Long-term safety and efficacy of microRNA-targeted therapy in chronic hepatitis C patients
•We present the long-term safety and efficacy outcome of patients treated with anti-miR therapy.•No long-term safety issues were observed among miravirsen-treated patients.•Targeting miR-122 may be an effective and safe treatment strategy for HCV infection. MicroRNA-122 (miR-122) is an important hos...
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| Veröffentlicht in: | Antiviral research 2014-11, Vol.111, p.53-59 |
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| creator | van der Ree, Meike H. van der Meer, Adriaan J. de Bruijne, Joep Maan, Raoel van Vliet, Andre Welzel, Tania M. Zeuzem, Stefan Lawitz, Eric J. Rodriguez-Torres, Maribel Kupcova, Viera Wiercinska-Drapalo, Alcija Hodges, Michael R. Janssen, Harry L.A. Reesink, Hendrik W. |
| description | •We present the long-term safety and efficacy outcome of patients treated with anti-miR therapy.•No long-term safety issues were observed among miravirsen-treated patients.•Targeting miR-122 may be an effective and safe treatment strategy for HCV infection.
MicroRNA-122 (miR-122) is an important host factor for hepatitis C virus (HCV) and promotes HCV RNA accumulation. Decreased intra-hepatic levels of miR-122 were observed in patients with hepatocellular carcinoma, suggesting a potential role of miR-122 in the development of HCC. Miravirsen targets miR-122 and resulted in a dose dependent and prolonged decrease of HCV RNA levels in chronic hepatitis C patients. The aim of this study was to establish the sustained virological response rate to peginterferon (P) and ribavirin (R) following miravirsen dosing and to assess long-term safety in patients treated with miravirsen.
In this multicenter, retrospective follow-up study we included 36 treatment naïve patients with chronic hepatitis C genotype 1 who received five weekly subcutaneous injections with miravirsen or placebo over a 29-day period in a phase 2a study. Patients were offered PR therapy 3weeks (3mg/kg group) or 6weeks (5 or 7mg/kg group) after completion of miravirsen or placebo dosing.
PR therapy was started in 14/36 patients of whom 12 had received miravirsen. SVR was achieved in 7/12 patients previously dosed with miravirsen. All patients dosed with 7mg/kg miravirsen who were subsequently treated with PR achieved SVR. One patient had a prolonged undetectable HCV RNA period from week 14 to week 29 after baseline without subsequent antiviral therapy and relapsed thereafter. None of the patients treated with anti-miR-122 developed HCC or other liver-related complications.
No long-term safety issues were observed among 27 miravirsen-treated patients. Targeting miR-122 may be an effective and safe treatment strategy for HCV infection and should be investigated in larger clinical trials. |
| doi_str_mv | 10.1016/j.antiviral.2014.08.015 |
| format | Article |
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MicroRNA-122 (miR-122) is an important host factor for hepatitis C virus (HCV) and promotes HCV RNA accumulation. Decreased intra-hepatic levels of miR-122 were observed in patients with hepatocellular carcinoma, suggesting a potential role of miR-122 in the development of HCC. Miravirsen targets miR-122 and resulted in a dose dependent and prolonged decrease of HCV RNA levels in chronic hepatitis C patients. The aim of this study was to establish the sustained virological response rate to peginterferon (P) and ribavirin (R) following miravirsen dosing and to assess long-term safety in patients treated with miravirsen.
In this multicenter, retrospective follow-up study we included 36 treatment naïve patients with chronic hepatitis C genotype 1 who received five weekly subcutaneous injections with miravirsen or placebo over a 29-day period in a phase 2a study. Patients were offered PR therapy 3weeks (3mg/kg group) or 6weeks (5 or 7mg/kg group) after completion of miravirsen or placebo dosing.
PR therapy was started in 14/36 patients of whom 12 had received miravirsen. SVR was achieved in 7/12 patients previously dosed with miravirsen. All patients dosed with 7mg/kg miravirsen who were subsequently treated with PR achieved SVR. One patient had a prolonged undetectable HCV RNA period from week 14 to week 29 after baseline without subsequent antiviral therapy and relapsed thereafter. None of the patients treated with anti-miR-122 developed HCC or other liver-related complications.
No long-term safety issues were observed among 27 miravirsen-treated patients. Targeting miR-122 may be an effective and safe treatment strategy for HCV infection and should be investigated in larger clinical trials.</description><identifier>ISSN: 0166-3542</identifier><identifier>EISSN: 1872-9096</identifier><identifier>DOI: 10.1016/j.antiviral.2014.08.015</identifier><identifier>PMID: 25218783</identifier><identifier>CODEN: ARSRDR</identifier><language>eng</language><publisher>Kidlington: Elsevier B.V</publisher><subject>Adult ; Aged ; Anti-miRNA treatment ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Antiviral Agents - administration & dosage ; Antiviral Agents - adverse effects ; Biological and medical sciences ; Female ; Follow-Up Studies ; Hepacivirus - drug effects ; Hepacivirus - genetics ; Hepacivirus - physiology ; Hepatitis C virus ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - genetics ; Hepatitis C, Chronic - metabolism ; Hepatitis C, Chronic - virology ; Human viral diseases ; Humans ; Infectious diseases ; Male ; Medical sciences ; MicroRNAs - adverse effects ; MicroRNAs - genetics ; MicroRNAs - metabolism ; MicroRNAs - therapeutic use ; MicroRNA’s ; Middle Aged ; miR-122 ; Oligonucleotides - administration & dosage ; Pharmacology. Drug treatments ; Retrospective Studies ; Time Factors ; Treatment Outcome ; Viral diseases ; Viral hepatitis ; Virus Replication - drug effects</subject><ispartof>Antiviral research, 2014-11, Vol.111, p.53-59</ispartof><rights>2014 Elsevier B.V.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2014 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c434t-1e00a9ad9b125f8dda70777b2ddcd03c013c6dec34312939b57314034fa4853a3</citedby><cites>FETCH-LOGICAL-c434t-1e00a9ad9b125f8dda70777b2ddcd03c013c6dec34312939b57314034fa4853a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0166354214002526$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28887970$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25218783$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>van der Ree, Meike H.</creatorcontrib><creatorcontrib>van der Meer, Adriaan J.</creatorcontrib><creatorcontrib>de Bruijne, Joep</creatorcontrib><creatorcontrib>Maan, Raoel</creatorcontrib><creatorcontrib>van Vliet, Andre</creatorcontrib><creatorcontrib>Welzel, Tania M.</creatorcontrib><creatorcontrib>Zeuzem, Stefan</creatorcontrib><creatorcontrib>Lawitz, Eric J.</creatorcontrib><creatorcontrib>Rodriguez-Torres, Maribel</creatorcontrib><creatorcontrib>Kupcova, Viera</creatorcontrib><creatorcontrib>Wiercinska-Drapalo, Alcija</creatorcontrib><creatorcontrib>Hodges, Michael R.</creatorcontrib><creatorcontrib>Janssen, Harry L.A.</creatorcontrib><creatorcontrib>Reesink, Hendrik W.</creatorcontrib><title>Long-term safety and efficacy of microRNA-targeted therapy in chronic hepatitis C patients</title><title>Antiviral research</title><addtitle>Antiviral Res</addtitle><description>•We present the long-term safety and efficacy outcome of patients treated with anti-miR therapy.•No long-term safety issues were observed among miravirsen-treated patients.•Targeting miR-122 may be an effective and safe treatment strategy for HCV infection.
MicroRNA-122 (miR-122) is an important host factor for hepatitis C virus (HCV) and promotes HCV RNA accumulation. Decreased intra-hepatic levels of miR-122 were observed in patients with hepatocellular carcinoma, suggesting a potential role of miR-122 in the development of HCC. Miravirsen targets miR-122 and resulted in a dose dependent and prolonged decrease of HCV RNA levels in chronic hepatitis C patients. The aim of this study was to establish the sustained virological response rate to peginterferon (P) and ribavirin (R) following miravirsen dosing and to assess long-term safety in patients treated with miravirsen.
In this multicenter, retrospective follow-up study we included 36 treatment naïve patients with chronic hepatitis C genotype 1 who received five weekly subcutaneous injections with miravirsen or placebo over a 29-day period in a phase 2a study. Patients were offered PR therapy 3weeks (3mg/kg group) or 6weeks (5 or 7mg/kg group) after completion of miravirsen or placebo dosing.
PR therapy was started in 14/36 patients of whom 12 had received miravirsen. SVR was achieved in 7/12 patients previously dosed with miravirsen. All patients dosed with 7mg/kg miravirsen who were subsequently treated with PR achieved SVR. One patient had a prolonged undetectable HCV RNA period from week 14 to week 29 after baseline without subsequent antiviral therapy and relapsed thereafter. None of the patients treated with anti-miR-122 developed HCC or other liver-related complications.
No long-term safety issues were observed among 27 miravirsen-treated patients. Targeting miR-122 may be an effective and safe treatment strategy for HCV infection and should be investigated in larger clinical trials.</description><subject>Adult</subject><subject>Aged</subject><subject>Anti-miRNA treatment</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>Biological and medical sciences</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Hepacivirus - drug effects</subject><subject>Hepacivirus - genetics</subject><subject>Hepacivirus - physiology</subject><subject>Hepatitis C virus</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatitis C, Chronic - genetics</subject><subject>Hepatitis C, Chronic - metabolism</subject><subject>Hepatitis C, Chronic - virology</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>MicroRNAs - adverse effects</subject><subject>MicroRNAs - genetics</subject><subject>MicroRNAs - metabolism</subject><subject>MicroRNAs - therapeutic use</subject><subject>MicroRNA’s</subject><subject>Middle Aged</subject><subject>miR-122</subject><subject>Oligonucleotides - administration & dosage</subject><subject>Pharmacology. Drug treatments</subject><subject>Retrospective Studies</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Viral diseases</subject><subject>Viral hepatitis</subject><subject>Virus Replication - drug effects</subject><issn>0166-3542</issn><issn>1872-9096</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqN0T2PEzEQBmALgbhw8BfADRLNLv7atV1G0fEhRSAhaGisiT17cbTZDbZzUv49jhKOEiq7eGbsmZeQN5y1nPH-_a6FqcSHmGBsBeOqZaZlvHtCFtxo0Vhm-6dkUWXfyE6JG_Ii5x1jrNfWPCc3ohPVGbkgP9fzdN8UTHuaYcByojAFisMQPfgTnQe6jz7N374smwLpHgsGWraY4HCicaJ-m-YperrFA5RYYqYrer7hVPJL8myAMeOr63lLfny4-7761Ky_fvy8Wq4br6QqDUfGwEKwGy66wYQAmmmtNyIEH5j0jEvfB_RSSS6stJtOS66YVAMo00mQt-Tdpe8hzb-OmIvbx-xxHGHC-Zgd75WuTZhS_0GFtZ1UvahUX2idPueEgzukuId0cpy5cwZu5x4zcOcMHDOuZlArX18fOW72GB7r_iy9grdXANnDOCSYfMx_nTFGW82qW14c1u09REwu-7pZjyEm9MWFOf7zM78BC92ovw</recordid><startdate>20141101</startdate><enddate>20141101</enddate><creator>van der Ree, Meike H.</creator><creator>van der Meer, Adriaan J.</creator><creator>de Bruijne, Joep</creator><creator>Maan, Raoel</creator><creator>van Vliet, Andre</creator><creator>Welzel, Tania M.</creator><creator>Zeuzem, Stefan</creator><creator>Lawitz, Eric J.</creator><creator>Rodriguez-Torres, Maribel</creator><creator>Kupcova, Viera</creator><creator>Wiercinska-Drapalo, Alcija</creator><creator>Hodges, Michael R.</creator><creator>Janssen, Harry L.A.</creator><creator>Reesink, Hendrik W.</creator><general>Elsevier B.V</general><general>Elsevier</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>7T7</scope><scope>7TM</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope></search><sort><creationdate>20141101</creationdate><title>Long-term safety and efficacy of microRNA-targeted therapy in chronic hepatitis C patients</title><author>van der Ree, Meike H. ; van der Meer, Adriaan J. ; de Bruijne, Joep ; Maan, Raoel ; van Vliet, Andre ; Welzel, Tania M. ; Zeuzem, Stefan ; Lawitz, Eric J. ; Rodriguez-Torres, Maribel ; Kupcova, Viera ; Wiercinska-Drapalo, Alcija ; Hodges, Michael R. ; Janssen, Harry L.A. ; Reesink, Hendrik W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c434t-1e00a9ad9b125f8dda70777b2ddcd03c013c6dec34312939b57314034fa4853a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Anti-miRNA treatment</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>Biological and medical sciences</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Hepacivirus - drug effects</topic><topic>Hepacivirus - genetics</topic><topic>Hepacivirus - physiology</topic><topic>Hepatitis C virus</topic><topic>Hepatitis C, Chronic - drug therapy</topic><topic>Hepatitis C, Chronic - genetics</topic><topic>Hepatitis C, Chronic - metabolism</topic><topic>Hepatitis C, Chronic - virology</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Male</topic><topic>Medical sciences</topic><topic>MicroRNAs - adverse effects</topic><topic>MicroRNAs - genetics</topic><topic>MicroRNAs - metabolism</topic><topic>MicroRNAs - therapeutic use</topic><topic>MicroRNA’s</topic><topic>Middle Aged</topic><topic>miR-122</topic><topic>Oligonucleotides - administration & dosage</topic><topic>Pharmacology. Drug treatments</topic><topic>Retrospective Studies</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Viral diseases</topic><topic>Viral hepatitis</topic><topic>Virus Replication - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>van der Ree, Meike H.</creatorcontrib><creatorcontrib>van der Meer, Adriaan J.</creatorcontrib><creatorcontrib>de Bruijne, Joep</creatorcontrib><creatorcontrib>Maan, Raoel</creatorcontrib><creatorcontrib>van Vliet, Andre</creatorcontrib><creatorcontrib>Welzel, Tania M.</creatorcontrib><creatorcontrib>Zeuzem, Stefan</creatorcontrib><creatorcontrib>Lawitz, Eric J.</creatorcontrib><creatorcontrib>Rodriguez-Torres, Maribel</creatorcontrib><creatorcontrib>Kupcova, Viera</creatorcontrib><creatorcontrib>Wiercinska-Drapalo, Alcija</creatorcontrib><creatorcontrib>Hodges, Michael R.</creatorcontrib><creatorcontrib>Janssen, Harry L.A.</creatorcontrib><creatorcontrib>Reesink, Hendrik W.</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>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Antiviral research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>van der Ree, Meike H.</au><au>van der Meer, Adriaan J.</au><au>de Bruijne, Joep</au><au>Maan, Raoel</au><au>van Vliet, Andre</au><au>Welzel, Tania M.</au><au>Zeuzem, Stefan</au><au>Lawitz, Eric J.</au><au>Rodriguez-Torres, Maribel</au><au>Kupcova, Viera</au><au>Wiercinska-Drapalo, Alcija</au><au>Hodges, Michael R.</au><au>Janssen, Harry L.A.</au><au>Reesink, Hendrik W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term safety and efficacy of microRNA-targeted therapy in chronic hepatitis C patients</atitle><jtitle>Antiviral research</jtitle><addtitle>Antiviral Res</addtitle><date>2014-11-01</date><risdate>2014</risdate><volume>111</volume><spage>53</spage><epage>59</epage><pages>53-59</pages><issn>0166-3542</issn><eissn>1872-9096</eissn><coden>ARSRDR</coden><abstract>•We present the long-term safety and efficacy outcome of patients treated with anti-miR therapy.•No long-term safety issues were observed among miravirsen-treated patients.•Targeting miR-122 may be an effective and safe treatment strategy for HCV infection.
MicroRNA-122 (miR-122) is an important host factor for hepatitis C virus (HCV) and promotes HCV RNA accumulation. Decreased intra-hepatic levels of miR-122 were observed in patients with hepatocellular carcinoma, suggesting a potential role of miR-122 in the development of HCC. Miravirsen targets miR-122 and resulted in a dose dependent and prolonged decrease of HCV RNA levels in chronic hepatitis C patients. The aim of this study was to establish the sustained virological response rate to peginterferon (P) and ribavirin (R) following miravirsen dosing and to assess long-term safety in patients treated with miravirsen.
In this multicenter, retrospective follow-up study we included 36 treatment naïve patients with chronic hepatitis C genotype 1 who received five weekly subcutaneous injections with miravirsen or placebo over a 29-day period in a phase 2a study. Patients were offered PR therapy 3weeks (3mg/kg group) or 6weeks (5 or 7mg/kg group) after completion of miravirsen or placebo dosing.
PR therapy was started in 14/36 patients of whom 12 had received miravirsen. SVR was achieved in 7/12 patients previously dosed with miravirsen. All patients dosed with 7mg/kg miravirsen who were subsequently treated with PR achieved SVR. One patient had a prolonged undetectable HCV RNA period from week 14 to week 29 after baseline without subsequent antiviral therapy and relapsed thereafter. None of the patients treated with anti-miR-122 developed HCC or other liver-related complications.
No long-term safety issues were observed among 27 miravirsen-treated patients. Targeting miR-122 may be an effective and safe treatment strategy for HCV infection and should be investigated in larger clinical trials.</abstract><cop>Kidlington</cop><pub>Elsevier B.V</pub><pmid>25218783</pmid><doi>10.1016/j.antiviral.2014.08.015</doi><tpages>7</tpages></addata></record> |
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| subjects | Adult Aged Anti-miRNA treatment Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Antiviral Agents - administration & dosage Antiviral Agents - adverse effects Biological and medical sciences Female Follow-Up Studies Hepacivirus - drug effects Hepacivirus - genetics Hepacivirus - physiology Hepatitis C virus Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - genetics Hepatitis C, Chronic - metabolism Hepatitis C, Chronic - virology Human viral diseases Humans Infectious diseases Male Medical sciences MicroRNAs - adverse effects MicroRNAs - genetics MicroRNAs - metabolism MicroRNAs - therapeutic use MicroRNA’s Middle Aged miR-122 Oligonucleotides - administration & dosage Pharmacology. Drug treatments Retrospective Studies Time Factors Treatment Outcome Viral diseases Viral hepatitis Virus Replication - drug effects |
| title | Long-term safety and efficacy of microRNA-targeted therapy in chronic hepatitis C patients |
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