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.
- Author:
Kwan Sik LEE
1
;
Young Oh KWEON
;
Soon Ho UM
;
Byung Ho KIM
;
Young Suk LIM
;
Seung Woon PAIK
;
Jeong HEO
;
Heon Ju LEE
;
Dong Joon KIM
;
Tae Hun KIM
;
Young Sok LEE
;
Kwan Soo BYUN
;
Daeghon KIM
;
Myung Seok LEE
;
Kyungha YU
;
Dong Jin SUH
Author Information
- Publication Type:Randomized Controlled Trial ; Original Article
- Keywords: Hepatitis B; Entecavir; Long-term effects; Lamivudine
- MeSH: Alanine Transaminase; DNA; Hepatitis B virus; Hepatitis B*; Hepatitis B, Chronic*; Hepatitis*; Hepatitis, Chronic*; Humans; Incidence; Lamivudine*
- From:Clinical and Molecular Hepatology 2017;23(4):331-339
- CountryRepublic of Korea
- Language:English
- 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.
