Two-year treatment outcome of chronic hepatitis B infection treated with besifovir vs. entecavir: Results from a multicentre study

Man Fung Yuen, Sang Hoon Ahn, Kwan Sik Lee, Soon Ho Um, Mong Cho, Seung Kew Yoon, Jin Woo Lee, Neung Hwa Park, Young Oh Kweon, Joo Hyun Sohn, Jiyoon Lee, Jeong Ae Kim, Ching Lung Lai, Kwang Hyub Han

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Abstract

Background & Aims We aimed to compare the viral suppression, safety and rate of drug resistance between besifovir (a new acyclic nucleotide analogue) and entecavir. Methods Treatment-naïve 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 a virological breakthrough due to drug non-compliance. No patient 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 tolerated and also had a good clinical safety profile.

Original languageEnglish
Pages (from-to)526-532
Number of pages7
JournalJournal of Hepatology
Volume62
Issue number3
DOIs
Publication statusPublished - 2015 Mar 1

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Chronic Hepatitis B
Multicenter Studies
Infection
Carnitine
Drug Resistance
DNA
Safety
Mutation
((1-((2-amino-9H-purin-9-yl)methyl)cyclopropyl)oxy)methylphosphonic acid dipivoxyl
entecavir
Serology
Biochemistry
Antiviral Agents
Creatinine
Therapeutics
Nucleotides
Liver
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Hepatology

Cite this

Yuen, Man Fung ; Ahn, Sang Hoon ; Lee, Kwan Sik ; Um, Soon Ho ; Cho, Mong ; Yoon, Seung Kew ; Lee, Jin Woo ; Park, Neung Hwa ; Kweon, Young Oh ; Sohn, Joo Hyun ; Lee, Jiyoon ; Kim, Jeong Ae ; Lai, Ching Lung ; Han, Kwang Hyub. / Two-year treatment outcome of chronic hepatitis B infection treated with besifovir vs. entecavir : Results from a multicentre study. In: Journal of Hepatology. 2015 ; Vol. 62, No. 3. pp. 526-532.
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title = "Two-year treatment outcome of chronic hepatitis B infection treated with besifovir vs. entecavir: Results from a multicentre study",
abstract = "Background & Aims We aimed to compare the viral suppression, safety and rate of drug resistance between besifovir (a new acyclic nucleotide analogue) and entecavir. Methods Treatment-na{\"i}ve 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 a virological breakthrough due to drug non-compliance. No patient 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 tolerated and also had a good clinical safety profile.",
author = "Yuen, {Man Fung} and Ahn, {Sang Hoon} and Lee, {Kwan Sik} and Um, {Soon Ho} and Mong Cho and Yoon, {Seung Kew} and Lee, {Jin Woo} and Park, {Neung Hwa} and Kweon, {Young Oh} and Sohn, {Joo Hyun} and Jiyoon Lee and Kim, {Jeong Ae} and Lai, {Ching Lung} and Han, {Kwang Hyub}",
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Yuen, MF, Ahn, SH, Lee, KS, Um, SH, Cho, M, Yoon, SK, Lee, JW, Park, NH, Kweon, YO, Sohn, JH, Lee, J, Kim, JA, Lai, CL & Han, KH 2015, 'Two-year treatment outcome of chronic hepatitis B infection treated with besifovir vs. entecavir: Results from a multicentre study', Journal of Hepatology, vol. 62, no. 3, pp. 526-532. https://doi.org/10.1016/j.jhep.2014.10.026

Two-year treatment outcome of chronic hepatitis B infection treated with besifovir vs. entecavir : Results from a multicentre study. / Yuen, Man Fung; Ahn, Sang Hoon; Lee, Kwan Sik; Um, Soon Ho; Cho, Mong; Yoon, Seung Kew; Lee, Jin Woo; Park, Neung Hwa; Kweon, Young Oh; Sohn, Joo Hyun; Lee, Jiyoon; Kim, Jeong Ae; Lai, Ching Lung; Han, Kwang Hyub.

In: Journal of Hepatology, Vol. 62, No. 3, 01.03.2015, p. 526-532.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Two-year treatment outcome of chronic hepatitis B infection treated with besifovir vs. entecavir

T2 - Results from a multicentre study

AU - Yuen, Man Fung

AU - Ahn, Sang Hoon

AU - Lee, Kwan Sik

AU - Um, Soon Ho

AU - Cho, Mong

AU - Yoon, Seung Kew

AU - Lee, Jin Woo

AU - Park, Neung Hwa

AU - Kweon, Young Oh

AU - Sohn, Joo Hyun

AU - Lee, Jiyoon

AU - Kim, Jeong Ae

AU - Lai, Ching Lung

AU - Han, Kwang Hyub

PY - 2015/3/1

Y1 - 2015/3/1

N2 - Background & Aims We aimed to compare the viral suppression, safety and rate of drug resistance between besifovir (a new acyclic nucleotide analogue) and entecavir. Methods Treatment-naïve 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 a virological breakthrough due to drug non-compliance. No patient 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 tolerated and also had a good clinical safety profile.

AB - Background & Aims We aimed to compare the viral suppression, safety and rate of drug resistance between besifovir (a new acyclic nucleotide analogue) and entecavir. Methods Treatment-naïve 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 a virological breakthrough due to drug non-compliance. No patient 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 tolerated and also had a good clinical safety profile.

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