TITLE: Entecavir Improve Liver Function and Fibrosis in Patients with Hepatitis B Virus-associated Liver Cirrhosis: 2 Years Study.
AUTHORS (FIRST NAME, LAST NAME): Hyeonsu Park1, Oh Sang Kwon1, Jong Joon Lee1, Young Kul Jung1, Duck Joo Choi1, Yun Soo Kim1, Ju Hyun Kim1
Institutional Author(s):
INSTITUTIONS (ALL): 1. Internal Medicine, Gachon University Gil Medical Center, Inchon, Korea, Republic of.
ABSTRACT BODY: Background and aims: Entecavir (ETV) induces biochemical and histologic improvement of the liver in patients with chronic hepatitis B. This study aimed to verify whether ETV improves liver function and fibrosis in patients with hepatitis B virus (HBV)-associated liver cirrhosis (LC) during 2 years treatment.
Methods: A total 145 naïve patients with HBV associated LC was treated by ETV for at least 2 years, between March 2007 and December 2012. All patients had HBV DNA level over than 4 log10 copies/mL and ALT level over than 40 IU/mL, because of regulation of Korea national health insurance. Exclusion criteria were the patients who 1) skipped the ETV more than 3 months and 2) developed hepatocelullar carcinoma within 2 years after ETV treatment. For the evaluation of liver function, laboratory findings, model for end stage liver disease (MELD) score, Child-Pugh (CP) score and class were compared between the baseline and 2 years after ETV treatment. For the evaluation of fibrosis, AST platelet ratio index (APRI) score, FIB-4 index, and fibrosis index (FI) were compared between the baseline and 2 years after ETV treatment.
Results: The final 111 patients were enrolled. The mean age was 53±9 years old and 62.2% of patients was male. The baseline mean AST and ALT were 110±83 IU/L and 110±87 IU/L, respectively. The mean HBV DNA level was 6.8±1.2 log10 copies/mL. At 2 years after ETV treatment, the rate of ALT normalization was 77.8%, HBeAg loss in HBeAg positive-patients (n=58) was 43.1% and the undetectable rate of HBV DNA (by real-time polymerase chain reaction) was 90.1%. The changes of total bilirubin, albumin, platelet count, MELD score, and CP score between the two time points were from 2.1±3.2 to 1.3±1.0 mg/dL (p=0.014), from 3.6±0.6 to 4.1±0.5 g/dL (p<0.001), from 102±44 to 110±48×1000>/mm3 (p=0.013), from 9.2±5.2 to 6.7±5.2 (p<0.001), and from 6.4±1.8 to 5.5±1.0 (p<0.001), respectively. The distribution of CP class at baseline was 66.7% in A, 26.1% in B, and 7.2% in C. The distribution of CP class at 2 year after ETV treatment was 88.3% in A, 10.8% in B, and 0.9% in C. The improvement of CP class between the two time points was significant (p<0.001). The changes of APRI score, FIB-4 index, and FI between the two time points were from 3.2±2.4 to 1.1±0.9 (p<0.001), from 6.8±4.1 to 4.3±3.0 (p<0.001), and from 3.4±0.9 to 2.9±0.9 (p<0.001), respectively.
Conclusions: Entecavir improves not only liver function but also fibrosis in patients with HBV-associated LC for long-term treatment.