{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,14]],"date-time":"2026-03-14T14:04:46Z","timestamp":1773497086568,"version":"3.50.1"},"reference-count":32,"publisher":"Public Library of Science (PLoS)","issue":"5","license":[{"start":{"date-parts":[[2021,5,13]],"date-time":"2021-05-13T00:00:00Z","timestamp":1620864000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background\/Purpose<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>In a patient subset meeting WOCBP criteria and with baseline HBV DNA &gt;200,000 IU\/mL, rates of viral suppression with TAF or TDF in achieving the target of HBV DNA &lt;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.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>In 275 of 1298 (21%) patients meeting WOCBP criteria with high viral load, 93% and 96% had HBV DNA &lt;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.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0251552","type":"journal-article","created":{"date-parts":[[2021,5,13]],"date-time":"2021-05-13T17:45:27Z","timestamp":1620927927000},"page":"e0251552","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":12,"title":["Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV"],"prefix":"10.1371","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3723-6688","authenticated-orcid":true,"given":"Calvin Q.","family":"Pan","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ting-Tsung","family":"Chang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Si Hyun","family":"Bae","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maurizia","family":"Brunetto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wai-Kay","family":"Seto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carla S.","family":"Coffin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susanna K.","family":"Tan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shuyuan","family":"Mo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John F.","family":"Flaherty","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anuj","family":"Gaggar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mindie H.","family":"Nguyen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mustafa Kemal","family":"\u00c7elen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander","family":"Thompson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward J.","family":"Gane","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2021,5,13]]},"reference":[{"key":"pone.0251552.ref001","doi-asserted-by":"crossref","first-page":"1546","DOI":"10.1016\/S0140-6736(15)61412-X","article-title":"Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013","volume":"386","author":"A Schweitzer","year":"2015","journal-title":"Lancet"},{"key":"pone.0251552.ref002","unstructured":"World Health Organization. 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Prevention, prophylaxis, treatment and follow-up: position paper produced by Australian, UK and New Zealand key opinion leaders","volume":"65","author":"K Visvanathan","year":"2016","journal-title":"Gut"},{"key":"pone.0251552.ref006","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1016\/j.jhep.2013.02.015","article-title":"Mother-to-infant transmission of hepatitis B virus infection: significance of maternal viral load and strategies for intervention","volume":"59","author":"WH Wen","year":"2013","journal-title":"J Hepatol"},{"key":"pone.0251552.ref007","doi-asserted-by":"crossref","first-page":"e18","DOI":"10.1111\/j.1365-2893.2011.01492.x","article-title":"Virologic factors associated with failure to passive-active immunoprophylaxis in infants born to HBsAg-positive mothers","volume":"19","author":"H Zou","year":"2012","journal-title":"J Viral 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Hepatology"},{"key":"pone.0251552.ref017","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s12072-015-9675-4","article-title":"Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update","volume":"10","author":"SK Sarin","year":"2016","journal-title":"Hepatology International"},{"key":"pone.0251552.ref018","article-title":"Prevention of mother-to-child transmission of hepatitis B virus: guidelines on antiviral prophylaxis in pregnancy","author":"World Health Organization","year":"2020"},{"key":"pone.0251552.ref019","doi-asserted-by":"crossref","first-page":"185","DOI":"10.1016\/S2468-1253(16)30024-3","article-title":"Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial","volume":"1","author":"HL Chan","year":"2016","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"pone.0251552.ref020","doi-asserted-by":"crossref","first-page":"196","DOI":"10.1016\/S2468-1253(16)30107-8","article-title":"Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial","volume":"1","author":"M Buti","year":"2016","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"pone.0251552.ref021","doi-asserted-by":"crossref","first-page":"672","DOI":"10.1016\/j.jhep.2017.11.039","article-title":"96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection","volume":"68","author":"K Agarwal","year":"2018","journal-title":"J Hepatol"},{"key":"pone.0251552.ref022","doi-asserted-by":"crossref","first-page":"533","DOI":"10.1016\/j.jhep.2014.10.035","article-title":"Twenty-eight day safety, antiviral activity, and pharmacokinetics of tenofovir alafenamide for treatment of chronic hepatitis B infection","volume":"62","author":"K Agarwal","year":"2015","journal-title":"J Hepatol"},{"key":"pone.0251552.ref023","doi-asserted-by":"crossref","first-page":"3563","DOI":"10.1128\/AAC.00128-15","article-title":"Implications of efficient hepatic delivery by tenofovir alafenamide (GS-7340) for hepatitis B virus therapy","volume":"59","author":"E Murakami","year":"2015","journal-title":"Antimicrob Agents Chemother"},{"key":"pone.0251552.ref024","unstructured":"Prescribing information for Vemlidy\u00ae, U.S. Food and Drug Administration, revised 02\/2020."},{"key":"pone.0251552.ref025","unstructured":"World Health Organization. Sexual and Reproductive Health. Infertility Definitions and Terminology. http:\/\/www.who.int\/reproductivehealth\/topics\/infertility\/definitions\/en\/. 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