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Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial
Antiviral activity of TMC435, an oral, once-daily, HCV NS3/4A protease inhibitor, was evaluated with pegylated interferon-α2a/ribavirin (P/R) in HCV genotype-1 patients. Optimal Protease inhibitor Enhancement of Response to TherApy (OPERA-1; TMC435-C201; NCT00561353) is a Phase IIa, randomized, plac...
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| Published in: | Antiviral therapy 2011-01, Vol.16 (7), p.1021-1033 |
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| creator | MANNS, Michael REESINK, Henk SEKAR, Vanitha SIMMEN, Kenneth VERLOES, Rene BERG, Thomas DUSHEIKO, Geoffrey FLISIAK, Robert MARCELLIN, Patrick MORENO, Christophe LENZ, Oliver MEYVISCH, Paul PEETERS, Monika |
| description | Antiviral activity of TMC435, an oral, once-daily, HCV NS3/4A protease inhibitor, was evaluated with pegylated interferon-α2a/ribavirin (P/R) in HCV genotype-1 patients.
Optimal Protease inhibitor Enhancement of Response to TherApy (OPERA-1; TMC435-C201; NCT00561353) is a Phase IIa, randomized, placebo-controlled study. Treatment-naive patients (n=74) received 25, 75 or 200 mg TMC435 once daily, or placebo for 7 days followed by 21 days of triple therapy with P/R, or triple therapy for 28 days. Treatment-experienced patients (n=37; 56.8% with cirrhosis) received 75, 150 or 200 mg TMC435 once daily, or placebo with P/R for 28 days. Patients continued P/R up to week 48.
Treatment-naive patients who received initial monotherapy had a rapid decline in HCV RNA by day 3. At day 7, HCV RNA reductions were greatest for the 75 and 200 mg doses (0.02, -2.63, -3.43 and -4.13 log(10) IU/ml for placebo, and TMC435 25, 75 and 200 mg, respectively). At day 28, all patients who received triple therapy with TMC435 75 or 200 mg had HCV RNA |
| doi_str_mv | 10.3851/IMP1894 |
| format | article |
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Optimal Protease inhibitor Enhancement of Response to TherApy (OPERA-1; TMC435-C201; NCT00561353) is a Phase IIa, randomized, placebo-controlled study. Treatment-naive patients (n=74) received 25, 75 or 200 mg TMC435 once daily, or placebo for 7 days followed by 21 days of triple therapy with P/R, or triple therapy for 28 days. Treatment-experienced patients (n=37; 56.8% with cirrhosis) received 75, 150 or 200 mg TMC435 once daily, or placebo with P/R for 28 days. Patients continued P/R up to week 48.
Treatment-naive patients who received initial monotherapy had a rapid decline in HCV RNA by day 3. At day 7, HCV RNA reductions were greatest for the 75 and 200 mg doses (0.02, -2.63, -3.43 and -4.13 log(10) IU/ml for placebo, and TMC435 25, 75 and 200 mg, respectively). At day 28, all patients who received triple therapy with TMC435 75 or 200 mg had HCV RNA<25 IU/ml versus 4/9 for placebo. In total, 18/28 treatment-experienced patients (9/9 prior relapsers, 9/19 non-responders) who received TMC435 had HCV RNA<25 IU/ml at day 28 versus 0/9 for placebo; similar results were observed for the 150 and 200 mg doses. Most adverse events were grade 1/2. No relevant changes in laboratory parameters occurred, except mild and reversible bilirubin elevations, mostly at the 200 mg dose.
Once-daily TMC435 with P/R showed potent, dose-dependent antiviral activity over 28 days, and had a favourable tolerability profile.</description><identifier>ISSN: 1359-6535</identifier><identifier>EISSN: 2040-2058</identifier><identifier>DOI: 10.3851/IMP1894</identifier><identifier>PMID: 22024518</identifier><language>eng</language><publisher>London: International Medical Press</publisher><subject><![CDATA[Adolescent ; Adult ; Aged ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Antiviral Agents - administration & dosage ; Antiviral Agents - adverse effects ; Antiviral Agents - therapeutic use ; Bilirubin - analysis ; Biological and medical sciences ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Genotype ; Hepacivirus - drug effects ; Hepatitis C - drug therapy ; Hepatitis C - virology ; Heterocyclic Compounds, 3-Ring - administration & dosage ; Heterocyclic Compounds, 3-Ring - adverse effects ; Heterocyclic Compounds, 3-Ring - therapeutic use ; Human viral diseases ; Humans ; Infectious diseases ; Interferon-alpha - administration & dosage ; Interferon-alpha - therapeutic use ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Polyethylene Glycols - administration & dosage ; Polyethylene Glycols - therapeutic use ; Protease Inhibitors - administration & dosage ; Protease Inhibitors - adverse effects ; Protease Inhibitors - therapeutic use ; Recombinant Proteins - administration & dosage ; Recombinant Proteins - therapeutic use ; Ribavirin - administration & dosage ; Ribavirin - pharmacology ; Ribavirin - therapeutic use ; RNA, Viral - blood ; Simeprevir ; Sulfonamides - administration & dosage ; Sulfonamides - adverse effects ; Sulfonamides - therapeutic use ; Viral diseases ; Viral hepatitis ; Viral Load]]></subject><ispartof>Antiviral therapy, 2011-01, Vol.16 (7), p.1021-1033</ispartof><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c310t-31b1b478fde8121608a79fbdb35c0e83a8d1e4a299ccf99f5afc39e942304a143</citedby><cites>FETCH-LOGICAL-c310t-31b1b478fde8121608a79fbdb35c0e83a8d1e4a299ccf99f5afc39e942304a143</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24728651$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22024518$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>MANNS, Michael</creatorcontrib><creatorcontrib>REESINK, Henk</creatorcontrib><creatorcontrib>SEKAR, Vanitha</creatorcontrib><creatorcontrib>SIMMEN, Kenneth</creatorcontrib><creatorcontrib>VERLOES, Rene</creatorcontrib><creatorcontrib>BERG, Thomas</creatorcontrib><creatorcontrib>DUSHEIKO, Geoffrey</creatorcontrib><creatorcontrib>FLISIAK, Robert</creatorcontrib><creatorcontrib>MARCELLIN, Patrick</creatorcontrib><creatorcontrib>MORENO, Christophe</creatorcontrib><creatorcontrib>LENZ, Oliver</creatorcontrib><creatorcontrib>MEYVISCH, Paul</creatorcontrib><creatorcontrib>PEETERS, Monika</creatorcontrib><title>Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial</title><title>Antiviral therapy</title><addtitle>Antivir Ther</addtitle><description>Antiviral activity of TMC435, an oral, once-daily, HCV NS3/4A protease inhibitor, was evaluated with pegylated interferon-α2a/ribavirin (P/R) in HCV genotype-1 patients.
Optimal Protease inhibitor Enhancement of Response to TherApy (OPERA-1; TMC435-C201; NCT00561353) is a Phase IIa, randomized, placebo-controlled study. Treatment-naive patients (n=74) received 25, 75 or 200 mg TMC435 once daily, or placebo for 7 days followed by 21 days of triple therapy with P/R, or triple therapy for 28 days. Treatment-experienced patients (n=37; 56.8% with cirrhosis) received 75, 150 or 200 mg TMC435 once daily, or placebo with P/R for 28 days. Patients continued P/R up to week 48.
Treatment-naive patients who received initial monotherapy had a rapid decline in HCV RNA by day 3. At day 7, HCV RNA reductions were greatest for the 75 and 200 mg doses (0.02, -2.63, -3.43 and -4.13 log(10) IU/ml for placebo, and TMC435 25, 75 and 200 mg, respectively). At day 28, all patients who received triple therapy with TMC435 75 or 200 mg had HCV RNA<25 IU/ml versus 4/9 for placebo. In total, 18/28 treatment-experienced patients (9/9 prior relapsers, 9/19 non-responders) who received TMC435 had HCV RNA<25 IU/ml at day 28 versus 0/9 for placebo; similar results were observed for the 150 and 200 mg doses. Most adverse events were grade 1/2. No relevant changes in laboratory parameters occurred, except mild and reversible bilirubin elevations, mostly at the 200 mg dose.
Once-daily TMC435 with P/R showed potent, dose-dependent antiviral activity over 28 days, and had a favourable tolerability profile.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiviral agents</subject><subject>Antiviral Agents - administration & dosage</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Bilirubin - analysis</subject><subject>Biological and medical sciences</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Genotype</subject><subject>Hepacivirus - drug effects</subject><subject>Hepatitis C - drug therapy</subject><subject>Hepatitis C - virology</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>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Interferon-alpha - administration & dosage</subject><subject>Interferon-alpha - therapeutic use</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Polyethylene Glycols - administration & dosage</subject><subject>Polyethylene Glycols - therapeutic use</subject><subject>Protease Inhibitors - administration & dosage</subject><subject>Protease Inhibitors - adverse effects</subject><subject>Protease Inhibitors - therapeutic use</subject><subject>Recombinant Proteins - administration & dosage</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Ribavirin - administration & dosage</subject><subject>Ribavirin - pharmacology</subject><subject>Ribavirin - therapeutic use</subject><subject>RNA, Viral - blood</subject><subject>Simeprevir</subject><subject>Sulfonamides - administration & dosage</subject><subject>Sulfonamides - adverse effects</subject><subject>Sulfonamides - therapeutic use</subject><subject>Viral diseases</subject><subject>Viral hepatitis</subject><subject>Viral Load</subject><issn>1359-6535</issn><issn>2040-2058</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><recordid>eNpFkE9LXDEUR0NpqVMt_QaSTenq1fydSborQ62CoohdP-7Lu7EpmeSZZArj2g_uk451deHH4cA9hHzi7Ks0mp-cX15zY9UbshBMsU4wbd6SBZfadkst9QH5UOsfxoSxjL0nB0IwoTQ3C_J4A1MY6d9QINKCdcqpIs2e5uSwGyHEHb29XCup6RS3lU54t4vQcKQhNSweS04nJQwwG0KaR_obJ2ihhUrX9A5TbrsJO06fR0ytfqNAC6Qxb8LDbGklQDwi7zzEih_395D8Ov1xuz7rLq5-nq-_X3ROctY6yQc-qJXxIxou-JIZWFk_jIPUjqGRYEaOCoS1znlrvQbvpEWrhGQKuJKH5Ms_71Ty_RZr6zehOowREuZt7ec4S8VXir2SruRaC_p-KmEDZddz1j8X7_fFZ_J479wOGxz_cy-JZ-DzHoDqIPr5eRfqK6dWwiw1l0-v1YkX</recordid><startdate>20110101</startdate><enddate>20110101</enddate><creator>MANNS, Michael</creator><creator>REESINK, Henk</creator><creator>SEKAR, Vanitha</creator><creator>SIMMEN, Kenneth</creator><creator>VERLOES, Rene</creator><creator>BERG, Thomas</creator><creator>DUSHEIKO, Geoffrey</creator><creator>FLISIAK, Robert</creator><creator>MARCELLIN, Patrick</creator><creator>MORENO, Christophe</creator><creator>LENZ, Oliver</creator><creator>MEYVISCH, Paul</creator><creator>PEETERS, Monika</creator><general>International Medical Press</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>20110101</creationdate><title>Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial</title><author>MANNS, Michael ; REESINK, Henk ; SEKAR, Vanitha ; SIMMEN, Kenneth ; VERLOES, Rene ; BERG, Thomas ; DUSHEIKO, Geoffrey ; FLISIAK, Robert ; MARCELLIN, Patrick ; MORENO, Christophe ; LENZ, Oliver ; MEYVISCH, Paul ; PEETERS, Monika</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c310t-31b1b478fde8121608a79fbdb35c0e83a8d1e4a299ccf99f5afc39e942304a143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiviral agents</topic><topic>Antiviral Agents - administration & dosage</topic><topic>Antiviral Agents - adverse effects</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Bilirubin - analysis</topic><topic>Biological and medical sciences</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Genotype</topic><topic>Hepacivirus - drug effects</topic><topic>Hepatitis C - drug therapy</topic><topic>Hepatitis C - virology</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>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Interferon-alpha - administration & dosage</topic><topic>Interferon-alpha - therapeutic use</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Polyethylene Glycols - administration & dosage</topic><topic>Polyethylene Glycols - therapeutic use</topic><topic>Protease Inhibitors - administration & dosage</topic><topic>Protease Inhibitors - adverse effects</topic><topic>Protease Inhibitors - therapeutic use</topic><topic>Recombinant Proteins - administration & dosage</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Ribavirin - administration & dosage</topic><topic>Ribavirin - pharmacology</topic><topic>Ribavirin - therapeutic use</topic><topic>RNA, Viral - blood</topic><topic>Simeprevir</topic><topic>Sulfonamides - administration & dosage</topic><topic>Sulfonamides - adverse effects</topic><topic>Sulfonamides - therapeutic use</topic><topic>Viral diseases</topic><topic>Viral hepatitis</topic><topic>Viral Load</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>MANNS, Michael</creatorcontrib><creatorcontrib>REESINK, Henk</creatorcontrib><creatorcontrib>SEKAR, Vanitha</creatorcontrib><creatorcontrib>SIMMEN, Kenneth</creatorcontrib><creatorcontrib>VERLOES, Rene</creatorcontrib><creatorcontrib>BERG, Thomas</creatorcontrib><creatorcontrib>DUSHEIKO, Geoffrey</creatorcontrib><creatorcontrib>FLISIAK, Robert</creatorcontrib><creatorcontrib>MARCELLIN, Patrick</creatorcontrib><creatorcontrib>MORENO, Christophe</creatorcontrib><creatorcontrib>LENZ, Oliver</creatorcontrib><creatorcontrib>MEYVISCH, Paul</creatorcontrib><creatorcontrib>PEETERS, Monika</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>Antiviral therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>MANNS, Michael</au><au>REESINK, Henk</au><au>SEKAR, Vanitha</au><au>SIMMEN, Kenneth</au><au>VERLOES, Rene</au><au>BERG, Thomas</au><au>DUSHEIKO, Geoffrey</au><au>FLISIAK, Robert</au><au>MARCELLIN, Patrick</au><au>MORENO, Christophe</au><au>LENZ, Oliver</au><au>MEYVISCH, Paul</au><au>PEETERS, Monika</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial</atitle><jtitle>Antiviral therapy</jtitle><addtitle>Antivir Ther</addtitle><date>2011-01-01</date><risdate>2011</risdate><volume>16</volume><issue>7</issue><spage>1021</spage><epage>1033</epage><pages>1021-1033</pages><issn>1359-6535</issn><eissn>2040-2058</eissn><abstract>Antiviral activity of TMC435, an oral, once-daily, HCV NS3/4A protease inhibitor, was evaluated with pegylated interferon-α2a/ribavirin (P/R) in HCV genotype-1 patients.
Optimal Protease inhibitor Enhancement of Response to TherApy (OPERA-1; TMC435-C201; NCT00561353) is a Phase IIa, randomized, placebo-controlled study. Treatment-naive patients (n=74) received 25, 75 or 200 mg TMC435 once daily, or placebo for 7 days followed by 21 days of triple therapy with P/R, or triple therapy for 28 days. Treatment-experienced patients (n=37; 56.8% with cirrhosis) received 75, 150 or 200 mg TMC435 once daily, or placebo with P/R for 28 days. Patients continued P/R up to week 48.
Treatment-naive patients who received initial monotherapy had a rapid decline in HCV RNA by day 3. At day 7, HCV RNA reductions were greatest for the 75 and 200 mg doses (0.02, -2.63, -3.43 and -4.13 log(10) IU/ml for placebo, and TMC435 25, 75 and 200 mg, respectively). At day 28, all patients who received triple therapy with TMC435 75 or 200 mg had HCV RNA<25 IU/ml versus 4/9 for placebo. In total, 18/28 treatment-experienced patients (9/9 prior relapsers, 9/19 non-responders) who received TMC435 had HCV RNA<25 IU/ml at day 28 versus 0/9 for placebo; similar results were observed for the 150 and 200 mg doses. Most adverse events were grade 1/2. No relevant changes in laboratory parameters occurred, except mild and reversible bilirubin elevations, mostly at the 200 mg dose.
Once-daily TMC435 with P/R showed potent, dose-dependent antiviral activity over 28 days, and had a favourable tolerability profile.</abstract><cop>London</cop><pub>International Medical Press</pub><pmid>22024518</pmid><doi>10.3851/IMP1894</doi><tpages>13</tpages></addata></record> |
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| ispartof | Antiviral therapy, 2011-01, Vol.16 (7), p.1021-1033 |
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| language | eng |
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| source | SAGE Open Access |
| subjects | Adolescent Adult Aged Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Antiviral Agents - administration & dosage Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Bilirubin - analysis Biological and medical sciences Double-Blind Method Drug Therapy, Combination Female Genotype Hepacivirus - drug effects Hepatitis C - drug therapy Hepatitis C - virology Heterocyclic Compounds, 3-Ring - administration & dosage Heterocyclic Compounds, 3-Ring - adverse effects Heterocyclic Compounds, 3-Ring - therapeutic use Human viral diseases Humans Infectious diseases Interferon-alpha - administration & dosage Interferon-alpha - therapeutic use Male Medical sciences Middle Aged Pharmacology. Drug treatments Polyethylene Glycols - administration & dosage Polyethylene Glycols - therapeutic use Protease Inhibitors - administration & dosage Protease Inhibitors - adverse effects Protease Inhibitors - therapeutic use Recombinant Proteins - administration & dosage Recombinant Proteins - therapeutic use Ribavirin - administration & dosage Ribavirin - pharmacology Ribavirin - therapeutic use RNA, Viral - blood Simeprevir Sulfonamides - administration & dosage Sulfonamides - adverse effects Sulfonamides - therapeutic use Viral diseases Viral hepatitis Viral Load |
| title | Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial |
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