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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Veröffentlicht in:Journal of viral hepatitis 2020-12, Vol.27 (12), p.1306-1318
Hauptverfasser: 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
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container_end_page 1318
container_issue 12
container_start_page 1306
container_title Journal of viral hepatitis
container_volume 27
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 (
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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 (&lt;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. 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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 (&lt;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. 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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 (&lt;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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source Wiley Online Library Journals Frontfile Complete
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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