Tenofovir Alafenamide for Drug-Resistant Hepatitis B: A Randomized Trial for Switching From Tenofovir Disoproxil Fumarate
DC Field | Value | Language |
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dc.contributor.author | Byun, Kwan Soo | - |
dc.contributor.author | Choi, Jonggi | - |
dc.contributor.author | Kim, Ji-Hoon | - |
dc.contributor.author | Lee, Yung Sang | - |
dc.contributor.author | Lee, Han Chu | - |
dc.contributor.author | Kim, Yoon Jun | - |
dc.contributor.author | Yoo, Byung Chul | - |
dc.contributor.author | Kwon, So Young | - |
dc.contributor.author | Gwak, Geum-Youn | - |
dc.contributor.author | Lim, Young-Suk | - |
dc.date.accessioned | 2022-02-22T13:42:36Z | - |
dc.date.available | 2022-02-22T13:42:36Z | - |
dc.date.created | 2022-02-15 | - |
dc.date.issued | 2022-02 | - |
dc.identifier.issn | 1542-3565 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/136508 | - |
dc.description.abstract | BACKGROUND & AIMS: It remains unknown whether tenofovir alafenamide (TAF) could replace tenofovir disoproxil fumarate (TDF) in patients with drug-resistant hepatitis B virus (HBV). METHODS: In this multicenter randomized non-inferiority trial, 174 patients with HBV resistant to multiple drugs (lamivudine, entecavir, and/or adefovir) under TDF monotherapy for >= 96 weeks were randomized 1:1 to switch to TAF (n = 87) or continue TDF (n = 87) for 48 weeks. The primary endpoint was proportion of patients with HBV DNA <60 IU/mL at week 48. RESULTS: At baseline, 84 and 80 patients had HBV DNA <60 IU/mL in the TAF and TDF groups, respectively. At week 48, the proportion of patients with HBV DNA <60 IU/mL was 98.9% (86/87) in TAF group, showing non-inferiority to TDF group (97.7%, 85/87; difference, 1.1%; 95% confidence interval, -2.7% to 5.0%). Changes in median alanine aminotransferase at week 48 from baseline were statistically different between TAF and TDF groups (-3 IU/L vs +2 IU/L; P = .02). TAF group showed a statistically greater increase in bone mineral density at spine (+1.84% vs +0.08%; P = .01) and numerically higher increase in mean estimated glomerular filtration rate (+8.2% vs +4.5%; P = .06) compared with TDF group. Compared with TDF group, TAF group showed significantly greater increases in mean body weight (0.71 vs -0.37 kg; P = .01) and total, low-density lipoprotein, and high-density lipoprotein cholesterol levels (P < .001 for all) at week 48 from baseline. CONCLUSIONS: TAF could be substituted for TDF in patients with multidrug-resistant HBV for improved bone and renal safety without a loss of efficacy. However, increases in body weight and cholesterol levels with TAF treatment would be a concern. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCIENCE INC | - |
dc.subject | HIV-1 INFECTION | - |
dc.subject | DOUBLE-BLIND | - |
dc.subject | PHASE-3 | - |
dc.subject | VIRUS | - |
dc.subject | MULTICENTER | - |
dc.title | Tenofovir Alafenamide for Drug-Resistant Hepatitis B: A Randomized Trial for Switching From Tenofovir Disoproxil Fumarate | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Byun, Kwan Soo | - |
dc.identifier.doi | 10.1016/j.cgh.2021.04.045 | - |
dc.identifier.scopusid | 2-s2.0-85109428486 | - |
dc.identifier.wosid | 000743591700029 | - |
dc.identifier.bibliographicCitation | CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, v.20, no.2, pp.427 - + | - |
dc.relation.isPartOf | CLINICAL GASTROENTEROLOGY AND HEPATOLOGY | - |
dc.citation.title | CLINICAL GASTROENTEROLOGY AND HEPATOLOGY | - |
dc.citation.volume | 20 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 427 | - |
dc.citation.endPage | + | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.subject.keywordPlus | HIV-1 INFECTION | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | PHASE-3 | - |
dc.subject.keywordPlus | VIRUS | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordAuthor | Hepatitis B | - |
dc.subject.keywordAuthor | Resistance | - |
dc.subject.keywordAuthor | Tenofovir Disoproxil Fumarate | - |
dc.subject.keywordAuthor | Tenofovir Alafenamide | - |
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