Clin Mol Hepatol.  2013 Jun;19(2):165-172. 10.3350/cmh.2013.19.2.165.

Efficacy and safety of entecavir plus carnitine complex (GODEX(R)) compared to entecavir monotherapy in patient with ALT elevated chronic hepatitis B: randomized, multicenter open-label trials. The GOAL study

• Jun DW
• Kim BI
• Cho YK
• Kim HJ
• Kwon YO
• Park SY
• Han SY
• Baek YH
• Jung YJ
• Kim HY
• Kim W
• Heo J
• Woo HY
• Hwang SG
• Rim KS
• Choi JY
• Bae SH
• Lee YS
• Lim YS
• Cheong JY
• Cho SW
• Lee BS
• Kim SH
• Sohn JH
• Kim TY
• Paik YH
• Kim JK
• Lee KS

• KMID: 1776804
• DOI: http://doi.org/10.3350/cmh.2013.19.2.165

Abstract

BACKGROUND/AIMS
Carnitine and vitamin complex (Godex(R)) 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-naive 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-gamma 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.

Keyword

Hepatitis B; Carnitine; Entecavir

MeSH Terms

Adult
Alanine Transaminase/blood
Antiviral Agents/*therapeutic use
Carnitine/*therapeutic use
DNA, Viral/analysis
Drug Therapy, Combination
Enzyme-Linked Immunospot Assay
Female
Guanine/*analogs & derivatives/therapeutic use
Hepatitis B Surface Antigens/blood
Hepatitis B e Antigens/blood
Hepatitis B virus/genetics
Hepatitis B, Chronic/*drug therapy
Humans
Interferon-gamma/metabolism
Male
Middle Aged
Mitochondria/physiology
Treatment Outcome
Vitamin B Complex/*therapeutic use
Antiviral Agents
DNA, Viral
Hepatitis B Surface Antigens
Hepatitis B e Antigens
Vitamin B Complex
Carnitine
Guanine
Interferon-gamma
Alanine Transaminase