 |
|
|
| |
The Antiviral Effects and Safety of Entecavir Versus Lamivudine Treatment in Nucleos(t)ide-naïve HBeAg-negative Korean Chronic Hepatitis B Patients: Week 48 Interim Analysis
|
| |
| |
Reported by Jules Levin
20th Conference of the Asian Pacific Association for the Study of the Liver 2010
Y.O. Kwon1, K.S. Lee2, D.J. Suh3, S.H. Um4, B.H. Kim5, S.W. Paik6, J. Heo7, H.J. Lee8, D.J. Kim9, T.H. Kim10, Y.S. Lee11, K.S. Byun12, D.G. Kim13, M.S. Lee14, R. Wilber15, H. Brett-Smith15 and C.H. Lee16
1Kyungpook National University Hospital, Kyungpook National University, Daegu, Republic of Korea; 2Gangnam Severance Hospital, Yonsei University, Seoul, Republic of Korea; 3Asan Medical Center, Ulsan University, Seoul, Republic of Korea; 4Korea University Anam Hospital, Korea University,
Seoul, Republic of Korea; 5Kyung Hee University Medical Center, Kyung Hee University, Seoul, Republic of Korea; 6Samsung Medical Center, Sungkyunkwan University, Seoul, Republic of Korea; 7Pusan National University Hospital, Pusan National University, Pusan, Republic of Korea;
8Yeungnam University Hospital, Yeungnam University, Daegu, Republic of Korea; 9Hallym University Medical Center, Chuncheon Sacred Heart Hospital, Hallym University, Chuncheon, Republic of Korea; 10Ewha Womans University Mokdong Hospital, Ewha Womans University, Seoul, Republic of Korea;
11The Catholic University of Korea Holy Family Hospital, Catholic University, Gyunggi Do, Republic of Korea; 12Korea University Guro Hospital, Korea University, Seoul, Republic of Korea; 13Chonbuk National University Hospital, Chonbuk National University, Jeonju, Republic of Korea;
14Hallym University Medical Center, Kangnam Sacred Heart Hospital, Hallym University, Seoul, Republic of Korea; 15Bristol-Myers Squibb, Research & Development, Wallingford, CT, USA; 16Bristol-Myers Squibb, Research & Development, Seoul, Republic of Korea
Conclusions
Significantly more patients achieved an undetectable HBV DNA level (<300 copies/mL) and normalized ALT in the ETV-treated group compared with the LVD-treated group
This suggests ETV has greater antiviral activity than LVD after 48 weeks' treatment in nucleos(t)ide-naïve HBeAg(-) Korean patients. This is consistent with reports from other worldwide studies
The safety profile of ETV is comparable to LVD, and similar to previous reports in HBeAg(-) patients
This poster represents data from Week 48 interim analysis of an ongoing trial
Introduction
The goal of chronic hepatitis B (CHB) treatment is to achieve sustained suppression of HBV DNA and remission of liver disease1
The Phase III global entecavir (ETV) registration trials demonstrated that ETV is more efficacious than lamivudine (LVD) in achieving histologic, virologic (HBV DNA), and biochemical (ALT normalization) improvements in nucleoside-naïve patients2,3
We present here a 48-week interim analysis comparing the efficacy of ETV versus LVD in nucleos(t)ide-naïve HBeAg(-) Korean patients (ETV-105 study)
Methods
Study population
120 nucleos(t)ide-naïve HBeAg(-) patients were prospectively enrolled and randomized in a double-blinded study to receive ETV 0.5 mg once daily (n=56) or LVD 100 mg once daily (n=64)
Genotypic resistance testing is planned at Week 96 in patients with virological breakthrough
Figure 1: ETV-105 study design
*defined by an undetectable HBV DNA by PCR
Patients with a missing measurement within a treatment window will be considered failures for the binary outcome (Non-Completer = Failure)
Figure 2: Mean HBV DNA through Week 48
Figure 3: Mean ALT through Week 48
Safety
Non-serious adverse events were reported in 42.86% of ETV, and 54.69% of LVD treated patients
Serious adverse events were reported in 3.57% of ETV, and 6.25% of LVD treated patients, however none of these were drug related
References
[1] Lok AS & McMahon BJ. Hepatology 2009;50:1-36. [2] Chang TT, et al. N Engl J Med. 2006;354:1001-10.
[3] Lai CL, et al. N Engl J Med. 2006;354:1011-20.
|
| |
|
|
|
|
|
