title: Two-year treatment outcome of chronic hepatitis B infection treated with besifovir vs. entecavir: results from a multicentre study.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Medicine, University of Hong Kong, Hong Kong.
authors.forename: Man-Fung
authors.initials: MF
authors.lastname: Yuen
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Ahn
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Kwan Sik
authors.initials: KS
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Soon Ho
authors.initials: SH
authors.lastname: Um
authors.affiliation: Department of Internal Medicine, Pusan National University School of Medicine, Yangsan, Republic of Korea.
authors.forename: Mong
authors.initials: M
authors.lastname: Cho
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Seung Kew
authors.initials: SK
authors.lastname: Yoon
authors.affiliation: Department of Internal Medicine, Inha University College of Medicine, Incheon, Republic of Korea.
authors.forename: Jin-Woo
authors.initials: JW
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan, Republic of Korea.
authors.forename: Neung Hwa
authors.initials: NH
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Republic of Korea.
authors.forename: Young-Oh
authors.initials: YO
authors.lastname: Kweon
authors.affiliation: Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Republic of Korea.
authors.forename: Joo Hyun
authors.initials: JH
authors.lastname: Sohn
authors.affiliation: LG Life Sciences, Ltd., Seoul, Republic of Korea.
authors.forename: Jiyoon
authors.initials: J
authors.lastname: Lee
authors.affiliation: LG Life Sciences, Ltd., Seoul, Republic of Korea.
authors.forename: Jeong-Ae
authors.initials: JA
authors.lastname: Kim
authors.affiliation: Department of Medicine, University of Hong Kong, Hong Kong. Electronic address: hrmelcl@hkucc.hku.hk.
authors.forename: Ching-Lung
authors.initials: CL
authors.lastname: Lai
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: gihankhys@yuhs.ac.
authors.forename: Kwang-Hyub
authors.initials: KH
authors.lastname: Han
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002331:Carnitine / Q000172:deficiency / Q000378:metabolism; D004279:DNA, Viral / Q000097:blood / Q000235:genetics; D005260:Female; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000378:metabolism / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D000069078:Seroconversion; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C487369:((1-((2-amino-9H-purin-9-yl)methyl)cyclopropyl)oxy)methylphosphonic acid dipivoxyl; D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D063065:Organophosphonates; C413685:entecavir; D006147:Guanine; D000410:Alanine Transaminase; D002331:Carnitine
keywords: Besifovir; Entecavir; LB80380; Resistance; Safety; Viral suppression