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Clinical outcomes in patients with hepatitis D, cirrhosis and persistent hepatitis B virus replication, and receiving long‐term tenofovir or entecavir

Summary Background Suppression of hepatitis B virus (HBV) replication with nucelos(t)ide analogues should be considered for patients with chronic hepatitis D virus (HDV) infection and ongoing HBV replication. Aim To verify the clinical outcome after long‐term entecavir or tenofovir treatment in pati...

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Published in:Alimentary pharmacology & therapeutics 2019-04, Vol.49 (8), p.1071-1076
Main Authors: Brancaccio, Giuseppina, Fasano, Massimo, Grossi, Adriano, Santantonio, Teresa Antonia, Gaeta, Giovanni B.
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description Summary Background Suppression of hepatitis B virus (HBV) replication with nucelos(t)ide analogues should be considered for patients with chronic hepatitis D virus (HDV) infection and ongoing HBV replication. Aim To verify the clinical outcome after long‐term entecavir or tenofovir treatment in patients with advanced fibrosis/cirrhosis, ineligible to peg‐interferon therapy. Methods Patients were prospectively followed‐up at 3‐6 month intervals; measured outcomes were decompensation, hepatocellular carcinoma (HCC), liver transplant and liver related death. HBV monoinfected patients receiving the same treatment served as reference after 1:1 matching by age, gender, platelet count, albumin level, bilirubin and INR. Results 56 HDV patients (48 with cirrhosis; median follow‐up 50 months) were enrolled; all achieved HBV DNA suppression. Death or liver transplant occurred in 19 patients, with a rate (n/1000 patient‐months) of 2.92 in HDV patients vs 0.38 in HBV monoinfected patients (P 
doi_str_mv 10.1111/apt.15188
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Aim To verify the clinical outcome after long‐term entecavir or tenofovir treatment in patients with advanced fibrosis/cirrhosis, ineligible to peg‐interferon therapy. Methods Patients were prospectively followed‐up at 3‐6 month intervals; measured outcomes were decompensation, hepatocellular carcinoma (HCC), liver transplant and liver related death. HBV monoinfected patients receiving the same treatment served as reference after 1:1 matching by age, gender, platelet count, albumin level, bilirubin and INR. Results 56 HDV patients (48 with cirrhosis; median follow‐up 50 months) were enrolled; all achieved HBV DNA suppression. Death or liver transplant occurred in 19 patients, with a rate (n/1000 patient‐months) of 2.92 in HDV patients vs 0.38 in HBV monoinfected patients (P &lt; 0.001); similarly, decompensation occurred at a rate of 1.53 vs 0.13 (P = 0.015), respectively, and the rate of HCC was almost thrice in HDV cohort (3.12 vs 1.12; P = 0.02) Platelet count, Child‐Pugh score and marginally HDV infection were associated with HCC development. Conclusion Patients with HDV infection and advanced liver disease maintain an increased risk of severe clinical events as compared with HBV monoinfected patients, during prolonged HBV DNA suppression with potent NA.</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/apt.15188</identifier><identifier>PMID: 30793345</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Adult ; Antiviral Agents - therapeutic use ; Bilirubin ; Carcinoma, Hepatocellular - epidemiology ; Chronic infection ; Cirrhosis ; Clinical outcomes ; Deoxyribonucleic acid ; DNA ; Female ; Fibrosis ; Follow-Up Studies ; Guanine - administration &amp; dosage ; Guanine - analogs &amp; derivatives ; Health risks ; Hepatitis ; Hepatitis B ; Hepatitis B - drug therapy ; Hepatitis B virus - drug effects ; Hepatitis D, Chronic - drug therapy ; Hepatocellular carcinoma ; Humans ; Infections ; Interferon ; Liver ; Liver cirrhosis ; Liver Cirrhosis - drug therapy ; Liver diseases ; Liver Neoplasms - epidemiology ; Liver transplantation ; Liver Transplantation - statistics &amp; numerical data ; Male ; Middle Aged ; Patients ; Platelets ; Prospective Studies ; Replication ; Tenofovir ; Tenofovir - therapeutic use ; Treatment Outcome ; Viruses</subject><ispartof>Alimentary pharmacology &amp; therapeutics, 2019-04, Vol.49 (8), p.1071-1076</ispartof><rights>2019 John Wiley &amp; Sons Ltd</rights><rights>2019 John Wiley &amp; Sons Ltd.</rights><rights>Copyright © 2019 John Wiley &amp; Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2838-113c8dffa487b9d51f528c932afba585de127c488e4145cd5be0d10b11c84e8e3</citedby><cites>FETCH-LOGICAL-c2838-113c8dffa487b9d51f528c932afba585de127c488e4145cd5be0d10b11c84e8e3</cites><orcidid>0000-0003-1573-6224 ; 0000-0001-5643-0139</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30793345$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Brancaccio, Giuseppina</creatorcontrib><creatorcontrib>Fasano, Massimo</creatorcontrib><creatorcontrib>Grossi, Adriano</creatorcontrib><creatorcontrib>Santantonio, Teresa Antonia</creatorcontrib><creatorcontrib>Gaeta, Giovanni B.</creatorcontrib><title>Clinical outcomes in patients with hepatitis D, cirrhosis and persistent hepatitis B virus replication, and receiving long‐term tenofovir or entecavir</title><title>Alimentary pharmacology &amp; therapeutics</title><addtitle>Aliment Pharmacol Ther</addtitle><description>Summary Background Suppression of hepatitis B virus (HBV) replication with nucelos(t)ide analogues should be considered for patients with chronic hepatitis D virus (HDV) infection and ongoing HBV replication. Aim To verify the clinical outcome after long‐term entecavir or tenofovir treatment in patients with advanced fibrosis/cirrhosis, ineligible to peg‐interferon therapy. Methods Patients were prospectively followed‐up at 3‐6 month intervals; measured outcomes were decompensation, hepatocellular carcinoma (HCC), liver transplant and liver related death. HBV monoinfected patients receiving the same treatment served as reference after 1:1 matching by age, gender, platelet count, albumin level, bilirubin and INR. Results 56 HDV patients (48 with cirrhosis; median follow‐up 50 months) were enrolled; all achieved HBV DNA suppression. Death or liver transplant occurred in 19 patients, with a rate (n/1000 patient‐months) of 2.92 in HDV patients vs 0.38 in HBV monoinfected patients (P &lt; 0.001); similarly, decompensation occurred at a rate of 1.53 vs 0.13 (P = 0.015), respectively, and the rate of HCC was almost thrice in HDV cohort (3.12 vs 1.12; P = 0.02) Platelet count, Child‐Pugh score and marginally HDV infection were associated with HCC development. Conclusion Patients with HDV infection and advanced liver disease maintain an increased risk of severe clinical events as compared with HBV monoinfected patients, during prolonged HBV DNA suppression with potent NA.</description><subject>Adult</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Bilirubin</subject><subject>Carcinoma, Hepatocellular - epidemiology</subject><subject>Chronic infection</subject><subject>Cirrhosis</subject><subject>Clinical outcomes</subject><subject>Deoxyribonucleic acid</subject><subject>DNA</subject><subject>Female</subject><subject>Fibrosis</subject><subject>Follow-Up Studies</subject><subject>Guanine - administration &amp; dosage</subject><subject>Guanine - analogs &amp; derivatives</subject><subject>Health risks</subject><subject>Hepatitis</subject><subject>Hepatitis B</subject><subject>Hepatitis B - drug therapy</subject><subject>Hepatitis B virus - drug effects</subject><subject>Hepatitis D, Chronic - drug therapy</subject><subject>Hepatocellular carcinoma</subject><subject>Humans</subject><subject>Infections</subject><subject>Interferon</subject><subject>Liver</subject><subject>Liver cirrhosis</subject><subject>Liver Cirrhosis - drug therapy</subject><subject>Liver diseases</subject><subject>Liver Neoplasms - epidemiology</subject><subject>Liver transplantation</subject><subject>Liver Transplantation - statistics &amp; numerical data</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Patients</subject><subject>Platelets</subject><subject>Prospective Studies</subject><subject>Replication</subject><subject>Tenofovir</subject><subject>Tenofovir - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Viruses</subject><issn>0269-2813</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNp1kc1q3TAQRkVpaG6TLPoCRdBNC3GikSxbXia3PykEmkWyNrI8zlWwJVeSE7LrI3TZ5-uTVMlNSyl0NpoPzhwEHyGvgB1BnmM9pyOQoNQzsgJRyYIzUT0nK8arpuAKxC55GeMNY6yqGX9BdgWrGyFKuSI_1qN11uiR-iUZP2Gk1tFZJ4suRXpn04Zu8CEnG-n7Q2psCBsfc9CupzOGvKbM_kWd0lsblkgDzmNWJ-vd4SMd0KC9te6ajt5d__z2PWGYaL72g88n1AeaTWh0DvtkZ9BjxIOnd49cffxwuT4rzr98-rw-OS8MV0IVAMKofhh0qequ6SUMkivTCK6HTkslewRem1IpLKGUppcdsh5YB2BUiQrFHnm79c7Bf10wpnay0eA4aod-iS0HJWXZ1JXK6Jt_0Bu_BJd_13IhQEFdQZWpd1vKBB9jwKGdg510uG-BtQ91tbmu9rGuzL5-Mi7dhP0f8nc_GTjeAnd2xPv_m9qTi8ut8hfslqK6</recordid><startdate>201904</startdate><enddate>201904</enddate><creator>Brancaccio, Giuseppina</creator><creator>Fasano, Massimo</creator><creator>Grossi, Adriano</creator><creator>Santantonio, Teresa Antonia</creator><creator>Gaeta, Giovanni B.</creator><general>Wiley Subscription Services, Inc</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>7T5</scope><scope>7TK</scope><scope>7U9</scope><scope>H94</scope><scope>M7N</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1573-6224</orcidid><orcidid>https://orcid.org/0000-0001-5643-0139</orcidid></search><sort><creationdate>201904</creationdate><title>Clinical outcomes in patients with hepatitis D, cirrhosis and persistent hepatitis B virus replication, and receiving long‐term tenofovir or entecavir</title><author>Brancaccio, Giuseppina ; Fasano, Massimo ; Grossi, Adriano ; Santantonio, Teresa Antonia ; Gaeta, Giovanni B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2838-113c8dffa487b9d51f528c932afba585de127c488e4145cd5be0d10b11c84e8e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Bilirubin</topic><topic>Carcinoma, Hepatocellular - epidemiology</topic><topic>Chronic infection</topic><topic>Cirrhosis</topic><topic>Clinical outcomes</topic><topic>Deoxyribonucleic acid</topic><topic>DNA</topic><topic>Female</topic><topic>Fibrosis</topic><topic>Follow-Up Studies</topic><topic>Guanine - administration &amp; dosage</topic><topic>Guanine - analogs &amp; derivatives</topic><topic>Health risks</topic><topic>Hepatitis</topic><topic>Hepatitis B</topic><topic>Hepatitis B - drug therapy</topic><topic>Hepatitis B virus - drug effects</topic><topic>Hepatitis D, Chronic - drug therapy</topic><topic>Hepatocellular carcinoma</topic><topic>Humans</topic><topic>Infections</topic><topic>Interferon</topic><topic>Liver</topic><topic>Liver cirrhosis</topic><topic>Liver Cirrhosis - drug therapy</topic><topic>Liver diseases</topic><topic>Liver Neoplasms - epidemiology</topic><topic>Liver transplantation</topic><topic>Liver Transplantation - statistics &amp; numerical data</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Patients</topic><topic>Platelets</topic><topic>Prospective Studies</topic><topic>Replication</topic><topic>Tenofovir</topic><topic>Tenofovir - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Viruses</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brancaccio, Giuseppina</creatorcontrib><creatorcontrib>Fasano, Massimo</creatorcontrib><creatorcontrib>Grossi, Adriano</creatorcontrib><creatorcontrib>Santantonio, Teresa Antonia</creatorcontrib><creatorcontrib>Gaeta, Giovanni B.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><jtitle>Alimentary pharmacology &amp; therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Brancaccio, Giuseppina</au><au>Fasano, Massimo</au><au>Grossi, Adriano</au><au>Santantonio, Teresa Antonia</au><au>Gaeta, Giovanni B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical outcomes in patients with hepatitis D, cirrhosis and persistent hepatitis B virus replication, and receiving long‐term tenofovir or entecavir</atitle><jtitle>Alimentary pharmacology &amp; therapeutics</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>2019-04</date><risdate>2019</risdate><volume>49</volume><issue>8</issue><spage>1071</spage><epage>1076</epage><pages>1071-1076</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><abstract>Summary Background Suppression of hepatitis B virus (HBV) replication with nucelos(t)ide analogues should be considered for patients with chronic hepatitis D virus (HDV) infection and ongoing HBV replication. Aim To verify the clinical outcome after long‐term entecavir or tenofovir treatment in patients with advanced fibrosis/cirrhosis, ineligible to peg‐interferon therapy. Methods Patients were prospectively followed‐up at 3‐6 month intervals; measured outcomes were decompensation, hepatocellular carcinoma (HCC), liver transplant and liver related death. HBV monoinfected patients receiving the same treatment served as reference after 1:1 matching by age, gender, platelet count, albumin level, bilirubin and INR. Results 56 HDV patients (48 with cirrhosis; median follow‐up 50 months) were enrolled; all achieved HBV DNA suppression. Death or liver transplant occurred in 19 patients, with a rate (n/1000 patient‐months) of 2.92 in HDV patients vs 0.38 in HBV monoinfected patients (P &lt; 0.001); similarly, decompensation occurred at a rate of 1.53 vs 0.13 (P = 0.015), respectively, and the rate of HCC was almost thrice in HDV cohort (3.12 vs 1.12; P = 0.02) Platelet count, Child‐Pugh score and marginally HDV infection were associated with HCC development. Conclusion Patients with HDV infection and advanced liver disease maintain an increased risk of severe clinical events as compared with HBV monoinfected patients, during prolonged HBV DNA suppression with potent NA.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>30793345</pmid><doi>10.1111/apt.15188</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0003-1573-6224</orcidid><orcidid>https://orcid.org/0000-0001-5643-0139</orcidid></addata></record>
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subjects Adult
Antiviral Agents - therapeutic use
Bilirubin
Carcinoma, Hepatocellular - epidemiology
Chronic infection
Cirrhosis
Clinical outcomes
Deoxyribonucleic acid
DNA
Female
Fibrosis
Follow-Up Studies
Guanine - administration & dosage
Guanine - analogs & derivatives
Health risks
Hepatitis
Hepatitis B
Hepatitis B - drug therapy
Hepatitis B virus - drug effects
Hepatitis D, Chronic - drug therapy
Hepatocellular carcinoma
Humans
Infections
Interferon
Liver
Liver cirrhosis
Liver Cirrhosis - drug therapy
Liver diseases
Liver Neoplasms - epidemiology
Liver transplantation
Liver Transplantation - statistics & numerical data
Male
Middle Aged
Patients
Platelets
Prospective Studies
Replication
Tenofovir
Tenofovir - therapeutic use
Treatment Outcome
Viruses
title Clinical outcomes in patients with hepatitis D, cirrhosis and persistent hepatitis B virus replication, and receiving long‐term tenofovir or entecavir
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