Efficacy and safety of lamivudine therapy in patients with liver cirrhosis associated with chronic hepatitis B

Yang, Soo Hyun; Chung, Young Hwa; Jung, Sung Ae; Song, Byung Cheol; Jung, Suk Won; Chang, Woo Young; Lee, Sang Soo; Lee, Han Chu; Lee, Yung Sang; Suh, Dong Jin

Abstract

BACKGROUND: Lamivudine has been reported to be effective and safe in the treatment of chronic hepatitis B. However, in patients with advanced liver cirrhosis (LC) who have less hepatic reserve function and so higher chances of serious complications, its outcomes remained to be clarified. We evaluated the effectiveness and safety of lamivudine in patients with LC caused by hepatitis B.
METHODS
Twenty four patients with HBV-associated LC who had clinical evidence of hepatic dysfunction (Child-Pugh Class A:B:C = 13:7:4) as well as 76 patients with biopsy-proven chronic hepatitis B (CH) as controls were administered with 150 mg of lamivudine orally everyday for at least more than 6 months. Serum HBeAg and HBV-DNA (liquid phase hybridization assay) as well as CBC, prothrombin time and biochemistry were tested sequentially during the follow-up period.
RESULTS
All patients in both groups became negative for HBV-DNA in their sera during the treatment. Five out of 24 LC (21%) and 33 (43%) of 76 CH patients were relapsed within the follow-up periods of median 19 and 22 months, respectively (p=0.42). HBeAg seroconversion was observed in 7 of 19 LC (37%) and 25 of 69 CH (36%) patients with positive HBeAg (p=0.52). The hemoglobin, white blood cell and platelet counts were not changed significantly in both groups during the follow-up periods. The prothrombin time, serum cholesterol and bilirubin levels were also not changed significantly during the treatment. All of 76 CH patients had not presented any fatal complication during the follow-up periods. In contrast, 3 out of 4 LC patients in Child-Pugh class C died of serious complications (1 out of 5 relapsers, 2 of 19 persistent responders, p=NS; 1 died of sepsis, 2 of variceal bleeding).
CONCLUSION
Lamivudine therapy may be as effective in patients with LC as in those with CH in terms of the clearance of serum HBV-DNA and the seroconversion of HBeAg. Our data also suggest that the lamivudine therapy is as safe even in decompensated LC as in CH.