Safety and efficacy of direct‐acting antivirals for the treatment of chronic hepatitis C in a real‐world population aged 65 years and older
Summary The availability of direct‐acting antiviral agents (DAA) regimens has expanded the pool of patients eligible for treatment. However, data on the virologic response and tolerability of DAAs in elderly patients are lacking. We evaluated the efficacy and safety of DAAs in patients with advanced...
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| Veröffentlicht in: | Journal of viral hepatitis 2017-06, Vol.24 (6), p.454-463 |
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| creator | Conti, F. Brillanti, S. Buonfiglioli, F. Vukotic, R. Morelli, M. C. Lalanne, C. Massari, M. Foschi, F. G. Bernabucci, V. Serio, I. Prati, G. M. Negri, E. Badia, L. Caraceni, P. Muratori, P. Vitale, G. Porro, A. Morotti, M. Mazzella, G. Andreone, P. |
| description | Summary
The availability of direct‐acting antiviral agents (DAA) regimens has expanded the pool of patients eligible for treatment. However, data on the virologic response and tolerability of DAAs in elderly patients are lacking. We evaluated the efficacy and safety of DAAs in patients with advanced fibrosis/cirrhosis in real‐life practice with the focus on those aged ≥65 years. Between January and December 2015, all consecutive patients with HCV‐related advanced fibrosis/cirrhosis treated with DAA at eleven tertiary referral centres in Emilia Romagna (Italy) were enrolled. Regimen choice was based on viral genotype and stage of disease, according to guidelines. The primary end point was sustained virologic response 12 weeks after the end of treatment (SVR12). Overall, 282 of 556 (50.7%) patients evaluated were elderly, most of them with cirrhosis. Antiviral therapy was stopped prematurely in four (1.4%) patients. Two patients, both with cirrhosis, died during treatment due to worsening of liver/renal function. SVR12 was achieved by 94.7% and was comparable to that obtained in patients aged |
| doi_str_mv | 10.1111/jvh.12663 |
| format | Article |
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The availability of direct‐acting antiviral agents (DAA) regimens has expanded the pool of patients eligible for treatment. However, data on the virologic response and tolerability of DAAs in elderly patients are lacking. We evaluated the efficacy and safety of DAAs in patients with advanced fibrosis/cirrhosis in real‐life practice with the focus on those aged ≥65 years. Between January and December 2015, all consecutive patients with HCV‐related advanced fibrosis/cirrhosis treated with DAA at eleven tertiary referral centres in Emilia Romagna (Italy) were enrolled. Regimen choice was based on viral genotype and stage of disease, according to guidelines. The primary end point was sustained virologic response 12 weeks after the end of treatment (SVR12). Overall, 282 of 556 (50.7%) patients evaluated were elderly, most of them with cirrhosis. Antiviral therapy was stopped prematurely in four (1.4%) patients. Two patients, both with cirrhosis, died during treatment due to worsening of liver/renal function. SVR12 was achieved by 94.7% and was comparable to that obtained in patients aged <65 (P=.074). Similar data were also reported in subgroup of patients aged ≥75 years. All patients with advanced fibrosis achieved virologic response. SVR12 was 80.8% in Child‐Pugh‐Turcotte (CTP)‐B cirrhosis and 95.4% in CTP‐A (P=.013). According to genotype, the SVR12 was achieved in 172 of 181 (95%) with genotype 1b cirrhosis and in 44 of 48 (91.7%) with genotype 2 cirrhosis. In conclusions, in a real‐world setting, DAAs are safe and effective in elderly patients with HCV‐related advanced fibrosis/cirrhosis, but SVR12 is lower with worsening CTP class.</description><identifier>ISSN: 1352-0504</identifier><identifier>EISSN: 1365-2893</identifier><identifier>DOI: 10.1111/jvh.12663</identifier><identifier>PMID: 27976461</identifier><language>eng</language><publisher>England</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antiviral Agents - adverse effects ; Antiviral Agents - therapeutic use ; antiviral therapy ; cirrhosis ; elderly ; Genotype ; Hepacivirus - classification ; Hepacivirus - genetics ; Hepacivirus - isolation & purification ; hepatitis C virus ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - virology ; Humans ; interferon‐free ; Italy ; Middle Aged ; Retrospective Studies ; Sustained Virologic Response ; Tertiary Care Centers ; Treatment Outcome ; Young Adult</subject><ispartof>Journal of viral hepatitis, 2017-06, Vol.24 (6), p.454-463</ispartof><rights>2017 John Wiley & Sons Ltd</rights><rights>2017 John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3603-9231156b3b0a78bd1705ab0651d29fa0346191c4d64f3e877bf7b4e695ff8be73</citedby><cites>FETCH-LOGICAL-c3603-9231156b3b0a78bd1705ab0651d29fa0346191c4d64f3e877bf7b4e695ff8be73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjvh.12663$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjvh.12663$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27976461$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Conti, F.</creatorcontrib><creatorcontrib>Brillanti, S.</creatorcontrib><creatorcontrib>Buonfiglioli, F.</creatorcontrib><creatorcontrib>Vukotic, R.</creatorcontrib><creatorcontrib>Morelli, M. C.</creatorcontrib><creatorcontrib>Lalanne, C.</creatorcontrib><creatorcontrib>Massari, M.</creatorcontrib><creatorcontrib>Foschi, F. G.</creatorcontrib><creatorcontrib>Bernabucci, V.</creatorcontrib><creatorcontrib>Serio, I.</creatorcontrib><creatorcontrib>Prati, G. M.</creatorcontrib><creatorcontrib>Negri, E.</creatorcontrib><creatorcontrib>Badia, L.</creatorcontrib><creatorcontrib>Caraceni, P.</creatorcontrib><creatorcontrib>Muratori, P.</creatorcontrib><creatorcontrib>Vitale, G.</creatorcontrib><creatorcontrib>Porro, A.</creatorcontrib><creatorcontrib>Morotti, M.</creatorcontrib><creatorcontrib>Mazzella, G.</creatorcontrib><creatorcontrib>Andreone, P.</creatorcontrib><title>Safety and efficacy of direct‐acting antivirals for the treatment of chronic hepatitis C in a real‐world population aged 65 years and older</title><title>Journal of viral hepatitis</title><addtitle>J Viral Hepat</addtitle><description>Summary
The availability of direct‐acting antiviral agents (DAA) regimens has expanded the pool of patients eligible for treatment. However, data on the virologic response and tolerability of DAAs in elderly patients are lacking. We evaluated the efficacy and safety of DAAs in patients with advanced fibrosis/cirrhosis in real‐life practice with the focus on those aged ≥65 years. Between January and December 2015, all consecutive patients with HCV‐related advanced fibrosis/cirrhosis treated with DAA at eleven tertiary referral centres in Emilia Romagna (Italy) were enrolled. Regimen choice was based on viral genotype and stage of disease, according to guidelines. The primary end point was sustained virologic response 12 weeks after the end of treatment (SVR12). Overall, 282 of 556 (50.7%) patients evaluated were elderly, most of them with cirrhosis. Antiviral therapy was stopped prematurely in four (1.4%) patients. Two patients, both with cirrhosis, died during treatment due to worsening of liver/renal function. SVR12 was achieved by 94.7% and was comparable to that obtained in patients aged <65 (P=.074). Similar data were also reported in subgroup of patients aged ≥75 years. All patients with advanced fibrosis achieved virologic response. SVR12 was 80.8% in Child‐Pugh‐Turcotte (CTP)‐B cirrhosis and 95.4% in CTP‐A (P=.013). According to genotype, the SVR12 was achieved in 172 of 181 (95%) with genotype 1b cirrhosis and in 44 of 48 (91.7%) with genotype 2 cirrhosis. In conclusions, in a real‐world setting, DAAs are safe and effective in elderly patients with HCV‐related advanced fibrosis/cirrhosis, but SVR12 is lower with worsening CTP class.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - therapeutic use</subject><subject>antiviral therapy</subject><subject>cirrhosis</subject><subject>elderly</subject><subject>Genotype</subject><subject>Hepacivirus - classification</subject><subject>Hepacivirus - genetics</subject><subject>Hepacivirus - isolation & purification</subject><subject>hepatitis C virus</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatitis C, Chronic - virology</subject><subject>Humans</subject><subject>interferon‐free</subject><subject>Italy</subject><subject>Middle Aged</subject><subject>Retrospective Studies</subject><subject>Sustained Virologic Response</subject><subject>Tertiary Care Centers</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1352-0504</issn><issn>1365-2893</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kU1O3DAYhq2KqtBpF71A5SVdBPwTO8kSjSg_GqkLaLeRY39mjDJxsD2DsuMIHKFn6VF6EjwMsMMbW3ofPZ8-vwh9o-SI5nN8u1keUSYl_4AOKJeiYHXD97ZvwQoiSLmPPsd4SwjlTNBPaJ9VTSVLSQ_Q45WykCasBoPBWqeVnrC32LgAOv1_eFQ6ueEm58ltXFB9xNYHnJaAUwCVVjCkLa-XwQ9O4yWMKrnkIp5jN2CFM9Rnzb0PvcGjH9d9zn1ObsBgKf79nUCF-Dzf9wbCF_TR5inw9eWeod8_T6_n58Xi19nF_GRRaC4JLxrGKRWy4x1RVd0ZWhGhOiIFNayxivC8XUN1aWRpOdRV1dmqK0E2wtq6g4rP0OHOOwZ_t4aY2pWLGvpeDeDXsaW1YLKmJWsy-mOH6uBjDGDbMbiVClNLSbstoM0FtM8FZPb7i3bdrcC8ka8_noHjHXDvepjeN7WXf853yifas5Ns</recordid><startdate>201706</startdate><enddate>201706</enddate><creator>Conti, F.</creator><creator>Brillanti, S.</creator><creator>Buonfiglioli, F.</creator><creator>Vukotic, R.</creator><creator>Morelli, M. C.</creator><creator>Lalanne, C.</creator><creator>Massari, M.</creator><creator>Foschi, F. G.</creator><creator>Bernabucci, V.</creator><creator>Serio, I.</creator><creator>Prati, G. M.</creator><creator>Negri, E.</creator><creator>Badia, L.</creator><creator>Caraceni, P.</creator><creator>Muratori, P.</creator><creator>Vitale, G.</creator><creator>Porro, A.</creator><creator>Morotti, M.</creator><creator>Mazzella, G.</creator><creator>Andreone, P.</creator><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>201706</creationdate><title>Safety and efficacy of direct‐acting antivirals for the treatment of chronic hepatitis C in a real‐world population aged 65 years and older</title><author>Conti, F. ; Brillanti, S. ; Buonfiglioli, F. ; Vukotic, R. ; Morelli, M. C. ; Lalanne, C. ; Massari, M. ; Foschi, F. G. ; Bernabucci, V. ; Serio, I. ; Prati, G. M. ; Negri, E. ; Badia, L. ; Caraceni, P. ; Muratori, P. ; Vitale, G. ; Porro, A. ; Morotti, M. ; Mazzella, G. ; Andreone, P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3603-9231156b3b0a78bd1705ab0651d29fa0346191c4d64f3e877bf7b4e695ff8be73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antiviral Agents - adverse effects</topic><topic>Antiviral Agents - therapeutic use</topic><topic>antiviral therapy</topic><topic>cirrhosis</topic><topic>elderly</topic><topic>Genotype</topic><topic>Hepacivirus - classification</topic><topic>Hepacivirus - genetics</topic><topic>Hepacivirus - isolation & purification</topic><topic>hepatitis C virus</topic><topic>Hepatitis C, Chronic - drug therapy</topic><topic>Hepatitis C, Chronic - virology</topic><topic>Humans</topic><topic>interferon‐free</topic><topic>Italy</topic><topic>Middle Aged</topic><topic>Retrospective Studies</topic><topic>Sustained Virologic Response</topic><topic>Tertiary Care Centers</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Conti, F.</creatorcontrib><creatorcontrib>Brillanti, S.</creatorcontrib><creatorcontrib>Buonfiglioli, F.</creatorcontrib><creatorcontrib>Vukotic, R.</creatorcontrib><creatorcontrib>Morelli, M. C.</creatorcontrib><creatorcontrib>Lalanne, C.</creatorcontrib><creatorcontrib>Massari, M.</creatorcontrib><creatorcontrib>Foschi, F. G.</creatorcontrib><creatorcontrib>Bernabucci, V.</creatorcontrib><creatorcontrib>Serio, I.</creatorcontrib><creatorcontrib>Prati, G. M.</creatorcontrib><creatorcontrib>Negri, E.</creatorcontrib><creatorcontrib>Badia, L.</creatorcontrib><creatorcontrib>Caraceni, P.</creatorcontrib><creatorcontrib>Muratori, P.</creatorcontrib><creatorcontrib>Vitale, G.</creatorcontrib><creatorcontrib>Porro, A.</creatorcontrib><creatorcontrib>Morotti, M.</creatorcontrib><creatorcontrib>Mazzella, G.</creatorcontrib><creatorcontrib>Andreone, P.</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 viral hepatitis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Conti, F.</au><au>Brillanti, S.</au><au>Buonfiglioli, F.</au><au>Vukotic, R.</au><au>Morelli, M. C.</au><au>Lalanne, C.</au><au>Massari, M.</au><au>Foschi, F. G.</au><au>Bernabucci, V.</au><au>Serio, I.</au><au>Prati, G. M.</au><au>Negri, E.</au><au>Badia, L.</au><au>Caraceni, P.</au><au>Muratori, P.</au><au>Vitale, G.</au><au>Porro, A.</au><au>Morotti, M.</au><au>Mazzella, G.</au><au>Andreone, P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and efficacy of direct‐acting antivirals for the treatment of chronic hepatitis C in a real‐world population aged 65 years and older</atitle><jtitle>Journal of viral hepatitis</jtitle><addtitle>J Viral Hepat</addtitle><date>2017-06</date><risdate>2017</risdate><volume>24</volume><issue>6</issue><spage>454</spage><epage>463</epage><pages>454-463</pages><issn>1352-0504</issn><eissn>1365-2893</eissn><abstract>Summary
The availability of direct‐acting antiviral agents (DAA) regimens has expanded the pool of patients eligible for treatment. However, data on the virologic response and tolerability of DAAs in elderly patients are lacking. We evaluated the efficacy and safety of DAAs in patients with advanced fibrosis/cirrhosis in real‐life practice with the focus on those aged ≥65 years. Between January and December 2015, all consecutive patients with HCV‐related advanced fibrosis/cirrhosis treated with DAA at eleven tertiary referral centres in Emilia Romagna (Italy) were enrolled. Regimen choice was based on viral genotype and stage of disease, according to guidelines. The primary end point was sustained virologic response 12 weeks after the end of treatment (SVR12). Overall, 282 of 556 (50.7%) patients evaluated were elderly, most of them with cirrhosis. Antiviral therapy was stopped prematurely in four (1.4%) patients. Two patients, both with cirrhosis, died during treatment due to worsening of liver/renal function. SVR12 was achieved by 94.7% and was comparable to that obtained in patients aged <65 (P=.074). Similar data were also reported in subgroup of patients aged ≥75 years. All patients with advanced fibrosis achieved virologic response. SVR12 was 80.8% in Child‐Pugh‐Turcotte (CTP)‐B cirrhosis and 95.4% in CTP‐A (P=.013). According to genotype, the SVR12 was achieved in 172 of 181 (95%) with genotype 1b cirrhosis and in 44 of 48 (91.7%) with genotype 2 cirrhosis. In conclusions, in a real‐world setting, DAAs are safe and effective in elderly patients with HCV‐related advanced fibrosis/cirrhosis, but SVR12 is lower with worsening CTP class.</abstract><cop>England</cop><pmid>27976461</pmid><doi>10.1111/jvh.12663</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Antiviral Agents - adverse effects Antiviral Agents - therapeutic use antiviral therapy cirrhosis elderly Genotype Hepacivirus - classification Hepacivirus - genetics Hepacivirus - isolation & purification hepatitis C virus Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - virology Humans interferon‐free Italy Middle Aged Retrospective Studies Sustained Virologic Response Tertiary Care Centers Treatment Outcome Young Adult |
| title | Safety and efficacy of direct‐acting antivirals for the treatment of chronic hepatitis C in a real‐world population aged 65 years and older |
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