Antiviral Activity and Safety of LB80380 in Hepatitis B e Antigen-Positive Chronic Hepatitis B Patients with Lamivudine-Resistant Disease
- Authors
- Yuen, Man-Fung; Han, Kwang-Hyub; Um, Soon-Ho; Yoon, Seung Kew; Kim, Hye-Ryon; Kim, John; Kim, Chung Ryeol; Lai, Ching-Lung
- Issue Date
- Mar-2010
- Publisher
- WILEY
- Citation
- HEPATOLOGY, v.51, no.3, pp 767 - 776
- Pages
- 10
- Indexed
- SCI
SCIE
SCOPUS
- Journal Title
- HEPATOLOGY
- Volume
- 51
- Number
- 3
- Start Page
- 767
- End Page
- 776
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/15123
- DOI
- 10.1002/hep.23462
- ISSN
- 0270-9139
1527-3350
- Abstract
- We aimed to determine the antiviral activity and safety of a new nucleotide analogue, LB80380, in chronic hepatitis B (CHB) patients with lamivudine-resistant virus. Sixty-five patients with lamivudine-resistant virus were randomized to receive five ascending daily doses (30,60, 90, 150, 240 mg) of LB80380. LB80380 was given together with lamivudine for the first 4 weeks, followed by 8 weeks of LB80380 monotherapy. This was then followed by 24 weeks of adefovir. Hepatitis B virus (HBV) DNA levels, serology, liver biochemistry, and safety were monitored. The extent of the HBV DNA reduction at week 12 was dose-dependent. The mean reduction from baseline was 2.81, 3.21, 3.92, 4.16, and 4.00 log(10) copies/mL for the five ascending dose groups. The dose-proportionate effect was statistically significant (P < 0.001) with a decrease of HBV DNA levels by an average of 1.54 log(10) copies/mL for every 1-unit increase in log(10) dose of LB80380. In 93.4% of patients, HBV DNA decreased by >2 log(10) copies/ml, and 11.5% of patients had undetectable HBV DNA levels (< 300 copies/mL) by week 12. HBV DNA suppression was maintained during the 24 weeks of adefovir treatment. Hepatitis B e antigen seroconversion and normalization of alanine aminotransferase were seen in 14.6% and 24.6% of patients, respectively, at week 12; 44.6% of patients experienced mild and self-limiting adverse events, none of which were attributed to the study drug. Conclusion: LB80380 at doses of up to 240 mg is safe, well tolerated, and effective at reducing viral load in CHB patients with lamivudine-resistant virus for a period of 12 weeks. (HEPATOLOGY 2010;51:767-776.)
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Collections - 2. Clinical Science > Department of Gastroenterology and Hepatology > 1. Journal Articles
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