HRP20210862T1 - Liječenje infekcije hepatitis delta virusom pomoću interferona lambda - Google Patents
Liječenje infekcije hepatitis delta virusom pomoću interferona lambda Download PDFInfo
- Publication number
- HRP20210862T1 HRP20210862T1 HRP20210862TT HRP20210862T HRP20210862T1 HR P20210862 T1 HRP20210862 T1 HR P20210862T1 HR P20210862T T HRP20210862T T HR P20210862TT HR P20210862 T HRP20210862 T HR P20210862T HR P20210862 T1 HRP20210862 T1 HR P20210862T1
- Authority
- HR
- Croatia
- Prior art keywords
- interferon lambda
- treatment
- use according
- patient
- serum
- Prior art date
Links
- 102000014150 Interferons Human genes 0.000 title claims 28
- 108010050904 Interferons Proteins 0.000 title claims 28
- 229940079322 interferon Drugs 0.000 title claims 28
- 241000724709 Hepatitis delta virus Species 0.000 title claims 9
- 230000009385 viral infection Effects 0.000 title 1
- 208000037262 Hepatitis delta Diseases 0.000 claims 10
- 208000029570 hepatitis D virus infection Diseases 0.000 claims 10
- 210000002966 serum Anatomy 0.000 claims 9
- 230000003612 virological effect Effects 0.000 claims 8
- 102100036475 Alanine aminotransferase 1 Human genes 0.000 claims 5
- 108010082126 Alanine transaminase Proteins 0.000 claims 5
- 208000019425 cirrhosis of liver Diseases 0.000 claims 3
- 238000001514 detection method Methods 0.000 claims 3
- 230000003908 liver function Effects 0.000 claims 3
- 108010003415 Aspartate Aminotransferases Proteins 0.000 claims 2
- 102000004625 Aspartate Aminotransferases Human genes 0.000 claims 2
- BPYKTIZUTYGOLE-IFADSCNNSA-N Bilirubin Chemical compound N1C(=O)C(C)=C(C=C)\C1=C\C1=C(C)C(CCC(O)=O)=C(CC2=C(C(C)=C(\C=C/3C(=C(C=C)C(=O)N\3)C)N2)CCC(O)=O)N1 BPYKTIZUTYGOLE-IFADSCNNSA-N 0.000 claims 2
- 206010016654 Fibrosis Diseases 0.000 claims 2
- 230000000840 anti-viral effect Effects 0.000 claims 2
- 230000007882 cirrhosis Effects 0.000 claims 2
- 208000019423 liver disease Diseases 0.000 claims 2
- 102100033312 Alpha-2-macroglobulin Human genes 0.000 claims 1
- 102000005666 Apolipoprotein A-I Human genes 0.000 claims 1
- 108010059886 Apolipoprotein A-I Proteins 0.000 claims 1
- 101710107035 Gamma-glutamyltranspeptidase Proteins 0.000 claims 1
- 101710173228 Glutathione hydrolase proenzyme Proteins 0.000 claims 1
- 102100025255 Haptoglobin Human genes 0.000 claims 1
- 108050005077 Haptoglobin Proteins 0.000 claims 1
- 108010015078 Pregnancy-Associated alpha 2-Macroglobulins Proteins 0.000 claims 1
- 102100027378 Prothrombin Human genes 0.000 claims 1
- 108010094028 Prothrombin Proteins 0.000 claims 1
- 102000007562 Serum Albumin Human genes 0.000 claims 1
- 108010071390 Serum Albumin Proteins 0.000 claims 1
- 102000006640 gamma-Glutamyltransferase Human genes 0.000 claims 1
- 208000015181 infectious disease Diseases 0.000 claims 1
- 230000000977 initiatory effect Effects 0.000 claims 1
- 229940039716 prothrombin Drugs 0.000 claims 1
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]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Gastroenterology & Hepatology (AREA)
- Organic Chemistry (AREA)
- Virology (AREA)
- General Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Claims (16)
1. Interferon lambda za uporabu u liječenju infekcije hepatitis delta virusom (HDV) kod humanog pacijenta, naznačen time što se interferon lambda primjenjuje pacijentu tijekom najmanje četiri tjedna.
2. Interferon lambda za uporabu u skladu sa patentnim zahtjevom 1, naznačen time što pacijent ima kompenziranu bolest jetre sa ili bez ciroze, poželjno pri čemu pacijent ima kompenziranu bolest jetre sa cirozom.
3. Interferon lambda za uporabu u skladu sa bilo kojim od patentnih zahtjeva 1 ili 2, naznačen time što je interferon lambda pegiliran, poželjno pri čemu je interferon lambda pegiliran interferon lambda-1a.
4. Interferon lambda za uporabu u skladu sa bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što:
interferon lambda se primjenjuje pri dozi od 120 mikrograma tjedno; ili
interferon lambda se primjenjuje pri dozi od 180 mikrograma tjedno.
5. Interferon lambda za uporabu u skladu sa bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što se interferon lambda primjenjuje subkutano.
6. Interferon lambda za uporabu u skladu sa bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što:
interferon lambda se primjenjuje tijekom najmanje 6 meseci; ili
interferon lambda se primjenjuje tijekom najmanje 48 tjedana.
7. Interferon lambda za uporabu u skladu sa bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što tijek liječenja rezultira HDV virusnim opterećenjem koje je ispod 100 kopija/ml seruma ili ispod 100 IU/ml seruma.
8. Interferon lambda za uporabu u skladu sa patentnim zahtjevom 7, naznačen time što HDV virusno opterećenje ostaje ispod 100 kopija/ml seruma ili ispod 100 IU/ml seruma tijekom najmanje 12 tjedana nakon kraja liječenja, poželjno pri čemu HDV virusno opterećenje ostaje ispod 100 kopija/ml seruma ili ispod 100 IU/ml seruma tijekom najmanje 24 tjedna nakon kraja liječenja.
9. Interferon lambda za uporabu u skladu sa bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što tok liječenja rezultira HDV virusnim opterećenjem koje je ispod nivoa detekcije.
10. Interferon lambda za uporabu u skladu sa patentnim zahtjevom 9, naznačen time što HDV virusno opterećenje ostaje ispod nivoa detekcije tijekom najmanje 12 tjedana nakon kraja liječenja, poželjno pri čemu HDV virusno opterećenje ostaje ispod nivoa detekcije tijekom najmanje 24 tjedna nakon kraja liječenja.
11. Interferon lambda za uporabu u skladu sa bilo kojim od patentnih zahtjeva 1 do 10, naznačen time što prije početka liječenja, pacijent ima nivo alanin aminotransferaze (ALT) u serumu koji je iznad gornje granice normalnog (ULN), i tok liječenja rezultira poboljšanjem nivoa ALT u serumu kod pacijenta do nivoa koji je unutar ULN.
12. Interferon lambda za uporabu u skladu sa bilo kojim od patentnih zahtjeva 1 do 11, naznačen time što tijek liječenja rezultira redukovanjem HBV virusnog opterećenja kod pacijenta u usporedbi sa početnom vrijednošću HBV virusnog opterećenja pacijenta na inicijaciji liječenja.
13. Interferon lambda za uporabu u skladu sa bilo kojim od patentnih zahtjeva 1 do 12, naznačen time što tok liječenja rezultira poboljšanom funkcijom jetre kod pacijenta, poželjno pri čemu:
poboljšana funkcija jetre je poboljšanje jednog ili više serumskih markera odabranih iz grupe koja se sastoji od serumskog albumina, bilirubina, alanin aminotransferaze (ALT), aspartat aminotransferaze (AST), protrombina, alfa2-makroglobulina, apolipoproteina A1, haptoglobina, gama-glutamil transpeptidaze (GGT); ili
poboljšana funkcija jetre je poboljšanje fibroze jetre.
14. Interferon lambda za uporabu u skladu sa patentnim zahtjevima 1 do 13, naznačen time što se pacijentu takođe primjenjuje drugi antivirusni ili anti-HDV agens.
15. Interferon lambda za uporabu u skladu sa bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što je interferon lambda jedino ili primarno antivirusno liječenje ili jedino ili primarno anti-HDV liječenje.
16. Interferon lambda za uporabu u skladu sa bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što je interferon lambda jedino anti-HDV liječenje koje se primjenjuje.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662297759P | 2016-02-19 | 2016-02-19 | |
| PCT/US2017/018466 WO2017143253A1 (en) | 2016-02-19 | 2017-02-17 | Treatment of hepatitis delta virus infection with interferon lambda |
| EP17753966.5A EP3416675B9 (en) | 2016-02-19 | 2017-02-17 | Treatment of hepatitis delta virus infection with interferon lambda |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20210862T1 true HRP20210862T1 (hr) | 2021-09-17 |
Family
ID=59625481
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20210862TT HRP20210862T1 (hr) | 2016-02-19 | 2021-05-31 | Liječenje infekcije hepatitis delta virusom pomoću interferona lambda |
Country Status (16)
| Country | Link |
|---|---|
| US (2) | US10953072B2 (hr) |
| EP (2) | EP3957319A1 (hr) |
| JP (2) | JP2019505553A (hr) |
| KR (1) | KR20180110127A (hr) |
| CN (1) | CN108883156A (hr) |
| CY (1) | CY1124220T1 (hr) |
| DK (1) | DK3416675T3 (hr) |
| ES (1) | ES2874592T3 (hr) |
| HR (1) | HRP20210862T1 (hr) |
| HU (1) | HUE055343T2 (hr) |
| LT (1) | LT3416675T (hr) |
| PL (1) | PL3416675T3 (hr) |
| PT (1) | PT3416675T (hr) |
| RS (1) | RS61944B1 (hr) |
| SI (1) | SI3416675T1 (hr) |
| WO (1) | WO2017143253A1 (hr) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11311519B2 (en) | 2014-05-01 | 2022-04-26 | Eiger Biopharmaceuticals, Inc. | Treatment of hepatitis delta virus infection |
| KR102514971B1 (ko) | 2015-04-21 | 2023-03-27 | 아이거 바이오파마슈티컬스 인코포레이티드 | 로나파르닙 및 리토나버를 포함하는 약제 조성물 |
| PL3416675T3 (pl) | 2016-02-19 | 2021-10-11 | Eiger Biopharmaceuticals, Inc. | Leczenie zakażenia wirusem zapalenia wątroby typu delta za pomocą interferonu lambda |
| GB201621728D0 (en) | 2016-12-20 | 2017-02-01 | Ucb Biopharma Sprl | Methods |
| CA3109955A1 (en) * | 2018-08-23 | 2020-02-27 | Eiger Biopharmaceuticals, Inc. | Treatment of hepatitis delta virus infection with interferon lambda |
| AU2020312735A1 (en) | 2019-07-18 | 2021-12-16 | Enyo Pharma | Method for decreasing adverse-effects of interferon |
| KR20210023737A (ko) * | 2019-08-21 | 2021-03-04 | 한국과학기술원 | 신규 인터페론 람다 변이체 및 이의 제조방법 |
| CA3156679A1 (en) * | 2019-10-16 | 2022-04-22 | Eiger Biopharmaceuticals, Inc. | METHODS OF TREATMENT OF HEPATITIS DELTA VIRUS INFECTIONS |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1294888B1 (en) | 2000-06-30 | 2007-04-25 | ZymoGenetics, Inc. | Interferon-like protein zcyto21 |
| US7038032B2 (en) | 2001-04-20 | 2006-05-02 | Zymogenetics, Inc. | Cytokine protein family |
| WO2004037995A2 (en) | 2002-10-23 | 2004-05-06 | Zymogenetics, Inc. | Methods for treating viral infection using il-28 and il-29 |
| ATE388963T1 (de) | 2003-08-07 | 2008-03-15 | Zymogenetics Inc | Homogene herstellungen von il-29 |
| WO2005097165A2 (en) * | 2004-04-02 | 2005-10-20 | Zymogenetics, Inc. | Il-28 and il-29 cysteine mutants for treating viral infection |
| CA2625208A1 (en) | 2005-10-04 | 2007-04-12 | Zymogenetics, Inc. | Production and purification of il-29 |
| JP2010504909A (ja) | 2006-09-14 | 2010-02-18 | メドジェニクス・メディカル・イスラエル・リミテッド | 長期持続性の医薬製剤 |
| WO2009124309A2 (en) | 2008-04-04 | 2009-10-08 | The Trustees Of The University Of Pennsylvania | Vaccines and immunotherapeutics using il-28 and compositions and methods of using the same |
| WO2011088126A2 (en) | 2010-01-13 | 2011-07-21 | Eiger Biopharmaceuticals, Inc. | Treatment of viral infection with prenyltransferase inhibitors |
| US9579377B2 (en) * | 2011-06-14 | 2017-02-28 | Globeimmune, Inc. | Yeast-based compositions and methods for the treatment or prevention of hepatitis delta virus infection |
| CA2846092A1 (en) * | 2011-08-25 | 2013-02-28 | Nanogen Pharmaceutical Biotechnology | Peg-interferon lambda 1 conjugates |
| US8454947B1 (en) | 2012-03-01 | 2013-06-04 | Nanogen Pharmaceutical Biotechnology | PEG-interferon lambda 1 conjugates |
| SG11201501255PA (en) * | 2012-08-30 | 2015-03-30 | Replicor Inc | Methods for the treatment of hepatitis b and hepatitis d infections |
| JP2015536950A (ja) * | 2012-11-02 | 2015-12-24 | ファーマサイクリックス，インク． | Ｔｅｃファミリーキナーゼ阻害剤アジュバント療法 |
| DK3137078T3 (da) * | 2014-05-01 | 2019-06-11 | Eiger Biopharmaceuticals Inc | Behandling af hepatitis delta-virusinfektion |
| DK3370723T3 (da) * | 2015-11-04 | 2021-01-25 | Eiger Biopharmaceuticals Inc | Behandling af hepatitis delta-virusinfektion |
| PL3416675T3 (pl) | 2016-02-19 | 2021-10-11 | Eiger Biopharmaceuticals, Inc. | Leczenie zakażenia wirusem zapalenia wątroby typu delta za pomocą interferonu lambda |
| CA3109955A1 (en) | 2018-08-23 | 2020-02-27 | Eiger Biopharmaceuticals, Inc. | Treatment of hepatitis delta virus infection with interferon lambda |
-
2017
- 2017-02-17 PL PL17753966T patent/PL3416675T3/pl unknown
- 2017-02-17 ES ES17753966T patent/ES2874592T3/es active Active
- 2017-02-17 CN CN201780020097.4A patent/CN108883156A/zh active Pending
- 2017-02-17 EP EP21164362.2A patent/EP3957319A1/en active Pending
- 2017-02-17 US US15/999,239 patent/US10953072B2/en active Active
- 2017-02-17 KR KR1020187026586A patent/KR20180110127A/ko unknown
- 2017-02-17 SI SI201730795T patent/SI3416675T1/sl unknown
- 2017-02-17 DK DK17753966.5T patent/DK3416675T3/da active
- 2017-02-17 WO PCT/US2017/018466 patent/WO2017143253A1/en active Application Filing
- 2017-02-17 PT PT177539665T patent/PT3416675T/pt unknown
- 2017-02-17 EP EP17753966.5A patent/EP3416675B9/en active Active
- 2017-02-17 HU HUE17753966A patent/HUE055343T2/hu unknown
- 2017-02-17 JP JP2018543599A patent/JP2019505553A/ja active Pending
- 2017-02-17 RS RS20210703A patent/RS61944B1/sr unknown
- 2017-02-17 LT LTEP17753966.5T patent/LT3416675T/lt unknown
-
2021
- 2021-02-18 US US17/178,424 patent/US20210228686A1/en active Pending
- 2021-05-31 HR HRP20210862TT patent/HRP20210862T1/hr unknown
- 2021-06-10 CY CY20211100511T patent/CY1124220T1/el unknown
-
2022
- 2022-09-02 JP JP2022140259A patent/JP2022172279A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP3957319A1 (en) | 2022-02-23 |
| ES2874592T3 (es) | 2021-11-05 |
| EP3416675B9 (en) | 2021-07-14 |
| LT3416675T (lt) | 2021-06-25 |
| KR20180110127A (ko) | 2018-10-08 |
| PL3416675T3 (pl) | 2021-10-11 |
| EP3416675A4 (en) | 2020-01-08 |
| US20210228686A1 (en) | 2021-07-29 |
| US20190111110A1 (en) | 2019-04-18 |
| CY1124220T1 (el) | 2022-05-27 |
| EP3416675B1 (en) | 2021-03-24 |
| WO2017143253A1 (en) | 2017-08-24 |
| CN108883156A (zh) | 2018-11-23 |
| SI3416675T1 (sl) | 2021-09-30 |
| DK3416675T3 (da) | 2021-06-14 |
| JP2019505553A (ja) | 2019-02-28 |
| JP2022172279A (ja) | 2022-11-15 |
| RS61944B1 (sr) | 2021-07-30 |
| US10953072B2 (en) | 2021-03-23 |
| PT3416675T (pt) | 2021-06-14 |
| HUE055343T2 (hu) | 2022-05-28 |
| EP3416675A1 (en) | 2018-12-26 |
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