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.
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
Similar
MEDLINE
...
LILACS
LIS