ribofuranosyl pyrimidines and purines and their derivatives
US8492539B2 (en) 2004-09-14 2013-07-23 Gilead Pharmasset Llc Preparation of 2′-fluoro-2′-alkyl-substituted or other optionally substituted ribofuranosyl pyrimidines and purines and their derivatives
US8957046B2 (en) 2007-03-30 2015-02-17 Gilead Pharmasset Llc Nucleoside phosphoramidate prodrugs
US9585906B2 (en) 2007-03-30 2017-03-07 Gilead Pharmasset Llc Nucleoside phosphoramidate prodrugs
US9045520B2 (en) 2008-12-23 2015-06-02 Gilead Pharmasset Llc Synthesis of purine nucleosides
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
US9394331B2 (en) 2010-11-30 2016-07-19 Gilead Pharmasset Llc 2′-spiro-nucleosides and derivatives thereof useful for treating hepatitis C virus and dengue virus infections
US9393256B2 (en) 2011-09-16 2016-07-19 Gilead Pharmasset Llc Methods for treating HCV
US9549941B2 (en) 2011-11-29 2017-01-24 Gilead Pharmasset Llc Compositions and methods for treating hepatitis C virus
US12121529B2 (en) 2023-11-16 2024-10-22 Gilead Sciences, Inc. Nucleoside phosphoramidate prodrugs

Also Published As

Publication number Publication date
JP2003507322A (en) 2003-02-25
PE20001369A1 (en) 2000-12-09
WO2000037110A2 (en) 2000-06-29
AR021876A1 (en) 2002-08-07
AU2157000A (en) 2000-07-12
CA2354536A1 (en) 2000-06-29
EP1140143A2 (en) 2001-10-10

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