Hepatitis B patients who were treated with a combination of the
antiviral entecavir (Baraclude) and a vitamin called carnitine complex
(Godex) quickly achieved normal alanine transaminase (ALT) levels within
three months, compared to patients treated with only entecavir. The
study, published in the journal Clinical and Molecular Hepatology,
followed 119 patients and found that 95.2% achieved normal ALT levels
(indicating a healthy liver) within three months, compared to 58.9%
treated with just entecavir.
—Christine. M. Kukka, Project Manager, HBV Advocate
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.
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.
Department of Internal medicine, Hanyang University College of Medicine, Seoul, Korea.
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.
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.
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.
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.
Labels: adjuvant therapies, carnitine, entecavir, treatment response, vitamin therapy