A Prospective Study of Therapeutic Effect of 6 Months Trial with Lamivudine in Patients with Chronic Viral Hepatitis B / 대한간학회지

ABSTRACT

BACKGROUND/AIMS: The purpose of this study was to evaluate the effectiveness of lamivudine treatment in patients with chronic liver disease caused by chronic infection of hepatitis B virus (HBV). METHODS: Thirty-ive patients with chronic infection of HBV were included in this study who were diagnosed at Hanyang University Hospital from January 1998 to January 1999. They received 150mg of lamivudine per oral once daily for 6 months with follow-p of liver function test, serum HBV DNA and serologic markers for hepatitis B virus every two months. Lamivudine was well tolerated. Eight patients underwent liver biopsies before entering the study and follow-p biopsies were done at 5 patients. RESULTS: Out of all 35 patients, chronic hepatitis patients histologically confirmed were 8, chronic hepatitis patients clinically diagnosed were 25 and liver cirrhosis patients clinically diagnosed were 2. The mean age was 35.7 years. Male-female ratio was 2.21. There was no hepatitis B surface antigen (HBsAg) negative seroconversion. The HBeAg loss rate was 26.9%(7/26) and HBeAg seroconversion rate was 10.7%(3/28) at the end of follow-p. Ten patients were anti-Be positive prior to treatment, 3 of them became anti-Be negative at the end of follow-p. Five patients underwent follow-p liver biopsies, in which histologic improvements were shown in 4 cases. Serum replicative HBV DNA by bDNA assay was decreased in all patients and HBV DNA was undetectable in 52.9%(9/17) at the end of treatment. Out of the 15 patients with abnormal alanine aminotransferase (ALT) levels at baseline, ALT level in 7 patients(46.7%) was normalized at treatment completion. Pretherapy ALT level was the only predictive factor for loss of HBeAg by stepwise logistic regression analysis(odds ratio 1.0208) (95% Confidence Interval 1.0023 ~ 1.0396) (p value=0.0271). CONCLUSIONS: Lamivudine induced sustained suppression of HBV replication during treatment in all patients. In treating patients with lamivudine, who had chronic liver disease due to chronic infection of HBV, the improvement of liver function test and suppression of viral replication appeared early and was sustained during the 6months treatment. This, in turn, may induce histological improvement as well. Pretherapy ALT level was the only predictive determinant for HBeAg loss during lamivudine therapy, and that should be kept in mind in selecting patients for treatment.