Real-world outcomes in patients with chronic hepatitis C: primary results of the PROBE study
BACKGROUNDThis large prospective multicentre cohort study aimed to improve knowledge of therapy for chronic hepatitis C (CHC) in real clinical practice. METHODSA diverse population of adults with CHC including patients with comorbid conditions, laboratory abnormalities and demographic features [como...
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| Veröffentlicht in: | European journal of gastroenterology & hepatology 2014-04, Vol.26 (4), p.388-395 |
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| container_title | European journal of gastroenterology & hepatology |
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| creator | Craxì, Antonio Piccinino, Felice Ciancio, Alessia Iannacone, Claudio Deodato, Barbara Golotta, Caterina Ascione, Antonio |
| description | BACKGROUNDThis large prospective multicentre cohort study aimed to improve knowledge of therapy for chronic hepatitis C (CHC) in real clinical practice.
METHODSA diverse population of adults with CHC including patients with comorbid conditions, laboratory abnormalities and demographic features [comorbidities or special populations (CSP)] who were under-represented or excluded from peginterferon registration studies was treated with peginterferon α-2a (40 kDa) or α-2b (12 kDa) plus ribavirin at the investigator’s discretion.
RESULTSDuring the study, 5399 treatment-naive patients [2527 (46.8%) with CSP] received peginterferon α-2a (n=3513, 65.1%) or peginterferon α-2b (n=1886, 34.9%). The sustained virological response rate was 56.6% (3057/5399) overall, 59.7% (1716/2872) in patients without CSP and 53.1% (1341/2527) in patients with CSP. Significant predictors of sustained virological response included hepatitis C virus genotype 2 or 3 infection, absence of cirrhosis, hepatitis C virus RNA≤500 000 IU/ml, alanine transaminase quotient >3× the upper limit of normal, age ≤65 years, BMI |
| doi_str_mv | 10.1097/MEG.0000000000000039 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1505257732</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1505257732</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3059-36af9adb584e0bbc611594af496c86c3b2a562eb462f28bbf06ef3694ba8c8e13</originalsourceid><addsrcrecordid>eNp9kE1LAzEQhoMotlb_gUiOXrYmm4_deNNSq1BRioIHYUnSWXZ129QkS_Hfu6VV0INzGRied4Z5EDqlZEiJyi7ux5Mh-VVM7aE-5RlLhMyzfdQnSvBEKvrSQ0chvBFCM0azQ9RLuZAqp6qPXmegm2TtfDPHro3WLSDgeolXOtawjAGv61hhW3m3rC2uYDOPdcCjS7zy9UL7T-whtE1HuhLHCvDj7OF6jENs55_H6KDUTYCTXR-g55vx0-g2mT5M7kZX08QyIlTCpC6VnhuRcyDGWEmpUFyXXEmbS8tMqoVMwXCZlmluTEkklEwqbnRuc6BsgM63e1fefbQQYrGog4Wm0UtwbSioICIVWcbSDuVb1HoXgoey2L1RUFJsvBad1-Kv1y52trvQmgXMf0LfIjsg3wJr10Tw4b1p1-CLqrMbq_93fwFoC4SX</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1505257732</pqid></control><display><type>article</type><title>Real-world outcomes in patients with chronic hepatitis C: primary results of the PROBE study</title><source>MEDLINE</source><source>Journals@Ovid Ovid Autoload</source><creator>Craxì, Antonio ; Piccinino, Felice ; Ciancio, Alessia ; Iannacone, Claudio ; Deodato, Barbara ; Golotta, Caterina ; Ascione, Antonio</creator><creatorcontrib>Craxì, Antonio ; Piccinino, Felice ; Ciancio, Alessia ; Iannacone, Claudio ; Deodato, Barbara ; Golotta, Caterina ; Ascione, Antonio</creatorcontrib><description>BACKGROUNDThis large prospective multicentre cohort study aimed to improve knowledge of therapy for chronic hepatitis C (CHC) in real clinical practice.
METHODSA diverse population of adults with CHC including patients with comorbid conditions, laboratory abnormalities and demographic features [comorbidities or special populations (CSP)] who were under-represented or excluded from peginterferon registration studies was treated with peginterferon α-2a (40 kDa) or α-2b (12 kDa) plus ribavirin at the investigator’s discretion.
RESULTSDuring the study, 5399 treatment-naive patients [2527 (46.8%) with CSP] received peginterferon α-2a (n=3513, 65.1%) or peginterferon α-2b (n=1886, 34.9%). The sustained virological response rate was 56.6% (3057/5399) overall, 59.7% (1716/2872) in patients without CSP and 53.1% (1341/2527) in patients with CSP. Significant predictors of sustained virological response included hepatitis C virus genotype 2 or 3 infection, absence of cirrhosis, hepatitis C virus RNA≤500 000 IU/ml, alanine transaminase quotient >3× the upper limit of normal, age ≤65 years, BMI<25 kg/m, at least 80% of the planned exposure to peginterferon and ribavirin and prescription of peginterferon α-2a.
CONCLUSIONThe results provide detailed information on the outcome of therapy for CHC in a diverse Italian population that included a large number of patients with CSP and provides an insight into the generalizability of the results obtained in the more restricted setting of randomized registration trials.</description><identifier>ISSN: 0954-691X</identifier><identifier>EISSN: 1473-5687</identifier><identifier>DOI: 10.1097/MEG.0000000000000039</identifier><identifier>PMID: 24569819</identifier><language>eng</language><publisher>England: Wolters Kluwer Health | Lippincott Williams & Wilkins</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antiviral Agents - adverse effects ; Antiviral Agents - therapeutic use ; Comorbidity ; Drug Therapy, Combination ; Female ; Genotype ; Hepacivirus - drug effects ; Hepacivirus - genetics ; Hepatitis C, Chronic - diagnosis ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - epidemiology ; Humans ; Interferon-alpha - adverse effects ; Interferon-alpha - therapeutic use ; Italy - epidemiology ; Male ; Middle Aged ; Polyethylene Glycols - adverse effects ; Polyethylene Glycols - therapeutic use ; Prospective Studies ; Recombinant Proteins - adverse effects ; Recombinant Proteins - therapeutic use ; Recurrence ; Remission Induction ; Ribavirin - adverse effects ; Ribavirin - therapeutic use ; RNA, Viral - blood ; Time Factors ; Treatment Outcome ; Viral Load ; Young Adult</subject><ispartof>European journal of gastroenterology & hepatology, 2014-04, Vol.26 (4), p.388-395</ispartof><rights>2014 Wolters Kluwer Health | Lippincott Williams & Wilkins</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3059-36af9adb584e0bbc611594af496c86c3b2a562eb462f28bbf06ef3694ba8c8e13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,778,782,27913,27914</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24569819$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Craxì, Antonio</creatorcontrib><creatorcontrib>Piccinino, Felice</creatorcontrib><creatorcontrib>Ciancio, Alessia</creatorcontrib><creatorcontrib>Iannacone, Claudio</creatorcontrib><creatorcontrib>Deodato, Barbara</creatorcontrib><creatorcontrib>Golotta, Caterina</creatorcontrib><creatorcontrib>Ascione, Antonio</creatorcontrib><title>Real-world outcomes in patients with chronic hepatitis C: primary results of the PROBE study</title><title>European journal of gastroenterology & hepatology</title><addtitle>Eur J Gastroenterol Hepatol</addtitle><description>BACKGROUNDThis large prospective multicentre cohort study aimed to improve knowledge of therapy for chronic hepatitis C (CHC) in real clinical practice.
METHODSA diverse population of adults with CHC including patients with comorbid conditions, laboratory abnormalities and demographic features [comorbidities or special populations (CSP)] who were under-represented or excluded from peginterferon registration studies was treated with peginterferon α-2a (40 kDa) or α-2b (12 kDa) plus ribavirin at the investigator’s discretion.
RESULTSDuring the study, 5399 treatment-naive patients [2527 (46.8%) with CSP] received peginterferon α-2a (n=3513, 65.1%) or peginterferon α-2b (n=1886, 34.9%). The sustained virological response rate was 56.6% (3057/5399) overall, 59.7% (1716/2872) in patients without CSP and 53.1% (1341/2527) in patients with CSP. Significant predictors of sustained virological response included hepatitis C virus genotype 2 or 3 infection, absence of cirrhosis, hepatitis C virus RNA≤500 000 IU/ml, alanine transaminase quotient >3× the upper limit of normal, age ≤65 years, BMI<25 kg/m, at least 80% of the planned exposure to peginterferon and ribavirin and prescription of peginterferon α-2a.
CONCLUSIONThe results provide detailed information on the outcome of therapy for CHC in a diverse Italian population that included a large number of patients with CSP and provides an insight into the generalizability of the results obtained in the more restricted setting of randomized registration trials.</description><subject>Adolescent</subject><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>Comorbidity</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Genotype</subject><subject>Hepacivirus - drug effects</subject><subject>Hepacivirus - genetics</subject><subject>Hepatitis C, Chronic - diagnosis</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatitis C, Chronic - epidemiology</subject><subject>Humans</subject><subject>Interferon-alpha - adverse effects</subject><subject>Interferon-alpha - therapeutic use</subject><subject>Italy - epidemiology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Polyethylene Glycols - adverse effects</subject><subject>Polyethylene Glycols - therapeutic use</subject><subject>Prospective Studies</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Recurrence</subject><subject>Remission Induction</subject><subject>Ribavirin - adverse effects</subject><subject>Ribavirin - therapeutic use</subject><subject>RNA, Viral - blood</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Viral Load</subject><subject>Young Adult</subject><issn>0954-691X</issn><issn>1473-5687</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE1LAzEQhoMotlb_gUiOXrYmm4_deNNSq1BRioIHYUnSWXZ129QkS_Hfu6VV0INzGRied4Z5EDqlZEiJyi7ux5Mh-VVM7aE-5RlLhMyzfdQnSvBEKvrSQ0chvBFCM0azQ9RLuZAqp6qPXmegm2TtfDPHro3WLSDgeolXOtawjAGv61hhW3m3rC2uYDOPdcCjS7zy9UL7T-whtE1HuhLHCvDj7OF6jENs55_H6KDUTYCTXR-g55vx0-g2mT5M7kZX08QyIlTCpC6VnhuRcyDGWEmpUFyXXEmbS8tMqoVMwXCZlmluTEkklEwqbnRuc6BsgM63e1fefbQQYrGog4Wm0UtwbSioICIVWcbSDuVb1HoXgoey2L1RUFJsvBad1-Kv1y52trvQmgXMf0LfIjsg3wJr10Tw4b1p1-CLqrMbq_93fwFoC4SX</recordid><startdate>201404</startdate><enddate>201404</enddate><creator>Craxì, Antonio</creator><creator>Piccinino, Felice</creator><creator>Ciancio, Alessia</creator><creator>Iannacone, Claudio</creator><creator>Deodato, Barbara</creator><creator>Golotta, Caterina</creator><creator>Ascione, Antonio</creator><general>Wolters Kluwer Health | Lippincott Williams & Wilkins</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>201404</creationdate><title>Real-world outcomes in patients with chronic hepatitis C: primary results of the PROBE study</title><author>Craxì, Antonio ; Piccinino, Felice ; Ciancio, Alessia ; Iannacone, Claudio ; Deodato, Barbara ; Golotta, Caterina ; Ascione, Antonio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3059-36af9adb584e0bbc611594af496c86c3b2a562eb462f28bbf06ef3694ba8c8e13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adolescent</topic><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>Comorbidity</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Genotype</topic><topic>Hepacivirus - drug effects</topic><topic>Hepacivirus - genetics</topic><topic>Hepatitis C, Chronic - diagnosis</topic><topic>Hepatitis C, Chronic - drug therapy</topic><topic>Hepatitis C, Chronic - epidemiology</topic><topic>Humans</topic><topic>Interferon-alpha - adverse effects</topic><topic>Interferon-alpha - therapeutic use</topic><topic>Italy - epidemiology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Polyethylene Glycols - adverse effects</topic><topic>Polyethylene Glycols - therapeutic use</topic><topic>Prospective Studies</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Recurrence</topic><topic>Remission Induction</topic><topic>Ribavirin - adverse effects</topic><topic>Ribavirin - therapeutic use</topic><topic>RNA, Viral - blood</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Viral Load</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Craxì, Antonio</creatorcontrib><creatorcontrib>Piccinino, Felice</creatorcontrib><creatorcontrib>Ciancio, Alessia</creatorcontrib><creatorcontrib>Iannacone, Claudio</creatorcontrib><creatorcontrib>Deodato, Barbara</creatorcontrib><creatorcontrib>Golotta, Caterina</creatorcontrib><creatorcontrib>Ascione, Antonio</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>European journal of gastroenterology & hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Craxì, Antonio</au><au>Piccinino, Felice</au><au>Ciancio, Alessia</au><au>Iannacone, Claudio</au><au>Deodato, Barbara</au><au>Golotta, Caterina</au><au>Ascione, Antonio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Real-world outcomes in patients with chronic hepatitis C: primary results of the PROBE study</atitle><jtitle>European journal of gastroenterology & hepatology</jtitle><addtitle>Eur J Gastroenterol Hepatol</addtitle><date>2014-04</date><risdate>2014</risdate><volume>26</volume><issue>4</issue><spage>388</spage><epage>395</epage><pages>388-395</pages><issn>0954-691X</issn><eissn>1473-5687</eissn><abstract>BACKGROUNDThis large prospective multicentre cohort study aimed to improve knowledge of therapy for chronic hepatitis C (CHC) in real clinical practice.
METHODSA diverse population of adults with CHC including patients with comorbid conditions, laboratory abnormalities and demographic features [comorbidities or special populations (CSP)] who were under-represented or excluded from peginterferon registration studies was treated with peginterferon α-2a (40 kDa) or α-2b (12 kDa) plus ribavirin at the investigator’s discretion.
RESULTSDuring the study, 5399 treatment-naive patients [2527 (46.8%) with CSP] received peginterferon α-2a (n=3513, 65.1%) or peginterferon α-2b (n=1886, 34.9%). The sustained virological response rate was 56.6% (3057/5399) overall, 59.7% (1716/2872) in patients without CSP and 53.1% (1341/2527) in patients with CSP. Significant predictors of sustained virological response included hepatitis C virus genotype 2 or 3 infection, absence of cirrhosis, hepatitis C virus RNA≤500 000 IU/ml, alanine transaminase quotient >3× the upper limit of normal, age ≤65 years, BMI<25 kg/m, at least 80% of the planned exposure to peginterferon and ribavirin and prescription of peginterferon α-2a.
CONCLUSIONThe results provide detailed information on the outcome of therapy for CHC in a diverse Italian population that included a large number of patients with CSP and provides an insight into the generalizability of the results obtained in the more restricted setting of randomized registration trials.</abstract><cop>England</cop><pub>Wolters Kluwer Health | Lippincott Williams & Wilkins</pub><pmid>24569819</pmid><doi>10.1097/MEG.0000000000000039</doi><tpages>8</tpages></addata></record> |
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| subjects | Adolescent Adult Aged Aged, 80 and over Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Comorbidity Drug Therapy, Combination Female Genotype Hepacivirus - drug effects Hepacivirus - genetics Hepatitis C, Chronic - diagnosis Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - epidemiology Humans Interferon-alpha - adverse effects Interferon-alpha - therapeutic use Italy - epidemiology Male Middle Aged Polyethylene Glycols - adverse effects Polyethylene Glycols - therapeutic use Prospective Studies Recombinant Proteins - adverse effects Recombinant Proteins - therapeutic use Recurrence Remission Induction Ribavirin - adverse effects Ribavirin - therapeutic use RNA, Viral - blood Time Factors Treatment Outcome Viral Load Young Adult |
| title | Real-world outcomes in patients with chronic hepatitis C: primary results of the PROBE study |
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