Effect and Safety of 12 Week Lamivudine Therapy in Patients with Chronic Hepatitis B

Suh, Dong Jin; Chung, Young Hwa; Lee, Yung Sang; Lee, Min Ho; Han, Kwang Hyub

Abstract

BACKGROUND/AIMS
Lamivudine, an oral nucleoside analogue, effectively inhibits hepatitis B virus replication and reduces hepatic necroinflammation in patients with chronic hepatitis B. This study investigated the effect and safety of 12 week lamivudine therapy in Korean patients with chronic hepatitis B (CHB).
METHODS
In an open clinical trial, 113 patients with CHB were enrolled. They received 100 mg of lamivudine orally once daily for 12 weeks, and they were followed until 2 weeks after cessation of lamivudine. HBV DNA (by bDNA assay), liver enzymes, creatine phosphokinase, creatinine and CBC were checked at 0, 2, 4, 8, 12 and 14 weeks. Compliance and side effects were evaluated at the same time.
RESULTS
After receiving lamivudine 100 mg, serum HBV DNA levels fell rapidly, remaining in 94.3% below baseline values at 2 weeks and 99.8% below baseline values at 12 weeks. Serum HBV DNA was cleared in 75.2% and alanine aminotransferase level (ALT) was normalized in 64.8% at 12 weeks. Cumulative percentage of HBeAg clearance (defined by clearance of serum HBV DNA and HBeAg) was 14.4%. Clearance of HBV DNA was more frequent in patients with lower pretreatment serum HBV DNA and higher ALT. During the treatment periods, adverse effects were negligible and transient. Two weeks after cessation of lamivudine, serum HBV DNA reappeared in 70.6% of responders.
CONCLUSION
It is suggested that lamivudine is effective and safe in the treatment of CHB in Korean patients, but further study for adequate duration of treatment is needed because of high recurrence after 12 weeks therapy.