Clinical trial: extended treatment duration of peginterferon‐alpha2b plus ribavirin for 72 and 96 weeks in hepatitis C genotype 1‐infected late responders
Summary Background The benefits of prolonging peginterferon and ribavirin after 48 weeks of treatment to maximize sustained virological responses (SVR) in hepatitis C virus (HCV) genotype 1‐infected patients remain to be understood. Aim To investigate whether extended treatment longer than 72 week...
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| Veröffentlicht in: | Alimentary pharmacology & therapeutics 2009-08, Vol.30 (4), p.343-351 |
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| creator | NAGAKI, M. SHIMIZU, M. SUGIHARA, J. I. TOMITA, E. SANO, C. NAIKI, T. KIMURA, K. AMANO, K. SAKAI, T. NINOMIYA, M. KOJIMA, T. KATSUMURA, N. FUJIMOTO, M. MORIWAKI, H. |
| description | Summary
Background The benefits of prolonging peginterferon and ribavirin after 48 weeks of treatment to maximize sustained virological responses (SVR) in hepatitis C virus (HCV) genotype 1‐infected patients remain to be understood.
Aim To investigate whether extended treatment longer than 72 weeks may be superior to 72‐week treatment.
Methods A total of 120 treatment‐naïve or retreated patients with HCV genotype 1 were treated with peginterferon‐alpha‐2b (1.5 μg/kg/week) plus weight‐based ribavirin. We had 34 late responders, in whom HCV RNA first became undetectable at week 12–48, and randomized them into three groups receiving standard‐dose peginterferon‐alpha‐2b plus low‐dose ribavirin (200 mg/day) for extended 24 weeks (group A), receiving low‐dose peginterferon‐alpha‐2b (0.75 μg/kg/week) plus low‐dose ribavirin for extended 48 weeks (group B) or no extended treatment (group C), and evaluated the outcome according to their virological response.
Results Multivariate analysis showed that the treatment for 96 weeks was identified as a significant, independent factor associated with SVR in HCV genotype 1‐infected late responders in comparison with group A [odds ratio (OR), 10.002; P = 0.080] and group C (OR, 17.748; P = 0.025).
Conclusion Extending the treatment duration from 48 weeks to 96 weeks improves SVR rates in genotype 1‐infected patients with late virological response to peginterferon‐alpha‐2b and ribavirin. |
| doi_str_mv | 10.1111/j.1365-2036.2009.04048.x |
| format | Article |
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Background The benefits of prolonging peginterferon and ribavirin after 48 weeks of treatment to maximize sustained virological responses (SVR) in hepatitis C virus (HCV) genotype 1‐infected patients remain to be understood.
Aim To investigate whether extended treatment longer than 72 weeks may be superior to 72‐week treatment.
Methods A total of 120 treatment‐naïve or retreated patients with HCV genotype 1 were treated with peginterferon‐alpha‐2b (1.5 μg/kg/week) plus weight‐based ribavirin. We had 34 late responders, in whom HCV RNA first became undetectable at week 12–48, and randomized them into three groups receiving standard‐dose peginterferon‐alpha‐2b plus low‐dose ribavirin (200 mg/day) for extended 24 weeks (group A), receiving low‐dose peginterferon‐alpha‐2b (0.75 μg/kg/week) plus low‐dose ribavirin for extended 48 weeks (group B) or no extended treatment (group C), and evaluated the outcome according to their virological response.
Results Multivariate analysis showed that the treatment for 96 weeks was identified as a significant, independent factor associated with SVR in HCV genotype 1‐infected late responders in comparison with group A [odds ratio (OR), 10.002; P = 0.080] and group C (OR, 17.748; P = 0.025).
Conclusion Extending the treatment duration from 48 weeks to 96 weeks improves SVR rates in genotype 1‐infected patients with late virological response to peginterferon‐alpha‐2b and ribavirin.</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/j.1365-2036.2009.04048.x</identifier><identifier>PMID: 19485982</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Analysis of Variance ; Antiviral Agents - administration & dosage ; Biological and medical sciences ; Digestive system ; Drug Therapy, Combination ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Genotype ; Hepacivirus - genetics ; Hepatitis C virus ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - genetics ; Hepatitis C, Chronic - virology ; Human viral diseases ; Humans ; Infectious diseases ; Interferon-alpha - administration & dosage ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Polyethylene Glycols - administration & dosage ; Recombinant Proteins ; Ribavirin - administration & dosage ; Time Factors ; Treatment Outcome ; Viral diseases ; Viral hepatitis</subject><ispartof>Alimentary pharmacology & therapeutics, 2009-08, Vol.30 (4), p.343-351</ispartof><rights>2009 Blackwell Publishing Ltd</rights><rights>2009 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5458-b5dc21af04cf7e01ef15d4c0c460cfc8220920c53c98971282f7376f7a08bdc83</citedby><cites>FETCH-LOGICAL-c5458-b5dc21af04cf7e01ef15d4c0c460cfc8220920c53c98971282f7376f7a08bdc83</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.1365-2036.2009.04048.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2036.2009.04048.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,1433,27923,27924,45573,45574,46408,46832</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21742659$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19485982$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>NAGAKI, M.</creatorcontrib><creatorcontrib>SHIMIZU, M.</creatorcontrib><creatorcontrib>SUGIHARA, J. I.</creatorcontrib><creatorcontrib>TOMITA, E.</creatorcontrib><creatorcontrib>SANO, C.</creatorcontrib><creatorcontrib>NAIKI, T.</creatorcontrib><creatorcontrib>KIMURA, K.</creatorcontrib><creatorcontrib>AMANO, K.</creatorcontrib><creatorcontrib>SAKAI, T.</creatorcontrib><creatorcontrib>NINOMIYA, M.</creatorcontrib><creatorcontrib>KOJIMA, T.</creatorcontrib><creatorcontrib>KATSUMURA, N.</creatorcontrib><creatorcontrib>FUJIMOTO, M.</creatorcontrib><creatorcontrib>MORIWAKI, H.</creatorcontrib><title>Clinical trial: extended treatment duration of peginterferon‐alpha2b plus ribavirin for 72 and 96 weeks in hepatitis C genotype 1‐infected late responders</title><title>Alimentary pharmacology & therapeutics</title><addtitle>Aliment Pharmacol Ther</addtitle><description>Summary
Background The benefits of prolonging peginterferon and ribavirin after 48 weeks of treatment to maximize sustained virological responses (SVR) in hepatitis C virus (HCV) genotype 1‐infected patients remain to be understood.
Aim To investigate whether extended treatment longer than 72 weeks may be superior to 72‐week treatment.
Methods A total of 120 treatment‐naïve or retreated patients with HCV genotype 1 were treated with peginterferon‐alpha‐2b (1.5 μg/kg/week) plus weight‐based ribavirin. We had 34 late responders, in whom HCV RNA first became undetectable at week 12–48, and randomized them into three groups receiving standard‐dose peginterferon‐alpha‐2b plus low‐dose ribavirin (200 mg/day) for extended 24 weeks (group A), receiving low‐dose peginterferon‐alpha‐2b (0.75 μg/kg/week) plus low‐dose ribavirin for extended 48 weeks (group B) or no extended treatment (group C), and evaluated the outcome according to their virological response.
Results Multivariate analysis showed that the treatment for 96 weeks was identified as a significant, independent factor associated with SVR in HCV genotype 1‐infected late responders in comparison with group A [odds ratio (OR), 10.002; P = 0.080] and group C (OR, 17.748; P = 0.025).
Conclusion Extending the treatment duration from 48 weeks to 96 weeks improves SVR rates in genotype 1‐infected patients with late virological response to peginterferon‐alpha‐2b and ribavirin.</description><subject>Adult</subject><subject>Aged</subject><subject>Analysis of Variance</subject><subject>Antiviral Agents - administration & dosage</subject><subject>Biological and medical sciences</subject><subject>Digestive system</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Genotype</subject><subject>Hepacivirus - genetics</subject><subject>Hepatitis C virus</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatitis C, Chronic - genetics</subject><subject>Hepatitis C, Chronic - virology</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Interferon-alpha - administration & dosage</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Polyethylene Glycols - administration & dosage</subject><subject>Recombinant Proteins</subject><subject>Ribavirin - administration & dosage</subject><subject>Time Factors</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>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkUtuFDEQhlsIRIbAFZA3wGqasvthG4lFNOIlRYJFWFtudznx0ONubHcys4vEBTgCZ8tJ8DCjsEN4Y1v11V8lfUVBKJQ0n9frklZts2RQtSUDkCXUUIty-6BY3BceFgtgrVwyQauT4kmMawBoObDHxQmVtWikYIvi12pw3hk9kBScHt4Q3Cb0Pfb5jzpt0CfSz0EnN3oyWjLhpfMJg8Uw-rvbn3qYrjTryDTMkQTX6WsXnCd2DIQzon1PZHt3--MG8VskuXCFU85KLpIVuUQ_pt2EhOYg5y2alOcOOiEJGKcxrxHi0-KR1UPEZ8f7tPj6_t3F6uPy_POHT6uz86Vp6kYsu6Y3jGoLtbEcgaKlTV8bMHULxhrBGEgGpqmMFJJTJpjlFW8t1yC63ojqtHh1yJ3C-H3GmNTGRYPDoD2Oc1S8qhre8Boy-fKfJAPGqJR1BsUBNGGMMaBVU3AbHXaKgtp7VGu116X2utTeo_rjUW1z6_PjjLnbYP-38SguAy-OgI7Zng3aGxfvOUZ5zdpGZu7tgbtxA-7-ewF19uVi_6p-A3LBvYw</recordid><startdate>200908</startdate><enddate>200908</enddate><creator>NAGAKI, M.</creator><creator>SHIMIZU, M.</creator><creator>SUGIHARA, J. I.</creator><creator>TOMITA, E.</creator><creator>SANO, C.</creator><creator>NAIKI, T.</creator><creator>KIMURA, K.</creator><creator>AMANO, K.</creator><creator>SAKAI, T.</creator><creator>NINOMIYA, M.</creator><creator>KOJIMA, T.</creator><creator>KATSUMURA, N.</creator><creator>FUJIMOTO, M.</creator><creator>MORIWAKI, H.</creator><general>Blackwell Publishing Ltd</general><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>7U9</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>200908</creationdate><title>Clinical trial: extended treatment duration of peginterferon‐alpha2b plus ribavirin for 72 and 96 weeks in hepatitis C genotype 1‐infected late responders</title><author>NAGAKI, M. ; SHIMIZU, M. ; SUGIHARA, J. I. ; TOMITA, E. ; SANO, C. ; NAIKI, T. ; KIMURA, K. ; AMANO, K. ; SAKAI, T. ; NINOMIYA, M. ; KOJIMA, T. ; KATSUMURA, N. ; FUJIMOTO, M. ; MORIWAKI, H.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5458-b5dc21af04cf7e01ef15d4c0c460cfc8220920c53c98971282f7376f7a08bdc83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Analysis of Variance</topic><topic>Antiviral Agents - administration & dosage</topic><topic>Biological and medical sciences</topic><topic>Digestive system</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Genotype</topic><topic>Hepacivirus - genetics</topic><topic>Hepatitis C virus</topic><topic>Hepatitis C, Chronic - drug therapy</topic><topic>Hepatitis C, Chronic - genetics</topic><topic>Hepatitis C, Chronic - virology</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Interferon-alpha - administration & dosage</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Polyethylene Glycols - administration & dosage</topic><topic>Recombinant Proteins</topic><topic>Ribavirin - administration & dosage</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Viral diseases</topic><topic>Viral hepatitis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>NAGAKI, M.</creatorcontrib><creatorcontrib>SHIMIZU, M.</creatorcontrib><creatorcontrib>SUGIHARA, J. I.</creatorcontrib><creatorcontrib>TOMITA, E.</creatorcontrib><creatorcontrib>SANO, C.</creatorcontrib><creatorcontrib>NAIKI, T.</creatorcontrib><creatorcontrib>KIMURA, K.</creatorcontrib><creatorcontrib>AMANO, K.</creatorcontrib><creatorcontrib>SAKAI, T.</creatorcontrib><creatorcontrib>NINOMIYA, M.</creatorcontrib><creatorcontrib>KOJIMA, T.</creatorcontrib><creatorcontrib>KATSUMURA, N.</creatorcontrib><creatorcontrib>FUJIMOTO, M.</creatorcontrib><creatorcontrib>MORIWAKI, H.</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>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Alimentary pharmacology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>NAGAKI, M.</au><au>SHIMIZU, M.</au><au>SUGIHARA, J. I.</au><au>TOMITA, E.</au><au>SANO, C.</au><au>NAIKI, T.</au><au>KIMURA, K.</au><au>AMANO, K.</au><au>SAKAI, T.</au><au>NINOMIYA, M.</au><au>KOJIMA, T.</au><au>KATSUMURA, N.</au><au>FUJIMOTO, M.</au><au>MORIWAKI, H.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical trial: extended treatment duration of peginterferon‐alpha2b plus ribavirin for 72 and 96 weeks in hepatitis C genotype 1‐infected late responders</atitle><jtitle>Alimentary pharmacology & therapeutics</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>2009-08</date><risdate>2009</risdate><volume>30</volume><issue>4</issue><spage>343</spage><epage>351</epage><pages>343-351</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><abstract>Summary
Background The benefits of prolonging peginterferon and ribavirin after 48 weeks of treatment to maximize sustained virological responses (SVR) in hepatitis C virus (HCV) genotype 1‐infected patients remain to be understood.
Aim To investigate whether extended treatment longer than 72 weeks may be superior to 72‐week treatment.
Methods A total of 120 treatment‐naïve or retreated patients with HCV genotype 1 were treated with peginterferon‐alpha‐2b (1.5 μg/kg/week) plus weight‐based ribavirin. We had 34 late responders, in whom HCV RNA first became undetectable at week 12–48, and randomized them into three groups receiving standard‐dose peginterferon‐alpha‐2b plus low‐dose ribavirin (200 mg/day) for extended 24 weeks (group A), receiving low‐dose peginterferon‐alpha‐2b (0.75 μg/kg/week) plus low‐dose ribavirin for extended 48 weeks (group B) or no extended treatment (group C), and evaluated the outcome according to their virological response.
Results Multivariate analysis showed that the treatment for 96 weeks was identified as a significant, independent factor associated with SVR in HCV genotype 1‐infected late responders in comparison with group A [odds ratio (OR), 10.002; P = 0.080] and group C (OR, 17.748; P = 0.025).
Conclusion Extending the treatment duration from 48 weeks to 96 weeks improves SVR rates in genotype 1‐infected patients with late virological response to peginterferon‐alpha‐2b and ribavirin.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>19485982</pmid><doi>10.1111/j.1365-2036.2009.04048.x</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Analysis of Variance Antiviral Agents - administration & dosage Biological and medical sciences Digestive system Drug Therapy, Combination Female Gastroenterology. Liver. Pancreas. Abdomen Genotype Hepacivirus - genetics Hepatitis C virus Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - genetics Hepatitis C, Chronic - virology Human viral diseases Humans Infectious diseases Interferon-alpha - administration & dosage Male Medical sciences Middle Aged Pharmacology. Drug treatments Polyethylene Glycols - administration & dosage Recombinant Proteins Ribavirin - administration & dosage Time Factors Treatment Outcome Viral diseases Viral hepatitis |
| title | Clinical trial: extended treatment duration of peginterferon‐alpha2b plus ribavirin for 72 and 96 weeks in hepatitis C genotype 1‐infected late responders |
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