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4CPS-093 Long-term efficacy of second-generation direct-acting antiviral agents (daas-2) for hcv treatment: a meta-analysis

BackgroundEfficacy of second-generation direct-acting antiviral agents (DAAs-2) in terms of sustained viral response (SVR) 12 weeks after the end of treatment (EOT) has widely been proven.1–5 However, long-term efficacy is still controversial due to the low number of available studies with a small n...

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Published in:European journal of hospital pharmacy. Science and practice 2018-03, Vol.25 (Suppl 1), p.A85-A85
Main Authors: Inserra, C, Davies, SE Campbell, Bignamini, A, Minghetti, P
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container_title European journal of hospital pharmacy. Science and practice
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creator Inserra, C
Davies, SE Campbell
Bignamini, A
Minghetti, P
description BackgroundEfficacy of second-generation direct-acting antiviral agents (DAAs-2) in terms of sustained viral response (SVR) 12 weeks after the end of treatment (EOT) has widely been proven.1–5 However, long-term efficacy is still controversial due to the low number of available studies with a small number of patients.PurposeThe objective of the study is to conduct a systematic review and, if possible, a meta-analysis of existing clinical evidence in terms of long-term efficacy (SVR longer than 12 weeks after EOT) of DAAs-2 for HCV treatment.Material and methodsA systematic review was performed with the use of CENTRAL, MEDLINE, Embase, Pubmed and SBBL-CILEA/METACRAWLER databases. Trials were initially screened by the title. Second, full papers and abstracts were analysed. The meta-analysis included randomised controlled trials (RCTs) with adult patients affected by HCV, treated with DAAs-2 and assessed for longer than 12 weeks after EOT. Study quality assessment was undertaken using the Jadad scale. Heterogeneity analysis of the studies was conducted with Chi-square and I2: the statistical analysis of the efficacy rate was performed using the meta package with the R software 6. The effect estimate was expressed in risk ratio (RR) with 95% confidence interval (CI 95%) and pooled using a random effects model.ResultsOf the 106 identified studies, 11 high-quality RCTs were included for meta-analysis (25 were duplicate publications, 70 did not meet the inclusion criteria). Considered genotypes were 1 (nine), 2 (one) and 3 (one). Meta-analysis included 3720 patients (2698 treated with DAAs-2; 1022 treated with placebo or a first-generation DAA±ribavirin± PEG-interferon). Heterogeneity between studies was high (p
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Trials were initially screened by the title. Second, full papers and abstracts were analysed. The meta-analysis included randomised controlled trials (RCTs) with adult patients affected by HCV, treated with DAAs-2 and assessed for longer than 12 weeks after EOT. Study quality assessment was undertaken using the Jadad scale. Heterogeneity analysis of the studies was conducted with Chi-square and I2: the statistical analysis of the efficacy rate was performed using the meta package with the R software 6. The effect estimate was expressed in risk ratio (RR) with 95% confidence interval (CI 95%) and pooled using a random effects model.ResultsOf the 106 identified studies, 11 high-quality RCTs were included for meta-analysis (25 were duplicate publications, 70 did not meet the inclusion criteria). Considered genotypes were 1 (nine), 2 (one) and 3 (one). Meta-analysis included 3720 patients (2698 treated with DAAs-2; 1022 treated with placebo or a first-generation DAA±ribavirin± PEG-interferon). Heterogeneity between studies was high (p&lt;0.001; I2=90.2%), however it was absorbed by the model (t2=0.08). Long-term efficacy was expressed as SVR 24 weeks after EOT, since longer timescales were not available. According to the pooled RR, the incidence of efficacy was 1.5 (95% CI: 1.24 to 1.83, p&lt;0.001).ConclusionThe meta-analysis demonstrated that DAAs-2 for HCV treatment have long-term efficacy at SVR 24 weeks after the EOT. However, the number of studies is mostly based on genotype 1. More RCTs are required to confirm long-term efficacy at more than 6 months after EOT for all treated genotypes.References and/or Acknowledgements1. https://www.epatitec.info/terapie/terapia-ledipasvir-sofosbuvir/efficacia-terapeutica2. https://www.epatitec.info/terapie/terapia-ombitasvir-paritaprevir-dasabuvir/efficacia-terapeutica3. https://www.epatitec.info/terapie/terapia-daclatasvir/efficacia-terapeutica4. https://www.epatitec.info/terapie/terapia-simeprevir/efficacia-terapeutica5. https://www.epatitec.info/terapie/terapia-sofosbuvir/efficacia-terapeuticaR Foundation for Statistical Computing (Version 3.3.3).No conflict of interest</description><identifier>ISSN: 2047-9956</identifier><identifier>EISSN: 2047-9964</identifier><identifier>DOI: 10.1136/ejhpharm-2018-eahpconf.184</identifier><language>eng</language><publisher>London: BMJ Publishing Group LTD</publisher><subject>Antiviral drugs ; Meta-analysis ; Section 4: Clinical pharmacy services ; Systematic review</subject><ispartof>European journal of hospital pharmacy. Science and practice, 2018-03, Vol.25 (Suppl 1), p.A85-A85</ispartof><rights>2018, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>Copyright: 2018 © 2018, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>2018 2018, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>2018, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7535417/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7535417/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids></links><search><creatorcontrib>Inserra, C</creatorcontrib><creatorcontrib>Davies, SE Campbell</creatorcontrib><creatorcontrib>Bignamini, A</creatorcontrib><creatorcontrib>Minghetti, P</creatorcontrib><title>4CPS-093 Long-term efficacy of second-generation direct-acting antiviral agents (daas-2) for hcv treatment: a meta-analysis</title><title>European journal of hospital pharmacy. Science and practice</title><description>BackgroundEfficacy of second-generation direct-acting antiviral agents (DAAs-2) in terms of sustained viral response (SVR) 12 weeks after the end of treatment (EOT) has widely been proven.1–5 However, long-term efficacy is still controversial due to the low number of available studies with a small number of patients.PurposeThe objective of the study is to conduct a systematic review and, if possible, a meta-analysis of existing clinical evidence in terms of long-term efficacy (SVR longer than 12 weeks after EOT) of DAAs-2 for HCV treatment.Material and methodsA systematic review was performed with the use of CENTRAL, MEDLINE, Embase, Pubmed and SBBL-CILEA/METACRAWLER databases. Trials were initially screened by the title. Second, full papers and abstracts were analysed. The meta-analysis included randomised controlled trials (RCTs) with adult patients affected by HCV, treated with DAAs-2 and assessed for longer than 12 weeks after EOT. Study quality assessment was undertaken using the Jadad scale. Heterogeneity analysis of the studies was conducted with Chi-square and I2: the statistical analysis of the efficacy rate was performed using the meta package with the R software 6. The effect estimate was expressed in risk ratio (RR) with 95% confidence interval (CI 95%) and pooled using a random effects model.ResultsOf the 106 identified studies, 11 high-quality RCTs were included for meta-analysis (25 were duplicate publications, 70 did not meet the inclusion criteria). Considered genotypes were 1 (nine), 2 (one) and 3 (one). Meta-analysis included 3720 patients (2698 treated with DAAs-2; 1022 treated with placebo or a first-generation DAA±ribavirin± PEG-interferon). Heterogeneity between studies was high (p&lt;0.001; I2=90.2%), however it was absorbed by the model (t2=0.08). Long-term efficacy was expressed as SVR 24 weeks after EOT, since longer timescales were not available. According to the pooled RR, the incidence of efficacy was 1.5 (95% CI: 1.24 to 1.83, p&lt;0.001).ConclusionThe meta-analysis demonstrated that DAAs-2 for HCV treatment have long-term efficacy at SVR 24 weeks after the EOT. However, the number of studies is mostly based on genotype 1. More RCTs are required to confirm long-term efficacy at more than 6 months after EOT for all treated genotypes.References and/or Acknowledgements1. https://www.epatitec.info/terapie/terapia-ledipasvir-sofosbuvir/efficacia-terapeutica2. https://www.epatitec.info/terapie/terapia-ombitasvir-paritaprevir-dasabuvir/efficacia-terapeutica3. https://www.epatitec.info/terapie/terapia-daclatasvir/efficacia-terapeutica4. https://www.epatitec.info/terapie/terapia-simeprevir/efficacia-terapeutica5. https://www.epatitec.info/terapie/terapia-sofosbuvir/efficacia-terapeuticaR Foundation for Statistical Computing (Version 3.3.3).No conflict of interest</description><subject>Antiviral drugs</subject><subject>Meta-analysis</subject><subject>Section 4: Clinical pharmacy services</subject><subject>Systematic review</subject><issn>2047-9956</issn><issn>2047-9964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNp9kc2KFDEUhQtRcBjnHYJudJGZ_FYSF4I0oyM0KKjrcJNKutJ0VbVJuqEXghtf1Ccxw_yAG1f3wvnu4VxO172k5JJS3l-F7bgfIU-YEapxgHHvlzleUi2edGeMCIWN6cXTx132z7uLUpIjknNtBDdn3U-x-vIVE8P__Pq9XuYNriFPKMSYPPgTWiIqobkOeBPmkKGmZUZDysFXDL6meYNgrumYMuwQNKYW9HoAKJi9QXHJaPRHVHOAOjXtLQI0hQoYZtidSiovumcRdiVc3M_z7vuH62-rG7z-_PHT6v0aO0aMwCrygVPJgx409JHTYAjxgnrnFGNSOT1E5ZRwIAwBYnrmBsEkJ8xoQpTg5927O9_9wU1h8C1LC2z3OU2QT3aBZP9V5jTazXK0SnIpqGoGr-4N8vLjEEq12-WQ2xfFMimZ6qXp_08RSjjTnJpGyTvKTdvHCJTY207tQ6e3B9o-dGpbp_wvd4ya_Q</recordid><startdate>20180301</startdate><enddate>20180301</enddate><creator>Inserra, C</creator><creator>Davies, SE Campbell</creator><creator>Bignamini, A</creator><creator>Minghetti, P</creator><general>BMJ Publishing Group LTD</general><general>BMJ Group</general><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope></search><sort><creationdate>20180301</creationdate><title>4CPS-093 Long-term efficacy of second-generation direct-acting antiviral agents (daas-2) for hcv treatment: a meta-analysis</title><author>Inserra, C ; Davies, SE Campbell ; Bignamini, A ; Minghetti, P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b2094-7f3d3153e8d8a6f31e900c41cbb72257b8df7b74ba490a0962bd4253029800743</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Antiviral drugs</topic><topic>Meta-analysis</topic><topic>Section 4: Clinical pharmacy services</topic><topic>Systematic review</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Inserra, C</creatorcontrib><creatorcontrib>Davies, SE Campbell</creatorcontrib><creatorcontrib>Bignamini, A</creatorcontrib><creatorcontrib>Minghetti, P</creatorcontrib><collection>ProQuest Central (Corporate)</collection><collection>ProQuest Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</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)</collection><collection>ProQuest Central</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</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>PubMed Central (Full Participant titles)</collection><jtitle>European journal of hospital pharmacy. Science and practice</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Inserra, C</au><au>Davies, SE Campbell</au><au>Bignamini, A</au><au>Minghetti, P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>4CPS-093 Long-term efficacy of second-generation direct-acting antiviral agents (daas-2) for hcv treatment: a meta-analysis</atitle><jtitle>European journal of hospital pharmacy. Science and practice</jtitle><date>2018-03-01</date><risdate>2018</risdate><volume>25</volume><issue>Suppl 1</issue><spage>A85</spage><epage>A85</epage><pages>A85-A85</pages><issn>2047-9956</issn><eissn>2047-9964</eissn><abstract>BackgroundEfficacy of second-generation direct-acting antiviral agents (DAAs-2) in terms of sustained viral response (SVR) 12 weeks after the end of treatment (EOT) has widely been proven.1–5 However, long-term efficacy is still controversial due to the low number of available studies with a small number of patients.PurposeThe objective of the study is to conduct a systematic review and, if possible, a meta-analysis of existing clinical evidence in terms of long-term efficacy (SVR longer than 12 weeks after EOT) of DAAs-2 for HCV treatment.Material and methodsA systematic review was performed with the use of CENTRAL, MEDLINE, Embase, Pubmed and SBBL-CILEA/METACRAWLER databases. Trials were initially screened by the title. Second, full papers and abstracts were analysed. The meta-analysis included randomised controlled trials (RCTs) with adult patients affected by HCV, treated with DAAs-2 and assessed for longer than 12 weeks after EOT. Study quality assessment was undertaken using the Jadad scale. Heterogeneity analysis of the studies was conducted with Chi-square and I2: the statistical analysis of the efficacy rate was performed using the meta package with the R software 6. The effect estimate was expressed in risk ratio (RR) with 95% confidence interval (CI 95%) and pooled using a random effects model.ResultsOf the 106 identified studies, 11 high-quality RCTs were included for meta-analysis (25 were duplicate publications, 70 did not meet the inclusion criteria). Considered genotypes were 1 (nine), 2 (one) and 3 (one). Meta-analysis included 3720 patients (2698 treated with DAAs-2; 1022 treated with placebo or a first-generation DAA±ribavirin± PEG-interferon). Heterogeneity between studies was high (p&lt;0.001; I2=90.2%), however it was absorbed by the model (t2=0.08). Long-term efficacy was expressed as SVR 24 weeks after EOT, since longer timescales were not available. According to the pooled RR, the incidence of efficacy was 1.5 (95% CI: 1.24 to 1.83, p&lt;0.001).ConclusionThe meta-analysis demonstrated that DAAs-2 for HCV treatment have long-term efficacy at SVR 24 weeks after the EOT. However, the number of studies is mostly based on genotype 1. More RCTs are required to confirm long-term efficacy at more than 6 months after EOT for all treated genotypes.References and/or Acknowledgements1. https://www.epatitec.info/terapie/terapia-ledipasvir-sofosbuvir/efficacia-terapeutica2. https://www.epatitec.info/terapie/terapia-ombitasvir-paritaprevir-dasabuvir/efficacia-terapeutica3. https://www.epatitec.info/terapie/terapia-daclatasvir/efficacia-terapeutica4. https://www.epatitec.info/terapie/terapia-simeprevir/efficacia-terapeutica5. https://www.epatitec.info/terapie/terapia-sofosbuvir/efficacia-terapeuticaR Foundation for Statistical Computing (Version 3.3.3).No conflict of interest</abstract><cop>London</cop><pub>BMJ Publishing Group LTD</pub><doi>10.1136/ejhpharm-2018-eahpconf.184</doi><oa>free_for_read</oa></addata></record>
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subjects Antiviral drugs
Meta-analysis
Section 4: Clinical pharmacy services
Systematic review
title 4CPS-093 Long-term efficacy of second-generation direct-acting antiviral agents (daas-2) for hcv treatment: a meta-analysis
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