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Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV
Use of tenofovir disoproxil fumarate (TDF) improves patient outcomes in preventing mother-to-child transmission (pMTCT) of the hepatitis B virus (HBV) in mothers with chronic HBV and high viral loads. Given the lack of data for tenofovir alafenamide (TAF) in pMTCT, rates of early viral suppression w...
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Published in: | PloS one 2021-05, Vol.16 (5), p.e0251552-e0251552 |
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creator | Pan, Calvin Q Chang, Ting-Tsung Bae, Si Hyun Brunetto, Maurizia Seto, Wai-Kay Coffin, Carla S Tan, Susanna K Mo, Shuyuan Flaherty, John F Gaggar, Anuj Nguyen, Mindie H Çelen, Mustafa Kemal Thompson, Alexander Gane, Edward J |
description | Use of tenofovir disoproxil fumarate (TDF) improves patient outcomes in preventing mother-to-child transmission (pMTCT) of the hepatitis B virus (HBV) in mothers with chronic HBV and high viral loads. Given the lack of data for tenofovir alafenamide (TAF) in pMTCT, rates of early viral suppression with TAF and TDF were evaluated in women of childbearing potential (WOCBP) participating in 2 randomized, double-blind, Phase 3 studies in chronic HBV.
In a patient subset meeting WOCBP criteria and with baseline HBV DNA >200,000 IU/mL, rates of viral suppression with TAF or TDF in achieving the target of HBV DNA |
doi_str_mv | 10.1371/journal.pone.0251552 |
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In a patient subset meeting WOCBP criteria and with baseline HBV DNA >200,000 IU/mL, rates of viral suppression with TAF or TDF in achieving the target of HBV DNA <200,000 IU/mL at weeks 12 and 24 were assessed. Multivariate logistic regression was used to identify factors predictive of failure to suppress HBV DNA to the target level.
In 275 of 1298 (21%) patients meeting WOCBP criteria with high viral load, 93% and 96% had HBV DNA <200,000 IU/mL at weeks 12 and 24, respectively. Results for TAF (n = 194) vs TDF (n = 81) treatment were similar at weeks 12 and 24 (94% vs. 90% and 97% vs. 93%), respectively. High baseline HBV DNA level, genotype D infection, and prior interferon (week 24 only) were predictive of failure to achieve the target level. Both treatments were well tolerated with TAF showing less impact on renal and bone parameters.
In WOCBP with high VL, no differences were found between TAF and TDF in reducing HBV DNA to levels associated with lower transmission risk. These data support ongoing studies of TAF for pMTCT.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0251552</identifier><identifier>PMID: 33984038</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Alanine ; Alanine transaminase ; Analysis ; Antigens ; Antiretroviral drugs ; Antiviral drugs ; Biological response modifiers ; Biology and life sciences ; Care and treatment ; Chronic infection ; Clinical trials ; Complications and side effects ; Deoxyribonucleic acid ; Disease prevention ; DNA ; Editing ; FDA approval ; Health care facilities ; Health risks ; Hepatitis ; Hepatitis B ; Hepatitis B surface antigen ; Hepatocytes ; Hospitals ; Infections ; Intracellular levels ; Kinetics ; Liver ; Liver diseases ; Liver transplantation ; Magnetohydrodynamic stability ; Medicine ; Medicine and health sciences ; Patient outcomes ; People and Places ; Pregnancy ; Research and Analysis Methods ; Risk analysis ; Risk factors ; Tenofovir ; Vaccines ; Viruses ; Womens health</subject><ispartof>PloS one, 2021-05, Vol.16 (5), p.e0251552-e0251552</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Pan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 Pan et al 2021 Pan et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c625t-6c47447b464ade826ce4467158cfddc130f3c369cd0fc2c76d98df2ee904ab93</citedby><cites>FETCH-LOGICAL-c625t-6c47447b464ade826ce4467158cfddc130f3c369cd0fc2c76d98df2ee904ab93</cites><orcidid>0000-0002-3723-6688</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2526806680/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2526806680?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33984038$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pan, Calvin Q</creatorcontrib><creatorcontrib>Chang, Ting-Tsung</creatorcontrib><creatorcontrib>Bae, Si Hyun</creatorcontrib><creatorcontrib>Brunetto, Maurizia</creatorcontrib><creatorcontrib>Seto, Wai-Kay</creatorcontrib><creatorcontrib>Coffin, Carla S</creatorcontrib><creatorcontrib>Tan, Susanna K</creatorcontrib><creatorcontrib>Mo, Shuyuan</creatorcontrib><creatorcontrib>Flaherty, John F</creatorcontrib><creatorcontrib>Gaggar, Anuj</creatorcontrib><creatorcontrib>Nguyen, Mindie H</creatorcontrib><creatorcontrib>Çelen, Mustafa Kemal</creatorcontrib><creatorcontrib>Thompson, Alexander</creatorcontrib><creatorcontrib>Gane, Edward J</creatorcontrib><title>Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Use of tenofovir disoproxil fumarate (TDF) improves patient outcomes in preventing mother-to-child transmission (pMTCT) of the hepatitis B virus (HBV) in mothers with chronic HBV and high viral loads. Given the lack of data for tenofovir alafenamide (TAF) in pMTCT, rates of early viral suppression with TAF and TDF were evaluated in women of childbearing potential (WOCBP) participating in 2 randomized, double-blind, Phase 3 studies in chronic HBV.
In a patient subset meeting WOCBP criteria and with baseline HBV DNA >200,000 IU/mL, rates of viral suppression with TAF or TDF in achieving the target of HBV DNA <200,000 IU/mL at weeks 12 and 24 were assessed. Multivariate logistic regression was used to identify factors predictive of failure to suppress HBV DNA to the target level.
In 275 of 1298 (21%) patients meeting WOCBP criteria with high viral load, 93% and 96% had HBV DNA <200,000 IU/mL at weeks 12 and 24, respectively. Results for TAF (n = 194) vs TDF (n = 81) treatment were similar at weeks 12 and 24 (94% vs. 90% and 97% vs. 93%), respectively. High baseline HBV DNA level, genotype D infection, and prior interferon (week 24 only) were predictive of failure to achieve the target level. Both treatments were well tolerated with TAF showing less impact on renal and bone parameters.
In WOCBP with high VL, no differences were found between TAF and TDF in reducing HBV DNA to levels associated with lower transmission risk. These data support ongoing studies of TAF for pMTCT.</description><subject>Alanine</subject><subject>Alanine transaminase</subject><subject>Analysis</subject><subject>Antigens</subject><subject>Antiretroviral drugs</subject><subject>Antiviral drugs</subject><subject>Biological response modifiers</subject><subject>Biology and life sciences</subject><subject>Care and treatment</subject><subject>Chronic infection</subject><subject>Clinical trials</subject><subject>Complications and side effects</subject><subject>Deoxyribonucleic acid</subject><subject>Disease prevention</subject><subject>DNA</subject><subject>Editing</subject><subject>FDA approval</subject><subject>Health care facilities</subject><subject>Health risks</subject><subject>Hepatitis</subject><subject>Hepatitis B</subject><subject>Hepatitis B surface antigen</subject><subject>Hepatocytes</subject><subject>Hospitals</subject><subject>Infections</subject><subject>Intracellular levels</subject><subject>Kinetics</subject><subject>Liver</subject><subject>Liver diseases</subject><subject>Liver transplantation</subject><subject>Magnetohydrodynamic stability</subject><subject>Medicine</subject><subject>Medicine and health sciences</subject><subject>Patient outcomes</subject><subject>People and Places</subject><subject>Pregnancy</subject><subject>Research and Analysis Methods</subject><subject>Risk analysis</subject><subject>Risk factors</subject><subject>Tenofovir</subject><subject>Vaccines</subject><subject>Viruses</subject><subject>Womens 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Kemal</au><au>Thompson, Alexander</au><au>Gane, Edward J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2021-05-13</date><risdate>2021</risdate><volume>16</volume><issue>5</issue><spage>e0251552</spage><epage>e0251552</epage><pages>e0251552-e0251552</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Use of tenofovir disoproxil fumarate (TDF) improves patient outcomes in preventing mother-to-child transmission (pMTCT) of the hepatitis B virus (HBV) in mothers with chronic HBV and high viral loads. Given the lack of data for tenofovir alafenamide (TAF) in pMTCT, rates of early viral suppression with TAF and TDF were evaluated in women of childbearing potential (WOCBP) participating in 2 randomized, double-blind, Phase 3 studies in chronic HBV.
In a patient subset meeting WOCBP criteria and with baseline HBV DNA >200,000 IU/mL, rates of viral suppression with TAF or TDF in achieving the target of HBV DNA <200,000 IU/mL at weeks 12 and 24 were assessed. Multivariate logistic regression was used to identify factors predictive of failure to suppress HBV DNA to the target level.
In 275 of 1298 (21%) patients meeting WOCBP criteria with high viral load, 93% and 96% had HBV DNA <200,000 IU/mL at weeks 12 and 24, respectively. Results for TAF (n = 194) vs TDF (n = 81) treatment were similar at weeks 12 and 24 (94% vs. 90% and 97% vs. 93%), respectively. High baseline HBV DNA level, genotype D infection, and prior interferon (week 24 only) were predictive of failure to achieve the target level. Both treatments were well tolerated with TAF showing less impact on renal and bone parameters.
In WOCBP with high VL, no differences were found between TAF and TDF in reducing HBV DNA to levels associated with lower transmission risk. These data support ongoing studies of TAF for pMTCT.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>33984038</pmid><doi>10.1371/journal.pone.0251552</doi><tpages>e0251552</tpages><orcidid>https://orcid.org/0000-0002-3723-6688</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Alanine Alanine transaminase Analysis Antigens Antiretroviral drugs Antiviral drugs Biological response modifiers Biology and life sciences Care and treatment Chronic infection Clinical trials Complications and side effects Deoxyribonucleic acid Disease prevention DNA Editing FDA approval Health care facilities Health risks Hepatitis Hepatitis B Hepatitis B surface antigen Hepatocytes Hospitals Infections Intracellular levels Kinetics Liver Liver diseases Liver transplantation Magnetohydrodynamic stability Medicine Medicine and health sciences Patient outcomes People and Places Pregnancy Research and Analysis Methods Risk analysis Risk factors Tenofovir Vaccines Viruses Womens health |
title | Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV |
url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-03-09T17%3A34%3A56IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Antiviral%20kinetics%20of%20tenofovir%20alafenamide%20and%20tenofovir%20disoproxil%20fumarate%20over%2024%20weeks%20in%20women%20of%20childbearing%20potential%20with%20chronic%20HBV&rft.jtitle=PloS%20one&rft.au=Pan,%20Calvin%20Q&rft.date=2021-05-13&rft.volume=16&rft.issue=5&rft.spage=e0251552&rft.epage=e0251552&rft.pages=e0251552-e0251552&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0251552&rft_dat=%3Cgale_plos_%3EA661690309%3C/gale_plos_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c625t-6c47447b464ade826ce4467158cfddc130f3c369cd0fc2c76d98df2ee904ab93%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2526806680&rft_id=info:pmid/33984038&rft_galeid=A661690309&rfr_iscdi=true |