Clin Mol Hepatol.
2017 Dec;23(4):331-339. 10.3350/cmh.2016.0040.
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
- Affiliations
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- 1Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. LEEKS519@yuhs.ac
- 2Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.
- 3Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
- 4Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University School of Medicine, Seoul, Korea.
- 5Department of Internal Medicine, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, Korea.
- 6Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
- 7Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
- 8Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yeungnam University Hospital, Yeungnam University College of Medicine, Daegu, Korea.
- 9Center for Liver and Digestive Diseases, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea.
- 10Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
- 11Department of Internal Medicine, The Catholic University of Korea Bucheon St. Mary's Hospital, Bucheon, Korea.
- 12Division of Gastroenterology and Hepatology, Department of Internal Medicine, Research Institute of Clinical Medicine, Chonbuk National University Medical School and Hospital, Jeonju, Korea.
- 13Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
- 14Research & Development, BristolMyers Squibb, Seoul, Korea.
- 15Department of Internal Medicine, Vievis Namuh Hospital, Seoul; Korea.
- KMID: 2406042
- DOI: http://doi.org/10.3350/cmh.2016.0040
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.
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