Inhibitory effect of branched-chain amino acid granules on progression of compensated liver cirrhosis due to hepatitis C virus.
BACKGROUND
A phase II randomized controlled trial was conducted in patients with compensated liver cirrhosis to investigate the inhibitory effect of branched-chain amino acid (BCAA) granules for oral use (TK-98) on disease progression.


METHODS
Patients who had compensated liver cirrhosis due to hepatitis C virus with baseline serum albumin levels between 3.6 and 4.5 g/dl were assigned to the TK-98 group, which was treated with BCAA granules (TK-98) for 168 weeks, or to a control group (no treatment).


RESULTS
No symptoms indicating decompensated cirrhosis, including ascites, edema, and hepatic encephalopathy were reported in either the TK-98 or control group during the study observation period. Hepatocellular carcinoma (HCC) was noted in eight of the 39 patients studied, and of these three received TK-98 (15.8%) and five were untreated (25.0%). A time-to-event analysis for the effect of BCAA therapy on development of HCC revealed no statistically significant differences between the two groups. However, an additional analysis of data from a subgroup with a baseline serum albumin level of <4.0 g/dl showed that the incidence of HCC was likely to be lower in BCAA-treated patients.


CONCLUSIONS
BCAA may inhibit hepatic carcinogenesis in patients with compensated cirrhosis with a serum albumin level of <4.0 g/dl.
Kobayashi
Masahiro
M
Department of Gastroenterology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan.
Ikeda
Kenji
K
Arase
Yasuji
Y
Suzuki
Yoshiyuki
Y
Suzuki
Fumitaka
F
Akuta
Norio
N
Hosaka
Tetsuya
T
Murashima
Naoya
N
Saitoh
Satoshi
S
Someya
Takashi
T
Tsubota
Akihito
A
Kumada
Hiromitsu
H
D000284:Administration, Oral; D000368:Aged; D000597:Amino Acids, Branched-Chain / Q000008:administration & dosage*; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000209:etiology / Q000517:prevention & control; D004279:DNA, Viral / Q000032:analysis; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology; D018937:Hepatitis C Antibodies / Q000032:analysis; D019698:Hepatitis C, Chronic / Q000097:blood / Q000150:complications* / Q000821:virology; D006801:Humans; D008103:Liver Cirrhosis / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D008113:Liver Neoplasms / Q000097:blood / Q000209:etiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D012709:Serum Albumin / Q000378:metabolism; D013997:Time Factors; D016896:Treatment Outcome
D000597:Amino Acids, Branched-Chain; D004279:DNA, Viral; D018937:Hepatitis C Antibodies; D012709:Serum Albumin