Tenofovir‐based combination therapy or monotherapy for multidrug‐resistant chronic hepatitis B: Long‐term data from a multicenter cohort study
The treatment of multidrug‐resistant (MDR) chronic hepatitis B (CHB) is challenging. Herein, we report a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)‐based therapy for MDR CHB in a real‐life setting. The inclusion criteria comprised patients with res...
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creator | Yim, Hyung Joon Suh, Sang Jun Jung, Young Kul Hwang, Seong Gyu Seo, Yeon Seok Um, Soon Ho Lee, Sae Hwan Kim, Young Seok Jang, Jae Young Kim, In Hee Kim, Hyoung Su Kim, Ji Hoon Lee, Young Sun Yoon, Eileen L. Song, Myeong Jun Park, Jun Yong |
description | The treatment of multidrug‐resistant (MDR) chronic hepatitis B (CHB) is challenging. Herein, we report a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)‐based therapy for MDR CHB in a real‐life setting. The inclusion criteria comprised patients with resistance to more than two nucleos(t)ide analogue (NA) classes and hepatitis B virus (HBV) DNA level of ≥200 IU/mL. The primary end‐point was virologic response (VR), defined as undetectable HBV DNA ( |
doi_str_mv | 10.1111/jvh.13363 |
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Herein, we report a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)‐based therapy for MDR CHB in a real‐life setting. The inclusion criteria comprised patients with resistance to more than two nucleos(t)ide analogue (NA) classes and hepatitis B virus (HBV) DNA level of ≥200 IU/mL. The primary end‐point was virologic response (VR), defined as undetectable HBV DNA (<20 IU/mL) after 60 months. A total of 236 patients met the inclusion criteria. The mean HBV DNA level was 4.16 ± 1.44 log IU/mL; 26.7% of patients had liver cirrhosis. Before the initiation of TDF, 33.5%, 44.9% and 21.6% of patients had mutations resistant to L‐NA + adefovir, L‐NA + entecavir (ETV) and L‐NA + adefovir + ETV, respectively. A total of 184 patients received TDF‐based combination therapy [TDF + ETV (n = 178) or TDF + L‐NA (n = 6)], and 52 patients received TDF monotherapy. In the entire cohort, the VR rates were 77.2%, 89.9% and 92.2% at 12, 36 and 60 months, respectively. The VR rates were not significantly different between the combination therapy and the monotherapy group after 12 (76.2% vs 80.4%, P = .533), 36 (89.8% vs 90.3%, P = 1.000) or 60 (92.9% vs 87.5%, P = .499) months. Also, there was no significant difference in the cumulative VR rates for 5 years between the treatment groups (P = .910). Newly developed antiviral resistance was not observed. TDF‐based therapy was effective for the treatment of MDR CHB. The efficacy of TDF monotherapy was not different from that of the TDF‐based combination therapy.</description><identifier>ISSN: 1352-0504</identifier><identifier>EISSN: 1365-2893</identifier><identifier>DOI: 10.1111/jvh.13363</identifier><identifier>PMID: 32706461</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Adefovir ; Antiretroviral drugs ; chronic hepatitis B ; Cirrhosis ; Cohort analysis ; Combination therapy ; Deoxyribonucleic acid ; DNA ; Drug resistance ; Hepatitis B ; Interferon ; Liver cirrhosis ; multidrug resistance ; Multidrug resistant organisms ; Tenofovir ; therapy</subject><ispartof>Journal of viral hepatitis, 2020-12, Vol.27 (12), p.1306-1318</ispartof><rights>2020 John Wiley & Sons Ltd</rights><rights>2020 John Wiley & Sons Ltd.</rights><rights>Copyright © 2020 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3133-e0c0ce37490b28e234fdb749d47cca1441277303124b262e668795f0965ea5cf3</cites><orcidid>0000-0002-6036-2754 ; 0000-0001-6324-2224</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.13363$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjvh.13363$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32706461$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yim, Hyung Joon</creatorcontrib><creatorcontrib>Suh, Sang Jun</creatorcontrib><creatorcontrib>Jung, Young Kul</creatorcontrib><creatorcontrib>Hwang, Seong Gyu</creatorcontrib><creatorcontrib>Seo, Yeon Seok</creatorcontrib><creatorcontrib>Um, Soon Ho</creatorcontrib><creatorcontrib>Lee, Sae Hwan</creatorcontrib><creatorcontrib>Kim, Young Seok</creatorcontrib><creatorcontrib>Jang, Jae Young</creatorcontrib><creatorcontrib>Kim, In Hee</creatorcontrib><creatorcontrib>Kim, Hyoung Su</creatorcontrib><creatorcontrib>Kim, Ji Hoon</creatorcontrib><creatorcontrib>Lee, Young Sun</creatorcontrib><creatorcontrib>Yoon, Eileen L.</creatorcontrib><creatorcontrib>Song, Myeong Jun</creatorcontrib><creatorcontrib>Park, Jun Yong</creatorcontrib><title>Tenofovir‐based combination therapy or monotherapy for multidrug‐resistant chronic hepatitis B: Long‐term data from a multicenter cohort study</title><title>Journal of viral hepatitis</title><addtitle>J Viral Hepat</addtitle><description>The treatment of multidrug‐resistant (MDR) chronic hepatitis B (CHB) is challenging. Herein, we report a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)‐based therapy for MDR CHB in a real‐life setting. The inclusion criteria comprised patients with resistance to more than two nucleos(t)ide analogue (NA) classes and hepatitis B virus (HBV) DNA level of ≥200 IU/mL. The primary end‐point was virologic response (VR), defined as undetectable HBV DNA (<20 IU/mL) after 60 months. A total of 236 patients met the inclusion criteria. The mean HBV DNA level was 4.16 ± 1.44 log IU/mL; 26.7% of patients had liver cirrhosis. Before the initiation of TDF, 33.5%, 44.9% and 21.6% of patients had mutations resistant to L‐NA + adefovir, L‐NA + entecavir (ETV) and L‐NA + adefovir + ETV, respectively. A total of 184 patients received TDF‐based combination therapy [TDF + ETV (n = 178) or TDF + L‐NA (n = 6)], and 52 patients received TDF monotherapy. In the entire cohort, the VR rates were 77.2%, 89.9% and 92.2% at 12, 36 and 60 months, respectively. The VR rates were not significantly different between the combination therapy and the monotherapy group after 12 (76.2% vs 80.4%, P = .533), 36 (89.8% vs 90.3%, P = 1.000) or 60 (92.9% vs 87.5%, P = .499) months. Also, there was no significant difference in the cumulative VR rates for 5 years between the treatment groups (P = .910). Newly developed antiviral resistance was not observed. TDF‐based therapy was effective for the treatment of MDR CHB. The efficacy of TDF monotherapy was not different from that of the TDF‐based combination therapy.</description><subject>Adefovir</subject><subject>Antiretroviral drugs</subject><subject>chronic hepatitis B</subject><subject>Cirrhosis</subject><subject>Cohort analysis</subject><subject>Combination therapy</subject><subject>Deoxyribonucleic acid</subject><subject>DNA</subject><subject>Drug resistance</subject><subject>Hepatitis B</subject><subject>Interferon</subject><subject>Liver cirrhosis</subject><subject>multidrug resistance</subject><subject>Multidrug resistant organisms</subject><subject>Tenofovir</subject><subject>therapy</subject><issn>1352-0504</issn><issn>1365-2893</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp1kc1u1DAURi1ERUthwQsgS2xgkdb_nrArVaGtRmJT2EaOc0M8SuzBdopmxyN0wRPyJHhIy6IS3thXPvdcWx9Cryg5oWWdbm6HE8q54k_QEeVKVmxV86f7s2QVkUQcoucpbQihnEn6DB1ypokSih6hXzfgQx9uXfz98641CTpsw9Q6b7ILHucBotnucIh4Cj48lP2-nsfsujh_K40RkkvZ-IztEIN3Fg-wLYbsEv7wHq-D31MZ4oQ7kw3uY5iwWRQWfLkoU4cQM0557nYv0EFvxgQv7_dj9OXjxc35ZbX-_Onq_GxdWV6-WwGxxALXoiYtWwHjou_aUnVCW2uoEJRpzQmnTLRMMVBqpWvZk1pJMNL2_Bi9XbzbGL7PkHIzuWRhHI2HMKeGCVb6tax1Qd88Qjdhjr68rlBSqZppyQr1bqFsDClF6JttdJOJu4aSZh9VU6Jq_kZV2Nf3xrmdoPtHPmRTgNMF-OFG2P3f1Fx_vVyUfwAYeKJw</recordid><startdate>202012</startdate><enddate>202012</enddate><creator>Yim, Hyung Joon</creator><creator>Suh, Sang Jun</creator><creator>Jung, Young Kul</creator><creator>Hwang, Seong Gyu</creator><creator>Seo, Yeon Seok</creator><creator>Um, Soon Ho</creator><creator>Lee, Sae Hwan</creator><creator>Kim, Young Seok</creator><creator>Jang, Jae Young</creator><creator>Kim, In Hee</creator><creator>Kim, Hyoung Su</creator><creator>Kim, Ji Hoon</creator><creator>Lee, Young Sun</creator><creator>Yoon, Eileen L.</creator><creator>Song, Myeong Jun</creator><creator>Park, Jun Yong</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-6036-2754</orcidid><orcidid>https://orcid.org/0000-0001-6324-2224</orcidid></search><sort><creationdate>202012</creationdate><title>Tenofovir‐based combination therapy or monotherapy for multidrug‐resistant chronic hepatitis B: Long‐term data from a multicenter cohort study</title><author>Yim, Hyung Joon ; Suh, Sang Jun ; Jung, Young Kul ; Hwang, Seong Gyu ; Seo, Yeon Seok ; Um, Soon Ho ; Lee, Sae Hwan ; Kim, Young Seok ; Jang, Jae Young ; Kim, In Hee ; Kim, Hyoung Su ; Kim, Ji Hoon ; Lee, Young Sun ; Yoon, Eileen L. ; Song, Myeong Jun ; Park, Jun Yong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3133-e0c0ce37490b28e234fdb749d47cca1441277303124b262e668795f0965ea5cf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adefovir</topic><topic>Antiretroviral drugs</topic><topic>chronic hepatitis B</topic><topic>Cirrhosis</topic><topic>Cohort analysis</topic><topic>Combination therapy</topic><topic>Deoxyribonucleic acid</topic><topic>DNA</topic><topic>Drug resistance</topic><topic>Hepatitis B</topic><topic>Interferon</topic><topic>Liver cirrhosis</topic><topic>multidrug resistance</topic><topic>Multidrug resistant organisms</topic><topic>Tenofovir</topic><topic>therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yim, Hyung Joon</creatorcontrib><creatorcontrib>Suh, Sang Jun</creatorcontrib><creatorcontrib>Jung, Young Kul</creatorcontrib><creatorcontrib>Hwang, Seong Gyu</creatorcontrib><creatorcontrib>Seo, Yeon Seok</creatorcontrib><creatorcontrib>Um, Soon Ho</creatorcontrib><creatorcontrib>Lee, Sae Hwan</creatorcontrib><creatorcontrib>Kim, Young Seok</creatorcontrib><creatorcontrib>Jang, Jae Young</creatorcontrib><creatorcontrib>Kim, In Hee</creatorcontrib><creatorcontrib>Kim, Hyoung Su</creatorcontrib><creatorcontrib>Kim, Ji Hoon</creatorcontrib><creatorcontrib>Lee, Young Sun</creatorcontrib><creatorcontrib>Yoon, Eileen L.</creatorcontrib><creatorcontrib>Song, Myeong Jun</creatorcontrib><creatorcontrib>Park, Jun Yong</creatorcontrib><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><collection>MEDLINE - Academic</collection><jtitle>Journal of viral hepatitis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yim, Hyung Joon</au><au>Suh, Sang Jun</au><au>Jung, Young Kul</au><au>Hwang, Seong Gyu</au><au>Seo, Yeon Seok</au><au>Um, Soon Ho</au><au>Lee, Sae Hwan</au><au>Kim, Young Seok</au><au>Jang, Jae Young</au><au>Kim, In Hee</au><au>Kim, Hyoung Su</au><au>Kim, Ji Hoon</au><au>Lee, Young Sun</au><au>Yoon, Eileen L.</au><au>Song, Myeong Jun</au><au>Park, Jun Yong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Tenofovir‐based combination therapy or monotherapy for multidrug‐resistant chronic hepatitis B: Long‐term data from a multicenter cohort study</atitle><jtitle>Journal of viral hepatitis</jtitle><addtitle>J Viral Hepat</addtitle><date>2020-12</date><risdate>2020</risdate><volume>27</volume><issue>12</issue><spage>1306</spage><epage>1318</epage><pages>1306-1318</pages><issn>1352-0504</issn><eissn>1365-2893</eissn><abstract>The treatment of multidrug‐resistant (MDR) chronic hepatitis B (CHB) is challenging. Herein, we report a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)‐based therapy for MDR CHB in a real‐life setting. The inclusion criteria comprised patients with resistance to more than two nucleos(t)ide analogue (NA) classes and hepatitis B virus (HBV) DNA level of ≥200 IU/mL. The primary end‐point was virologic response (VR), defined as undetectable HBV DNA (<20 IU/mL) after 60 months. A total of 236 patients met the inclusion criteria. The mean HBV DNA level was 4.16 ± 1.44 log IU/mL; 26.7% of patients had liver cirrhosis. Before the initiation of TDF, 33.5%, 44.9% and 21.6% of patients had mutations resistant to L‐NA + adefovir, L‐NA + entecavir (ETV) and L‐NA + adefovir + ETV, respectively. A total of 184 patients received TDF‐based combination therapy [TDF + ETV (n = 178) or TDF + L‐NA (n = 6)], and 52 patients received TDF monotherapy. In the entire cohort, the VR rates were 77.2%, 89.9% and 92.2% at 12, 36 and 60 months, respectively. The VR rates were not significantly different between the combination therapy and the monotherapy group after 12 (76.2% vs 80.4%, P = .533), 36 (89.8% vs 90.3%, P = 1.000) or 60 (92.9% vs 87.5%, P = .499) months. Also, there was no significant difference in the cumulative VR rates for 5 years between the treatment groups (P = .910). Newly developed antiviral resistance was not observed. TDF‐based therapy was effective for the treatment of MDR CHB. The efficacy of TDF monotherapy was not different from that of the TDF‐based combination therapy.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32706461</pmid><doi>10.1111/jvh.13363</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0002-6036-2754</orcidid><orcidid>https://orcid.org/0000-0001-6324-2224</orcidid></addata></record> |
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subjects | Adefovir Antiretroviral drugs chronic hepatitis B Cirrhosis Cohort analysis Combination therapy Deoxyribonucleic acid DNA Drug resistance Hepatitis B Interferon Liver cirrhosis multidrug resistance Multidrug resistant organisms Tenofovir therapy |
title | Tenofovir‐based combination therapy or monotherapy for multidrug‐resistant chronic hepatitis B: Long‐term data from a multicenter cohort study |
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