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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
Clinical and Molecular Hepatology ; : 331-339, 2017.
Article in English | WPRIM | ID: wpr-216530
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] DNA16 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.
Subject(s)

Full text: Available Index: WPRIM (Western Pacific) Main subject: DNA / Hepatitis B virus / Incidence / Lamivudine / Hepatitis B, Chronic / Alanine Transaminase / Hepatitis / Hepatitis B / Hepatitis, Chronic Type of study: Controlled clinical trial / Incidence study / Prognostic study Limits: Humans Language: English Journal: Clinical and Molecular Hepatology Year: 2017 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: DNA / Hepatitis B virus / Incidence / Lamivudine / Hepatitis B, Chronic / Alanine Transaminase / Hepatitis / Hepatitis B / Hepatitis, Chronic Type of study: Controlled clinical trial / Incidence study / Prognostic study Limits: Humans Language: English Journal: Clinical and Molecular Hepatology Year: 2017 Type: Article