Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

Purpose To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Infection 2018-10, Vol.46 (5), p.607-615
Hauptverfasser: Ascione, Antonio, De Luca, Massimo, Melazzini, Mario, Montilla, Simona, Trotta, Maria Paola, Petta, Salvatore, Puoti, Massimo, Sangiovanni, Vincenzo, Messina, Vincenzo, Bruno, Savino, Izzi, Antonio, Villa, Erica, Aghemo, Alessio, Zignego, Anna Linda, Orlandini, Alessandra, Fontanella, Luca, Gasbarrini, Antonio, Marzioni, Marco, Giannini, Edoardo G., Craxì, Antonio
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page 615
container_issue 5
container_start_page 607
container_title Infection
container_volume 46
creator Ascione, Antonio
De Luca, Massimo
Melazzini, Mario
Montilla, Simona
Trotta, Maria Paola
Petta, Salvatore
Puoti, Massimo
Sangiovanni, Vincenzo
Messina, Vincenzo
Bruno, Savino
Izzi, Antonio
Villa, Erica
Aghemo, Alessio
Zignego, Anna Linda
Orlandini, Alessandra
Fontanella, Luca
Gasbarrini, Antonio
Marzioni, Marco
Giannini, Edoardo G.
Craxì, Antonio
description Purpose To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin
doi_str_mv 10.1007/s15010-018-1157-x
format Article
fullrecord <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2695264158</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2045840681</sourcerecordid><originalsourceid>FETCH-LOGICAL-c358x-4e64c127741f81a58d963d6f101ea187f8fbccdc325a86c1827f14319cec603e3</originalsourceid><addsrcrecordid>eNp9kc1u1TAQhS0EopeWB2CDLLFOOxP_xFmiK6CVKrEAurUcx25d9cbBTsrNK_AUPAtPVke3wKpIluZ4_M0ZyYeQNwinCNCcZRSAUAGqClE01f4Z2SBnbQVtw56TDTCASmEtj8irnG8BQLS8eUmO6laB4pJtyM8vxrtpoWboqfM-WGMXGj2Nuy5MJt-HdDaaVOSY3HopMg5mVb3JppuLouPdnGkK3doOAy1nNFNww5RpvHeJSvH71-JMyvRHmG7o-faKXrshTsvoKFIbUrqJOeQT8sKbu-xeP9Zj8u3jh6_b8-ry86eL7fvLyjKh9hV3klusm4ajV2iE6lvJeukR0BlUjVe-s7a3rBZGSYuqbnz5FGytsxKYY8fk3cF3TPH77PKkb-OchrJS17IVteQo1H8p4EJxkAoLhQfKpphzcl6PKexMWjSCXjPSh4x0yUivGel9mXn76Dx3O9f_nfgTSgHqA5DL03Dt0r_VT7s-AB29nvc</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2045840681</pqid></control><display><type>article</type><title>Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Ascione, Antonio ; De Luca, Massimo ; Melazzini, Mario ; Montilla, Simona ; Trotta, Maria Paola ; Petta, Salvatore ; Puoti, Massimo ; Sangiovanni, Vincenzo ; Messina, Vincenzo ; Bruno, Savino ; Izzi, Antonio ; Villa, Erica ; Aghemo, Alessio ; Zignego, Anna Linda ; Orlandini, Alessandra ; Fontanella, Luca ; Gasbarrini, Antonio ; Marzioni, Marco ; Giannini, Edoardo G. ; Craxì, Antonio</creator><creatorcontrib>Ascione, Antonio ; De Luca, Massimo ; Melazzini, Mario ; Montilla, Simona ; Trotta, Maria Paola ; Petta, Salvatore ; Puoti, Massimo ; Sangiovanni, Vincenzo ; Messina, Vincenzo ; Bruno, Savino ; Izzi, Antonio ; Villa, Erica ; Aghemo, Alessio ; Zignego, Anna Linda ; Orlandini, Alessandra ; Fontanella, Luca ; Gasbarrini, Antonio ; Marzioni, Marco ; Giannini, Edoardo G. ; Craxì, Antonio ; ABACUS Study Group ; For the ABACUS Study Group</creatorcontrib><description>Purpose To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin &lt; 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p  &lt; 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p  &lt; 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin &lt; 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p  = 0.029) as the only variable independently associated with SVR12. Conclusion Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.</description><identifier>ISSN: 0300-8126</identifier><identifier>EISSN: 1439-0973</identifier><identifier>DOI: 10.1007/s15010-018-1157-x</identifier><identifier>PMID: 29808463</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject><![CDATA[Aged ; Aged, 80 and over ; Albumins ; Anilides - administration & dosage ; Antiretroviral drugs ; Antiviral Agents - administration & dosage ; Antiviral Agents - adverse effects ; Antiviral Agents - therapeutic use ; Antiviral drugs ; Bilirubin ; Biomarkers ; Carbamates - administration & dosage ; Cirrhosis ; Drug therapy ; Drug Therapy, Combination ; Effectiveness ; Family Medicine ; Female ; General Practice ; Genotype ; Genotypes ; Hepacivirus - genetics ; Hepatitis C ; Hepatitis C, Chronic - complications ; Hepatitis C, Chronic - diagnosis ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - virology ; Humans ; Hypertension ; Infectious Diseases ; Interferon ; Internal Medicine ; Liver cirrhosis ; Liver Cirrhosis - diagnosis ; Liver Cirrhosis - etiology ; Liver diseases ; Macrocyclic Compounds - administration & dosage ; Male ; Medicine ; Medicine & Public Health ; Multivariate analysis ; Original Paper ; Patient safety ; Patients ; Pharmacokinetics ; Pharmacology ; Ribavirin ; Ribavirin - administration & dosage ; Ribonucleic acid ; Ritonavir ; Ritonavir - administration & dosage ; RNA ; Safety ; Sulfonamides - administration & dosage ; Treatment Outcome ; Uracil - administration & dosage ; Uracil - analogs & derivatives ; Viruses]]></subject><ispartof>Infection, 2018-10, Vol.46 (5), p.607-615</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2018</rights><rights>Infection is a copyright of Springer, (2018). All Rights Reserved.</rights><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2018.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c358x-4e64c127741f81a58d963d6f101ea187f8fbccdc325a86c1827f14319cec603e3</citedby><cites>FETCH-LOGICAL-c358x-4e64c127741f81a58d963d6f101ea187f8fbccdc325a86c1827f14319cec603e3</cites><orcidid>0000-0003-2040-8380</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s15010-018-1157-x$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s15010-018-1157-x$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51298</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29808463$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ascione, Antonio</creatorcontrib><creatorcontrib>De Luca, Massimo</creatorcontrib><creatorcontrib>Melazzini, Mario</creatorcontrib><creatorcontrib>Montilla, Simona</creatorcontrib><creatorcontrib>Trotta, Maria Paola</creatorcontrib><creatorcontrib>Petta, Salvatore</creatorcontrib><creatorcontrib>Puoti, Massimo</creatorcontrib><creatorcontrib>Sangiovanni, Vincenzo</creatorcontrib><creatorcontrib>Messina, Vincenzo</creatorcontrib><creatorcontrib>Bruno, Savino</creatorcontrib><creatorcontrib>Izzi, Antonio</creatorcontrib><creatorcontrib>Villa, Erica</creatorcontrib><creatorcontrib>Aghemo, Alessio</creatorcontrib><creatorcontrib>Zignego, Anna Linda</creatorcontrib><creatorcontrib>Orlandini, Alessandra</creatorcontrib><creatorcontrib>Fontanella, Luca</creatorcontrib><creatorcontrib>Gasbarrini, Antonio</creatorcontrib><creatorcontrib>Marzioni, Marco</creatorcontrib><creatorcontrib>Giannini, Edoardo G.</creatorcontrib><creatorcontrib>Craxì, Antonio</creatorcontrib><creatorcontrib>ABACUS Study Group</creatorcontrib><creatorcontrib>For the ABACUS Study Group</creatorcontrib><title>Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis</title><title>Infection</title><addtitle>Infection</addtitle><addtitle>Infection</addtitle><description>Purpose To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin &lt; 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p  &lt; 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p  &lt; 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin &lt; 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p  = 0.029) as the only variable independently associated with SVR12. Conclusion Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Albumins</subject><subject>Anilides - administration &amp; dosage</subject><subject>Antiretroviral drugs</subject><subject>Antiviral Agents - administration &amp; dosage</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Antiviral drugs</subject><subject>Bilirubin</subject><subject>Biomarkers</subject><subject>Carbamates - administration &amp; dosage</subject><subject>Cirrhosis</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Effectiveness</subject><subject>Family Medicine</subject><subject>Female</subject><subject>General Practice</subject><subject>Genotype</subject><subject>Genotypes</subject><subject>Hepacivirus - genetics</subject><subject>Hepatitis C</subject><subject>Hepatitis C, Chronic - complications</subject><subject>Hepatitis C, Chronic - diagnosis</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatitis C, Chronic - virology</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Infectious Diseases</subject><subject>Interferon</subject><subject>Internal Medicine</subject><subject>Liver cirrhosis</subject><subject>Liver Cirrhosis - diagnosis</subject><subject>Liver Cirrhosis - etiology</subject><subject>Liver diseases</subject><subject>Macrocyclic Compounds - administration &amp; dosage</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Multivariate analysis</subject><subject>Original Paper</subject><subject>Patient safety</subject><subject>Patients</subject><subject>Pharmacokinetics</subject><subject>Pharmacology</subject><subject>Ribavirin</subject><subject>Ribavirin - administration &amp; dosage</subject><subject>Ribonucleic acid</subject><subject>Ritonavir</subject><subject>Ritonavir - administration &amp; dosage</subject><subject>RNA</subject><subject>Safety</subject><subject>Sulfonamides - administration &amp; dosage</subject><subject>Treatment Outcome</subject><subject>Uracil - administration &amp; dosage</subject><subject>Uracil - analogs &amp; derivatives</subject><subject>Viruses</subject><issn>0300-8126</issn><issn>1439-0973</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kc1u1TAQhS0EopeWB2CDLLFOOxP_xFmiK6CVKrEAurUcx25d9cbBTsrNK_AUPAtPVke3wKpIluZ4_M0ZyYeQNwinCNCcZRSAUAGqClE01f4Z2SBnbQVtw56TDTCASmEtj8irnG8BQLS8eUmO6laB4pJtyM8vxrtpoWboqfM-WGMXGj2Nuy5MJt-HdDaaVOSY3HopMg5mVb3JppuLouPdnGkK3doOAy1nNFNww5RpvHeJSvH71-JMyvRHmG7o-faKXrshTsvoKFIbUrqJOeQT8sKbu-xeP9Zj8u3jh6_b8-ry86eL7fvLyjKh9hV3klusm4ajV2iE6lvJeukR0BlUjVe-s7a3rBZGSYuqbnz5FGytsxKYY8fk3cF3TPH77PKkb-OchrJS17IVteQo1H8p4EJxkAoLhQfKpphzcl6PKexMWjSCXjPSh4x0yUivGel9mXn76Dx3O9f_nfgTSgHqA5DL03Dt0r_VT7s-AB29nvc</recordid><startdate>20181001</startdate><enddate>20181001</enddate><creator>Ascione, Antonio</creator><creator>De Luca, Massimo</creator><creator>Melazzini, Mario</creator><creator>Montilla, Simona</creator><creator>Trotta, Maria Paola</creator><creator>Petta, Salvatore</creator><creator>Puoti, Massimo</creator><creator>Sangiovanni, Vincenzo</creator><creator>Messina, Vincenzo</creator><creator>Bruno, Savino</creator><creator>Izzi, Antonio</creator><creator>Villa, Erica</creator><creator>Aghemo, Alessio</creator><creator>Zignego, Anna Linda</creator><creator>Orlandini, Alessandra</creator><creator>Fontanella, Luca</creator><creator>Gasbarrini, Antonio</creator><creator>Marzioni, Marco</creator><creator>Giannini, Edoardo G.</creator><creator>Craxì, Antonio</creator><general>Springer Berlin Heidelberg</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>7QL</scope><scope>7RV</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>RC3</scope><orcidid>https://orcid.org/0000-0003-2040-8380</orcidid></search><sort><creationdate>20181001</creationdate><title>Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis</title><author>Ascione, Antonio ; De Luca, Massimo ; Melazzini, Mario ; Montilla, Simona ; Trotta, Maria Paola ; Petta, Salvatore ; Puoti, Massimo ; Sangiovanni, Vincenzo ; Messina, Vincenzo ; Bruno, Savino ; Izzi, Antonio ; Villa, Erica ; Aghemo, Alessio ; Zignego, Anna Linda ; Orlandini, Alessandra ; Fontanella, Luca ; Gasbarrini, Antonio ; Marzioni, Marco ; Giannini, Edoardo G. ; Craxì, Antonio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c358x-4e64c127741f81a58d963d6f101ea187f8fbccdc325a86c1827f14319cec603e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Albumins</topic><topic>Anilides - administration &amp; dosage</topic><topic>Antiretroviral drugs</topic><topic>Antiviral Agents - administration &amp; dosage</topic><topic>Antiviral Agents - adverse effects</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Antiviral drugs</topic><topic>Bilirubin</topic><topic>Biomarkers</topic><topic>Carbamates - administration &amp; dosage</topic><topic>Cirrhosis</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Effectiveness</topic><topic>Family Medicine</topic><topic>Female</topic><topic>General Practice</topic><topic>Genotype</topic><topic>Genotypes</topic><topic>Hepacivirus - genetics</topic><topic>Hepatitis C</topic><topic>Hepatitis C, Chronic - complications</topic><topic>Hepatitis C, Chronic - diagnosis</topic><topic>Hepatitis C, Chronic - drug therapy</topic><topic>Hepatitis C, Chronic - virology</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Infectious Diseases</topic><topic>Interferon</topic><topic>Internal Medicine</topic><topic>Liver cirrhosis</topic><topic>Liver Cirrhosis - diagnosis</topic><topic>Liver Cirrhosis - etiology</topic><topic>Liver diseases</topic><topic>Macrocyclic Compounds - administration &amp; dosage</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Multivariate analysis</topic><topic>Original Paper</topic><topic>Patient safety</topic><topic>Patients</topic><topic>Pharmacokinetics</topic><topic>Pharmacology</topic><topic>Ribavirin</topic><topic>Ribavirin - administration &amp; dosage</topic><topic>Ribonucleic acid</topic><topic>Ritonavir</topic><topic>Ritonavir - administration &amp; dosage</topic><topic>RNA</topic><topic>Safety</topic><topic>Sulfonamides - administration &amp; dosage</topic><topic>Treatment Outcome</topic><topic>Uracil - administration &amp; dosage</topic><topic>Uracil - analogs &amp; derivatives</topic><topic>Viruses</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ascione, Antonio</creatorcontrib><creatorcontrib>De Luca, Massimo</creatorcontrib><creatorcontrib>Melazzini, Mario</creatorcontrib><creatorcontrib>Montilla, Simona</creatorcontrib><creatorcontrib>Trotta, Maria Paola</creatorcontrib><creatorcontrib>Petta, Salvatore</creatorcontrib><creatorcontrib>Puoti, Massimo</creatorcontrib><creatorcontrib>Sangiovanni, Vincenzo</creatorcontrib><creatorcontrib>Messina, Vincenzo</creatorcontrib><creatorcontrib>Bruno, Savino</creatorcontrib><creatorcontrib>Izzi, Antonio</creatorcontrib><creatorcontrib>Villa, Erica</creatorcontrib><creatorcontrib>Aghemo, Alessio</creatorcontrib><creatorcontrib>Zignego, Anna Linda</creatorcontrib><creatorcontrib>Orlandini, Alessandra</creatorcontrib><creatorcontrib>Fontanella, Luca</creatorcontrib><creatorcontrib>Gasbarrini, Antonio</creatorcontrib><creatorcontrib>Marzioni, Marco</creatorcontrib><creatorcontrib>Giannini, Edoardo G.</creatorcontrib><creatorcontrib>Craxì, Antonio</creatorcontrib><creatorcontrib>ABACUS Study Group</creatorcontrib><creatorcontrib>For the ABACUS Study Group</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>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing &amp; Allied Health Database</collection><collection>Virology and AIDS Abstracts</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>ProQuest Public Health Database</collection><collection>Technology Research Database</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 One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>Genetics Abstracts</collection><jtitle>Infection</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ascione, Antonio</au><au>De Luca, Massimo</au><au>Melazzini, Mario</au><au>Montilla, Simona</au><au>Trotta, Maria Paola</au><au>Petta, Salvatore</au><au>Puoti, Massimo</au><au>Sangiovanni, Vincenzo</au><au>Messina, Vincenzo</au><au>Bruno, Savino</au><au>Izzi, Antonio</au><au>Villa, Erica</au><au>Aghemo, Alessio</au><au>Zignego, Anna Linda</au><au>Orlandini, Alessandra</au><au>Fontanella, Luca</au><au>Gasbarrini, Antonio</au><au>Marzioni, Marco</au><au>Giannini, Edoardo G.</au><au>Craxì, Antonio</au><aucorp>ABACUS Study Group</aucorp><aucorp>For the ABACUS Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis</atitle><jtitle>Infection</jtitle><stitle>Infection</stitle><addtitle>Infection</addtitle><date>2018-10-01</date><risdate>2018</risdate><volume>46</volume><issue>5</issue><spage>607</spage><epage>615</epage><pages>607-615</pages><issn>0300-8126</issn><eissn>1439-0973</eissn><abstract>Purpose To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin &lt; 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p  &lt; 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p  &lt; 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin &lt; 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p  = 0.029) as the only variable independently associated with SVR12. Conclusion Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>29808463</pmid><doi>10.1007/s15010-018-1157-x</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-2040-8380</orcidid><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 0300-8126
ispartof Infection, 2018-10, Vol.46 (5), p.607-615
issn 0300-8126
1439-0973
language eng
recordid cdi_proquest_journals_2695264158
source MEDLINE; Springer Nature - Complete Springer Journals
subjects Aged
Aged, 80 and over
Albumins
Anilides - administration & dosage
Antiretroviral drugs
Antiviral Agents - administration & dosage
Antiviral Agents - adverse effects
Antiviral Agents - therapeutic use
Antiviral drugs
Bilirubin
Biomarkers
Carbamates - administration & dosage
Cirrhosis
Drug therapy
Drug Therapy, Combination
Effectiveness
Family Medicine
Female
General Practice
Genotype
Genotypes
Hepacivirus - genetics
Hepatitis C
Hepatitis C, Chronic - complications
Hepatitis C, Chronic - diagnosis
Hepatitis C, Chronic - drug therapy
Hepatitis C, Chronic - virology
Humans
Hypertension
Infectious Diseases
Interferon
Internal Medicine
Liver cirrhosis
Liver Cirrhosis - diagnosis
Liver Cirrhosis - etiology
Liver diseases
Macrocyclic Compounds - administration & dosage
Male
Medicine
Medicine & Public Health
Multivariate analysis
Original Paper
Patient safety
Patients
Pharmacokinetics
Pharmacology
Ribavirin
Ribavirin - administration & dosage
Ribonucleic acid
Ritonavir
Ritonavir - administration & dosage
RNA
Safety
Sulfonamides - administration & dosage
Treatment Outcome
Uracil - administration & dosage
Uracil - analogs & derivatives
Viruses
title Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-21T11%3A03%3A24IST&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=Safety%20and%20efficacy%20of%20ombitasvir/paritaprevir/ritonavir/dasabuvir%20plus%20ribavirin%20in%20patients%20over%2065%C2%A0years%20with%20HCV%20genotype%201%20cirrhosis&rft.jtitle=Infection&rft.au=Ascione,%20Antonio&rft.aucorp=ABACUS%20Study%20Group&rft.date=2018-10-01&rft.volume=46&rft.issue=5&rft.spage=607&rft.epage=615&rft.pages=607-615&rft.issn=0300-8126&rft.eissn=1439-0973&rft_id=info:doi/10.1007/s15010-018-1157-x&rft_dat=%3Cproquest_cross%3E2045840681%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=2045840681&rft_id=info:pmid/29808463&rfr_iscdi=true