Evaluating the renal safety of tenofovir disoproxil fumarate in hepatitis B patients without chronic kidney disease
The nephrotoxicity of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB) patients without chronic kidney disease (CKD) remains controversial. We aimed to evaluate nephrotoxicity of TDF in this population. In this hospital‐based cohort study, CHB patients who received either TDF or ente...
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| Veröffentlicht in: | Journal of viral hepatitis 2021-11, Vol.28 (11), p.1579-1586 |
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| creator | Tsai, Hsin‐Ju Chuang, Ya‐Wen Yang, Sheng‐Shun Chang, Yan‐Zin Chang, Horng‐Rong Lee, Teng‐Yu |
| description | The nephrotoxicity of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB) patients without chronic kidney disease (CKD) remains controversial. We aimed to evaluate nephrotoxicity of TDF in this population. In this hospital‐based cohort study, CHB patients who received either TDF or entecavir (ETV) therapy, and did not have underlying CKD, were retrospectively recruited from January, 2008 to January, 2019. After excluding those with confounding conditions, 257 TDF‐treated patients were matched through propensity scores with 514 ETV‐treated patients. Cumulative incidences of, and hazard ratios (HRs) for the CKD guideline‐defined renal dysfunction, were analysed. The mean decline in glomerular filtration rate was similar over 60 months (TDF vs. ETV: 10.1 ml/min/1.73 m2, 95% confidence interval [CI]: 7.4–12.7 vs. 8.0 ml/min/1.73 m2, 95% CI: 6.4–9.6; p = .34). The 5‐year cumulative incidence of renal dysfunction was not significantly different (TDF vs. ETV: 10.4%, 95% CI: 5.6–18.0 vs. 5.8%, 95% CI: 3.6–9.0; p = .18). However, in multivariable stratified analysis, TDF was associated with an increased risk of renal dysfunction in the elderly (age ≥60 years), when compared to ETV (HR 2.86, 95% CI: 1.02–8.01; p |
| doi_str_mv | 10.1111/jvh.13603 |
| format | Article |
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We aimed to evaluate nephrotoxicity of TDF in this population. In this hospital‐based cohort study, CHB patients who received either TDF or entecavir (ETV) therapy, and did not have underlying CKD, were retrospectively recruited from January, 2008 to January, 2019. After excluding those with confounding conditions, 257 TDF‐treated patients were matched through propensity scores with 514 ETV‐treated patients. Cumulative incidences of, and hazard ratios (HRs) for the CKD guideline‐defined renal dysfunction, were analysed. The mean decline in glomerular filtration rate was similar over 60 months (TDF vs. ETV: 10.1 ml/min/1.73 m2, 95% confidence interval [CI]: 7.4–12.7 vs. 8.0 ml/min/1.73 m2, 95% CI: 6.4–9.6; p = .34). The 5‐year cumulative incidence of renal dysfunction was not significantly different (TDF vs. ETV: 10.4%, 95% CI: 5.6–18.0 vs. 5.8%, 95% CI: 3.6–9.0; p = .18). However, in multivariable stratified analysis, TDF was associated with an increased risk of renal dysfunction in the elderly (age ≥60 years), when compared to ETV (HR 2.86, 95% CI: 1.02–8.01; p < .05). For confirming the effect of TDF amongst the elderly, 61 TDF‐treated patients were further matched with 183 ETV‐treated patients, with 5‐year cumulative incidence of renal dysfunction being significantly higher in TDF users (TDF vs. ETV: 34.4%, 95% CI: 17.7–59.8 vs. 15.5%, 95% CI: 9.4–25.1; p < .05). TDF use was independently related to renal dysfunction (HR 2.71, 95% CI: 1.19–6.14; p < .05). Although TDF is generally safe for CHB patients without CKD, it is best to be avoided in the elderly.</description><identifier>ISSN: 1352-0504</identifier><identifier>EISSN: 1365-2893</identifier><identifier>DOI: 10.1111/jvh.13603</identifier><identifier>PMID: 34464999</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Aged ; ageing ; Antiretroviral drugs ; Antiviral Agents - adverse effects ; Cohort Studies ; entecavir ; Glomerular filtration rate ; Hepatitis ; Hepatitis B ; Hepatitis B - drug therapy ; Hepatitis B virus ; Hepatitis B, Chronic - complications ; Hepatitis B, Chronic - drug therapy ; Humans ; Kidney diseases ; Middle Aged ; Patients ; renal dysfunction ; Renal function ; Renal Insufficiency, Chronic - complications ; Renal Insufficiency, Chronic - epidemiology ; Retrospective Studies ; Tenofovir ; Tenofovir - adverse effects ; Treatment Outcome</subject><ispartof>Journal of viral hepatitis, 2021-11, Vol.28 (11), p.1579-1586</ispartof><rights>2021 John Wiley & Sons Ltd</rights><rights>2021 John Wiley & Sons Ltd.</rights><rights>Copyright © 2021 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3533-e0dc60bedbbd5deef7f7d4ca72427313345b663fa98d4c5a61d30fa7408fe85d3</citedby><cites>FETCH-LOGICAL-c3533-e0dc60bedbbd5deef7f7d4ca72427313345b663fa98d4c5a61d30fa7408fe85d3</cites><orcidid>0000-0002-4097-4315 ; 0000-0002-6640-1339 ; 0000-0002-0535-7960</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjvh.13603$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjvh.13603$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34464999$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tsai, Hsin‐Ju</creatorcontrib><creatorcontrib>Chuang, Ya‐Wen</creatorcontrib><creatorcontrib>Yang, Sheng‐Shun</creatorcontrib><creatorcontrib>Chang, Yan‐Zin</creatorcontrib><creatorcontrib>Chang, Horng‐Rong</creatorcontrib><creatorcontrib>Lee, Teng‐Yu</creatorcontrib><title>Evaluating the renal safety of tenofovir disoproxil fumarate in hepatitis B patients without chronic kidney disease</title><title>Journal of viral hepatitis</title><addtitle>J Viral Hepat</addtitle><description>The nephrotoxicity of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB) patients without chronic kidney disease (CKD) remains controversial. We aimed to evaluate nephrotoxicity of TDF in this population. In this hospital‐based cohort study, CHB patients who received either TDF or entecavir (ETV) therapy, and did not have underlying CKD, were retrospectively recruited from January, 2008 to January, 2019. After excluding those with confounding conditions, 257 TDF‐treated patients were matched through propensity scores with 514 ETV‐treated patients. Cumulative incidences of, and hazard ratios (HRs) for the CKD guideline‐defined renal dysfunction, were analysed. The mean decline in glomerular filtration rate was similar over 60 months (TDF vs. ETV: 10.1 ml/min/1.73 m2, 95% confidence interval [CI]: 7.4–12.7 vs. 8.0 ml/min/1.73 m2, 95% CI: 6.4–9.6; p = .34). The 5‐year cumulative incidence of renal dysfunction was not significantly different (TDF vs. ETV: 10.4%, 95% CI: 5.6–18.0 vs. 5.8%, 95% CI: 3.6–9.0; p = .18). However, in multivariable stratified analysis, TDF was associated with an increased risk of renal dysfunction in the elderly (age ≥60 years), when compared to ETV (HR 2.86, 95% CI: 1.02–8.01; p < .05). For confirming the effect of TDF amongst the elderly, 61 TDF‐treated patients were further matched with 183 ETV‐treated patients, with 5‐year cumulative incidence of renal dysfunction being significantly higher in TDF users (TDF vs. ETV: 34.4%, 95% CI: 17.7–59.8 vs. 15.5%, 95% CI: 9.4–25.1; p < .05). TDF use was independently related to renal dysfunction (HR 2.71, 95% CI: 1.19–6.14; p < .05). Although TDF is generally safe for CHB patients without CKD, it is best to be avoided in the elderly.</description><subject>Aged</subject><subject>ageing</subject><subject>Antiretroviral drugs</subject><subject>Antiviral Agents - adverse effects</subject><subject>Cohort Studies</subject><subject>entecavir</subject><subject>Glomerular filtration rate</subject><subject>Hepatitis</subject><subject>Hepatitis B</subject><subject>Hepatitis B - drug therapy</subject><subject>Hepatitis B virus</subject><subject>Hepatitis B, Chronic - complications</subject><subject>Hepatitis B, Chronic - drug therapy</subject><subject>Humans</subject><subject>Kidney diseases</subject><subject>Middle Aged</subject><subject>Patients</subject><subject>renal dysfunction</subject><subject>Renal function</subject><subject>Renal Insufficiency, Chronic - complications</subject><subject>Renal Insufficiency, Chronic - epidemiology</subject><subject>Retrospective Studies</subject><subject>Tenofovir</subject><subject>Tenofovir - adverse effects</subject><subject>Treatment Outcome</subject><issn>1352-0504</issn><issn>1365-2893</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kD1PwzAQhi0EglIY-APIEhNDwI7tfIxQlS9VYgHWyInPxCXExXZa-u9xKbBxy52s5175HoROKLmgsS7ny_aCsoywHTSKXSRpUbLdzSzShAjCD9Ch93NCKEsF3UcHjPOMl2U5Qn66lN0gg-lfcWgBO-hlh73UENbYahygt9oujcPKeLtw9tN0WA_v0skA2PS4hUXcDsbja7yZoA8er0xo7RBw0zrbmwa_GdXDehMB0sMR2tOy83D808fo-Wb6NLlLZo-395OrWdIwwVgCRDUZqUHVtRIKQOc6V7yRecrTnFHGuKizjGlZFvFZyIwqRrTMOSk0FEKxMTrb5sZvfwzgQzW3g4v3-SoVRcoZp9HZGJ1vqcZZ7x3oauFMvG9dUVJt9FZRb_WtN7KnP4lD_Q7qj_z1GYHLLbAyHaz_T6oeXu62kV8ezobI</recordid><startdate>202111</startdate><enddate>202111</enddate><creator>Tsai, Hsin‐Ju</creator><creator>Chuang, Ya‐Wen</creator><creator>Yang, Sheng‐Shun</creator><creator>Chang, Yan‐Zin</creator><creator>Chang, Horng‐Rong</creator><creator>Lee, Teng‐Yu</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>7U9</scope><scope>H94</scope><scope>K9.</scope><orcidid>https://orcid.org/0000-0002-4097-4315</orcidid><orcidid>https://orcid.org/0000-0002-6640-1339</orcidid><orcidid>https://orcid.org/0000-0002-0535-7960</orcidid></search><sort><creationdate>202111</creationdate><title>Evaluating the renal safety of tenofovir disoproxil fumarate in hepatitis B patients without chronic kidney disease</title><author>Tsai, Hsin‐Ju ; Chuang, Ya‐Wen ; Yang, Sheng‐Shun ; Chang, Yan‐Zin ; Chang, Horng‐Rong ; Lee, Teng‐Yu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3533-e0dc60bedbbd5deef7f7d4ca72427313345b663fa98d4c5a61d30fa7408fe85d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Aged</topic><topic>ageing</topic><topic>Antiretroviral drugs</topic><topic>Antiviral Agents - adverse effects</topic><topic>Cohort Studies</topic><topic>entecavir</topic><topic>Glomerular filtration rate</topic><topic>Hepatitis</topic><topic>Hepatitis B</topic><topic>Hepatitis B - drug therapy</topic><topic>Hepatitis B virus</topic><topic>Hepatitis B, Chronic - complications</topic><topic>Hepatitis B, Chronic - drug therapy</topic><topic>Humans</topic><topic>Kidney diseases</topic><topic>Middle Aged</topic><topic>Patients</topic><topic>renal dysfunction</topic><topic>Renal function</topic><topic>Renal Insufficiency, Chronic - complications</topic><topic>Renal Insufficiency, Chronic - epidemiology</topic><topic>Retrospective Studies</topic><topic>Tenofovir</topic><topic>Tenofovir - adverse effects</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tsai, Hsin‐Ju</creatorcontrib><creatorcontrib>Chuang, Ya‐Wen</creatorcontrib><creatorcontrib>Yang, Sheng‐Shun</creatorcontrib><creatorcontrib>Chang, Yan‐Zin</creatorcontrib><creatorcontrib>Chang, Horng‐Rong</creatorcontrib><creatorcontrib>Lee, Teng‐Yu</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>Journal of viral hepatitis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tsai, Hsin‐Ju</au><au>Chuang, Ya‐Wen</au><au>Yang, Sheng‐Shun</au><au>Chang, Yan‐Zin</au><au>Chang, Horng‐Rong</au><au>Lee, Teng‐Yu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluating the renal safety of tenofovir disoproxil fumarate in hepatitis B patients without chronic kidney disease</atitle><jtitle>Journal of viral hepatitis</jtitle><addtitle>J Viral Hepat</addtitle><date>2021-11</date><risdate>2021</risdate><volume>28</volume><issue>11</issue><spage>1579</spage><epage>1586</epage><pages>1579-1586</pages><issn>1352-0504</issn><eissn>1365-2893</eissn><abstract>The nephrotoxicity of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB) patients without chronic kidney disease (CKD) remains controversial. We aimed to evaluate nephrotoxicity of TDF in this population. In this hospital‐based cohort study, CHB patients who received either TDF or entecavir (ETV) therapy, and did not have underlying CKD, were retrospectively recruited from January, 2008 to January, 2019. After excluding those with confounding conditions, 257 TDF‐treated patients were matched through propensity scores with 514 ETV‐treated patients. Cumulative incidences of, and hazard ratios (HRs) for the CKD guideline‐defined renal dysfunction, were analysed. The mean decline in glomerular filtration rate was similar over 60 months (TDF vs. ETV: 10.1 ml/min/1.73 m2, 95% confidence interval [CI]: 7.4–12.7 vs. 8.0 ml/min/1.73 m2, 95% CI: 6.4–9.6; p = .34). The 5‐year cumulative incidence of renal dysfunction was not significantly different (TDF vs. ETV: 10.4%, 95% CI: 5.6–18.0 vs. 5.8%, 95% CI: 3.6–9.0; p = .18). However, in multivariable stratified analysis, TDF was associated with an increased risk of renal dysfunction in the elderly (age ≥60 years), when compared to ETV (HR 2.86, 95% CI: 1.02–8.01; p < .05). For confirming the effect of TDF amongst the elderly, 61 TDF‐treated patients were further matched with 183 ETV‐treated patients, with 5‐year cumulative incidence of renal dysfunction being significantly higher in TDF users (TDF vs. ETV: 34.4%, 95% CI: 17.7–59.8 vs. 15.5%, 95% CI: 9.4–25.1; p < .05). TDF use was independently related to renal dysfunction (HR 2.71, 95% CI: 1.19–6.14; p < .05). Although TDF is generally safe for CHB patients without CKD, it is best to be avoided in the elderly.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>34464999</pmid><doi>10.1111/jvh.13603</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-4097-4315</orcidid><orcidid>https://orcid.org/0000-0002-6640-1339</orcidid><orcidid>https://orcid.org/0000-0002-0535-7960</orcidid></addata></record> |
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| subjects | Aged ageing Antiretroviral drugs Antiviral Agents - adverse effects Cohort Studies entecavir Glomerular filtration rate Hepatitis Hepatitis B Hepatitis B - drug therapy Hepatitis B virus Hepatitis B, Chronic - complications Hepatitis B, Chronic - drug therapy Humans Kidney diseases Middle Aged Patients renal dysfunction Renal function Renal Insufficiency, Chronic - complications Renal Insufficiency, Chronic - epidemiology Retrospective Studies Tenofovir Tenofovir - adverse effects Treatment Outcome |
| title | Evaluating the renal safety of tenofovir disoproxil fumarate in hepatitis B patients without chronic kidney disease |
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