Efficacy and safety of entecavir versus lamivudine over 5 years of treatment: A randomized controlled trial in Korean patients with hepatitis B e antigen-negative chronic hepatitis B
DC Field | Value | Language |
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dc.contributor.author | Lee, Kwan Sik | - |
dc.contributor.author | Kweon, Young-Oh | - |
dc.contributor.author | Um, Soon-Ho | - |
dc.contributor.author | Kim, Byung-Ho | - |
dc.contributor.author | Lim, Young Suk | - |
dc.contributor.author | Paik, Seung Woon | - |
dc.contributor.author | Heo, Jeong | - |
dc.contributor.author | Lee, Heon-Ju | - |
dc.contributor.author | Kim, Dong Joon | - |
dc.contributor.author | Kim, Tae Hun | - |
dc.contributor.author | Lee, Young-Sok | - |
dc.contributor.author | Byun, Kwan Soo | - |
dc.contributor.author | Kim, Daeghon | - |
dc.contributor.author | Lee, Myung Seok | - |
dc.contributor.author | Yu, Kyungha | - |
dc.contributor.author | Suh, Dong Jin | - |
dc.date.accessioned | 2021-09-02T22:45:55Z | - |
dc.date.available | 2021-09-02T22:45:55Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2017-12 | - |
dc.identifier.issn | 2287-2728 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/81430 | - |
dc.description.abstract | Background/Aims: Long-term data on antiviral therapy in Korean patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) are limited. This study evaluated the efficacy and safety of entecavir (ETV) and lamivudine (LAM) over 240 weeks. Methods: Treatment-naive patients with HBeAg-negative CHB were randomized to receive ETV 0.5 mg/day or LAM 100 mg/day during the 96 week double-blind phase, followed by open-label treatment through week 240. The primary endpoint was the proportion of patients with virologic response (VR; hepatitis B virus [HBV] DNA< 300 copies/mL) at week 24. Secondary objectives included alanine aminotransferase (ALT) normalization and emergence of ETV resistance (week 96), VR and log reduction in HBV DNA levels (week 240), and safety evaluation. Results: In total, 120 patients (> 16 years old) were included (ETV, n= 56; LAM, n= 64). Baseline characteristics were comparable between the two groups. A significantly higher proportion of ETV-treated patients achieved VR compared to LAM at week 24 (92.9% vs. 67.2%, P= 0.0006), week 96 (94.6% vs. 48.4%, P< 0.0001), and week 240 (95.0% vs. 47.6%, P< 0.0001). At week 96, ALT normalization was observed in 87.5% and 51.6% of ETV and LAM patients, respectively (P< 0.0001). Virologic breakthrough occurred in one patient (1.8%) receiving ETV and 26 patients (42.6%) receiving LAM (P< 0.0001) up to week 96. Emergence of resistance to ETV was not detected. The incidence of serious adverse events was low and unrelated to the study medications. Conclusions: Long-term ETV treatment was superior to LAM, with a significantly higher proportion of patients achieving VR. Both treatments were well tolerated. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | KOREAN ASSOC STUDY LIVER | - |
dc.subject | CLINICAL-PRACTICE GUIDELINES | - |
dc.subject | VIRUS | - |
dc.subject | THERAPY | - |
dc.subject | MANAGEMENT | - |
dc.subject | EPIDEMIOLOGY | - |
dc.subject | MULTICENTER | - |
dc.subject | INFECTION | - |
dc.subject | GENOTYPES | - |
dc.subject | RELAPSE | - |
dc.title | Efficacy and safety of entecavir versus lamivudine over 5 years of treatment: A randomized controlled trial in Korean patients with hepatitis B e antigen-negative chronic hepatitis B | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Um, Soon-Ho | - |
dc.contributor.affiliatedAuthor | Byun, Kwan Soo | - |
dc.identifier.doi | 10.3350/cmh.2016.0040 | - |
dc.identifier.scopusid | 2-s2.0-85058754948 | - |
dc.identifier.wosid | 000418699200011 | - |
dc.identifier.bibliographicCitation | CLINICAL AND MOLECULAR HEPATOLOGY, v.23, no.4, pp.331 - 339 | - |
dc.relation.isPartOf | CLINICAL AND MOLECULAR HEPATOLOGY | - |
dc.citation.title | CLINICAL AND MOLECULAR HEPATOLOGY | - |
dc.citation.volume | 23 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 331 | - |
dc.citation.endPage | 339 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.identifier.kciid | ART002291697 | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.subject.keywordPlus | CLINICAL-PRACTICE GUIDELINES | - |
dc.subject.keywordPlus | VIRUS | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | MANAGEMENT | - |
dc.subject.keywordPlus | EPIDEMIOLOGY | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | INFECTION | - |
dc.subject.keywordPlus | GENOTYPES | - |
dc.subject.keywordPlus | RELAPSE | - |
dc.subject.keywordAuthor | Hepatitis B | - |
dc.subject.keywordAuthor | Entecavir | - |
dc.subject.keywordAuthor | Long-term effects | - |
dc.subject.keywordAuthor | Lamivudine | - |
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