Once-daily simeprevir with peginterferon and ribavirin for treatment-experienced HCV genotype 1-infected patients in Japan: the CONCERTO-2 and CONCERTO-3 studies
Background Efficacy of available therapies for patients with HCV who have previously failed treatment is limited. Two Phase III, open-label trials in Japan investigated efficacy and safety of simeprevir and peginterferon-α-2a/ribavirin (PR) combination therapy in treatment-experienced patients with...
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| Veröffentlicht in: | Journal of gastroenterology 2014-05, Vol.49 (5), p.941-953 |
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| creator | Izumi, Namiki Hayashi, Norio Kumada, Hiromitsu Okanoue, Takeshi Tsubouchi, Hirohito Yatsuhashi, Hiroshi Kato, Mai Ki, Rito Komada, Yuji Seto, Chiharu Goto, Shoichiro |
| description | Background
Efficacy of available therapies for patients with HCV who have previously failed treatment is limited. Two Phase III, open-label trials in Japan investigated efficacy and safety of simeprevir and peginterferon-α-2a/ribavirin (PR) combination therapy in treatment-experienced patients with genotype 1 HCV infection.
Methods
In CONCERTO-2, prior non-responders to IFN-based therapy (
N
= 106) received simeprevir (TMC435) 100 mg QD with PR for 12 (SMV12,
n
= 53) or 24 weeks (SMV24,
n
= 53) followed by response-guided therapy (RGT) with PR for 12/36 (SMV12) or 0/24 (SMV24) weeks. In CONCERTO-3, relapsers after IFN-based therapy (
N
= 49) received simeprevir 100 mg QD with PR for 12 weeks followed by RGT with PR for 12/36 weeks. Primary endpoints were the rates of sustained virologic response 12 weeks after treatment end (SVR12).
Results
SVR12 rates were 52.8 % (SMV12) and 35.8 % (SMV24) for prior non-responders, and 95.9 % for prior relapsers (SMV12;
p
≤ 0.0001 vs null hypothesis, respectively). Most prior non-responders (SMV12: 81.1 %; SMV24: 73.6 %) and prior relapsers (95.9 %) met RGT criteria and completed PR to Week 24. Of these, 60.5 %, 48.7 %, and 95.7 %, respectively, achieved SVR12. Viral breakthrough occurred in 13.2 % (SMV12) and 11.3 % (SMV24) of prior non-responders; no viral breakthrough occurred in prior relapsers. Viral relapse occurred in 38.6 % (SMV12) and 51.1 % (SMV24) of prior non-responders and 8.2 % of prior relapsers. Simeprevir with PR was generally well tolerated in both studies.
Conclusion
Re-treatment with 12 weeks of simeprevir QD with PR provided high SVR in treatment-experienced patients with chronic HCV genotype 1 infection, and allowed most patients to complete treatment in 24 weeks. |
| doi_str_mv | 10.1007/s00535-014-0949-8 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1544006475</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1544006475</sourcerecordid><originalsourceid>FETCH-LOGICAL-c457t-1b9a58755b0ca8e91f882e70c029f2d4e78ebf91b12577f3b82d407cf4515faa3</originalsourceid><addsrcrecordid>eNp9kUFrFTEUhYMo9ln9AW4k4MZNNMkkk4w7GWprKX0g1W3IzNy8przJjEmm-n5O_6mpry0i1FXIud8598JB6DWj7xml6kOiVFaSUCYIbURD9BO0YqIosuH8KVoVURDGlDhAL1K6opRVVOrn6ICLmtdashW6WYceyGD9doeTH2GOcO0j_unzJZ5h40OG6CBOAdsw4Og7W8Y-YDdFnCPYPELIBH7NED2UqAGftN_xBsKUdzNgRnxw0OeizzYXIidc3Kd2tuEjzpeA2_V5e_T1Yk34nw0P3wqnvAwe0kv0zNltgld37yH69vnooj0hZ-vjL-2nM9ILqTJhXWOlVlJ2tLcaGua05qBoT3nj-CBAaehcwzrGpVKu6nQRqeqdkEw6a6tD9G6fO8fpxwIpm9GnHrZbG2BakmFSCEproWRB3_6DXk1LDOU6w-tG1kLXFfsfxSQXXDSirgrF9lQfp5QiODNHP9q4M4ya25bNvmVTWja3LRtdPG_ukpduhOHBcV9rAfgeSGUUNhD_Wv1o6m9NPbE8</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1524249463</pqid></control><display><type>article</type><title>Once-daily simeprevir with peginterferon and ribavirin for treatment-experienced HCV genotype 1-infected patients in Japan: the CONCERTO-2 and CONCERTO-3 studies</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Izumi, Namiki ; Hayashi, Norio ; Kumada, Hiromitsu ; Okanoue, Takeshi ; Tsubouchi, Hirohito ; Yatsuhashi, Hiroshi ; Kato, Mai ; Ki, Rito ; Komada, Yuji ; Seto, Chiharu ; Goto, Shoichiro</creator><creatorcontrib>Izumi, Namiki ; Hayashi, Norio ; Kumada, Hiromitsu ; Okanoue, Takeshi ; Tsubouchi, Hirohito ; Yatsuhashi, Hiroshi ; Kato, Mai ; Ki, Rito ; Komada, Yuji ; Seto, Chiharu ; Goto, Shoichiro</creatorcontrib><description>Background
Efficacy of available therapies for patients with HCV who have previously failed treatment is limited. Two Phase III, open-label trials in Japan investigated efficacy and safety of simeprevir and peginterferon-α-2a/ribavirin (PR) combination therapy in treatment-experienced patients with genotype 1 HCV infection.
Methods
In CONCERTO-2, prior non-responders to IFN-based therapy (
N
= 106) received simeprevir (TMC435) 100 mg QD with PR for 12 (SMV12,
n
= 53) or 24 weeks (SMV24,
n
= 53) followed by response-guided therapy (RGT) with PR for 12/36 (SMV12) or 0/24 (SMV24) weeks. In CONCERTO-3, relapsers after IFN-based therapy (
N
= 49) received simeprevir 100 mg QD with PR for 12 weeks followed by RGT with PR for 12/36 weeks. Primary endpoints were the rates of sustained virologic response 12 weeks after treatment end (SVR12).
Results
SVR12 rates were 52.8 % (SMV12) and 35.8 % (SMV24) for prior non-responders, and 95.9 % for prior relapsers (SMV12;
p
≤ 0.0001 vs null hypothesis, respectively). Most prior non-responders (SMV12: 81.1 %; SMV24: 73.6 %) and prior relapsers (95.9 %) met RGT criteria and completed PR to Week 24. Of these, 60.5 %, 48.7 %, and 95.7 %, respectively, achieved SVR12. Viral breakthrough occurred in 13.2 % (SMV12) and 11.3 % (SMV24) of prior non-responders; no viral breakthrough occurred in prior relapsers. Viral relapse occurred in 38.6 % (SMV12) and 51.1 % (SMV24) of prior non-responders and 8.2 % of prior relapsers. Simeprevir with PR was generally well tolerated in both studies.
Conclusion
Re-treatment with 12 weeks of simeprevir QD with PR provided high SVR in treatment-experienced patients with chronic HCV genotype 1 infection, and allowed most patients to complete treatment in 24 weeks.</description><identifier>ISSN: 0944-1174</identifier><identifier>EISSN: 1435-5922</identifier><identifier>DOI: 10.1007/s00535-014-0949-8</identifier><identifier>PMID: 24626851</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject><![CDATA[Abdominal Surgery ; Adult ; Aged ; Antiviral Agents - administration & dosage ; Antiviral Agents - adverse effects ; Antiviral Agents - therapeutic use ; Antiviral drugs ; Biliary Tract ; Chronic infection ; Clinical trials ; Colorectal Surgery ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Gastroenterology ; Genotype ; Genotype & phenotype ; Genotypes ; Hepacivirus - genetics ; Hepacivirus - isolation & purification ; Hepatitis C virus ; Hepatitis C, Chronic - drug therapy ; Hepatology ; Heterocyclic Compounds, 3-Ring - administration & dosage ; Heterocyclic Compounds, 3-Ring - adverse effects ; Heterocyclic Compounds, 3-Ring - therapeutic use ; Humans ; Interferon ; Interferon-alpha - administration & dosage ; Interferon-alpha - adverse effects ; Interferon-alpha - therapeutic use ; Japan ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Original Article—Liver ; Pancreas ; Patients ; Polyethylene Glycols - administration & dosage ; Polyethylene Glycols - adverse effects ; Polyethylene Glycols - therapeutic use ; Recombinant Proteins - administration & dosage ; Recombinant Proteins - adverse effects ; Recombinant Proteins - therapeutic use ; Recurrence ; Ribavirin ; Ribavirin - administration & dosage ; Ribavirin - adverse effects ; Ribavirin - therapeutic use ; Simeprevir ; Sulfonamides - administration & dosage ; Sulfonamides - adverse effects ; Sulfonamides - therapeutic use ; Surgical Oncology ; Young Adult]]></subject><ispartof>Journal of gastroenterology, 2014-05, Vol.49 (5), p.941-953</ispartof><rights>Springer Japan 2014</rights><rights>Springer Japan 2014.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c457t-1b9a58755b0ca8e91f882e70c029f2d4e78ebf91b12577f3b82d407cf4515faa3</citedby><cites>FETCH-LOGICAL-c457t-1b9a58755b0ca8e91f882e70c029f2d4e78ebf91b12577f3b82d407cf4515faa3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00535-014-0949-8$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00535-014-0949-8$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24626851$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Izumi, Namiki</creatorcontrib><creatorcontrib>Hayashi, Norio</creatorcontrib><creatorcontrib>Kumada, Hiromitsu</creatorcontrib><creatorcontrib>Okanoue, Takeshi</creatorcontrib><creatorcontrib>Tsubouchi, Hirohito</creatorcontrib><creatorcontrib>Yatsuhashi, Hiroshi</creatorcontrib><creatorcontrib>Kato, Mai</creatorcontrib><creatorcontrib>Ki, Rito</creatorcontrib><creatorcontrib>Komada, Yuji</creatorcontrib><creatorcontrib>Seto, Chiharu</creatorcontrib><creatorcontrib>Goto, Shoichiro</creatorcontrib><title>Once-daily simeprevir with peginterferon and ribavirin for treatment-experienced HCV genotype 1-infected patients in Japan: the CONCERTO-2 and CONCERTO-3 studies</title><title>Journal of gastroenterology</title><addtitle>J Gastroenterol</addtitle><addtitle>J Gastroenterol</addtitle><description>Background
Efficacy of available therapies for patients with HCV who have previously failed treatment is limited. Two Phase III, open-label trials in Japan investigated efficacy and safety of simeprevir and peginterferon-α-2a/ribavirin (PR) combination therapy in treatment-experienced patients with genotype 1 HCV infection.
Methods
In CONCERTO-2, prior non-responders to IFN-based therapy (
N
= 106) received simeprevir (TMC435) 100 mg QD with PR for 12 (SMV12,
n
= 53) or 24 weeks (SMV24,
n
= 53) followed by response-guided therapy (RGT) with PR for 12/36 (SMV12) or 0/24 (SMV24) weeks. In CONCERTO-3, relapsers after IFN-based therapy (
N
= 49) received simeprevir 100 mg QD with PR for 12 weeks followed by RGT with PR for 12/36 weeks. Primary endpoints were the rates of sustained virologic response 12 weeks after treatment end (SVR12).
Results
SVR12 rates were 52.8 % (SMV12) and 35.8 % (SMV24) for prior non-responders, and 95.9 % for prior relapsers (SMV12;
p
≤ 0.0001 vs null hypothesis, respectively). Most prior non-responders (SMV12: 81.1 %; SMV24: 73.6 %) and prior relapsers (95.9 %) met RGT criteria and completed PR to Week 24. Of these, 60.5 %, 48.7 %, and 95.7 %, respectively, achieved SVR12. Viral breakthrough occurred in 13.2 % (SMV12) and 11.3 % (SMV24) of prior non-responders; no viral breakthrough occurred in prior relapsers. Viral relapse occurred in 38.6 % (SMV12) and 51.1 % (SMV24) of prior non-responders and 8.2 % of prior relapsers. Simeprevir with PR was generally well tolerated in both studies.
Conclusion
Re-treatment with 12 weeks of simeprevir QD with PR provided high SVR in treatment-experienced patients with chronic HCV genotype 1 infection, and allowed most patients to complete treatment in 24 weeks.</description><subject>Abdominal Surgery</subject><subject>Adult</subject><subject>Aged</subject><subject>Antiviral Agents - administration & dosage</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Antiviral drugs</subject><subject>Biliary Tract</subject><subject>Chronic infection</subject><subject>Clinical trials</subject><subject>Colorectal Surgery</subject><subject>Drug Administration Schedule</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Genotype</subject><subject>Genotype & phenotype</subject><subject>Genotypes</subject><subject>Hepacivirus - genetics</subject><subject>Hepacivirus - isolation & purification</subject><subject>Hepatitis C virus</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatology</subject><subject>Heterocyclic Compounds, 3-Ring - administration & dosage</subject><subject>Heterocyclic Compounds, 3-Ring - adverse effects</subject><subject>Heterocyclic Compounds, 3-Ring - therapeutic use</subject><subject>Humans</subject><subject>Interferon</subject><subject>Interferon-alpha - administration & dosage</subject><subject>Interferon-alpha - adverse effects</subject><subject>Interferon-alpha - therapeutic use</subject><subject>Japan</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Original Article—Liver</subject><subject>Pancreas</subject><subject>Patients</subject><subject>Polyethylene Glycols - administration & dosage</subject><subject>Polyethylene Glycols - adverse effects</subject><subject>Polyethylene Glycols - therapeutic use</subject><subject>Recombinant Proteins - administration & dosage</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Recurrence</subject><subject>Ribavirin</subject><subject>Ribavirin - administration & dosage</subject><subject>Ribavirin - adverse effects</subject><subject>Ribavirin - therapeutic use</subject><subject>Simeprevir</subject><subject>Sulfonamides - administration & dosage</subject><subject>Sulfonamides - adverse effects</subject><subject>Sulfonamides - therapeutic use</subject><subject>Surgical Oncology</subject><subject>Young Adult</subject><issn>0944-1174</issn><issn>1435-5922</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kUFrFTEUhYMo9ln9AW4k4MZNNMkkk4w7GWprKX0g1W3IzNy8przJjEmm-n5O_6mpry0i1FXIud8598JB6DWj7xml6kOiVFaSUCYIbURD9BO0YqIosuH8KVoVURDGlDhAL1K6opRVVOrn6ICLmtdashW6WYceyGD9doeTH2GOcO0j_unzJZ5h40OG6CBOAdsw4Og7W8Y-YDdFnCPYPELIBH7NED2UqAGftN_xBsKUdzNgRnxw0OeizzYXIidc3Kd2tuEjzpeA2_V5e_T1Yk34nw0P3wqnvAwe0kv0zNltgld37yH69vnooj0hZ-vjL-2nM9ILqTJhXWOlVlJ2tLcaGua05qBoT3nj-CBAaehcwzrGpVKu6nQRqeqdkEw6a6tD9G6fO8fpxwIpm9GnHrZbG2BakmFSCEproWRB3_6DXk1LDOU6w-tG1kLXFfsfxSQXXDSirgrF9lQfp5QiODNHP9q4M4ya25bNvmVTWja3LRtdPG_ukpduhOHBcV9rAfgeSGUUNhD_Wv1o6m9NPbE8</recordid><startdate>20140501</startdate><enddate>20140501</enddate><creator>Izumi, Namiki</creator><creator>Hayashi, Norio</creator><creator>Kumada, Hiromitsu</creator><creator>Okanoue, Takeshi</creator><creator>Tsubouchi, Hirohito</creator><creator>Yatsuhashi, Hiroshi</creator><creator>Kato, Mai</creator><creator>Ki, Rito</creator><creator>Komada, Yuji</creator><creator>Seto, Chiharu</creator><creator>Goto, Shoichiro</creator><general>Springer Japan</general><general>Springer Nature B.V</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>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7U9</scope></search><sort><creationdate>20140501</creationdate><title>Once-daily simeprevir with peginterferon and ribavirin for treatment-experienced HCV genotype 1-infected patients in Japan: the CONCERTO-2 and CONCERTO-3 studies</title><author>Izumi, Namiki ; Hayashi, Norio ; Kumada, Hiromitsu ; Okanoue, Takeshi ; Tsubouchi, Hirohito ; Yatsuhashi, Hiroshi ; Kato, Mai ; Ki, Rito ; Komada, Yuji ; Seto, Chiharu ; Goto, Shoichiro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c457t-1b9a58755b0ca8e91f882e70c029f2d4e78ebf91b12577f3b82d407cf4515faa3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Abdominal Surgery</topic><topic>Adult</topic><topic>Aged</topic><topic>Antiviral Agents - administration & dosage</topic><topic>Antiviral Agents - adverse effects</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Antiviral drugs</topic><topic>Biliary Tract</topic><topic>Chronic infection</topic><topic>Clinical trials</topic><topic>Colorectal Surgery</topic><topic>Drug Administration Schedule</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Gastroenterology</topic><topic>Genotype</topic><topic>Genotype & phenotype</topic><topic>Genotypes</topic><topic>Hepacivirus - genetics</topic><topic>Hepacivirus - isolation & purification</topic><topic>Hepatitis C virus</topic><topic>Hepatitis C, Chronic - drug therapy</topic><topic>Hepatology</topic><topic>Heterocyclic Compounds, 3-Ring - administration & dosage</topic><topic>Heterocyclic Compounds, 3-Ring - adverse effects</topic><topic>Heterocyclic Compounds, 3-Ring - therapeutic use</topic><topic>Humans</topic><topic>Interferon</topic><topic>Interferon-alpha - administration & dosage</topic><topic>Interferon-alpha - adverse effects</topic><topic>Interferon-alpha - therapeutic use</topic><topic>Japan</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Original Article—Liver</topic><topic>Pancreas</topic><topic>Patients</topic><topic>Polyethylene Glycols - administration & dosage</topic><topic>Polyethylene Glycols - adverse effects</topic><topic>Polyethylene Glycols - therapeutic use</topic><topic>Recombinant Proteins - administration & dosage</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Recurrence</topic><topic>Ribavirin</topic><topic>Ribavirin - administration & dosage</topic><topic>Ribavirin - adverse effects</topic><topic>Ribavirin - therapeutic use</topic><topic>Simeprevir</topic><topic>Sulfonamides - administration & dosage</topic><topic>Sulfonamides - adverse effects</topic><topic>Sulfonamides - therapeutic use</topic><topic>Surgical Oncology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Izumi, Namiki</creatorcontrib><creatorcontrib>Hayashi, Norio</creatorcontrib><creatorcontrib>Kumada, Hiromitsu</creatorcontrib><creatorcontrib>Okanoue, Takeshi</creatorcontrib><creatorcontrib>Tsubouchi, Hirohito</creatorcontrib><creatorcontrib>Yatsuhashi, Hiroshi</creatorcontrib><creatorcontrib>Kato, Mai</creatorcontrib><creatorcontrib>Ki, Rito</creatorcontrib><creatorcontrib>Komada, Yuji</creatorcontrib><creatorcontrib>Seto, Chiharu</creatorcontrib><creatorcontrib>Goto, Shoichiro</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Virology and AIDS Abstracts</collection><jtitle>Journal of gastroenterology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Izumi, Namiki</au><au>Hayashi, Norio</au><au>Kumada, Hiromitsu</au><au>Okanoue, Takeshi</au><au>Tsubouchi, Hirohito</au><au>Yatsuhashi, Hiroshi</au><au>Kato, Mai</au><au>Ki, Rito</au><au>Komada, Yuji</au><au>Seto, Chiharu</au><au>Goto, Shoichiro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Once-daily simeprevir with peginterferon and ribavirin for treatment-experienced HCV genotype 1-infected patients in Japan: the CONCERTO-2 and CONCERTO-3 studies</atitle><jtitle>Journal of gastroenterology</jtitle><stitle>J Gastroenterol</stitle><addtitle>J Gastroenterol</addtitle><date>2014-05-01</date><risdate>2014</risdate><volume>49</volume><issue>5</issue><spage>941</spage><epage>953</epage><pages>941-953</pages><issn>0944-1174</issn><eissn>1435-5922</eissn><abstract>Background
Efficacy of available therapies for patients with HCV who have previously failed treatment is limited. Two Phase III, open-label trials in Japan investigated efficacy and safety of simeprevir and peginterferon-α-2a/ribavirin (PR) combination therapy in treatment-experienced patients with genotype 1 HCV infection.
Methods
In CONCERTO-2, prior non-responders to IFN-based therapy (
N
= 106) received simeprevir (TMC435) 100 mg QD with PR for 12 (SMV12,
n
= 53) or 24 weeks (SMV24,
n
= 53) followed by response-guided therapy (RGT) with PR for 12/36 (SMV12) or 0/24 (SMV24) weeks. In CONCERTO-3, relapsers after IFN-based therapy (
N
= 49) received simeprevir 100 mg QD with PR for 12 weeks followed by RGT with PR for 12/36 weeks. Primary endpoints were the rates of sustained virologic response 12 weeks after treatment end (SVR12).
Results
SVR12 rates were 52.8 % (SMV12) and 35.8 % (SMV24) for prior non-responders, and 95.9 % for prior relapsers (SMV12;
p
≤ 0.0001 vs null hypothesis, respectively). Most prior non-responders (SMV12: 81.1 %; SMV24: 73.6 %) and prior relapsers (95.9 %) met RGT criteria and completed PR to Week 24. Of these, 60.5 %, 48.7 %, and 95.7 %, respectively, achieved SVR12. Viral breakthrough occurred in 13.2 % (SMV12) and 11.3 % (SMV24) of prior non-responders; no viral breakthrough occurred in prior relapsers. Viral relapse occurred in 38.6 % (SMV12) and 51.1 % (SMV24) of prior non-responders and 8.2 % of prior relapsers. Simeprevir with PR was generally well tolerated in both studies.
Conclusion
Re-treatment with 12 weeks of simeprevir QD with PR provided high SVR in treatment-experienced patients with chronic HCV genotype 1 infection, and allowed most patients to complete treatment in 24 weeks.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>24626851</pmid><doi>10.1007/s00535-014-0949-8</doi><tpages>13</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0944-1174 |
| ispartof | Journal of gastroenterology, 2014-05, Vol.49 (5), p.941-953 |
| issn | 0944-1174 1435-5922 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1544006475 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Abdominal Surgery Adult Aged Antiviral Agents - administration & dosage Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Antiviral drugs Biliary Tract Chronic infection Clinical trials Colorectal Surgery Drug Administration Schedule Drug Therapy, Combination Female Gastroenterology Genotype Genotype & phenotype Genotypes Hepacivirus - genetics Hepacivirus - isolation & purification Hepatitis C virus Hepatitis C, Chronic - drug therapy Hepatology Heterocyclic Compounds, 3-Ring - administration & dosage Heterocyclic Compounds, 3-Ring - adverse effects Heterocyclic Compounds, 3-Ring - therapeutic use Humans Interferon Interferon-alpha - administration & dosage Interferon-alpha - adverse effects Interferon-alpha - therapeutic use Japan Male Medicine Medicine & Public Health Middle Aged Original Article—Liver Pancreas Patients Polyethylene Glycols - administration & dosage Polyethylene Glycols - adverse effects Polyethylene Glycols - therapeutic use Recombinant Proteins - administration & dosage Recombinant Proteins - adverse effects Recombinant Proteins - therapeutic use Recurrence Ribavirin Ribavirin - administration & dosage Ribavirin - adverse effects Ribavirin - therapeutic use Simeprevir Sulfonamides - administration & dosage Sulfonamides - adverse effects Sulfonamides - therapeutic use Surgical Oncology Young Adult |
| title | Once-daily simeprevir with peginterferon and ribavirin for treatment-experienced HCV genotype 1-infected patients in Japan: the CONCERTO-2 and CONCERTO-3 studies |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-12T17%3A45%3A29IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Once-daily%20simeprevir%20with%20peginterferon%20and%20ribavirin%20for%20treatment-experienced%20HCV%20genotype%201-infected%20patients%20in%20Japan:%20the%20CONCERTO-2%20and%20CONCERTO-3%20studies&rft.jtitle=Journal%20of%20gastroenterology&rft.au=Izumi,%20Namiki&rft.date=2014-05-01&rft.volume=49&rft.issue=5&rft.spage=941&rft.epage=953&rft.pages=941-953&rft.issn=0944-1174&rft.eissn=1435-5922&rft_id=info:doi/10.1007/s00535-014-0949-8&rft_dat=%3Cproquest_cross%3E1544006475%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1524249463&rft_id=info:pmid/24626851&rfr_iscdi=true |