{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T06:28:08Z","timestamp":1781072888959,"version":"3.54.1"},"reference-count":54,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"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":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Tenofovir alafenamide (TAF), a prodrug of tenofovir, delivers high levels of active drug to hepatocytes and is given in a lower dose than tenofovir disoproxil fumarate (TDF). TAF reduces viral replication in patients with chronic hepatitis B (CHB) similar to TDF and has shown a lower risk of the renal and bone toxicities associated with TDF use. This post\u2010marketing surveillance study examined the safety and effectiveness of TAF in treatment\u2010na\u00efve and \u2010experienced CHB patients who received TAF for 144\u2009weeks at real\u2010world clinical sites in Japan. Safety assessments included the incidence of adverse drug reactions (ADRs), renal and bone events, and changes in selected laboratory parameters. Effectiveness was based on the proportion of patients with HBV DNA levels below the lower limit of quantitation or &lt;29\u2009IU\/mL. This analysis included 580 patients; 18.4% of whom were treatment\u2010na\u00efve. The cumulative incidence of ADRs was 0.21 per 100 person\u2010months, and the incidence of serious ADRs was 0.01 (95% CI, 0.00\u20130.04) per 100 person\u2010months. There were no ADRs of declines in estimated glomerular filtration rates, renal failure or proximal tubulopathy. The most common ADR was hypophosphataemia in seven (1.2%) patients. Two (0.4%) patients each had decreased blood phosphorus, bone mineral density decreased, dizziness and alopecia. Overall, the proportion of virologically suppressed patients increased from 68.8% at baseline to 97.5% at Week\u2009144. These results confirm the real\u2010world safety and effectiveness of TAF in Japanese patients with CHB and are consistent with the findings of other evaluations of the safety and efficacy of TAF in CHB.<\/jats:p>","DOI":"10.1111\/jvh.13912","type":"journal-article","created":{"date-parts":[[2024,1,2]],"date-time":"2024-01-02T05:05:53Z","timestamp":1704171953000},"page":"165-175","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Real\u2010world safety and effectiveness of tenofovir alafenamide for 144\u2009weeks in Japanese patients with chronic hepatitis B"],"prefix":"10.1111","volume":"31","author":[{"given":"Shuhei","family":"Hige","sequence":"first","affiliation":[{"name":"Department of Gastroenterology Sapporo\u2010Kosei General Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kouji","family":"Aoki","sequence":"additional","affiliation":[{"name":"Gilead Sciences K.K.  Chiyoda\u2010Ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Nakamoto","sequence":"additional","affiliation":[{"name":"Gilead Sciences K.K.  Chiyoda\u2010Ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John F.","family":"Flaherty","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irina","family":"Botros","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hajime","family":"Mizutani","sequence":"additional","affiliation":[{"name":"Gilead Sciences K.K.  Chiyoda\u2010Ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akinobu","family":"Ishizaki","sequence":"additional","affiliation":[{"name":"Gilead Sciences K.K.  Chiyoda\u2010Ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroki","family":"Konishi","sequence":"additional","affiliation":[{"name":"Gilead Sciences K.K.  Chiyoda\u2010Ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Yuan","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahisa","family":"Jinushi","sequence":"additional","affiliation":[{"name":"Gilead Sciences K.K.  Chiyoda\u2010Ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leslie J.","family":"Ng","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,1]]},"reference":[{"key":"e_1_2_10_2_1","volume-title":"Global progress report on HIV, viral hepatitis, and sexually transmitted infections, 2021. Accountability for the Global Health Sector Strategies 2016\u20132021: Actions for Impact","author":"World Health Organization","year":"2021"},{"key":"e_1_2_10_3_1","volume-title":"Global Health Sector Strategy on Viral Hepatitis 2016\u20132021. Towards Ending Viral Hepatitis","author":"World Health Organization","year":"2016"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61425-1"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1053\/jhep.2001.26815"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1053\/gast.2002.37058"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051285"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2007.08.025"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0802878"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2017.11.039"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(16)30107-8"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(16)30024-3"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.15901"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(11)70314-0"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v20.i33.11641"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01064-18"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/jvh.12613"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2893.2011.01533.x"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-012-2402-2"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.28916"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1155\/2021\/3259833"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-020-01698-4"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13659"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S143286"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiu471"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2016.08.008"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2018.06.023"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2018.11.001"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12072-015-9675-4"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2017.03.021"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1111\/hepr.13504"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.29800"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.49.5.1898-1906.2005"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1021\/mp3002045"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00128-15"},{"key":"e_1_2_10_36_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e3182965d45"},{"key":"e_1_2_10_37_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.14686"},{"key":"e_1_2_10_38_1","doi-asserted-by":"publisher","DOI":"10.3892\/etm.2021.10760"},{"key":"e_1_2_10_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.31793"},{"key":"e_1_2_10_40_1","doi-asserted-by":"publisher","DOI":"10.1111\/liv.15261"},{"key":"e_1_2_10_41_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep4.1964"},{"key":"e_1_2_10_42_1","volume-title":"Japan prescribing information","author":"VEMLIDY (tenofovir alafenamide fumarate)","year":"2020"},{"key":"e_1_2_10_43_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-150-9-200905050-00006"},{"key":"e_1_2_10_44_1","doi-asserted-by":"publisher","DOI":"10.1111\/jvh.13500"},{"key":"e_1_2_10_45_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.17107"},{"key":"e_1_2_10_46_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(19)30421-2"},{"key":"e_1_2_10_47_1","doi-asserted-by":"publisher","DOI":"10.5009\/gnl18183"},{"key":"e_1_2_10_48_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.16788"},{"issue":"4","key":"e_1_2_10_49_1","first-page":"184","article-title":"Is tenofovir alafenamide safer than tenofovir disoproxil fumarate for the kidneys?","volume":"18","author":"Aloy B","year":"2016","journal-title":"AIDS Rev"},{"key":"e_1_2_10_50_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000002223"},{"key":"e_1_2_10_51_1","doi-asserted-by":"publisher","DOI":"10.3350\/cmh.2021.0314"},{"key":"e_1_2_10_52_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0261760"},{"key":"e_1_2_10_53_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)61412-X"},{"key":"e_1_2_10_54_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(18)30056-6"},{"key":"e_1_2_10_55_1","doi-asserted-by":"publisher","DOI":"10.1111\/hepr.12897"}],"container-title":["Journal of Viral Hepatitis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jvh.13912","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,16]],"date-time":"2024-03-16T07:00:39Z","timestamp":1710572439000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jvh.13912"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1]]},"references-count":54,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2024,4]]}},"alternative-id":["10.1111\/jvh.13912"],"URL":"https:\/\/doi.org\/10.1111\/jvh.13912","archive":["Portico"],"relation":{},"ISSN":["1352-0504","1365-2893"],"issn-type":[{"value":"1352-0504","type":"print"},{"value":"1365-2893","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1]]},"assertion":[{"value":"2023-08-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-12-13","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-01-01","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}