Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe.
Identifieur interne : 000389 ( PubMed/Corpus ); précédent : 000388; suivant : 000390Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe.
Auteurs : Alison D. Marshall ; Evan B. Cunningham ; Stine Nielsen ; Alessio Aghemo ; Hannu Alho ; Markus Backmund ; Philip Bruggmann ; Olav Dalgard ; Carole Seguin-Devaux ; Robert Flisiak ; Graham R. Foster ; Liana Gheorghe ; David Goldberg ; Ioannis Goulis ; Matthew Hickman ; Patrick Hoffmann ; Ligita Jancorien ; Peter Jarcuska ; Martin K Berg ; Leondios G. Kostrikis ; Mihály Makara ; Matti Maimets ; Rui Tato Marinho ; Mojca Mati I ; Suzanne Norris ; Sigur Ur Lafsson ; Anne Vrehus ; Jean-Michel Pawlotsky ; James Pocock ; Geert Robaeys ; Carlos Roncero ; Marieta Simonova ; Jan Sperl ; Michele Tait ; Ieva Tolmane ; Stefan Tomaselli ; Marc Van Der Valk ; Adriana Vince ; Gregory J. Dore ; Jeffrey V. Lazarus ; Jason GrebelySource :
- The lancet. Gastroenterology & hepatology [ 2468-1253 ] ; 2017.
Abstract
All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions. Among the 35 European countries and jurisdictions included, the most commonly reimbursed DAA was ombitasvir, paritaprevir, and ritonavir, with dasabuvir, and with or without ribavirin (33 [94%] countries and jurisdictions). 16 (46%) countries and jurisdictions required patients to have fibrosis at stage F2 or higher, 29 (83%) had no listed restrictions based on drug or alcohol use, 33 (94%) required a specialist prescriber, and 34 (97%) had no additional restrictions for people co-infected with HIV and hepatitis C virus. These findings have implications for meeting WHO targets, with evidence of some countries not following the 2016 hepatitis C virus treatment guidelines by the European Association for the Study of Liver.
DOI: 10.1016/S2468-1253(17)30284-4
PubMed: 28986139
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe.</title><author><name sortKey="Marshall, Alison D" sort="Marshall, Alison D" uniqKey="Marshall A" first="Alison D" last="Marshall">Alison D. Marshall</name><affiliation><nlm:affiliation>The Kirby Institute, UNSW Sydney, NSW, Australia. Electronic address: amarshall@kirby.unsw.edu.au.</nlm:affiliation></affiliation></author><author><name sortKey="Cunningham, Evan B" sort="Cunningham, Evan B" uniqKey="Cunningham E" first="Evan B" last="Cunningham">Evan B. Cunningham</name><affiliation><nlm:affiliation>The Kirby Institute, UNSW Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Nielsen, Stine" sort="Nielsen, Stine" uniqKey="Nielsen S" first="Stine" last="Nielsen">Stine Nielsen</name><affiliation><nlm:affiliation>INHSU, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Aghemo, Alessio" sort="Aghemo, Alessio" uniqKey="Aghemo A" first="Alessio" last="Aghemo">Alessio Aghemo</name><affiliation><nlm:affiliation>Department of Biomedical Sciences and Humanitas Clinical and Research Center, Humanitas University, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Alho, Hannu" sort="Alho, Hannu" uniqKey="Alho H" first="Hannu" last="Alho">Hannu Alho</name><affiliation><nlm:affiliation>Abdominal Center, Helsinki University Hospital, Helsinki University, Helsinki, Finland.</nlm:affiliation></affiliation></author><author><name sortKey="Backmund, Markus" sort="Backmund, Markus" uniqKey="Backmund M" first="Markus" last="Backmund">Markus Backmund</name><affiliation><nlm:affiliation>Ludwig-Maximilians-University, Munich, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Bruggmann, Philip" sort="Bruggmann, Philip" uniqKey="Bruggmann P" first="Philip" last="Bruggmann">Philip Bruggmann</name><affiliation><nlm:affiliation>Arud Centres for Addiction Medicine, Zürich, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Dalgard, Olav" sort="Dalgard, Olav" uniqKey="Dalgard O" first="Olav" last="Dalgard">Olav Dalgard</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Akershus University Hospital, University of Oslo, Oslo, Norway.</nlm:affiliation></affiliation></author><author><name sortKey="Seguin Devaux, Carole" sort="Seguin Devaux, Carole" uniqKey="Seguin Devaux C" first="Carole" last="Seguin-Devaux">Carole Seguin-Devaux</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Luxembourg Institute of Health, Luxembourg City, Luxembourg.</nlm:affiliation></affiliation></author><author><name sortKey="Flisiak, Robert" sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name><affiliation><nlm:affiliation>Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Foster, Graham R" sort="Foster, Graham R" uniqKey="Foster G" first="Graham R" last="Foster">Graham R. Foster</name><affiliation><nlm:affiliation>Queen Mary University of London, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Gheorghe, Liana" sort="Gheorghe, Liana" uniqKey="Gheorghe L" first="Liana" last="Gheorghe">Liana Gheorghe</name><affiliation><nlm:affiliation>Gastroenterology and Hepatology, Fundeni Clinical Institute, Bucharest, Romania.</nlm:affiliation></affiliation></author><author><name sortKey="Goldberg, David" sort="Goldberg, David" uniqKey="Goldberg D" first="David" last="Goldberg">David Goldberg</name><affiliation><nlm:affiliation>Health Protection Scotland, Glasgow, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Goulis, Ioannis" sort="Goulis, Ioannis" uniqKey="Goulis I" first="Ioannis" last="Goulis">Ioannis Goulis</name><affiliation><nlm:affiliation>Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.</nlm:affiliation></affiliation></author><author><name sortKey="Hickman, Matthew" sort="Hickman, Matthew" uniqKey="Hickman M" first="Matthew" last="Hickman">Matthew Hickman</name><affiliation><nlm:affiliation>Social Medicine, University of Bristol, Bristol, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Hoffmann, Patrick" sort="Hoffmann, Patrick" uniqKey="Hoffmann P" first="Patrick" last="Hoffmann">Patrick Hoffmann</name><affiliation><nlm:affiliation>Ministry of Health, Luxembourg City, Luxembourg.</nlm:affiliation></affiliation></author><author><name sortKey="Jancorien, Ligita" sort="Jancorien, Ligita" uniqKey="Jancorien L" first="Ligita" last="Jancorien">Ligita Jancorien</name><affiliation><nlm:affiliation>Centre of Infectious Diseases, Vilnius University Hospital Santaros Klinikos, Vilnius University, Vilnius, Lithuania.</nlm:affiliation></affiliation></author><author><name sortKey="Jarcuska, Peter" sort="Jarcuska, Peter" uniqKey="Jarcuska P" first="Peter" last="Jarcuska">Peter Jarcuska</name><affiliation><nlm:affiliation>First Department of Internal Medicine, University Hospital, University of Pavol Jozef Safarik, Kosice, Slovakia.</nlm:affiliation></affiliation></author><author><name sortKey="K Berg, Martin" sort="K Berg, Martin" uniqKey="K Berg M" first="Martin" last="K Berg">Martin K Berg</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.</nlm:affiliation></affiliation></author><author><name sortKey="Kostrikis, Leondios G" sort="Kostrikis, Leondios G" uniqKey="Kostrikis L" first="Leondios G" last="Kostrikis">Leondios G. Kostrikis</name><affiliation><nlm:affiliation>University of Cyprus, Nicosia, Cyprus.</nlm:affiliation></affiliation></author><author><name sortKey="Makara, Mihaly" sort="Makara, Mihaly" uniqKey="Makara M" first="Mihály" last="Makara">Mihály Makara</name><affiliation><nlm:affiliation>Hepatology Center, St István and St László Hospital, Budapest, Hungary.</nlm:affiliation></affiliation></author><author><name sortKey="Maimets, Matti" sort="Maimets, Matti" uniqKey="Maimets M" first="Matti" last="Maimets">Matti Maimets</name><affiliation><nlm:affiliation>Department of Internal Medicine, University of Tartu, Estonia.</nlm:affiliation></affiliation></author><author><name sortKey="Marinho, Rui Tato" sort="Marinho, Rui Tato" uniqKey="Marinho R" first="Rui Tato" last="Marinho">Rui Tato Marinho</name><affiliation><nlm:affiliation>Department of Gastroenterology and Hepatology, Hospital Santa Maria, Medical School Lisbon, University of Lisbon, Lisbon, Portugal.</nlm:affiliation></affiliation></author><author><name sortKey="Mati I, Mojca" sort="Mati I, Mojca" uniqKey="Mati I M" first="Mojca" last="Mati I">Mojca Mati I</name><affiliation><nlm:affiliation>Clinic for Infectious Diseases and Febrile Illnesses, University Medical Centre, Ljubljana, Slovenia.</nlm:affiliation></affiliation></author><author><name sortKey="Norris, Suzanne" sort="Norris, Suzanne" uniqKey="Norris S" first="Suzanne" last="Norris">Suzanne Norris</name><affiliation><nlm:affiliation>National Hepatitis C Treatment Programme, Health Service Executive, Dr Steevens' Hospital, Dublin, Ireland.</nlm:affiliation></affiliation></author><author><name sortKey=" Lafsson, Sigur Ur" sort=" Lafsson, Sigur Ur" uniqKey=" Lafsson S" first="Sigur Ur" last=" Lafsson">Sigur Ur Lafsson</name><affiliation><nlm:affiliation>Division of Gastroenterology, Department of Medicine, Landspitali University Hospital, Reykjavik, Iceland.</nlm:affiliation></affiliation></author><author><name sortKey=" Vrehus, Anne" sort=" Vrehus, Anne" uniqKey=" Vrehus A" first="Anne" last=" Vrehus">Anne Vrehus</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Odense University Hospital, University of Southern Denmark, Odense, Denmark.</nlm:affiliation></affiliation></author><author><name sortKey="Pawlotsky, Jean Michel" sort="Pawlotsky, Jean Michel" uniqKey="Pawlotsky J" first="Jean-Michel" last="Pawlotsky">Jean-Michel Pawlotsky</name><affiliation><nlm:affiliation>Hopital Henri Mondor, Universite Paris Est, Créteil, France.</nlm:affiliation></affiliation></author><author><name sortKey="Pocock, James" sort="Pocock, James" uniqKey="Pocock J" first="James" last="Pocock">James Pocock</name><affiliation><nlm:affiliation>Gastroenterology Department, Mater Dei Hospital, Msida, Malta.</nlm:affiliation></affiliation></author><author><name sortKey="Robaeys, Geert" sort="Robaeys, Geert" uniqKey="Robaeys G" first="Geert" last="Robaeys">Geert Robaeys</name><affiliation><nlm:affiliation>Department of Gastroenterology and Hepatology, Ziekenhuis Oost Limburg, Genk, Belgium; Department of Medicine and Life Sciences, University of Hasselt, Hasselt, Belgium; Department of Hepatology, UZ Leuven, Leuven, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Roncero, Carlos" sort="Roncero, Carlos" uniqKey="Roncero C" first="Carlos" last="Roncero">Carlos Roncero</name><affiliation><nlm:affiliation>Addiction and Dual Diagnosis Unit, Psychiatric Department, Hospital Universitario Vall d'Hebron, Universidad Autónoma de Barcelona, Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Simonova, Marieta" sort="Simonova, Marieta" uniqKey="Simonova M" first="Marieta" last="Simonova">Marieta Simonova</name><affiliation><nlm:affiliation>Department of Gastroenterology, Hepato-Pancreato-Biliary Surgery and Transplantology, Military Medical Academy, Sofia, Bulgaria.</nlm:affiliation></affiliation></author><author><name sortKey="Sperl, Jan" sort="Sperl, Jan" uniqKey="Sperl J" first="Jan" last="Sperl">Jan Sperl</name><affiliation><nlm:affiliation>Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Tait, Michele" sort="Tait, Michele" uniqKey="Tait M" first="Michele" last="Tait">Michele Tait</name><affiliation><nlm:affiliation>National Hepatitis C Treatment Programme, Health Service Executive, Dr Steevens' Hospital, Dublin, Ireland.</nlm:affiliation></affiliation></author><author><name sortKey="Tolmane, Ieva" sort="Tolmane, Ieva" uniqKey="Tolmane I" first="Ieva" last="Tolmane">Ieva Tolmane</name><affiliation><nlm:affiliation>Department of Hepatology, Infectology Center of Latvia, Riga East University Hospital, Riga, Latvia; Faculty of Medicine, University of Latvia, Riga, Latvia.</nlm:affiliation></affiliation></author><author><name sortKey="Tomaselli, Stefan" sort="Tomaselli, Stefan" uniqKey="Tomaselli S" first="Stefan" last="Tomaselli">Stefan Tomaselli</name><affiliation><nlm:affiliation>Office of Public Health, Vaduz, Liechtenstein.</nlm:affiliation></affiliation></author><author><name sortKey="Van Der Valk, Marc" sort="Van Der Valk, Marc" uniqKey="Van Der Valk M" first="Marc" last="Van Der Valk">Marc Van Der Valk</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Academic Medical Center, Amsterdam, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Vince, Adriana" sort="Vince, Adriana" uniqKey="Vince A" first="Adriana" last="Vince">Adriana Vince</name><affiliation><nlm:affiliation>University Hospital for Infectious Diseases, University of Zagreb, Zagreb, Croatia.</nlm:affiliation></affiliation></author><author><name sortKey="Dore, Gregory J" sort="Dore, Gregory J" uniqKey="Dore G" first="Gregory J" last="Dore">Gregory J. Dore</name><affiliation><nlm:affiliation>The Kirby Institute, UNSW Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Lazarus, Jeffrey V" sort="Lazarus, Jeffrey V" uniqKey="Lazarus J" first="Jeffrey V" last="Lazarus">Jeffrey V. Lazarus</name><affiliation><nlm:affiliation>Barcelona Institute for Global Health (ISGlobal), Hospital Clínic, Univeristy of Barcelona, Barcelona, Spain; CHIP, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation></affiliation></author><author><name sortKey="Grebely, Jason" sort="Grebely, Jason" uniqKey="Grebely J" first="Jason" last="Grebely">Jason Grebely</name><affiliation><nlm:affiliation>The Kirby Institute, UNSW Sydney, NSW, Australia.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28986139</idno><idno type="pmid">28986139</idno><idno type="doi">10.1016/S2468-1253(17)30284-4</idno><idno type="wicri:Area/PubMed/Corpus">000389</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000389</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe.</title><author><name sortKey="Marshall, Alison D" sort="Marshall, Alison D" uniqKey="Marshall A" first="Alison D" last="Marshall">Alison D. Marshall</name><affiliation><nlm:affiliation>The Kirby Institute, UNSW Sydney, NSW, Australia. Electronic address: amarshall@kirby.unsw.edu.au.</nlm:affiliation></affiliation></author><author><name sortKey="Cunningham, Evan B" sort="Cunningham, Evan B" uniqKey="Cunningham E" first="Evan B" last="Cunningham">Evan B. Cunningham</name><affiliation><nlm:affiliation>The Kirby Institute, UNSW Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Nielsen, Stine" sort="Nielsen, Stine" uniqKey="Nielsen S" first="Stine" last="Nielsen">Stine Nielsen</name><affiliation><nlm:affiliation>INHSU, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Aghemo, Alessio" sort="Aghemo, Alessio" uniqKey="Aghemo A" first="Alessio" last="Aghemo">Alessio Aghemo</name><affiliation><nlm:affiliation>Department of Biomedical Sciences and Humanitas Clinical and Research Center, Humanitas University, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Alho, Hannu" sort="Alho, Hannu" uniqKey="Alho H" first="Hannu" last="Alho">Hannu Alho</name><affiliation><nlm:affiliation>Abdominal Center, Helsinki University Hospital, Helsinki University, Helsinki, Finland.</nlm:affiliation></affiliation></author><author><name sortKey="Backmund, Markus" sort="Backmund, Markus" uniqKey="Backmund M" first="Markus" last="Backmund">Markus Backmund</name><affiliation><nlm:affiliation>Ludwig-Maximilians-University, Munich, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Bruggmann, Philip" sort="Bruggmann, Philip" uniqKey="Bruggmann P" first="Philip" last="Bruggmann">Philip Bruggmann</name><affiliation><nlm:affiliation>Arud Centres for Addiction Medicine, Zürich, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Dalgard, Olav" sort="Dalgard, Olav" uniqKey="Dalgard O" first="Olav" last="Dalgard">Olav Dalgard</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Akershus University Hospital, University of Oslo, Oslo, Norway.</nlm:affiliation></affiliation></author><author><name sortKey="Seguin Devaux, Carole" sort="Seguin Devaux, Carole" uniqKey="Seguin Devaux C" first="Carole" last="Seguin-Devaux">Carole Seguin-Devaux</name><affiliation><nlm:affiliation>Department of Infection and Immunity, Luxembourg Institute of Health, Luxembourg City, Luxembourg.</nlm:affiliation></affiliation></author><author><name sortKey="Flisiak, Robert" sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name><affiliation><nlm:affiliation>Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Foster, Graham R" sort="Foster, Graham R" uniqKey="Foster G" first="Graham R" last="Foster">Graham R. Foster</name><affiliation><nlm:affiliation>Queen Mary University of London, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Gheorghe, Liana" sort="Gheorghe, Liana" uniqKey="Gheorghe L" first="Liana" last="Gheorghe">Liana Gheorghe</name><affiliation><nlm:affiliation>Gastroenterology and Hepatology, Fundeni Clinical Institute, Bucharest, Romania.</nlm:affiliation></affiliation></author><author><name sortKey="Goldberg, David" sort="Goldberg, David" uniqKey="Goldberg D" first="David" last="Goldberg">David Goldberg</name><affiliation><nlm:affiliation>Health Protection Scotland, Glasgow, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Goulis, Ioannis" sort="Goulis, Ioannis" uniqKey="Goulis I" first="Ioannis" last="Goulis">Ioannis Goulis</name><affiliation><nlm:affiliation>Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.</nlm:affiliation></affiliation></author><author><name sortKey="Hickman, Matthew" sort="Hickman, Matthew" uniqKey="Hickman M" first="Matthew" last="Hickman">Matthew Hickman</name><affiliation><nlm:affiliation>Social Medicine, University of Bristol, Bristol, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Hoffmann, Patrick" sort="Hoffmann, Patrick" uniqKey="Hoffmann P" first="Patrick" last="Hoffmann">Patrick Hoffmann</name><affiliation><nlm:affiliation>Ministry of Health, Luxembourg City, Luxembourg.</nlm:affiliation></affiliation></author><author><name sortKey="Jancorien, Ligita" sort="Jancorien, Ligita" uniqKey="Jancorien L" first="Ligita" last="Jancorien">Ligita Jancorien</name><affiliation><nlm:affiliation>Centre of Infectious Diseases, Vilnius University Hospital Santaros Klinikos, Vilnius University, Vilnius, Lithuania.</nlm:affiliation></affiliation></author><author><name sortKey="Jarcuska, Peter" sort="Jarcuska, Peter" uniqKey="Jarcuska P" first="Peter" last="Jarcuska">Peter Jarcuska</name><affiliation><nlm:affiliation>First Department of Internal Medicine, University Hospital, University of Pavol Jozef Safarik, Kosice, Slovakia.</nlm:affiliation></affiliation></author><author><name sortKey="K Berg, Martin" sort="K Berg, Martin" uniqKey="K Berg M" first="Martin" last="K Berg">Martin K Berg</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.</nlm:affiliation></affiliation></author><author><name sortKey="Kostrikis, Leondios G" sort="Kostrikis, Leondios G" uniqKey="Kostrikis L" first="Leondios G" last="Kostrikis">Leondios G. Kostrikis</name><affiliation><nlm:affiliation>University of Cyprus, Nicosia, Cyprus.</nlm:affiliation></affiliation></author><author><name sortKey="Makara, Mihaly" sort="Makara, Mihaly" uniqKey="Makara M" first="Mihály" last="Makara">Mihály Makara</name><affiliation><nlm:affiliation>Hepatology Center, St István and St László Hospital, Budapest, Hungary.</nlm:affiliation></affiliation></author><author><name sortKey="Maimets, Matti" sort="Maimets, Matti" uniqKey="Maimets M" first="Matti" last="Maimets">Matti Maimets</name><affiliation><nlm:affiliation>Department of Internal Medicine, University of Tartu, Estonia.</nlm:affiliation></affiliation></author><author><name sortKey="Marinho, Rui Tato" sort="Marinho, Rui Tato" uniqKey="Marinho R" first="Rui Tato" last="Marinho">Rui Tato Marinho</name><affiliation><nlm:affiliation>Department of Gastroenterology and Hepatology, Hospital Santa Maria, Medical School Lisbon, University of Lisbon, Lisbon, Portugal.</nlm:affiliation></affiliation></author><author><name sortKey="Mati I, Mojca" sort="Mati I, Mojca" uniqKey="Mati I M" first="Mojca" last="Mati I">Mojca Mati I</name><affiliation><nlm:affiliation>Clinic for Infectious Diseases and Febrile Illnesses, University Medical Centre, Ljubljana, Slovenia.</nlm:affiliation></affiliation></author><author><name sortKey="Norris, Suzanne" sort="Norris, Suzanne" uniqKey="Norris S" first="Suzanne" last="Norris">Suzanne Norris</name><affiliation><nlm:affiliation>National Hepatitis C Treatment Programme, Health Service Executive, Dr Steevens' Hospital, Dublin, Ireland.</nlm:affiliation></affiliation></author><author><name sortKey=" Lafsson, Sigur Ur" sort=" Lafsson, Sigur Ur" uniqKey=" Lafsson S" first="Sigur Ur" last=" Lafsson">Sigur Ur Lafsson</name><affiliation><nlm:affiliation>Division of Gastroenterology, Department of Medicine, Landspitali University Hospital, Reykjavik, Iceland.</nlm:affiliation></affiliation></author><author><name sortKey=" Vrehus, Anne" sort=" Vrehus, Anne" uniqKey=" Vrehus A" first="Anne" last=" Vrehus">Anne Vrehus</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Odense University Hospital, University of Southern Denmark, Odense, Denmark.</nlm:affiliation></affiliation></author><author><name sortKey="Pawlotsky, Jean Michel" sort="Pawlotsky, Jean Michel" uniqKey="Pawlotsky J" first="Jean-Michel" last="Pawlotsky">Jean-Michel Pawlotsky</name><affiliation><nlm:affiliation>Hopital Henri Mondor, Universite Paris Est, Créteil, France.</nlm:affiliation></affiliation></author><author><name sortKey="Pocock, James" sort="Pocock, James" uniqKey="Pocock J" first="James" last="Pocock">James Pocock</name><affiliation><nlm:affiliation>Gastroenterology Department, Mater Dei Hospital, Msida, Malta.</nlm:affiliation></affiliation></author><author><name sortKey="Robaeys, Geert" sort="Robaeys, Geert" uniqKey="Robaeys G" first="Geert" last="Robaeys">Geert Robaeys</name><affiliation><nlm:affiliation>Department of Gastroenterology and Hepatology, Ziekenhuis Oost Limburg, Genk, Belgium; Department of Medicine and Life Sciences, University of Hasselt, Hasselt, Belgium; Department of Hepatology, UZ Leuven, Leuven, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Roncero, Carlos" sort="Roncero, Carlos" uniqKey="Roncero C" first="Carlos" last="Roncero">Carlos Roncero</name><affiliation><nlm:affiliation>Addiction and Dual Diagnosis Unit, Psychiatric Department, Hospital Universitario Vall d'Hebron, Universidad Autónoma de Barcelona, Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Simonova, Marieta" sort="Simonova, Marieta" uniqKey="Simonova M" first="Marieta" last="Simonova">Marieta Simonova</name><affiliation><nlm:affiliation>Department of Gastroenterology, Hepato-Pancreato-Biliary Surgery and Transplantology, Military Medical Academy, Sofia, Bulgaria.</nlm:affiliation></affiliation></author><author><name sortKey="Sperl, Jan" sort="Sperl, Jan" uniqKey="Sperl J" first="Jan" last="Sperl">Jan Sperl</name><affiliation><nlm:affiliation>Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Tait, Michele" sort="Tait, Michele" uniqKey="Tait M" first="Michele" last="Tait">Michele Tait</name><affiliation><nlm:affiliation>National Hepatitis C Treatment Programme, Health Service Executive, Dr Steevens' Hospital, Dublin, Ireland.</nlm:affiliation></affiliation></author><author><name sortKey="Tolmane, Ieva" sort="Tolmane, Ieva" uniqKey="Tolmane I" first="Ieva" last="Tolmane">Ieva Tolmane</name><affiliation><nlm:affiliation>Department of Hepatology, Infectology Center of Latvia, Riga East University Hospital, Riga, Latvia; Faculty of Medicine, University of Latvia, Riga, Latvia.</nlm:affiliation></affiliation></author><author><name sortKey="Tomaselli, Stefan" sort="Tomaselli, Stefan" uniqKey="Tomaselli S" first="Stefan" last="Tomaselli">Stefan Tomaselli</name><affiliation><nlm:affiliation>Office of Public Health, Vaduz, Liechtenstein.</nlm:affiliation></affiliation></author><author><name sortKey="Van Der Valk, Marc" sort="Van Der Valk, Marc" uniqKey="Van Der Valk M" first="Marc" last="Van Der Valk">Marc Van Der Valk</name><affiliation><nlm:affiliation>Department of Infectious Diseases, Academic Medical Center, Amsterdam, Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Vince, Adriana" sort="Vince, Adriana" uniqKey="Vince A" first="Adriana" last="Vince">Adriana Vince</name><affiliation><nlm:affiliation>University Hospital for Infectious Diseases, University of Zagreb, Zagreb, Croatia.</nlm:affiliation></affiliation></author><author><name sortKey="Dore, Gregory J" sort="Dore, Gregory J" uniqKey="Dore G" first="Gregory J" last="Dore">Gregory J. Dore</name><affiliation><nlm:affiliation>The Kirby Institute, UNSW Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Lazarus, Jeffrey V" sort="Lazarus, Jeffrey V" uniqKey="Lazarus J" first="Jeffrey V" last="Lazarus">Jeffrey V. Lazarus</name><affiliation><nlm:affiliation>Barcelona Institute for Global Health (ISGlobal), Hospital Clínic, Univeristy of Barcelona, Barcelona, Spain; CHIP, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation></affiliation></author><author><name sortKey="Grebely, Jason" sort="Grebely, Jason" uniqKey="Grebely J" first="Jason" last="Grebely">Jason Grebely</name><affiliation><nlm:affiliation>The Kirby Institute, UNSW Sydney, NSW, Australia.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The lancet. Gastroenterology & hepatology</title><idno type="eISSN">2468-1253</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions. Among the 35 European countries and jurisdictions included, the most commonly reimbursed DAA was ombitasvir, paritaprevir, and ritonavir, with dasabuvir, and with or without ribavirin (33 [94%] countries and jurisdictions). 16 (46%) countries and jurisdictions required patients to have fibrosis at stage F2 or higher, 29 (83%) had no listed restrictions based on drug or alcohol use, 33 (94%) required a specialist prescriber, and 34 (97%) had no additional restrictions for people co-infected with HIV and hepatitis C virus. These findings have implications for meeting WHO targets, with evidence of some countries not following the 2016 hepatitis C virus treatment guidelines by the European Association for the Study of Liver.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">28986139</PMID><DateCreated><Year>2017</Year><Month>10</Month><Day>07</Day></DateCreated><DateRevised><Year>2017</Year><Month>10</Month><Day>07</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2468-1253</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2017</Year><Month>Oct</Month><Day>03</Day></PubDate></JournalIssue><Title>The lancet. Gastroenterology & hepatology</Title><ISOAbbreviation>Lancet Gastroenterol Hepatol</ISOAbbreviation></Journal><ArticleTitle>Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">S2468-1253(17)30284-4</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S2468-1253(17)30284-4</ELocationID><Abstract><AbstractText>All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions. Among the 35 European countries and jurisdictions included, the most commonly reimbursed DAA was ombitasvir, paritaprevir, and ritonavir, with dasabuvir, and with or without ribavirin (33 [94%] countries and jurisdictions). 16 (46%) countries and jurisdictions required patients to have fibrosis at stage F2 or higher, 29 (83%) had no listed restrictions based on drug or alcohol use, 33 (94%) required a specialist prescriber, and 34 (97%) had no additional restrictions for people co-infected with HIV and hepatitis C virus. These findings have implications for meeting WHO targets, with evidence of some countries not following the 2016 hepatitis C virus treatment guidelines by the European Association for the Study of Liver.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Marshall</LastName><ForeName>Alison D</ForeName><Initials>AD</Initials><AffiliationInfo><Affiliation>The Kirby Institute, UNSW Sydney, NSW, Australia. Electronic address: amarshall@kirby.unsw.edu.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cunningham</LastName><ForeName>Evan B</ForeName><Initials>EB</Initials><AffiliationInfo><Affiliation>The Kirby Institute, UNSW Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nielsen</LastName><ForeName>Stine</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>INHSU, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aghemo</LastName><ForeName>Alessio</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Biomedical Sciences and Humanitas Clinical and Research Center, Humanitas University, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Alho</LastName><ForeName>Hannu</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Abdominal Center, Helsinki University Hospital, Helsinki University, Helsinki, Finland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Backmund</LastName><ForeName>Markus</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Ludwig-Maximilians-University, Munich, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bruggmann</LastName><ForeName>Philip</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Arud Centres for Addiction Medicine, Zürich, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dalgard</LastName><ForeName>Olav</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, Akershus University Hospital, University of Oslo, Oslo, Norway.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Seguin-Devaux</LastName><ForeName>Carole</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Infection and Immunity, Luxembourg Institute of Health, Luxembourg City, Luxembourg.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Flisiak</LastName><ForeName>Robert</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Foster</LastName><ForeName>Graham R</ForeName><Initials>GR</Initials><AffiliationInfo><Affiliation>Queen Mary University of London, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gheorghe</LastName><ForeName>Liana</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Gastroenterology and Hepatology, Fundeni Clinical Institute, Bucharest, Romania.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goldberg</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Health Protection Scotland, Glasgow, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goulis</LastName><ForeName>Ioannis</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hickman</LastName><ForeName>Matthew</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Social Medicine, University of Bristol, Bristol, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hoffmann</LastName><ForeName>Patrick</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Ministry of Health, Luxembourg City, Luxembourg.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jancorienė</LastName><ForeName>Ligita</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Centre of Infectious Diseases, Vilnius University Hospital Santaros Klinikos, Vilnius University, Vilnius, Lithuania.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jarcuska</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>First Department of Internal Medicine, University Hospital, University of Pavol Jozef Safarik, Kosice, Slovakia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kåberg</LastName><ForeName>Martin</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kostrikis</LastName><ForeName>Leondios G</ForeName><Initials>LG</Initials><AffiliationInfo><Affiliation>University of Cyprus, Nicosia, Cyprus.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Makara</LastName><ForeName>Mihály</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Hepatology Center, St István and St László Hospital, Budapest, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Maimets</LastName><ForeName>Matti</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, University of Tartu, Estonia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marinho</LastName><ForeName>Rui Tato</ForeName><Initials>RT</Initials><AffiliationInfo><Affiliation>Department of Gastroenterology and Hepatology, Hospital Santa Maria, Medical School Lisbon, University of Lisbon, Lisbon, Portugal.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Matičič</LastName><ForeName>Mojca</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Clinic for Infectious Diseases and Febrile Illnesses, University Medical Centre, Ljubljana, Slovenia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Norris</LastName><ForeName>Suzanne</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>National Hepatitis C Treatment Programme, Health Service Executive, Dr Steevens' Hospital, Dublin, Ireland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ólafsson</LastName><ForeName>Sigurður</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Division of Gastroenterology, Department of Medicine, Landspitali University Hospital, Reykjavik, Iceland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Øvrehus</LastName><ForeName>Anne</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, Odense University Hospital, University of Southern Denmark, Odense, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pawlotsky</LastName><ForeName>Jean-Michel</ForeName><Initials>JM</Initials><AffiliationInfo><Affiliation>Hopital Henri Mondor, Universite Paris Est, Créteil, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pocock</LastName><ForeName>James</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Gastroenterology Department, Mater Dei Hospital, Msida, Malta.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robaeys</LastName><ForeName>Geert</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Gastroenterology and Hepatology, Ziekenhuis Oost Limburg, Genk, Belgium; Department of Medicine and Life Sciences, University of Hasselt, Hasselt, Belgium; Department of Hepatology, UZ Leuven, Leuven, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Roncero</LastName><ForeName>Carlos</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Addiction and Dual Diagnosis Unit, Psychiatric Department, Hospital Universitario Vall d'Hebron, Universidad Autónoma de Barcelona, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Simonova</LastName><ForeName>Marieta</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Gastroenterology, Hepato-Pancreato-Biliary Surgery and Transplantology, Military Medical Academy, Sofia, Bulgaria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sperl</LastName><ForeName>Jan</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tait</LastName><ForeName>Michele</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>National Hepatitis C Treatment Programme, Health Service Executive, Dr Steevens' Hospital, Dublin, Ireland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tolmane</LastName><ForeName>Ieva</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Department of Hepatology, Infectology Center of Latvia, Riga East University Hospital, Riga, Latvia; Faculty of Medicine, University of Latvia, Riga, Latvia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tomaselli</LastName><ForeName>Stefan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Office of Public Health, Vaduz, Liechtenstein.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van der Valk</LastName><ForeName>Marc</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, Academic Medical Center, Amsterdam, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vince</LastName><ForeName>Adriana</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>University Hospital for Infectious Diseases, University of Zagreb, Zagreb, Croatia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dore</LastName><ForeName>Gregory J</ForeName><Initials>GJ</Initials><AffiliationInfo><Affiliation>The Kirby Institute, UNSW Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lazarus</LastName><ForeName>Jeffrey V</ForeName><Initials>JV</Initials><AffiliationInfo><Affiliation>Barcelona Institute for Global Health (ISGlobal), Hospital Clínic, Univeristy of Barcelona, Barcelona, Spain; CHIP, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grebely</LastName><ForeName>Jason</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>The Kirby Institute, UNSW Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>International Network on Hepatitis in Substance Users (INHSU)</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>10</Month><Day>03</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Lancet Gastroenterol Hepatol</MedlineTA><NlmUniqueID>101690683</NlmUniqueID></MedlineJournalInfo></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>07</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2017</Year><Month>08</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>08</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>10</Month><Day>8</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>10</Month><Day>8</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>10</Month><Day>8</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28986139</ArticleId><ArticleId IdType="pii">S2468-1253(17)30284-4</ArticleId><ArticleId 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