Hepatic safety of efavirenz in HIV/hepatitis C virus-coinfected patients with advanced liver fibrosis
Summary Objective To assess the frequency of severe liver toxicity in HIV/hepatitis C (HCV)-coinfected patients with advanced liver fibrosis receiving efavirenz (EFV)-based antiretroviral combinations. Methods One hundred and eighty-nine previously antiretroviral naïve, HIV/HCV-coinfected patients,...
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| creator | Pineda, Juan A Neukam, Karin Mallolas, Josep López-Cortés, Luis F Cartón, José A Domingo, Pere Moreno, Santiago Iribarren, José A Clotet, Bonaventura Crespo, Manuel de Los Santos, Ignacio Ortega, Enrique Knobel, Hernando Jiménez-Expósito, María J Macías, Juan |
| description | Summary Objective To assess the frequency of severe liver toxicity in HIV/hepatitis C (HCV)-coinfected patients with advanced liver fibrosis receiving efavirenz (EFV)-based antiretroviral combinations. Methods One hundred and eighty-nine previously antiretroviral naïve, HIV/HCV-coinfected patients, who started a regimen including two nucleoside analogues plus EFV, and in whom the presence or absence of advanced liver fibrosis could be established, were retrospectively analyzed. Liver fibrosis was evaluated according to a stepwise algorithm including liver biopsy, transient elastography and FIB-4 index. Results Fifty-six patients had advanced fibrosis – 25 with cirrhosis – and 133 did not. Three (5.4%) subjects with and 9 (6.8%) ( p = 0.717) without advanced fibrosis developed grade 3–4 transaminase elevation (TE). Grade 4 total bilirubin elevation was seen in 5 (8.9%) patients with advanced fibrosis and in 1 (0.8%) without it ( p = 0.003). Liver events led to EFV discontinuation in 10 (5.3%) patients, 6 (10.7%) with and 4 (3%) without advanced fibrosis ( p = 0.031). Conclusions The hepatic tolerability of EFV was good in HIV/HCV-coinfected patients with advanced liver fibrosis. The frequency of grade 3–4 TE was similar to that observed in patients without advanced fibrosis, there was no death attributable to liver failure caused by drug toxicity and the rate of EFV discontinuations due to liver events was low. |
| doi_str_mv | 10.1016/j.jinf.2011.10.016 |
| format | Article |
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Methods One hundred and eighty-nine previously antiretroviral naïve, HIV/HCV-coinfected patients, who started a regimen including two nucleoside analogues plus EFV, and in whom the presence or absence of advanced liver fibrosis could be established, were retrospectively analyzed. Liver fibrosis was evaluated according to a stepwise algorithm including liver biopsy, transient elastography and FIB-4 index. Results Fifty-six patients had advanced fibrosis – 25 with cirrhosis – and 133 did not. Three (5.4%) subjects with and 9 (6.8%) ( p = 0.717) without advanced fibrosis developed grade 3–4 transaminase elevation (TE). Grade 4 total bilirubin elevation was seen in 5 (8.9%) patients with advanced fibrosis and in 1 (0.8%) without it ( p = 0.003). Liver events led to EFV discontinuation in 10 (5.3%) patients, 6 (10.7%) with and 4 (3%) without advanced fibrosis ( p = 0.031). Conclusions The hepatic tolerability of EFV was good in HIV/HCV-coinfected patients with advanced liver fibrosis. The frequency of grade 3–4 TE was similar to that observed in patients without advanced fibrosis, there was no death attributable to liver failure caused by drug toxicity and the rate of EFV discontinuations due to liver events was low.</description><identifier>ISSN: 0163-4453</identifier><identifier>EISSN: 1532-2742</identifier><identifier>DOI: 10.1016/j.jinf.2011.10.016</identifier><identifier>PMID: 22138553</identifier><identifier>CODEN: JINFD2</identifier><language>eng</language><publisher>Amsterdam: Elsevier Ltd</publisher><subject>Adult ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - therapeutic use ; Benzoxazines - adverse effects ; Benzoxazines - therapeutic use ; Biological and medical sciences ; Cirrhosis ; Coinfection ; Efavirenz ; Female ; General aspects ; Hepatitis C ; Hepatitis C - complications ; HIV ; HIV Infections - complications ; HIV Infections - drug therapy ; Human viral diseases ; Humans ; Infectious Disease ; Infectious diseases ; Liver - drug effects ; Liver - pathology ; Liver - virology ; Liver Cirrhosis - complications ; Liver Cirrhosis - pathology ; Liver fibrosis ; Male ; Medical sciences ; Middle Aged ; Transaminase elevations ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Viral hepatitis</subject><ispartof>The Journal of infection, 2012-02, Vol.64 (2), p.204-211</ispartof><rights>The British Infection Association</rights><rights>2011 The British Infection Association</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 The British Infection Association. Published by Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c472t-fa356b2d9bb8c104a7a6a5f101f5b75404523d8af18c1bd7b052bee38472b3783</citedby><cites>FETCH-LOGICAL-c472t-fa356b2d9bb8c104a7a6a5f101f5b75404523d8af18c1bd7b052bee38472b3783</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jinf.2011.10.016$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,45974</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25433611$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22138553$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pineda, Juan A</creatorcontrib><creatorcontrib>Neukam, Karin</creatorcontrib><creatorcontrib>Mallolas, Josep</creatorcontrib><creatorcontrib>López-Cortés, Luis F</creatorcontrib><creatorcontrib>Cartón, José A</creatorcontrib><creatorcontrib>Domingo, Pere</creatorcontrib><creatorcontrib>Moreno, Santiago</creatorcontrib><creatorcontrib>Iribarren, José A</creatorcontrib><creatorcontrib>Clotet, Bonaventura</creatorcontrib><creatorcontrib>Crespo, Manuel</creatorcontrib><creatorcontrib>de Los Santos, Ignacio</creatorcontrib><creatorcontrib>Ortega, Enrique</creatorcontrib><creatorcontrib>Knobel, Hernando</creatorcontrib><creatorcontrib>Jiménez-Expósito, María J</creatorcontrib><creatorcontrib>Macías, Juan</creatorcontrib><title>Hepatic safety of efavirenz in HIV/hepatitis C virus-coinfected patients with advanced liver fibrosis</title><title>The Journal of infection</title><addtitle>J Infect</addtitle><description>Summary Objective To assess the frequency of severe liver toxicity in HIV/hepatitis C (HCV)-coinfected patients with advanced liver fibrosis receiving efavirenz (EFV)-based antiretroviral combinations. Methods One hundred and eighty-nine previously antiretroviral naïve, HIV/HCV-coinfected patients, who started a regimen including two nucleoside analogues plus EFV, and in whom the presence or absence of advanced liver fibrosis could be established, were retrospectively analyzed. Liver fibrosis was evaluated according to a stepwise algorithm including liver biopsy, transient elastography and FIB-4 index. Results Fifty-six patients had advanced fibrosis – 25 with cirrhosis – and 133 did not. Three (5.4%) subjects with and 9 (6.8%) ( p = 0.717) without advanced fibrosis developed grade 3–4 transaminase elevation (TE). Grade 4 total bilirubin elevation was seen in 5 (8.9%) patients with advanced fibrosis and in 1 (0.8%) without it ( p = 0.003). Liver events led to EFV discontinuation in 10 (5.3%) patients, 6 (10.7%) with and 4 (3%) without advanced fibrosis ( p = 0.031). Conclusions The hepatic tolerability of EFV was good in HIV/HCV-coinfected patients with advanced liver fibrosis. The frequency of grade 3–4 TE was similar to that observed in patients without advanced fibrosis, there was no death attributable to liver failure caused by drug toxicity and the rate of EFV discontinuations due to liver events was low.</description><subject>Adult</subject><subject>Anti-HIV Agents - adverse effects</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Benzoxazines - adverse effects</subject><subject>Benzoxazines - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Cirrhosis</subject><subject>Coinfection</subject><subject>Efavirenz</subject><subject>Female</subject><subject>General aspects</subject><subject>Hepatitis C</subject><subject>Hepatitis C - complications</subject><subject>HIV</subject><subject>HIV Infections - complications</subject><subject>HIV Infections - drug therapy</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious Disease</subject><subject>Infectious diseases</subject><subject>Liver - drug effects</subject><subject>Liver - pathology</subject><subject>Liver - virology</subject><subject>Liver Cirrhosis - complications</subject><subject>Liver Cirrhosis - pathology</subject><subject>Liver fibrosis</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Transaminase elevations</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Viral hepatitis</subject><issn>0163-4453</issn><issn>1532-2742</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kk2P0zAQhi3Eii2FP8AB-YI4pevPJJUQ0qoCutJKe9iFq2U7Y61DmhQ7KSq_ngktIHHgZOmdZ8bjRybkFWcrznh51a7a2IeVYJxjsMLoCVlwLUUhKiWekgUmslBKy0vyPOeWMbaW6_IZuRSCy1pruSCwhb0do6fZBhiPdAgUgj3EBP0PGnu6vfly9fgLGWOmG4qVKRd-wIvBj9DQuQT9mOn3OD5S2xxs7zHu4gESDdGlIcf8glwE22V4eT6X5PPHDw-bbXF79-lmc31beFWJsQhW6tKJZu1c7TlTtrKl1QEfG7SrtGJKC9nUNnAsu6ZyTAsHIGvsdrKq5ZK8Pc3dp-HbBHk0u5g9dJ3tYZiyWWtVKimYQFKcSI8L5gTB7FPc2XQ0nJnZrmnNbNfMdudsdrkkr8_jJ7eD5k_Lb50IvDkDNnvbhYQyYv7LaSVlyTly704coIxDhGSyR4soDsX70TRD_P8e7_9p913sI974FY6Q22FKPWo23GRhmLmfe-ZvwDljumRS_gRL7K1Y</recordid><startdate>20120201</startdate><enddate>20120201</enddate><creator>Pineda, Juan A</creator><creator>Neukam, Karin</creator><creator>Mallolas, Josep</creator><creator>López-Cortés, Luis F</creator><creator>Cartón, José A</creator><creator>Domingo, Pere</creator><creator>Moreno, Santiago</creator><creator>Iribarren, José A</creator><creator>Clotet, Bonaventura</creator><creator>Crespo, Manuel</creator><creator>de Los Santos, Ignacio</creator><creator>Ortega, Enrique</creator><creator>Knobel, Hernando</creator><creator>Jiménez-Expósito, María J</creator><creator>Macías, Juan</creator><general>Elsevier Ltd</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>7T2</scope><scope>7U2</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope></search><sort><creationdate>20120201</creationdate><title>Hepatic safety of efavirenz in HIV/hepatitis C virus-coinfected patients with advanced liver fibrosis</title><author>Pineda, Juan A ; Neukam, Karin ; Mallolas, Josep ; López-Cortés, Luis F ; Cartón, José A ; Domingo, Pere ; Moreno, Santiago ; Iribarren, José A ; Clotet, Bonaventura ; Crespo, Manuel ; de Los Santos, Ignacio ; Ortega, Enrique ; Knobel, Hernando ; Jiménez-Expósito, María J ; Macías, Juan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c472t-fa356b2d9bb8c104a7a6a5f101f5b75404523d8af18c1bd7b052bee38472b3783</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adult</topic><topic>Anti-HIV Agents - adverse effects</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Benzoxazines - adverse effects</topic><topic>Benzoxazines - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Cirrhosis</topic><topic>Coinfection</topic><topic>Efavirenz</topic><topic>Female</topic><topic>General aspects</topic><topic>Hepatitis C</topic><topic>Hepatitis C - complications</topic><topic>HIV</topic><topic>HIV Infections - complications</topic><topic>HIV Infections - drug therapy</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious Disease</topic><topic>Infectious diseases</topic><topic>Liver - drug effects</topic><topic>Liver - pathology</topic><topic>Liver - virology</topic><topic>Liver Cirrhosis - complications</topic><topic>Liver Cirrhosis - pathology</topic><topic>Liver fibrosis</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Transaminase elevations</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><topic>Viral hepatitis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pineda, Juan A</creatorcontrib><creatorcontrib>Neukam, Karin</creatorcontrib><creatorcontrib>Mallolas, Josep</creatorcontrib><creatorcontrib>López-Cortés, Luis F</creatorcontrib><creatorcontrib>Cartón, José A</creatorcontrib><creatorcontrib>Domingo, Pere</creatorcontrib><creatorcontrib>Moreno, Santiago</creatorcontrib><creatorcontrib>Iribarren, José A</creatorcontrib><creatorcontrib>Clotet, Bonaventura</creatorcontrib><creatorcontrib>Crespo, Manuel</creatorcontrib><creatorcontrib>de Los Santos, Ignacio</creatorcontrib><creatorcontrib>Ortega, Enrique</creatorcontrib><creatorcontrib>Knobel, Hernando</creatorcontrib><creatorcontrib>Jiménez-Expósito, María J</creatorcontrib><creatorcontrib>Macías, Juan</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>Health and Safety Science Abstracts (Full archive)</collection><collection>Safety Science and Risk</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>The Journal of infection</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pineda, Juan A</au><au>Neukam, Karin</au><au>Mallolas, Josep</au><au>López-Cortés, Luis F</au><au>Cartón, José A</au><au>Domingo, Pere</au><au>Moreno, Santiago</au><au>Iribarren, José A</au><au>Clotet, Bonaventura</au><au>Crespo, Manuel</au><au>de Los Santos, Ignacio</au><au>Ortega, Enrique</au><au>Knobel, Hernando</au><au>Jiménez-Expósito, María J</au><au>Macías, Juan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Hepatic safety of efavirenz in HIV/hepatitis C virus-coinfected patients with advanced liver fibrosis</atitle><jtitle>The Journal of infection</jtitle><addtitle>J Infect</addtitle><date>2012-02-01</date><risdate>2012</risdate><volume>64</volume><issue>2</issue><spage>204</spage><epage>211</epage><pages>204-211</pages><issn>0163-4453</issn><eissn>1532-2742</eissn><coden>JINFD2</coden><abstract>Summary Objective To assess the frequency of severe liver toxicity in HIV/hepatitis C (HCV)-coinfected patients with advanced liver fibrosis receiving efavirenz (EFV)-based antiretroviral combinations. Methods One hundred and eighty-nine previously antiretroviral naïve, HIV/HCV-coinfected patients, who started a regimen including two nucleoside analogues plus EFV, and in whom the presence or absence of advanced liver fibrosis could be established, were retrospectively analyzed. Liver fibrosis was evaluated according to a stepwise algorithm including liver biopsy, transient elastography and FIB-4 index. Results Fifty-six patients had advanced fibrosis – 25 with cirrhosis – and 133 did not. Three (5.4%) subjects with and 9 (6.8%) ( p = 0.717) without advanced fibrosis developed grade 3–4 transaminase elevation (TE). Grade 4 total bilirubin elevation was seen in 5 (8.9%) patients with advanced fibrosis and in 1 (0.8%) without it ( p = 0.003). Liver events led to EFV discontinuation in 10 (5.3%) patients, 6 (10.7%) with and 4 (3%) without advanced fibrosis ( p = 0.031). Conclusions The hepatic tolerability of EFV was good in HIV/HCV-coinfected patients with advanced liver fibrosis. The frequency of grade 3–4 TE was similar to that observed in patients without advanced fibrosis, there was no death attributable to liver failure caused by drug toxicity and the rate of EFV discontinuations due to liver events was low.</abstract><cop>Amsterdam</cop><pub>Elsevier Ltd</pub><pmid>22138553</pmid><doi>10.1016/j.jinf.2011.10.016</doi><tpages>8</tpages></addata></record> |
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| subjects | Adult Anti-HIV Agents - adverse effects Anti-HIV Agents - therapeutic use Benzoxazines - adverse effects Benzoxazines - therapeutic use Biological and medical sciences Cirrhosis Coinfection Efavirenz Female General aspects Hepatitis C Hepatitis C - complications HIV HIV Infections - complications HIV Infections - drug therapy Human viral diseases Humans Infectious Disease Infectious diseases Liver - drug effects Liver - pathology Liver - virology Liver Cirrhosis - complications Liver Cirrhosis - pathology Liver fibrosis Male Medical sciences Middle Aged Transaminase elevations Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Viral hepatitis |
| title | Hepatic safety of efavirenz in HIV/hepatitis C virus-coinfected patients with advanced liver fibrosis |
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