Impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis
Background & Aims All oral direct acting antivirals (DAAs) effectively treat chronic hepatitis C virus (HCV) infection, but the benefits in advanced liver disease are unclear. We compared outcomes in treated and untreated patients with decompensated cirrhosis. Methods Patients with HCV and decom...
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| Veröffentlicht in: | Journal of hepatology 2016-06, Vol.64 (6), p.1224-1231 |
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| creator | Foster, Graham R Irving, William L Cheung, Michelle C.M Walker, Alex J Hudson, Benjamin E Verma, Suman McLauchlan, John Mutimer, David J Brown, Ashley Gelson, William T.H MacDonald, Douglas C Agarwal, Kosh |
| description | Background & Aims All oral direct acting antivirals (DAAs) effectively treat chronic hepatitis C virus (HCV) infection, but the benefits in advanced liver disease are unclear. We compared outcomes in treated and untreated patients with decompensated cirrhosis. Methods Patients with HCV and decompensated cirrhosis or at risk of irreversible disease were treated in an expanded access programme (EAP) in 2014. Treatment, by clinician choice, was with sofosbuvir, ledipasvir or daclatasvir, with or without ribavirin. For functional outcome comparison, untreated patients with HCV and decompensated cirrhosis who were registered on a database 6 months before treatment was available were retrospectively studied. Primary endpoint was sustained virological response 12 weeks post antiviral treatment (treated cohort) and the secondary endpoint (both cohorts) was adverse outcomes (worsening in MELD score or serious adverse event) within 6 months. Results 467 patients received treatment (409 decompensated cirrhosis). Viral clearance was achieved in 381 patients (81.6%) – 209 from 231 (90.5%) with genotype 1 and 132 from 192 (68.8%) with genotype 3. MELD scores improved in treated patients (mean change −0.85) but worsened in untreated patients (mean + 0.75) ( p |
| doi_str_mv | 10.1016/j.jhep.2016.01.029 |
| format | Article |
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We compared outcomes in treated and untreated patients with decompensated cirrhosis. Methods Patients with HCV and decompensated cirrhosis or at risk of irreversible disease were treated in an expanded access programme (EAP) in 2014. Treatment, by clinician choice, was with sofosbuvir, ledipasvir or daclatasvir, with or without ribavirin. For functional outcome comparison, untreated patients with HCV and decompensated cirrhosis who were registered on a database 6 months before treatment was available were retrospectively studied. Primary endpoint was sustained virological response 12 weeks post antiviral treatment (treated cohort) and the secondary endpoint (both cohorts) was adverse outcomes (worsening in MELD score or serious adverse event) within 6 months. Results 467 patients received treatment (409 decompensated cirrhosis). Viral clearance was achieved in 381 patients (81.6%) – 209 from 231 (90.5%) with genotype 1 and 132 from 192 (68.8%) with genotype 3. MELD scores improved in treated patients (mean change −0.85) but worsened in untreated patients (mean + 0.75) ( p <0.0001). Patients with initial serum albumin <35 g/L, aged >65 or with low (<135 mmol/L) baseline serum sodium concentrations were least likely to benefit from therapy. Conclusions All oral DAAs effectively cured HCV in patients with advanced liver disease. Viral clearance was associated with improvement in liver function within 6 months compared to untreated patients. The longer term impact of HCV treatment in patients with decompensated cirrhosis remains to be determined.</description><identifier>ISSN: 0168-8278</identifier><identifier>EISSN: 1600-0641</identifier><identifier>DOI: 10.1016/j.jhep.2016.01.029</identifier><identifier>PMID: 26829205</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Adult ; Aged ; Antiviral Agents - therapeutic use ; Daclatasvir ; Decompensated cirrhosis ; Female ; Gastroenterology and Hepatology ; Hepatitis C virus ; Hepatitis C, Chronic - complications ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - virology ; Humans ; Ledipasvir ; Liver Cirrhosis - drug therapy ; Male ; MELD score ; Middle Aged ; Outcome Assessment, Health Care ; Retrospective Studies ; Sofosbuvir ; Sofosbuvir - therapeutic use ; Sustained Virologic Response</subject><ispartof>Journal of hepatology, 2016-06, Vol.64 (6), p.1224-1231</ispartof><rights>European Association for the Study of the Liver</rights><rights>2016 European Association for the Study of the Liver</rights><rights>Copyright © 2016 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c455t-7c0ec93fe8eb2938bfc4789f91863a7d1e60ff40d093dd8d6e651902840ab8bd3</citedby><cites>FETCH-LOGICAL-c455t-7c0ec93fe8eb2938bfc4789f91863a7d1e60ff40d093dd8d6e651902840ab8bd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0168827816000659$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27903,27904,65309</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26829205$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Foster, Graham R</creatorcontrib><creatorcontrib>Irving, William L</creatorcontrib><creatorcontrib>Cheung, Michelle C.M</creatorcontrib><creatorcontrib>Walker, Alex J</creatorcontrib><creatorcontrib>Hudson, Benjamin E</creatorcontrib><creatorcontrib>Verma, Suman</creatorcontrib><creatorcontrib>McLauchlan, John</creatorcontrib><creatorcontrib>Mutimer, David J</creatorcontrib><creatorcontrib>Brown, Ashley</creatorcontrib><creatorcontrib>Gelson, William T.H</creatorcontrib><creatorcontrib>MacDonald, Douglas C</creatorcontrib><creatorcontrib>Agarwal, Kosh</creatorcontrib><creatorcontrib>HCV Research, UK</creatorcontrib><title>Impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis</title><title>Journal of hepatology</title><addtitle>J Hepatol</addtitle><description>Background & Aims All oral direct acting antivirals (DAAs) effectively treat chronic hepatitis C virus (HCV) infection, but the benefits in advanced liver disease are unclear. We compared outcomes in treated and untreated patients with decompensated cirrhosis. Methods Patients with HCV and decompensated cirrhosis or at risk of irreversible disease were treated in an expanded access programme (EAP) in 2014. Treatment, by clinician choice, was with sofosbuvir, ledipasvir or daclatasvir, with or without ribavirin. For functional outcome comparison, untreated patients with HCV and decompensated cirrhosis who were registered on a database 6 months before treatment was available were retrospectively studied. Primary endpoint was sustained virological response 12 weeks post antiviral treatment (treated cohort) and the secondary endpoint (both cohorts) was adverse outcomes (worsening in MELD score or serious adverse event) within 6 months. Results 467 patients received treatment (409 decompensated cirrhosis). Viral clearance was achieved in 381 patients (81.6%) – 209 from 231 (90.5%) with genotype 1 and 132 from 192 (68.8%) with genotype 3. MELD scores improved in treated patients (mean change −0.85) but worsened in untreated patients (mean + 0.75) ( p <0.0001). Patients with initial serum albumin <35 g/L, aged >65 or with low (<135 mmol/L) baseline serum sodium concentrations were least likely to benefit from therapy. Conclusions All oral DAAs effectively cured HCV in patients with advanced liver disease. Viral clearance was associated with improvement in liver function within 6 months compared to untreated patients. The longer term impact of HCV treatment in patients with decompensated cirrhosis remains to be determined.</description><subject>Adult</subject><subject>Aged</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Daclatasvir</subject><subject>Decompensated cirrhosis</subject><subject>Female</subject><subject>Gastroenterology and Hepatology</subject><subject>Hepatitis C virus</subject><subject>Hepatitis C, Chronic - complications</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatitis C, Chronic - virology</subject><subject>Humans</subject><subject>Ledipasvir</subject><subject>Liver Cirrhosis - drug therapy</subject><subject>Male</subject><subject>MELD score</subject><subject>Middle Aged</subject><subject>Outcome Assessment, Health Care</subject><subject>Retrospective Studies</subject><subject>Sofosbuvir</subject><subject>Sofosbuvir - therapeutic use</subject><subject>Sustained Virologic Response</subject><issn>0168-8278</issn><issn>1600-0641</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU2P1SAYhYnRONfRP-DCsHTT-kJbCokxMTd-TDKJC3VNKLy11H4J3Jncfy_NHV24cMULnHMCzyHkJYOSARNvxnIccCt5nktgJXD1iByYAChA1OwxOeQLWUjeyivyLMYRACpQ9VNyxYXkikNzIOPNvBmb6NpT5wPmKe_88oOaJfk7H8xE04DBbGfqF7qZ5HFJkd77NFA7hHXxluZH5PPkIz1mm6MO7TpvuEST0FHrQxjW6ONz8qQ3U8QXD-s1-f7xw7fj5-L2y6eb4_vbwtZNk4rWAlpV9Six46qSXW_rVqpeMSkq0zqGAvq-Bgeqck46gaJhCriswXSyc9U1eX3J3cL664Qx6dlHi9NkFlxPUbNWQd3UIKss5RepDWuMAXu9BT-bcNYM9M5Yj3pnrHfGGpjOjLPp1UP-qZvR_bX8gZoFby8CzL-88xh0tBmbxQth7Vb___x3_9jt5DNnM_3EM8ZxPYUl89NMR65Bf91b3kvemwfRqOo3s6ejxA</recordid><startdate>20160601</startdate><enddate>20160601</enddate><creator>Foster, Graham R</creator><creator>Irving, William L</creator><creator>Cheung, Michelle C.M</creator><creator>Walker, Alex J</creator><creator>Hudson, Benjamin E</creator><creator>Verma, Suman</creator><creator>McLauchlan, John</creator><creator>Mutimer, David J</creator><creator>Brown, Ashley</creator><creator>Gelson, William T.H</creator><creator>MacDonald, Douglas C</creator><creator>Agarwal, Kosh</creator><general>Elsevier B.V</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>7X8</scope></search><sort><creationdate>20160601</creationdate><title>Impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis</title><author>Foster, Graham R ; Irving, William L ; Cheung, Michelle C.M ; Walker, Alex J ; Hudson, Benjamin E ; Verma, Suman ; McLauchlan, John ; Mutimer, David J ; Brown, Ashley ; Gelson, William T.H ; MacDonald, Douglas C ; Agarwal, Kosh</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c455t-7c0ec93fe8eb2938bfc4789f91863a7d1e60ff40d093dd8d6e651902840ab8bd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Daclatasvir</topic><topic>Decompensated cirrhosis</topic><topic>Female</topic><topic>Gastroenterology and Hepatology</topic><topic>Hepatitis C virus</topic><topic>Hepatitis C, Chronic - complications</topic><topic>Hepatitis C, Chronic - drug therapy</topic><topic>Hepatitis C, Chronic - virology</topic><topic>Humans</topic><topic>Ledipasvir</topic><topic>Liver Cirrhosis - drug therapy</topic><topic>Male</topic><topic>MELD score</topic><topic>Middle Aged</topic><topic>Outcome Assessment, Health Care</topic><topic>Retrospective Studies</topic><topic>Sofosbuvir</topic><topic>Sofosbuvir - therapeutic use</topic><topic>Sustained Virologic Response</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Foster, Graham R</creatorcontrib><creatorcontrib>Irving, William L</creatorcontrib><creatorcontrib>Cheung, Michelle C.M</creatorcontrib><creatorcontrib>Walker, Alex J</creatorcontrib><creatorcontrib>Hudson, Benjamin E</creatorcontrib><creatorcontrib>Verma, Suman</creatorcontrib><creatorcontrib>McLauchlan, John</creatorcontrib><creatorcontrib>Mutimer, David J</creatorcontrib><creatorcontrib>Brown, Ashley</creatorcontrib><creatorcontrib>Gelson, William T.H</creatorcontrib><creatorcontrib>MacDonald, Douglas C</creatorcontrib><creatorcontrib>Agarwal, Kosh</creatorcontrib><creatorcontrib>HCV Research, UK</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Foster, Graham R</au><au>Irving, William L</au><au>Cheung, Michelle C.M</au><au>Walker, Alex J</au><au>Hudson, Benjamin E</au><au>Verma, Suman</au><au>McLauchlan, John</au><au>Mutimer, David J</au><au>Brown, Ashley</au><au>Gelson, William T.H</au><au>MacDonald, Douglas C</au><au>Agarwal, Kosh</au><aucorp>HCV Research, UK</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis</atitle><jtitle>Journal of hepatology</jtitle><addtitle>J Hepatol</addtitle><date>2016-06-01</date><risdate>2016</risdate><volume>64</volume><issue>6</issue><spage>1224</spage><epage>1231</epage><pages>1224-1231</pages><issn>0168-8278</issn><eissn>1600-0641</eissn><abstract>Background & Aims All oral direct acting antivirals (DAAs) effectively treat chronic hepatitis C virus (HCV) infection, but the benefits in advanced liver disease are unclear. We compared outcomes in treated and untreated patients with decompensated cirrhosis. Methods Patients with HCV and decompensated cirrhosis or at risk of irreversible disease were treated in an expanded access programme (EAP) in 2014. Treatment, by clinician choice, was with sofosbuvir, ledipasvir or daclatasvir, with or without ribavirin. For functional outcome comparison, untreated patients with HCV and decompensated cirrhosis who were registered on a database 6 months before treatment was available were retrospectively studied. Primary endpoint was sustained virological response 12 weeks post antiviral treatment (treated cohort) and the secondary endpoint (both cohorts) was adverse outcomes (worsening in MELD score or serious adverse event) within 6 months. Results 467 patients received treatment (409 decompensated cirrhosis). Viral clearance was achieved in 381 patients (81.6%) – 209 from 231 (90.5%) with genotype 1 and 132 from 192 (68.8%) with genotype 3. MELD scores improved in treated patients (mean change −0.85) but worsened in untreated patients (mean + 0.75) ( p <0.0001). Patients with initial serum albumin <35 g/L, aged >65 or with low (<135 mmol/L) baseline serum sodium concentrations were least likely to benefit from therapy. Conclusions All oral DAAs effectively cured HCV in patients with advanced liver disease. Viral clearance was associated with improvement in liver function within 6 months compared to untreated patients. The longer term impact of HCV treatment in patients with decompensated cirrhosis remains to be determined.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>26829205</pmid><doi>10.1016/j.jhep.2016.01.029</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Antiviral Agents - therapeutic use Daclatasvir Decompensated cirrhosis Female Gastroenterology and Hepatology Hepatitis C virus Hepatitis C, Chronic - complications Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - virology Humans Ledipasvir Liver Cirrhosis - drug therapy Male MELD score Middle Aged Outcome Assessment, Health Care Retrospective Studies Sofosbuvir Sofosbuvir - therapeutic use Sustained Virologic Response |
| title | Impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis |
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