Telaprevir‐based triple therapy for chronic hepatitis C patients with advanced fibrosis: a prospective clinical study
Summary Background Antiviral treatment is recommended for chronic hepatitis C patients with advanced fibrosis to reduce and prevent cirrhosis‐related complications. Aim To evaluate the efficacy and safety of telaprevir (TVR)‐based triple therapy for patients with advanced fibrosis in a clinical prac...
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Veröffentlicht in: | Alimentary pharmacology & therapeutics 2013-11, Vol.38 (9), p.1076-1085 |
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creator | Ogawa, E. Furusyo, N. Nakamuta, M. Kajiwara, E. Nomura, H. Dohmen, K. Takahashi, K. Satoh, T. Azuma, K. Kawano, A. Tanabe, Y. Kotoh, K. Shimoda, S. Hayashi, J. |
description | Summary
Background
Antiviral treatment is recommended for chronic hepatitis C patients with advanced fibrosis to reduce and prevent cirrhosis‐related complications.
Aim
To evaluate the efficacy and safety of telaprevir (TVR)‐based triple therapy for patients with advanced fibrosis in a clinical practice setting.
Methods
This prospective, multicentre study consisted of 102 patients with advanced fibrosis (METAVIR score F3‐4) who were infected with HCV genotype 1b. All received 12 weeks of TVR in combination with 24 weeks of pegylated interferon (PEG‐IFN) α2b and ribavirin (RBV).
Results
The sustained virological response (SVR) rate was 69.6% (71 of 102). Notably, for treatment‐naïve and prior relapse patients the SVR rate was over 80%. Previous treatment response, interleukin 28B polymorphism (rs8099917) and rapid virological response (undetectable HCV RNA at week 4) were independently associated with SVR. To achieve SVR, an adequate dosage of PEG‐IFNα2b (≥1.2 μg/kg/week) and RBV (≥7.5 mg/kg/day) is preferable; however, the mean weight‐adjusted TVR dosage had little impact on treatment outcome. Although severe blood cytopaenia and a dermatological disorder were frequently found, the rate of discontinuation due to adverse effects was 12.7%. The inosine triphosphatase CC allele (rs1127354) was independently associated with the development of severe anaemia, and lower serum albumin level ( |
doi_str_mv | 10.1111/apt.12494 |
format | Article |
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Background
Antiviral treatment is recommended for chronic hepatitis C patients with advanced fibrosis to reduce and prevent cirrhosis‐related complications.
Aim
To evaluate the efficacy and safety of telaprevir (TVR)‐based triple therapy for patients with advanced fibrosis in a clinical practice setting.
Methods
This prospective, multicentre study consisted of 102 patients with advanced fibrosis (METAVIR score F3‐4) who were infected with HCV genotype 1b. All received 12 weeks of TVR in combination with 24 weeks of pegylated interferon (PEG‐IFN) α2b and ribavirin (RBV).
Results
The sustained virological response (SVR) rate was 69.6% (71 of 102). Notably, for treatment‐naïve and prior relapse patients the SVR rate was over 80%. Previous treatment response, interleukin 28B polymorphism (rs8099917) and rapid virological response (undetectable HCV RNA at week 4) were independently associated with SVR. To achieve SVR, an adequate dosage of PEG‐IFNα2b (≥1.2 μg/kg/week) and RBV (≥7.5 mg/kg/day) is preferable; however, the mean weight‐adjusted TVR dosage had little impact on treatment outcome. Although severe blood cytopaenia and a dermatological disorder were frequently found, the rate of discontinuation due to adverse effects was 12.7%. The inosine triphosphatase CC allele (rs1127354) was independently associated with the development of severe anaemia, and lower serum albumin level (<35 g/L) was associated with the occurrence of infection.
Conclusions
The great gain in the SVR rate by telaprevir‐based triple therapy offsets the problems with adverse effects; thus, it should be considered as a potent treatment protocol for patients with advanced fibrosis, especially for those with treatment‐naïve and prior relapse.</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/apt.12494</identifier><identifier>PMID: 24099469</identifier><language>eng</language><publisher>Oxford: Blackwell</publisher><subject><![CDATA[Aged ; Albumin ; Anemia - epidemiology ; Anemia - etiology ; Antiviral Agents - administration & dosage ; Antiviral Agents - adverse effects ; Antiviral Agents - therapeutic use ; Biological and medical sciences ; Drug Therapy, Combination ; Female ; Genotype ; Hepacivirus - genetics ; Hepacivirus - isolation & purification ; Hepatitis C virus ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - physiopathology ; Human viral diseases ; Humans ; Infectious diseases ; Interferon-alpha - administration & dosage ; Interferon-alpha - adverse effects ; Interferon-alpha - therapeutic use ; Liver Cirrhosis - drug therapy ; Liver Cirrhosis - physiopathology ; Male ; Medical sciences ; Middle Aged ; Oligopeptides - administration & dosage ; Oligopeptides - adverse effects ; Oligopeptides - therapeutic use ; Polyethylene Glycols - administration & dosage ; Polyethylene Glycols - adverse effects ; Polyethylene Glycols - therapeutic use ; Prospective Studies ; Recombinant Proteins - administration & dosage ; Recombinant Proteins - adverse effects ; Recombinant Proteins - therapeutic use ; Recurrence ; Ribavirin - administration & dosage ; Ribavirin - therapeutic use ; Treatment Outcome ; Viral diseases ; Viral hepatitis]]></subject><ispartof>Alimentary pharmacology & therapeutics, 2013-11, Vol.38 (9), p.1076-1085</ispartof><rights>2013 John Wiley & Sons Ltd</rights><rights>2014 INIST-CNRS</rights><rights>2013 John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4234-8eab78d4c8056b249b80f92891581208066fb86c9d99bc8c8f093644a4b18f363</citedby><cites>FETCH-LOGICAL-c4234-8eab78d4c8056b249b80f92891581208066fb86c9d99bc8c8f093644a4b18f363</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%2Fapt.12494$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fapt.12494$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,781,785,1418,1434,27929,27930,45579,45580,46414,46838</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27792618$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24099469$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ogawa, E.</creatorcontrib><creatorcontrib>Furusyo, N.</creatorcontrib><creatorcontrib>Nakamuta, M.</creatorcontrib><creatorcontrib>Kajiwara, E.</creatorcontrib><creatorcontrib>Nomura, H.</creatorcontrib><creatorcontrib>Dohmen, K.</creatorcontrib><creatorcontrib>Takahashi, K.</creatorcontrib><creatorcontrib>Satoh, T.</creatorcontrib><creatorcontrib>Azuma, K.</creatorcontrib><creatorcontrib>Kawano, A.</creatorcontrib><creatorcontrib>Tanabe, Y.</creatorcontrib><creatorcontrib>Kotoh, K.</creatorcontrib><creatorcontrib>Shimoda, S.</creatorcontrib><creatorcontrib>Hayashi, J.</creatorcontrib><creatorcontrib>Kyushu University Liver Disease Study (KULDS) Group</creatorcontrib><creatorcontrib>The Kyushu University Liver Disease Study (KULDS) Group</creatorcontrib><title>Telaprevir‐based triple therapy for chronic hepatitis C patients with advanced fibrosis: a prospective clinical study</title><title>Alimentary pharmacology & therapeutics</title><addtitle>Aliment Pharmacol Ther</addtitle><description>Summary
Background
Antiviral treatment is recommended for chronic hepatitis C patients with advanced fibrosis to reduce and prevent cirrhosis‐related complications.
Aim
To evaluate the efficacy and safety of telaprevir (TVR)‐based triple therapy for patients with advanced fibrosis in a clinical practice setting.
Methods
This prospective, multicentre study consisted of 102 patients with advanced fibrosis (METAVIR score F3‐4) who were infected with HCV genotype 1b. All received 12 weeks of TVR in combination with 24 weeks of pegylated interferon (PEG‐IFN) α2b and ribavirin (RBV).
Results
The sustained virological response (SVR) rate was 69.6% (71 of 102). Notably, for treatment‐naïve and prior relapse patients the SVR rate was over 80%. Previous treatment response, interleukin 28B polymorphism (rs8099917) and rapid virological response (undetectable HCV RNA at week 4) were independently associated with SVR. To achieve SVR, an adequate dosage of PEG‐IFNα2b (≥1.2 μg/kg/week) and RBV (≥7.5 mg/kg/day) is preferable; however, the mean weight‐adjusted TVR dosage had little impact on treatment outcome. Although severe blood cytopaenia and a dermatological disorder were frequently found, the rate of discontinuation due to adverse effects was 12.7%. The inosine triphosphatase CC allele (rs1127354) was independently associated with the development of severe anaemia, and lower serum albumin level (<35 g/L) was associated with the occurrence of infection.
Conclusions
The great gain in the SVR rate by telaprevir‐based triple therapy offsets the problems with adverse effects; thus, it should be considered as a potent treatment protocol for patients with advanced fibrosis, especially for those with treatment‐naïve and prior relapse.</description><subject>Aged</subject><subject>Albumin</subject><subject>Anemia - epidemiology</subject><subject>Anemia - etiology</subject><subject>Antiviral Agents - administration & dosage</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Genotype</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 - physiopathology</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Interferon-alpha - administration & dosage</subject><subject>Interferon-alpha - adverse effects</subject><subject>Interferon-alpha - therapeutic use</subject><subject>Liver Cirrhosis - drug therapy</subject><subject>Liver Cirrhosis - physiopathology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Oligopeptides - administration & dosage</subject><subject>Oligopeptides - adverse effects</subject><subject>Oligopeptides - therapeutic use</subject><subject>Polyethylene Glycols - administration & dosage</subject><subject>Polyethylene Glycols - adverse effects</subject><subject>Polyethylene Glycols - therapeutic use</subject><subject>Prospective Studies</subject><subject>Recombinant Proteins - administration & dosage</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Recurrence</subject><subject>Ribavirin - administration & dosage</subject><subject>Ribavirin - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Viral diseases</subject><subject>Viral hepatitis</subject><issn>0269-2813</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkTtOAzEQhi0EgvAouABygwTFgu11vDYdinhJSFCEemV7x4rRJllsJ1E6jsAZOQmGBKiQmGam-Oafx4_QISVnNMe57tIZZVzxDdSjpegXjJRiE_UIE6pgkpY7aDfGZ0KIqAjbRjuME6W4UD20GEKruwBzH95f34yO0OAUfNcCTiMIultiNw3YjsJ04i0eQaeTTz7iAf6sYJIiXvg0wrqZ64nN3c6bMI0-XmCNu1x1YJOfA7atzwq6xTHNmuU-2nK6jXCwznvo6fpqOLgt7h9u7gaX94XlrOSFBG0q2XArSV-YfKKRxCkmFe1LyogkQjgjhVWNUsZKKx1RpeBcc0OlK0W5h05WunmVlxnEVI99tNC2egLTWawpF7xPmFLqHygvOaEVYxk9XaE2HxgDuLoLfqzDsqak_rSkzpbUX5Zk9mgtOzNjaH7Ibw8ycLwGdMz_cSH_0cdfrqoUE1Rm7nzFLXwLy78n1pePw9XoD_BNo_M</recordid><startdate>201311</startdate><enddate>201311</enddate><creator>Ogawa, E.</creator><creator>Furusyo, N.</creator><creator>Nakamuta, M.</creator><creator>Kajiwara, E.</creator><creator>Nomura, H.</creator><creator>Dohmen, K.</creator><creator>Takahashi, K.</creator><creator>Satoh, T.</creator><creator>Azuma, K.</creator><creator>Kawano, A.</creator><creator>Tanabe, Y.</creator><creator>Kotoh, K.</creator><creator>Shimoda, S.</creator><creator>Hayashi, J.</creator><general>Blackwell</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><scope>7U9</scope><scope>H94</scope></search><sort><creationdate>201311</creationdate><title>Telaprevir‐based triple therapy for chronic hepatitis C patients with advanced fibrosis: a prospective clinical study</title><author>Ogawa, E. ; Furusyo, N. ; Nakamuta, M. ; Kajiwara, E. ; Nomura, H. ; Dohmen, K. ; Takahashi, K. ; Satoh, T. ; Azuma, K. ; Kawano, A. ; Tanabe, Y. ; Kotoh, K. ; Shimoda, S. ; Hayashi, J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4234-8eab78d4c8056b249b80f92891581208066fb86c9d99bc8c8f093644a4b18f363</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Aged</topic><topic>Albumin</topic><topic>Anemia - epidemiology</topic><topic>Anemia - etiology</topic><topic>Antiviral Agents - administration & dosage</topic><topic>Antiviral Agents - adverse effects</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Genotype</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 - physiopathology</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Interferon-alpha - administration & dosage</topic><topic>Interferon-alpha - adverse effects</topic><topic>Interferon-alpha - therapeutic use</topic><topic>Liver Cirrhosis - drug therapy</topic><topic>Liver Cirrhosis - physiopathology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Oligopeptides - administration & dosage</topic><topic>Oligopeptides - adverse effects</topic><topic>Oligopeptides - therapeutic use</topic><topic>Polyethylene Glycols - administration & dosage</topic><topic>Polyethylene Glycols - adverse effects</topic><topic>Polyethylene Glycols - therapeutic use</topic><topic>Prospective Studies</topic><topic>Recombinant Proteins - administration & dosage</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Recurrence</topic><topic>Ribavirin - administration & dosage</topic><topic>Ribavirin - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Viral diseases</topic><topic>Viral hepatitis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ogawa, E.</creatorcontrib><creatorcontrib>Furusyo, N.</creatorcontrib><creatorcontrib>Nakamuta, M.</creatorcontrib><creatorcontrib>Kajiwara, E.</creatorcontrib><creatorcontrib>Nomura, H.</creatorcontrib><creatorcontrib>Dohmen, K.</creatorcontrib><creatorcontrib>Takahashi, K.</creatorcontrib><creatorcontrib>Satoh, T.</creatorcontrib><creatorcontrib>Azuma, K.</creatorcontrib><creatorcontrib>Kawano, A.</creatorcontrib><creatorcontrib>Tanabe, Y.</creatorcontrib><creatorcontrib>Kotoh, K.</creatorcontrib><creatorcontrib>Shimoda, S.</creatorcontrib><creatorcontrib>Hayashi, J.</creatorcontrib><creatorcontrib>Kyushu University Liver Disease Study (KULDS) Group</creatorcontrib><creatorcontrib>The Kyushu University Liver Disease Study (KULDS) Group</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><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Alimentary pharmacology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ogawa, E.</au><au>Furusyo, N.</au><au>Nakamuta, M.</au><au>Kajiwara, E.</au><au>Nomura, H.</au><au>Dohmen, K.</au><au>Takahashi, K.</au><au>Satoh, T.</au><au>Azuma, K.</au><au>Kawano, A.</au><au>Tanabe, Y.</au><au>Kotoh, K.</au><au>Shimoda, S.</au><au>Hayashi, J.</au><aucorp>Kyushu University Liver Disease Study (KULDS) Group</aucorp><aucorp>The Kyushu University Liver Disease Study (KULDS) Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Telaprevir‐based triple therapy for chronic hepatitis C patients with advanced fibrosis: a prospective clinical study</atitle><jtitle>Alimentary pharmacology & therapeutics</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>2013-11</date><risdate>2013</risdate><volume>38</volume><issue>9</issue><spage>1076</spage><epage>1085</epage><pages>1076-1085</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><abstract>Summary
Background
Antiviral treatment is recommended for chronic hepatitis C patients with advanced fibrosis to reduce and prevent cirrhosis‐related complications.
Aim
To evaluate the efficacy and safety of telaprevir (TVR)‐based triple therapy for patients with advanced fibrosis in a clinical practice setting.
Methods
This prospective, multicentre study consisted of 102 patients with advanced fibrosis (METAVIR score F3‐4) who were infected with HCV genotype 1b. All received 12 weeks of TVR in combination with 24 weeks of pegylated interferon (PEG‐IFN) α2b and ribavirin (RBV).
Results
The sustained virological response (SVR) rate was 69.6% (71 of 102). Notably, for treatment‐naïve and prior relapse patients the SVR rate was over 80%. Previous treatment response, interleukin 28B polymorphism (rs8099917) and rapid virological response (undetectable HCV RNA at week 4) were independently associated with SVR. To achieve SVR, an adequate dosage of PEG‐IFNα2b (≥1.2 μg/kg/week) and RBV (≥7.5 mg/kg/day) is preferable; however, the mean weight‐adjusted TVR dosage had little impact on treatment outcome. Although severe blood cytopaenia and a dermatological disorder were frequently found, the rate of discontinuation due to adverse effects was 12.7%. The inosine triphosphatase CC allele (rs1127354) was independently associated with the development of severe anaemia, and lower serum albumin level (<35 g/L) was associated with the occurrence of infection.
Conclusions
The great gain in the SVR rate by telaprevir‐based triple therapy offsets the problems with adverse effects; thus, it should be considered as a potent treatment protocol for patients with advanced fibrosis, especially for those with treatment‐naïve and prior relapse.</abstract><cop>Oxford</cop><pub>Blackwell</pub><pmid>24099469</pmid><doi>10.1111/apt.12494</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Aged Albumin Anemia - epidemiology Anemia - etiology Antiviral Agents - administration & dosage Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Biological and medical sciences Drug Therapy, Combination Female Genotype Hepacivirus - genetics Hepacivirus - isolation & purification Hepatitis C virus Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - physiopathology Human viral diseases Humans Infectious diseases Interferon-alpha - administration & dosage Interferon-alpha - adverse effects Interferon-alpha - therapeutic use Liver Cirrhosis - drug therapy Liver Cirrhosis - physiopathology Male Medical sciences Middle Aged Oligopeptides - administration & dosage Oligopeptides - adverse effects Oligopeptides - therapeutic use Polyethylene Glycols - administration & dosage Polyethylene Glycols - adverse effects Polyethylene Glycols - therapeutic use Prospective Studies Recombinant Proteins - administration & dosage Recombinant Proteins - adverse effects Recombinant Proteins - therapeutic use Recurrence Ribavirin - administration & dosage Ribavirin - therapeutic use Treatment Outcome Viral diseases Viral hepatitis |
title | Telaprevir‐based triple therapy for chronic hepatitis C patients with advanced fibrosis: a prospective clinical study |
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