Treatment with daily consensus interferon (CIFN) plus ribavirin in non-responder patients with chronic hepatitis C: A randomized open-label pilot study
Therapeutic options for hepatitis C non-responder patients are limited. We initiated an open-label pilot study to investigate the efficacy of CIFN plus ribavirin on viral kinetics, sustained virological response (SVR), and histological response in hepatitis C non-responder patients. Seventy-seven pa...
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| Veröffentlicht in: | Journal of hepatology 2006-02, Vol.44 (2), p.291-301 |
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| container_title | Journal of hepatology |
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| creator | Cornberg, Markus Hadem, Johannes Herrmann, Eva Schuppert, Frank Schmidt, Hartmut H.-J. Reiser, Markus Marschal, Oliver Steffen, Martin Manns, Michael P. Wedemeyer, Heiner |
| description | Therapeutic options for hepatitis C non-responder patients are limited.
We initiated an open-label pilot study to investigate the efficacy of CIFN plus ribavirin on viral kinetics, sustained virological response (SVR), and histological response in hepatitis C non-responder patients. Seventy-seven patients were enrolled to receive CIFN given daily in combination with 1000/1200mg ribavirin. An 8-week induction-dosing regimen of 18μg CIFN, followed by 9μg for 40 weeks was compared to 9μg CIFN for 48 weeks. 90% of patients were infected with HCV-genotype 1.
Overall, 82% of the patients demonstrated an early virological response, 65% had an end-of-treatment response, and the SVR was 30%. Interferon/ribavirin non-responders demonstrated a SVR of 22%. Induction-dosing resulted in a greater first-phase HCV-RNA decay that, however, did not translate to better SVRs, presumably due to more dose modifications. High ALT, younger age, and second-phase viral kinetics were associated with SVR. Only sustained responders and relapse patients showed an improved liver histology.
Daily dosing of CIFN plus ribavirin may be a promising concept for selected non-responder patients before considering therapies which are anti-viral but not curative. However, motivation and compliance are requisites and a CIFN induction is not required. |
| doi_str_mv | 10.1016/j.jhep.2005.10.021 |
| format | Article |
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We initiated an open-label pilot study to investigate the efficacy of CIFN plus ribavirin on viral kinetics, sustained virological response (SVR), and histological response in hepatitis C non-responder patients. Seventy-seven patients were enrolled to receive CIFN given daily in combination with 1000/1200mg ribavirin. An 8-week induction-dosing regimen of 18μg CIFN, followed by 9μg for 40 weeks was compared to 9μg CIFN for 48 weeks. 90% of patients were infected with HCV-genotype 1.
Overall, 82% of the patients demonstrated an early virological response, 65% had an end-of-treatment response, and the SVR was 30%. Interferon/ribavirin non-responders demonstrated a SVR of 22%. Induction-dosing resulted in a greater first-phase HCV-RNA decay that, however, did not translate to better SVRs, presumably due to more dose modifications. High ALT, younger age, and second-phase viral kinetics were associated with SVR. Only sustained responders and relapse patients showed an improved liver histology.
Daily dosing of CIFN plus ribavirin may be a promising concept for selected non-responder patients before considering therapies which are anti-viral but not curative. However, motivation and compliance are requisites and a CIFN induction is not required.</description><identifier>ISSN: 0168-8278</identifier><identifier>EISSN: 1600-0641</identifier><identifier>DOI: 10.1016/j.jhep.2005.10.021</identifier><identifier>PMID: 16360972</identifier><identifier>CODEN: JOHEEC</identifier><language>eng</language><publisher>Oxford: Elsevier B.V</publisher><subject>Adolescent ; Adult ; Aged ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Antiviral Agents - therapeutic use ; Biological and medical sciences ; Chronic hepatitis C ; Consensus interferon ; Daily dosing ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Follow-Up Studies ; Gastroenterology. Liver. Pancreas. Abdomen ; Genotype ; Hepacivirus - drug effects ; Hepacivirus - genetics ; Hepatitis C virus ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - virology ; Human viral diseases ; Humans ; Induction-dosing ; Infectious diseases ; Interferons - therapeutic use ; Male ; Medical sciences ; Middle Aged ; Non-responder ; Pharmacology. Drug treatments ; Pilot Projects ; Ribavirin ; Ribavirin - therapeutic use ; RNA, Viral - genetics ; Treatment Outcome ; Viral diseases ; Viral hepatitis</subject><ispartof>Journal of hepatology, 2006-02, Vol.44 (2), p.291-301</ispartof><rights>2005 European Association for the Study of the Liver</rights><rights>2006 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c384t-19a0daa3f0d028f9f77805982f7119ae797a012d1586fbd9c1a17c36e6fd5ff63</citedby><cites>FETCH-LOGICAL-c384t-19a0daa3f0d028f9f77805982f7119ae797a012d1586fbd9c1a17c36e6fd5ff63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0168827805007361$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17441844$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16360972$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cornberg, Markus</creatorcontrib><creatorcontrib>Hadem, Johannes</creatorcontrib><creatorcontrib>Herrmann, Eva</creatorcontrib><creatorcontrib>Schuppert, Frank</creatorcontrib><creatorcontrib>Schmidt, Hartmut H.-J.</creatorcontrib><creatorcontrib>Reiser, Markus</creatorcontrib><creatorcontrib>Marschal, Oliver</creatorcontrib><creatorcontrib>Steffen, Martin</creatorcontrib><creatorcontrib>Manns, Michael P.</creatorcontrib><creatorcontrib>Wedemeyer, Heiner</creatorcontrib><title>Treatment with daily consensus interferon (CIFN) plus ribavirin in non-responder patients with chronic hepatitis C: A randomized open-label pilot study</title><title>Journal of hepatology</title><addtitle>J Hepatol</addtitle><description>Therapeutic options for hepatitis C non-responder patients are limited.
We initiated an open-label pilot study to investigate the efficacy of CIFN plus ribavirin on viral kinetics, sustained virological response (SVR), and histological response in hepatitis C non-responder patients. Seventy-seven patients were enrolled to receive CIFN given daily in combination with 1000/1200mg ribavirin. An 8-week induction-dosing regimen of 18μg CIFN, followed by 9μg for 40 weeks was compared to 9μg CIFN for 48 weeks. 90% of patients were infected with HCV-genotype 1.
Overall, 82% of the patients demonstrated an early virological response, 65% had an end-of-treatment response, and the SVR was 30%. Interferon/ribavirin non-responders demonstrated a SVR of 22%. Induction-dosing resulted in a greater first-phase HCV-RNA decay that, however, did not translate to better SVRs, presumably due to more dose modifications. High ALT, younger age, and second-phase viral kinetics were associated with SVR. Only sustained responders and relapse patients showed an improved liver histology.
Daily dosing of CIFN plus ribavirin may be a promising concept for selected non-responder patients before considering therapies which are anti-viral but not curative. However, motivation and compliance are requisites and a CIFN induction is not required.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiviral agents</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Chronic hepatitis C</subject><subject>Consensus interferon</subject><subject>Daily dosing</subject><subject>Drug Administration Schedule</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Genotype</subject><subject>Hepacivirus - drug effects</subject><subject>Hepacivirus - genetics</subject><subject>Hepatitis C virus</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatitis C, Chronic - virology</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Induction-dosing</subject><subject>Infectious diseases</subject><subject>Interferons - therapeutic use</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Non-responder</subject><subject>Pharmacology. Drug treatments</subject><subject>Pilot Projects</subject><subject>Ribavirin</subject><subject>Ribavirin - therapeutic use</subject><subject>RNA, Viral - genetics</subject><subject>Treatment Outcome</subject><subject>Viral diseases</subject><subject>Viral hepatitis</subject><issn>0168-8278</issn><issn>1600-0641</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kUFvEzEUhC0EomnhD3BAvoDgsOF5d2N7EZcqolCpgks5W479rDja2IvtbRX-CH8XR4nUGydL429GTzOEvGGwZMD4p91yt8Vp2QKsqrCElj0jC8YBGuA9e04WFZKNbIW8IJc57wCgg6F_SS4Y7zgMol2Qv_cJddljKPTRly212o8HamLIGPKcqQ8Fk8MUA_2wvr358ZFOY5WT3-gHn3yoAA0xNAnzFIPFRCddfI3LpzyzrVZvaD206sVnuv5Mr2nSwca9_4OWxglDM-oNjnTyYyw0l9keXpEXTo8ZX5_fK_Lr5uv9-ntz9_Pb7fr6rjGd7EvDBg1W686BhVa6wQkhYTXI1glW_1AMQgNrLVtJ7jZ2MEwzYTqO3NmVc7y7Iu9PuVOKv2fMRe19NjiOOmCcsxLA5cD7toLtCTQp5pzQqSn5vU4HxUAd51A7dZxDHec4anWOanp7Tp83e7RPlnP_FXh3BnQ2enS1F-PzEyf6nsm-r9yXE4e1iwePSWVTWzZofUJTlI3-f3f8A8blq1U</recordid><startdate>20060201</startdate><enddate>20060201</enddate><creator>Cornberg, Markus</creator><creator>Hadem, Johannes</creator><creator>Herrmann, Eva</creator><creator>Schuppert, Frank</creator><creator>Schmidt, Hartmut H.-J.</creator><creator>Reiser, Markus</creator><creator>Marschal, Oliver</creator><creator>Steffen, Martin</creator><creator>Manns, Michael P.</creator><creator>Wedemeyer, Heiner</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><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>20060201</creationdate><title>Treatment with daily consensus interferon (CIFN) plus ribavirin in non-responder patients with chronic hepatitis C: A randomized open-label pilot study</title><author>Cornberg, Markus ; Hadem, Johannes ; Herrmann, Eva ; Schuppert, Frank ; Schmidt, Hartmut H.-J. ; Reiser, Markus ; Marschal, Oliver ; Steffen, Martin ; Manns, Michael P. ; Wedemeyer, Heiner</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c384t-19a0daa3f0d028f9f77805982f7119ae797a012d1586fbd9c1a17c36e6fd5ff63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiviral agents</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Chronic hepatitis C</topic><topic>Consensus interferon</topic><topic>Daily dosing</topic><topic>Drug Administration Schedule</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Genotype</topic><topic>Hepacivirus - drug effects</topic><topic>Hepacivirus - genetics</topic><topic>Hepatitis C virus</topic><topic>Hepatitis C, Chronic - drug therapy</topic><topic>Hepatitis C, Chronic - virology</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Induction-dosing</topic><topic>Infectious diseases</topic><topic>Interferons - therapeutic use</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Non-responder</topic><topic>Pharmacology. Drug treatments</topic><topic>Pilot Projects</topic><topic>Ribavirin</topic><topic>Ribavirin - therapeutic use</topic><topic>RNA, Viral - genetics</topic><topic>Treatment Outcome</topic><topic>Viral diseases</topic><topic>Viral hepatitis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cornberg, Markus</creatorcontrib><creatorcontrib>Hadem, Johannes</creatorcontrib><creatorcontrib>Herrmann, Eva</creatorcontrib><creatorcontrib>Schuppert, Frank</creatorcontrib><creatorcontrib>Schmidt, Hartmut H.-J.</creatorcontrib><creatorcontrib>Reiser, Markus</creatorcontrib><creatorcontrib>Marschal, Oliver</creatorcontrib><creatorcontrib>Steffen, Martin</creatorcontrib><creatorcontrib>Manns, Michael P.</creatorcontrib><creatorcontrib>Wedemeyer, Heiner</creatorcontrib><collection>Pascal-Francis</collection><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>Cornberg, Markus</au><au>Hadem, Johannes</au><au>Herrmann, Eva</au><au>Schuppert, Frank</au><au>Schmidt, Hartmut H.-J.</au><au>Reiser, Markus</au><au>Marschal, Oliver</au><au>Steffen, Martin</au><au>Manns, Michael P.</au><au>Wedemeyer, Heiner</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Treatment with daily consensus interferon (CIFN) plus ribavirin in non-responder patients with chronic hepatitis C: A randomized open-label pilot study</atitle><jtitle>Journal of hepatology</jtitle><addtitle>J Hepatol</addtitle><date>2006-02-01</date><risdate>2006</risdate><volume>44</volume><issue>2</issue><spage>291</spage><epage>301</epage><pages>291-301</pages><issn>0168-8278</issn><eissn>1600-0641</eissn><coden>JOHEEC</coden><abstract>Therapeutic options for hepatitis C non-responder patients are limited.
We initiated an open-label pilot study to investigate the efficacy of CIFN plus ribavirin on viral kinetics, sustained virological response (SVR), and histological response in hepatitis C non-responder patients. Seventy-seven patients were enrolled to receive CIFN given daily in combination with 1000/1200mg ribavirin. An 8-week induction-dosing regimen of 18μg CIFN, followed by 9μg for 40 weeks was compared to 9μg CIFN for 48 weeks. 90% of patients were infected with HCV-genotype 1.
Overall, 82% of the patients demonstrated an early virological response, 65% had an end-of-treatment response, and the SVR was 30%. Interferon/ribavirin non-responders demonstrated a SVR of 22%. Induction-dosing resulted in a greater first-phase HCV-RNA decay that, however, did not translate to better SVRs, presumably due to more dose modifications. High ALT, younger age, and second-phase viral kinetics were associated with SVR. Only sustained responders and relapse patients showed an improved liver histology.
Daily dosing of CIFN plus ribavirin may be a promising concept for selected non-responder patients before considering therapies which are anti-viral but not curative. However, motivation and compliance are requisites and a CIFN induction is not required.</abstract><cop>Oxford</cop><pub>Elsevier B.V</pub><pmid>16360972</pmid><doi>10.1016/j.jhep.2005.10.021</doi><tpages>11</tpages></addata></record> |
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| subjects | Adolescent Adult Aged Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Antiviral Agents - therapeutic use Biological and medical sciences Chronic hepatitis C Consensus interferon Daily dosing Drug Administration Schedule Drug Therapy, Combination Female Follow-Up Studies Gastroenterology. Liver. Pancreas. Abdomen Genotype Hepacivirus - drug effects Hepacivirus - genetics Hepatitis C virus Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - virology Human viral diseases Humans Induction-dosing Infectious diseases Interferons - therapeutic use Male Medical sciences Middle Aged Non-responder Pharmacology. Drug treatments Pilot Projects Ribavirin Ribavirin - therapeutic use RNA, Viral - genetics Treatment Outcome Viral diseases Viral hepatitis |
| title | Treatment with daily consensus interferon (CIFN) plus ribavirin in non-responder patients with chronic hepatitis C: A randomized open-label pilot study |
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