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Follow‐up of sustained virological responders with hepatitis C and advanced liver disease after interferon/ribavirin‐free treatment
Background The introduction of direct‐acting antivirals (DAA) has increased sustained virological response (SVR) rates in patients with advanced liver disease and chronic hepatitis C(CHC)infection. At present, data on clinical outcome and long‐term durability of viral eradication after successful DA...
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Published in: | Liver international 2018-06, Vol.38 (6), p.1028-1035 |
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creator | Kozbial, Karin Moser, Stephan Al‐Zoairy, Ramona Schwarzer, Remy Datz, Christian Stauber, Rudolf Laferl, Hermann Strasser, Michael Beinhardt, Sandra Stättermayer, Albert F. Gschwantler, Michael Zoller, Heinz Maieron, Andreas Graziadei, Ivo Trauner, Michael Steindl‐Munda, Petra Hofer, Harald Ferenci, Peter |
description | Background
The introduction of direct‐acting antivirals (DAA) has increased sustained virological response (SVR) rates in patients with advanced liver disease and chronic hepatitis C(CHC)infection. At present, data on clinical outcome and long‐term durability of viral eradication after successful DAA therapy are scarce.
Aim
To evaluate the long‐term success of viral eradication in patients with advanced fibrosis or cirrhosis treated with DAAs.
Methods
Five hundred and fifty‐one patients with advanced fibrosis (n = 158) or cirrhosis (CPS‐A:317,CPS‐B/C:76) and SVR after interferon and ribavirin‐free DAA therapy treated between October 2013 and April 2016 were studied with a median follow‐up of 65.6 (13.0‐155.3) weeks. Only patients without hepatocellular carcinoma (HCC) at baseline and without liver transplantation were included.
Results
Twelve patients (2.2%) died during follow‐up: the mortality rate was 0.6% in F3, 2.2% in CPS‐A and 5.3% in CPS‐B/C patients (P = .08). During follow‐up 36 patients with cirrhosis (9.1%) developed a liver related event, including 16 with de‐novo HCC (4.1%). Seven patients were transplanted at a median of 9.7 (range 3.8‐21.7) months after EOT. History of decompensation was significantly associated with liver related events during follow‐up (HR 7.9; 95% CI 2.7‐22.6; P |
doi_str_mv | 10.1111/liv.13629 |
format | article |
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The introduction of direct‐acting antivirals (DAA) has increased sustained virological response (SVR) rates in patients with advanced liver disease and chronic hepatitis C(CHC)infection. At present, data on clinical outcome and long‐term durability of viral eradication after successful DAA therapy are scarce.
Aim
To evaluate the long‐term success of viral eradication in patients with advanced fibrosis or cirrhosis treated with DAAs.
Methods
Five hundred and fifty‐one patients with advanced fibrosis (n = 158) or cirrhosis (CPS‐A:317,CPS‐B/C:76) and SVR after interferon and ribavirin‐free DAA therapy treated between October 2013 and April 2016 were studied with a median follow‐up of 65.6 (13.0‐155.3) weeks. Only patients without hepatocellular carcinoma (HCC) at baseline and without liver transplantation were included.
Results
Twelve patients (2.2%) died during follow‐up: the mortality rate was 0.6% in F3, 2.2% in CPS‐A and 5.3% in CPS‐B/C patients (P = .08). During follow‐up 36 patients with cirrhosis (9.1%) developed a liver related event, including 16 with de‐novo HCC (4.1%). Seven patients were transplanted at a median of 9.7 (range 3.8‐21.7) months after EOT. History of decompensation was significantly associated with liver related events during follow‐up (HR 7.9; 95% CI 2.7‐22.6; P < .001), and with mortality (HR 5.5; 95% CI 1.5‐20.2, P = .01).
Conclusions
Eradication of HCV by DAA therapy was durable irrespective of the DAA combination used. Most of the cured patients had an excellent long‐term clinical prognosis. Nevertheless, the risk of new occurrence of HCC remains worrisome and thus regular surveillance is obligatory even after clinical stabilization and improvement of the patient.</description><identifier>ISSN: 1478-3223</identifier><identifier>EISSN: 1478-3231</identifier><identifier>DOI: 10.1111/liv.13629</identifier><identifier>PMID: 29136329</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Aged ; Antiviral agents ; Antiviral Agents - therapeutic use ; Austria ; Carcinoma, Hepatocellular - complications ; Carcinoma, Hepatocellular - virology ; Chronic infection ; Cirrhosis ; Durability ; Eradication ; Female ; Fibrosis ; Follow-Up Studies ; follow‐up ; Hepatitis ; Hepatitis C ; Hepatitis C, Chronic - complications ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - mortality ; Hepatocellular carcinoma ; Humans ; Interferon ; Interferons ; interferon‐free treatment ; Liver ; Liver cirrhosis ; Liver Cirrhosis - complications ; Liver Cirrhosis - virology ; Liver diseases ; Liver Neoplasms - complications ; Liver Neoplasms - virology ; Liver transplantation ; Logistic Models ; Male ; Medical treatment ; Middle Aged ; Mortality ; Patients ; Ribavirin ; Sustained Virologic Response ; sustained virological response ; Therapy ; Transplantation</subject><ispartof>Liver international, 2018-06, Vol.38 (6), p.1028-1035</ispartof><rights>2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd</rights><rights>2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.</rights><rights>2018 John Wiley & Sons A/S</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3539-83e6c8bbca941826e7f55803deb499c05ddd435ed15b866a8fb2b6794dfb52d3</citedby><cites>FETCH-LOGICAL-c3539-83e6c8bbca941826e7f55803deb499c05ddd435ed15b866a8fb2b6794dfb52d3</cites><orcidid>0000-0002-5012-7662 ; 0000-0002-0785-9710 ; 0000-0002-2523-1708</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29136329$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kozbial, Karin</creatorcontrib><creatorcontrib>Moser, Stephan</creatorcontrib><creatorcontrib>Al‐Zoairy, Ramona</creatorcontrib><creatorcontrib>Schwarzer, Remy</creatorcontrib><creatorcontrib>Datz, Christian</creatorcontrib><creatorcontrib>Stauber, Rudolf</creatorcontrib><creatorcontrib>Laferl, Hermann</creatorcontrib><creatorcontrib>Strasser, Michael</creatorcontrib><creatorcontrib>Beinhardt, Sandra</creatorcontrib><creatorcontrib>Stättermayer, Albert F.</creatorcontrib><creatorcontrib>Gschwantler, Michael</creatorcontrib><creatorcontrib>Zoller, Heinz</creatorcontrib><creatorcontrib>Maieron, Andreas</creatorcontrib><creatorcontrib>Graziadei, Ivo</creatorcontrib><creatorcontrib>Trauner, Michael</creatorcontrib><creatorcontrib>Steindl‐Munda, Petra</creatorcontrib><creatorcontrib>Hofer, Harald</creatorcontrib><creatorcontrib>Ferenci, Peter</creatorcontrib><title>Follow‐up of sustained virological responders with hepatitis C and advanced liver disease after interferon/ribavirin‐free treatment</title><title>Liver international</title><addtitle>Liver Int</addtitle><description>Background
The introduction of direct‐acting antivirals (DAA) has increased sustained virological response (SVR) rates in patients with advanced liver disease and chronic hepatitis C(CHC)infection. At present, data on clinical outcome and long‐term durability of viral eradication after successful DAA therapy are scarce.
Aim
To evaluate the long‐term success of viral eradication in patients with advanced fibrosis or cirrhosis treated with DAAs.
Methods
Five hundred and fifty‐one patients with advanced fibrosis (n = 158) or cirrhosis (CPS‐A:317,CPS‐B/C:76) and SVR after interferon and ribavirin‐free DAA therapy treated between October 2013 and April 2016 were studied with a median follow‐up of 65.6 (13.0‐155.3) weeks. Only patients without hepatocellular carcinoma (HCC) at baseline and without liver transplantation were included.
Results
Twelve patients (2.2%) died during follow‐up: the mortality rate was 0.6% in F3, 2.2% in CPS‐A and 5.3% in CPS‐B/C patients (P = .08). During follow‐up 36 patients with cirrhosis (9.1%) developed a liver related event, including 16 with de‐novo HCC (4.1%). Seven patients were transplanted at a median of 9.7 (range 3.8‐21.7) months after EOT. History of decompensation was significantly associated with liver related events during follow‐up (HR 7.9; 95% CI 2.7‐22.6; P < .001), and with mortality (HR 5.5; 95% CI 1.5‐20.2, P = .01).
Conclusions
Eradication of HCV by DAA therapy was durable irrespective of the DAA combination used. Most of the cured patients had an excellent long‐term clinical prognosis. Nevertheless, the risk of new occurrence of HCC remains worrisome and thus regular surveillance is obligatory even after clinical stabilization and improvement of the patient.</description><subject>Aged</subject><subject>Antiviral agents</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Austria</subject><subject>Carcinoma, Hepatocellular - complications</subject><subject>Carcinoma, Hepatocellular - virology</subject><subject>Chronic infection</subject><subject>Cirrhosis</subject><subject>Durability</subject><subject>Eradication</subject><subject>Female</subject><subject>Fibrosis</subject><subject>Follow-Up Studies</subject><subject>follow‐up</subject><subject>Hepatitis</subject><subject>Hepatitis C</subject><subject>Hepatitis C, Chronic - complications</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatitis C, Chronic - mortality</subject><subject>Hepatocellular carcinoma</subject><subject>Humans</subject><subject>Interferon</subject><subject>Interferons</subject><subject>interferon‐free treatment</subject><subject>Liver</subject><subject>Liver cirrhosis</subject><subject>Liver Cirrhosis - complications</subject><subject>Liver Cirrhosis - virology</subject><subject>Liver diseases</subject><subject>Liver Neoplasms - complications</subject><subject>Liver Neoplasms - virology</subject><subject>Liver transplantation</subject><subject>Logistic Models</subject><subject>Male</subject><subject>Medical treatment</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Patients</subject><subject>Ribavirin</subject><subject>Sustained Virologic Response</subject><subject>sustained virological response</subject><subject>Therapy</subject><subject>Transplantation</subject><issn>1478-3223</issn><issn>1478-3231</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNp1kc9uVCEUh4mxsbW68AUMiRtdTIc_lzuXpZlYbTJJN41bApeDpWHgCtyZdOfObZ-xTyI6tYsmZXHgJB8fJ_wQekfJGW1rGfzujPKeyRfohHarYcEZpy8fz4wfo9el3BBCpRT0FTpmsuGcyRP0-zyFkPb3v-7mCSeHy1yq9hEs3vmcQvrhRx1whjKlaCEXvPf1Gl_DpKuvvuA11tFibXc6ju1SmwQytr6ALoC1q63zsVUHOcVl9kY3r4_tPZcBcM2g6xZifYOOnA4F3j7sp-jq_MvV-ttic_n1Yv15sxi54HIxcOjHwZhRy44OrIeVE2Ig3ILppByJsNZ2XIClwgx9rwdnmOlXsrPOCGb5Kfp40E45_ZyhVLX1ZYQQdIQ0F0Vl360IYaJv6Icn6E2ac2zDKUY62UkmBtGoTwdqzKmUDE5N2W91vlWUqL_hqPYl6l84jX3_YJzNFuwj-T-NBiwPwN4HuH3epDYX3w_KP6RancE</recordid><startdate>201806</startdate><enddate>201806</enddate><creator>Kozbial, Karin</creator><creator>Moser, Stephan</creator><creator>Al‐Zoairy, Ramona</creator><creator>Schwarzer, Remy</creator><creator>Datz, Christian</creator><creator>Stauber, Rudolf</creator><creator>Laferl, Hermann</creator><creator>Strasser, Michael</creator><creator>Beinhardt, Sandra</creator><creator>Stättermayer, Albert F.</creator><creator>Gschwantler, Michael</creator><creator>Zoller, Heinz</creator><creator>Maieron, Andreas</creator><creator>Graziadei, Ivo</creator><creator>Trauner, Michael</creator><creator>Steindl‐Munda, Petra</creator><creator>Hofer, Harald</creator><creator>Ferenci, Peter</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7T5</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-5012-7662</orcidid><orcidid>https://orcid.org/0000-0002-0785-9710</orcidid><orcidid>https://orcid.org/0000-0002-2523-1708</orcidid></search><sort><creationdate>201806</creationdate><title>Follow‐up of sustained virological responders with hepatitis C and advanced liver disease after interferon/ribavirin‐free treatment</title><author>Kozbial, Karin ; Moser, Stephan ; Al‐Zoairy, Ramona ; Schwarzer, Remy ; Datz, Christian ; Stauber, Rudolf ; Laferl, Hermann ; Strasser, Michael ; Beinhardt, Sandra ; Stättermayer, Albert F. ; Gschwantler, Michael ; Zoller, Heinz ; Maieron, Andreas ; Graziadei, Ivo ; Trauner, Michael ; Steindl‐Munda, Petra ; Hofer, Harald ; Ferenci, Peter</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3539-83e6c8bbca941826e7f55803deb499c05ddd435ed15b866a8fb2b6794dfb52d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aged</topic><topic>Antiviral agents</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Austria</topic><topic>Carcinoma, Hepatocellular - complications</topic><topic>Carcinoma, Hepatocellular - virology</topic><topic>Chronic infection</topic><topic>Cirrhosis</topic><topic>Durability</topic><topic>Eradication</topic><topic>Female</topic><topic>Fibrosis</topic><topic>Follow-Up Studies</topic><topic>follow‐up</topic><topic>Hepatitis</topic><topic>Hepatitis C</topic><topic>Hepatitis C, Chronic - complications</topic><topic>Hepatitis C, Chronic - drug therapy</topic><topic>Hepatitis C, Chronic - mortality</topic><topic>Hepatocellular carcinoma</topic><topic>Humans</topic><topic>Interferon</topic><topic>Interferons</topic><topic>interferon‐free treatment</topic><topic>Liver</topic><topic>Liver cirrhosis</topic><topic>Liver Cirrhosis - complications</topic><topic>Liver Cirrhosis - virology</topic><topic>Liver diseases</topic><topic>Liver Neoplasms - complications</topic><topic>Liver Neoplasms - virology</topic><topic>Liver transplantation</topic><topic>Logistic Models</topic><topic>Male</topic><topic>Medical treatment</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>Patients</topic><topic>Ribavirin</topic><topic>Sustained Virologic Response</topic><topic>sustained virological response</topic><topic>Therapy</topic><topic>Transplantation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kozbial, Karin</creatorcontrib><creatorcontrib>Moser, Stephan</creatorcontrib><creatorcontrib>Al‐Zoairy, Ramona</creatorcontrib><creatorcontrib>Schwarzer, Remy</creatorcontrib><creatorcontrib>Datz, Christian</creatorcontrib><creatorcontrib>Stauber, Rudolf</creatorcontrib><creatorcontrib>Laferl, Hermann</creatorcontrib><creatorcontrib>Strasser, Michael</creatorcontrib><creatorcontrib>Beinhardt, Sandra</creatorcontrib><creatorcontrib>Stättermayer, Albert F.</creatorcontrib><creatorcontrib>Gschwantler, Michael</creatorcontrib><creatorcontrib>Zoller, Heinz</creatorcontrib><creatorcontrib>Maieron, Andreas</creatorcontrib><creatorcontrib>Graziadei, Ivo</creatorcontrib><creatorcontrib>Trauner, Michael</creatorcontrib><creatorcontrib>Steindl‐Munda, Petra</creatorcontrib><creatorcontrib>Hofer, Harald</creatorcontrib><creatorcontrib>Ferenci, Peter</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Liver international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kozbial, Karin</au><au>Moser, Stephan</au><au>Al‐Zoairy, Ramona</au><au>Schwarzer, Remy</au><au>Datz, Christian</au><au>Stauber, Rudolf</au><au>Laferl, Hermann</au><au>Strasser, Michael</au><au>Beinhardt, Sandra</au><au>Stättermayer, Albert F.</au><au>Gschwantler, Michael</au><au>Zoller, Heinz</au><au>Maieron, Andreas</au><au>Graziadei, Ivo</au><au>Trauner, Michael</au><au>Steindl‐Munda, Petra</au><au>Hofer, Harald</au><au>Ferenci, Peter</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Follow‐up of sustained virological responders with hepatitis C and advanced liver disease after interferon/ribavirin‐free treatment</atitle><jtitle>Liver international</jtitle><addtitle>Liver Int</addtitle><date>2018-06</date><risdate>2018</risdate><volume>38</volume><issue>6</issue><spage>1028</spage><epage>1035</epage><pages>1028-1035</pages><issn>1478-3223</issn><eissn>1478-3231</eissn><abstract>Background
The introduction of direct‐acting antivirals (DAA) has increased sustained virological response (SVR) rates in patients with advanced liver disease and chronic hepatitis C(CHC)infection. At present, data on clinical outcome and long‐term durability of viral eradication after successful DAA therapy are scarce.
Aim
To evaluate the long‐term success of viral eradication in patients with advanced fibrosis or cirrhosis treated with DAAs.
Methods
Five hundred and fifty‐one patients with advanced fibrosis (n = 158) or cirrhosis (CPS‐A:317,CPS‐B/C:76) and SVR after interferon and ribavirin‐free DAA therapy treated between October 2013 and April 2016 were studied with a median follow‐up of 65.6 (13.0‐155.3) weeks. Only patients without hepatocellular carcinoma (HCC) at baseline and without liver transplantation were included.
Results
Twelve patients (2.2%) died during follow‐up: the mortality rate was 0.6% in F3, 2.2% in CPS‐A and 5.3% in CPS‐B/C patients (P = .08). During follow‐up 36 patients with cirrhosis (9.1%) developed a liver related event, including 16 with de‐novo HCC (4.1%). Seven patients were transplanted at a median of 9.7 (range 3.8‐21.7) months after EOT. History of decompensation was significantly associated with liver related events during follow‐up (HR 7.9; 95% CI 2.7‐22.6; P < .001), and with mortality (HR 5.5; 95% CI 1.5‐20.2, P = .01).
Conclusions
Eradication of HCV by DAA therapy was durable irrespective of the DAA combination used. Most of the cured patients had an excellent long‐term clinical prognosis. Nevertheless, the risk of new occurrence of HCC remains worrisome and thus regular surveillance is obligatory even after clinical stabilization and improvement of the patient.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>29136329</pmid><doi>10.1111/liv.13629</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-5012-7662</orcidid><orcidid>https://orcid.org/0000-0002-0785-9710</orcidid><orcidid>https://orcid.org/0000-0002-2523-1708</orcidid></addata></record> |
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subjects | Aged Antiviral agents Antiviral Agents - therapeutic use Austria Carcinoma, Hepatocellular - complications Carcinoma, Hepatocellular - virology Chronic infection Cirrhosis Durability Eradication Female Fibrosis Follow-Up Studies follow‐up Hepatitis Hepatitis C Hepatitis C, Chronic - complications Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - mortality Hepatocellular carcinoma Humans Interferon Interferons interferon‐free treatment Liver Liver cirrhosis Liver Cirrhosis - complications Liver Cirrhosis - virology Liver diseases Liver Neoplasms - complications Liver Neoplasms - virology Liver transplantation Logistic Models Male Medical treatment Middle Aged Mortality Patients Ribavirin Sustained Virologic Response sustained virological response Therapy Transplantation |
title | Follow‐up of sustained virological responders with hepatitis C and advanced liver disease after interferon/ribavirin‐free treatment |
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