A randomized trial of prolonged high dose of interferon plus ribavirin for hepatitis C patients nonresponders to interferon alone
Retreatment of chronic hepatitis C patients nonresponders to interferon (IFN) alone with the standard dose of IFN [3 million units (MU) thrice weekly (TIW)] plus ribavirin for 24 weeks has yielded low sustained virological response (SVR), averaging 8%. The aim of the present, open‐labelled, randomiz...
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| Veröffentlicht in: | Journal of viral hepatitis 2004-11, Vol.11 (6), p.543-551 |
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| creator | Fattovich, G. Zagni, I. Ribero, M. L. Castagnetti, E. Minola, E. Lomonaco, L. Scattolini, C. Fabris, P. Boccia, S. Giusti, M. Abbati, G. Felder, M. Rovere, P. Redaelli, A. Tonon, A. Tomba, A. Montanari, R. Paternoster, C. Distasi, M. Fornaciari, G. Tositti, G. Rizzo, C. Suppressa, S. Pantalena, M. Noventa, F. Tagger, A. |
| description | Retreatment of chronic hepatitis C patients nonresponders to interferon (IFN) alone with the standard dose of IFN [3 million units (MU) thrice weekly (TIW)] plus ribavirin for 24 weeks has yielded low sustained virological response (SVR), averaging 8%. The aim of the present, open‐labelled, randomized study was to evaluate the efficacy of IFN induction therapy followed by prolonged high dose of IFN plus ribavirin in nonresponders. One hundred and fifty‐one patients were randomized to receive 5 MU daily of IFN alfa‐2b (group 1, n = 73) or 5 MU TIW of IFN alfa 2b (group 2, n = 78) for 4 weeks followed by IFN (5 MU TIW) plus ribavirin (1000/1200 mg/daily) for 48 weeks in both groups. In an intention‐to‐treat analysis, the sustained virological response (SVR) at 24‐week follow‐up was 33 and 23% for group 1 and 2, respectively (P = 0.17). The overall SVR was 52 and 18% in patients with genotype 2/3 and 1/4, respectively. Among genotype 1/4 patients the SVR was 29 and 11% for age younger or older than 40 years. Compared with genotype 2/3 patients, the risk (95% confidence interval) of nonresponse to retreatment was 3.0‐fold (1.17–8.0) in younger genotype 1/4 patients and 8.4‐fold (3.0–23.29) in older genotype 1/4 patients. In conclusion these results suggest that retreatment with a reinforced regimen should be focused in nonresponder genotype 2/3 patients and younger genotype 1/4 patients, who are most likely to benefit. Induction therapy does not improve SVR. |
| doi_str_mv | 10.1111/j.1365-2893.2004.00538.x |
| format | Article |
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L. ; Castagnetti, E. ; Minola, E. ; Lomonaco, L. ; Scattolini, C. ; Fabris, P. ; Boccia, S. ; Giusti, M. ; Abbati, G. ; Felder, M. ; Rovere, P. ; Redaelli, A. ; Tonon, A. ; Tomba, A. ; Montanari, R. ; Paternoster, C. ; Distasi, M. ; Fornaciari, G. ; Tositti, G. ; Rizzo, C. ; Suppressa, S. ; Pantalena, M. ; Noventa, F. ; Tagger, A.</creator><creatorcontrib>Fattovich, G. ; Zagni, I. ; Ribero, M. L. ; Castagnetti, E. ; Minola, E. ; Lomonaco, L. ; Scattolini, C. ; Fabris, P. ; Boccia, S. ; Giusti, M. ; Abbati, G. ; Felder, M. ; Rovere, P. ; Redaelli, A. ; Tonon, A. ; Tomba, A. ; Montanari, R. ; Paternoster, C. ; Distasi, M. ; Fornaciari, G. ; Tositti, G. ; Rizzo, C. ; Suppressa, S. ; Pantalena, M. ; Noventa, F. ; Tagger, A.</creatorcontrib><description>Retreatment of chronic hepatitis C patients nonresponders to interferon (IFN) alone with the standard dose of IFN [3 million units (MU) thrice weekly (TIW)] plus ribavirin for 24 weeks has yielded low sustained virological response (SVR), averaging 8%. The aim of the present, open‐labelled, randomized study was to evaluate the efficacy of IFN induction therapy followed by prolonged high dose of IFN plus ribavirin in nonresponders. One hundred and fifty‐one patients were randomized to receive 5 MU daily of IFN alfa‐2b (group 1, n = 73) or 5 MU TIW of IFN alfa 2b (group 2, n = 78) for 4 weeks followed by IFN (5 MU TIW) plus ribavirin (1000/1200 mg/daily) for 48 weeks in both groups. In an intention‐to‐treat analysis, the sustained virological response (SVR) at 24‐week follow‐up was 33 and 23% for group 1 and 2, respectively (P = 0.17). The overall SVR was 52 and 18% in patients with genotype 2/3 and 1/4, respectively. Among genotype 1/4 patients the SVR was 29 and 11% for age younger or older than 40 years. Compared with genotype 2/3 patients, the risk (95% confidence interval) of nonresponse to retreatment was 3.0‐fold (1.17–8.0) in younger genotype 1/4 patients and 8.4‐fold (3.0–23.29) in older genotype 1/4 patients. In conclusion these results suggest that retreatment with a reinforced regimen should be focused in nonresponder genotype 2/3 patients and younger genotype 1/4 patients, who are most likely to benefit. Induction therapy does not improve SVR.</description><identifier>ISSN: 1352-0504</identifier><identifier>EISSN: 1365-2893</identifier><identifier>DOI: 10.1111/j.1365-2893.2004.00538.x</identifier><identifier>PMID: 15500555</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Science Ltd</publisher><subject>Adult ; Aged ; Antiviral Agents - administration & dosage ; Antiviral Agents - therapeutic use ; chronic hepatitis C ; Drug Therapy, Combination ; Female ; Hepacivirus - classification ; Hepacivirus - drug effects ; Hepacivirus - genetics ; Hepatitis C virus ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - virology ; high dose interferon ; Humans ; Interferon-alpha - administration & dosage ; Interferon-alpha - therapeutic use ; Male ; Middle Aged ; nonresponders to interferon ; prolonged therapy ; Recombinant Proteins ; ribavirin ; Ribavirin - administration & dosage ; Ribavirin - therapeutic use ; RNA, Viral - blood ; Time Factors ; Treatment Failure ; Treatment Outcome</subject><ispartof>Journal of viral hepatitis, 2004-11, Vol.11 (6), p.543-551</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5288-19f0c7bf50f3261ee07707ac6182326d94046dadb473fac5ae3876760e9df6563</citedby><cites>FETCH-LOGICAL-c5288-19f0c7bf50f3261ee07707ac6182326d94046dadb473fac5ae3876760e9df6563</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%2Fj.1365-2893.2004.00538.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2893.2004.00538.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15500555$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fattovich, G.</creatorcontrib><creatorcontrib>Zagni, I.</creatorcontrib><creatorcontrib>Ribero, M. L.</creatorcontrib><creatorcontrib>Castagnetti, E.</creatorcontrib><creatorcontrib>Minola, E.</creatorcontrib><creatorcontrib>Lomonaco, L.</creatorcontrib><creatorcontrib>Scattolini, C.</creatorcontrib><creatorcontrib>Fabris, P.</creatorcontrib><creatorcontrib>Boccia, S.</creatorcontrib><creatorcontrib>Giusti, M.</creatorcontrib><creatorcontrib>Abbati, G.</creatorcontrib><creatorcontrib>Felder, M.</creatorcontrib><creatorcontrib>Rovere, P.</creatorcontrib><creatorcontrib>Redaelli, A.</creatorcontrib><creatorcontrib>Tonon, A.</creatorcontrib><creatorcontrib>Tomba, A.</creatorcontrib><creatorcontrib>Montanari, R.</creatorcontrib><creatorcontrib>Paternoster, C.</creatorcontrib><creatorcontrib>Distasi, M.</creatorcontrib><creatorcontrib>Fornaciari, G.</creatorcontrib><creatorcontrib>Tositti, G.</creatorcontrib><creatorcontrib>Rizzo, C.</creatorcontrib><creatorcontrib>Suppressa, S.</creatorcontrib><creatorcontrib>Pantalena, M.</creatorcontrib><creatorcontrib>Noventa, F.</creatorcontrib><creatorcontrib>Tagger, A.</creatorcontrib><title>A randomized trial of prolonged high dose of interferon plus ribavirin for hepatitis C patients nonresponders to interferon alone</title><title>Journal of viral hepatitis</title><addtitle>J Viral Hepat</addtitle><description>Retreatment of chronic hepatitis C patients nonresponders to interferon (IFN) alone with the standard dose of IFN [3 million units (MU) thrice weekly (TIW)] plus ribavirin for 24 weeks has yielded low sustained virological response (SVR), averaging 8%. The aim of the present, open‐labelled, randomized study was to evaluate the efficacy of IFN induction therapy followed by prolonged high dose of IFN plus ribavirin in nonresponders. One hundred and fifty‐one patients were randomized to receive 5 MU daily of IFN alfa‐2b (group 1, n = 73) or 5 MU TIW of IFN alfa 2b (group 2, n = 78) for 4 weeks followed by IFN (5 MU TIW) plus ribavirin (1000/1200 mg/daily) for 48 weeks in both groups. In an intention‐to‐treat analysis, the sustained virological response (SVR) at 24‐week follow‐up was 33 and 23% for group 1 and 2, respectively (P = 0.17). The overall SVR was 52 and 18% in patients with genotype 2/3 and 1/4, respectively. Among genotype 1/4 patients the SVR was 29 and 11% for age younger or older than 40 years. Compared with genotype 2/3 patients, the risk (95% confidence interval) of nonresponse to retreatment was 3.0‐fold (1.17–8.0) in younger genotype 1/4 patients and 8.4‐fold (3.0–23.29) in older genotype 1/4 patients. In conclusion these results suggest that retreatment with a reinforced regimen should be focused in nonresponder genotype 2/3 patients and younger genotype 1/4 patients, who are most likely to benefit. Induction therapy does not improve SVR.</description><subject>Adult</subject><subject>Aged</subject><subject>Antiviral Agents - administration & dosage</subject><subject>Antiviral Agents - therapeutic use</subject><subject>chronic hepatitis C</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Hepacivirus - classification</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>high dose interferon</subject><subject>Humans</subject><subject>Interferon-alpha - administration & dosage</subject><subject>Interferon-alpha - therapeutic use</subject><subject>Male</subject><subject>Middle Aged</subject><subject>nonresponders to interferon</subject><subject>prolonged therapy</subject><subject>Recombinant Proteins</subject><subject>ribavirin</subject><subject>Ribavirin - administration & dosage</subject><subject>Ribavirin - therapeutic use</subject><subject>RNA, Viral - blood</subject><subject>Time Factors</subject><subject>Treatment Failure</subject><subject>Treatment Outcome</subject><issn>1352-0504</issn><issn>1365-2893</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNUU1v1DAUjBCIfsBfQD5xS_ocxx-RuFQr2oIqQBUfR8ubPHe9ZO1gZ8uWG_8ch10VbuCLR_Nm5ulpioJQqGh-Z-uKMsHLWrWsqgGaCoAzVe0eFccPg8cz5nUJHJqj4iSlNQBlNadPiyPKeXZwflz8PCfR-D5s3A_syRSdGUiwZIxhCP42Uyt3uyJ9SDjTzk8YLcbgyThsE4luae5cdJ7YEMkKRzO5ySWyIDNCPyXig4-YxuB7jIlM4e8Mk3fgs-KJNUPC54f_tPh08frj4qq8fn_5ZnF-XXa8VqqkrYVOLi0Hy2pBEUFKkKYTVNWZ6NsGGtGbftlIZk3HDTIlhRSAbW8FF-y0eLnPzbd922Ka9MalDofBeAzbpIUEEE0D_xRSqShVgmWh2gu7GFKKaPUY3cbEe01Bzz3ptZ7r0HMdeu5J_-5J77L1xWHHdrnB_o_xUEwWvNoLvrsB7_87WL_9fJVBtpd7u0sT7h7sJn7NdzLJ9Zd3l_pCifbmZsH0B_YLLwyx8A</recordid><startdate>200411</startdate><enddate>200411</enddate><creator>Fattovich, G.</creator><creator>Zagni, I.</creator><creator>Ribero, M. 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L. ; Castagnetti, E. ; Minola, E. ; Lomonaco, L. ; Scattolini, C. ; Fabris, P. ; Boccia, S. ; Giusti, M. ; Abbati, G. ; Felder, M. ; Rovere, P. ; Redaelli, A. ; Tonon, A. ; Tomba, A. ; Montanari, R. ; Paternoster, C. ; Distasi, M. ; Fornaciari, G. ; Tositti, G. ; Rizzo, C. ; Suppressa, S. ; Pantalena, M. ; Noventa, F. ; Tagger, A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5288-19f0c7bf50f3261ee07707ac6182326d94046dadb473fac5ae3876760e9df6563</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antiviral Agents - administration & dosage</topic><topic>Antiviral Agents - therapeutic use</topic><topic>chronic hepatitis C</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Hepacivirus - classification</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>high dose interferon</topic><topic>Humans</topic><topic>Interferon-alpha - administration & dosage</topic><topic>Interferon-alpha - therapeutic use</topic><topic>Male</topic><topic>Middle Aged</topic><topic>nonresponders to interferon</topic><topic>prolonged therapy</topic><topic>Recombinant Proteins</topic><topic>ribavirin</topic><topic>Ribavirin - administration & dosage</topic><topic>Ribavirin - therapeutic use</topic><topic>RNA, Viral - blood</topic><topic>Time Factors</topic><topic>Treatment Failure</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fattovich, G.</creatorcontrib><creatorcontrib>Zagni, I.</creatorcontrib><creatorcontrib>Ribero, M. 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L.</au><au>Castagnetti, E.</au><au>Minola, E.</au><au>Lomonaco, L.</au><au>Scattolini, C.</au><au>Fabris, P.</au><au>Boccia, S.</au><au>Giusti, M.</au><au>Abbati, G.</au><au>Felder, M.</au><au>Rovere, P.</au><au>Redaelli, A.</au><au>Tonon, A.</au><au>Tomba, A.</au><au>Montanari, R.</au><au>Paternoster, C.</au><au>Distasi, M.</au><au>Fornaciari, G.</au><au>Tositti, G.</au><au>Rizzo, C.</au><au>Suppressa, S.</au><au>Pantalena, M.</au><au>Noventa, F.</au><au>Tagger, A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized trial of prolonged high dose of interferon plus ribavirin for hepatitis C patients nonresponders to interferon alone</atitle><jtitle>Journal of viral hepatitis</jtitle><addtitle>J Viral Hepat</addtitle><date>2004-11</date><risdate>2004</risdate><volume>11</volume><issue>6</issue><spage>543</spage><epage>551</epage><pages>543-551</pages><issn>1352-0504</issn><eissn>1365-2893</eissn><abstract>Retreatment of chronic hepatitis C patients nonresponders to interferon (IFN) alone with the standard dose of IFN [3 million units (MU) thrice weekly (TIW)] plus ribavirin for 24 weeks has yielded low sustained virological response (SVR), averaging 8%. The aim of the present, open‐labelled, randomized study was to evaluate the efficacy of IFN induction therapy followed by prolonged high dose of IFN plus ribavirin in nonresponders. One hundred and fifty‐one patients were randomized to receive 5 MU daily of IFN alfa‐2b (group 1, n = 73) or 5 MU TIW of IFN alfa 2b (group 2, n = 78) for 4 weeks followed by IFN (5 MU TIW) plus ribavirin (1000/1200 mg/daily) for 48 weeks in both groups. In an intention‐to‐treat analysis, the sustained virological response (SVR) at 24‐week follow‐up was 33 and 23% for group 1 and 2, respectively (P = 0.17). The overall SVR was 52 and 18% in patients with genotype 2/3 and 1/4, respectively. Among genotype 1/4 patients the SVR was 29 and 11% for age younger or older than 40 years. Compared with genotype 2/3 patients, the risk (95% confidence interval) of nonresponse to retreatment was 3.0‐fold (1.17–8.0) in younger genotype 1/4 patients and 8.4‐fold (3.0–23.29) in older genotype 1/4 patients. In conclusion these results suggest that retreatment with a reinforced regimen should be focused in nonresponder genotype 2/3 patients and younger genotype 1/4 patients, who are most likely to benefit. Induction therapy does not improve SVR.</abstract><cop>Oxford, UK</cop><pub>Blackwell Science Ltd</pub><pmid>15500555</pmid><doi>10.1111/j.1365-2893.2004.00538.x</doi><tpages>9</tpages></addata></record> |
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| ispartof | Journal of viral hepatitis, 2004-11, Vol.11 (6), p.543-551 |
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| source | MEDLINE; Access via Wiley Online Library |
| subjects | Adult Aged Antiviral Agents - administration & dosage Antiviral Agents - therapeutic use chronic hepatitis C Drug Therapy, Combination Female Hepacivirus - classification Hepacivirus - drug effects Hepacivirus - genetics Hepatitis C virus Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - virology high dose interferon Humans Interferon-alpha - administration & dosage Interferon-alpha - therapeutic use Male Middle Aged nonresponders to interferon prolonged therapy Recombinant Proteins ribavirin Ribavirin - administration & dosage Ribavirin - therapeutic use RNA, Viral - blood Time Factors Treatment Failure Treatment Outcome |
| title | A randomized trial of prolonged high dose of interferon plus ribavirin for hepatitis C patients nonresponders to interferon alone |
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