한빛사논문
Abstract
Man-Fung Yuen1, a, Sang Hoon Ahn2, a, Kwan Sik Lee2, Soon Ho Um3, Mong Cho4, Seung Kew Yoon5, Jin-Woo Lee6, Neung Hwa Park7, Young-Oh Kweon8, Joo Hyun Sohn9, Jiyoon Lee10, Jeong-Ae Kim10, Ching-Lung Lai1,*, Kwang-Hyub Han2,*
1 Department of Medicine, University of Hong Kong, Hong Kong
2 Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
3 Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea
4 Department of Internal Medicine, Pusan National University School of Medicine, Yangsan, Korea
5 Department of Internal Medicine, The Catholic University of Korea, Seoul, Korea
6 Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea
7 Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan, Korea
8 Department of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Korea
9 Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea
10 LG Life Sciences, Ltd., Seoul, Korea
*Corresponding author. Address: Department of Internal Medicine, Yonsei University College. (Kwang-Hyub Han). Department of Medicine, The University of Hong Kong, Hong Kong. (Ching-Lung Lai).
a authors contributing equally for the study.
Abstract
Background and Aims
We aimed to compare the viral suppression, safety and rate of drug resistance between besifovir (a new acyclic nucleotide analog) and entecavir.
Methods
Treatment-naive chronic hepatitis B patients receiving besifovir 90 mg (n=31), 150 mg (n=28) and entecavir 0.5 mg (n=30) were monitored for liver biochemistry, viral serology, HBV DNA levels, development of drug resistance mutations, and adverse events throughout 96 weeks of treatment.
Results
The mean decline of HBV DNA levels from baseline to week 96 were 5.29, 5.15 and 5.67 logs IU/mL for patients receiving besifovir 90 mg, 150 mg and entecavir 0.5 mg respectively (p>0.05). Undetectable HBV DNA (<20 IU/mL) were achieved in 80.7%, 78.6% and 80%; ALT normalization in 90.3%, 78.6% and 93.3%; and loss of HBeAg in 20%, 21.4% and 22.2% of patients respectively (all p>0.05). One patient receiving besifovir 90 mg had virological breakthrough due to drug non-compliance. No patients developed drug resistance mutations. Ten patients had serious adverse events which were not related to the study medications. The most common side effect related to besifovir was carnitine depletion. Carnitine supplements were prescribed to 83.9% and 100% of patients, who had low carnitine level for any one time during follow-up, receiving besifovir 90 mg and 150 mg respectively. No patient had increased creatinine > 0.5 mg/dL from baseline
Conclusions
Besifovir had the same antiviral property as compared to entecavir over 96 weeks of treatment for chronic hepatitis B patients. Besifovir was well tolerable and also had good clinical safety profile.
Keywords : Besifovir; LB80380; Entecavir; Viral suppression; Resistance; Safety
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