Cited 12 times in
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 | 이관식 | - |
dc.date.accessioned | 2018-07-20T11:59:34Z | - |
dc.date.available | 2018-07-20T11:59:34Z | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 2287-2728 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/161599 | - |
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.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Korean Association for the Study of the Liver | - |
dc.relation.isPartOf | CLINICAL AND MOLECULAR HEPATOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
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.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Kwan Sik Lee | - |
dc.contributor.googleauthor | Young-Oh Kweon | - |
dc.contributor.googleauthor | Soon-Ho Um | - |
dc.contributor.googleauthor | Byung-Ho Kim | - |
dc.contributor.googleauthor | Young Suk Lim | - |
dc.contributor.googleauthor | Seung Woon Paik | - |
dc.contributor.googleauthor | Jeong Heo | - |
dc.contributor.googleauthor | Heon-Ju Lee | - |
dc.contributor.googleauthor | Dong Joon Kim | - |
dc.contributor.googleauthor | Tae Hun Kim | - |
dc.contributor.googleauthor | Young-Sok Lee | - |
dc.contributor.googleauthor | Kwan Soo Byun | - |
dc.contributor.googleauthor | Daeghon Kim | - |
dc.contributor.googleauthor | Myung Seok Lee | - |
dc.contributor.googleauthor | Kyungha Yu | - |
dc.contributor.googleauthor | Dong Jin Suh | - |
dc.identifier.doi | 10.3350/cmh.2016.0040 | - |
dc.contributor.localId | A02666 | - |
dc.relation.journalcode | J00557 | - |
dc.identifier.eissn | 2287-285X | - |
dc.identifier.pmid | 28946736 | - |
dc.subject.keyword | Entecavir | - |
dc.subject.keyword | Hepatitis B | - |
dc.subject.keyword | Lamivudine | - |
dc.subject.keyword | Long-term effects | - |
dc.contributor.alternativeName | Lee, Kwan Sik | - |
dc.contributor.affiliatedAuthor | Lee, Kwan Sik | - |
dc.citation.volume | 23 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 331 | - |
dc.citation.endPage | 339 | - |
dc.identifier.bibliographicCitation | CLINICAL AND MOLECULAR HEPATOLOGY, Vol.23(4) : 331-339, 2017 | - |
dc.identifier.rimsid | 61623 | - |
dc.type.rims | ART | - |
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