title: Efficacy and safety of entecavir plus carnitine complex (GODEX®) compared to entecavir monotherapy in patient with ALT elevated chronic hepatitis B: randomized, multicenter open-label trials. The GOAL study.
abstract: OBJECTIVE
  Carnitine and vitamin complex (Godex®) is widely used in patients with chronic liver disease who show elevated liver enzyme in South Korea. The purpose of this study is to identify the efficacy and safety of carnitine from entecavir combination therapy in Alanine aminotransferase (ALT) elevated Chronic Hepatitis B (CHB) patients.
  
  
  METHODS
  130 treatment-naïve patients with CHB were enrolled from 13 sites. The patients were randomly selected to the entecavir and the complex of entecavir and carnitine. The primary endpoint of the study is ALT normalization level after 12 months.
  
  
  RESULTS
  Among the 130 patients, 119 patients completed the study treatment. The ALT normalization at 3 months was 58.9% for the monotherapy and 95.2% for the combination therapy (P<0.0001). ALT normalization rate at 12 months was 85.7% for the monotherapy and 100% for the combination group (P=0.0019). The rate of less than HBV DNA 300 copies/mL at 12 months was not statistically significant (P=0.5318) 75.9% for the monotherapy, 70.7% for the combination and it was. Quantification of HBsAg level was not different from the monotherapy to combination at 12 months. Changes of ELISPOT value to evaluate the INF-γ secretion by HBsAg showed the increasing trend of combination therapy compare to mono-treatment.
  
  
  CONCLUSIONS
  ALT normalization rate was higher in carnitine complex combination group than entecavir group in CHB. Combination group was faster than entecavir mono-treatment group on ALT normalization rate. HBV DNA normalization rate and the serum HBV-DNA level were not changed by carnitine complex treatment.
authors.affiliation: Department of Internal medicine, Hanyang University College of Medicine, Seoul, Korea.
authors.forename: Dae Won
authors.initials: DW
authors.lastname: Jun
authors.forename: Byung Ik
authors.initials: BI
authors.lastname: Kim
authors.forename: Yong Kyun
authors.initials: YK
authors.lastname: Cho
authors.forename: Hong Ju
authors.initials: HJ
authors.lastname: Kim
authors.forename: Young Oh
authors.initials: YO
authors.lastname: Kwon
authors.forename: Soo Young
authors.initials: SY
authors.lastname: Park
authors.forename: Sang Young
authors.initials: SY
authors.lastname: Han
authors.forename: Yang Hyun
authors.initials: YH
authors.lastname: Baek
authors.forename: Yong Jin
authors.initials: YJ
authors.lastname: Jung
authors.forename: Hwi Young
authors.initials: HY
authors.lastname: Kim
authors.forename: Won
authors.initials: W
authors.lastname: Kim
authors.forename: Jeong
authors.initials: J
authors.lastname: Heo
authors.forename: Hyun Young
authors.initials: HY
authors.lastname: Woo
authors.forename: Seong Gyu
authors.initials: SG
authors.lastname: Hwang
authors.forename: Kyu Sung
authors.initials: KS
authors.lastname: Rim
authors.forename: Jong Young
authors.initials: JY
authors.lastname: Choi
authors.forename: Si Hyun
authors.initials: SH
authors.lastname: Bae
authors.forename: Young Sang
authors.initials: YS
authors.lastname: Lee
authors.forename: Young Suck
authors.initials: YS
authors.lastname: Lim
authors.forename: Jae Youn
authors.initials: JY
authors.lastname: Cheong
authors.forename: Sung Won
authors.initials: SW
authors.lastname: Cho
authors.forename: Byung Seok
authors.initials: BS
authors.lastname: Lee
authors.forename: Seok Hyun
authors.initials: SH
authors.lastname: Kim
authors.forename: Joo Hyun
authors.initials: JH
authors.lastname: Sohn
authors.forename: Tae Yeob
authors.initials: TY
authors.lastname: Kim
authors.forename: Yong Han
authors.initials: YH
authors.lastname: Paik
authors.forename: Ja Kyung
authors.initials: JK
authors.lastname: Kim
authors.forename: Kwan Sik
authors.initials: KS
authors.lastname: Lee
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D002331:Carnitine / Q000627:therapeutic use*; D004279:DNA, Viral / Q000032:analysis; D004359:Drug Therapy, Combination; D058501:Enzyme-Linked Immunospot Assay; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D007371:Interferon-gamma / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D008928:Mitochondria / Q000502:physiology; D016896:Treatment Outcome; D014803:Vitamin B Complex / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D014803:Vitamin B Complex; C413685:entecavir; D006147:Guanine; D007371:Interferon-gamma; D000410:Alanine Transaminase; D002331:Carnitine
keywords: Carnitine; Entecavir; Hepatitis B