Lamivudine for Acute Hepatitis B Infection

Antiviral therapy with agents including lamivudine (Epivir-HBV), adefovir (Hepsera), entecavir (Baraclude), and telbivudine (Tyzeka) has been shown to be effective in the treatment of chronic hepatitis B, but it is unclear whether these agents are useful for treating acute hepatitis B virus (HBV) infection.

As reported in the January 2007 issue of Hepatology, Indian researchers conducted a study to evaluate the efficacy of lamivudine in 71 participants with acute hepatitis B. Patients with serum bilirubin levels of more than 5 mg/dL were randomly assigned to receive either 100 mg daily lamivudine for 3 months (n = 31) or placebo (n = 40).

Patients were considered to have severe acute hepatitis B if they fulfilled 2 of the following criteria:

• hepatic encephalopathy;

• serum bilirubin >/= 10.0 mg/dL;

• international normalized ratio (INR) >/= 1.6.

Results

• 22 patients (71.0%) in the lamivudine arm and 25 (62.5%) in the placebo group had severe acute hepatitis B.

• At Week 4, HBV DNA levels were significantly lower in the lamivudine arm compared with the placebo group (median 3.6721 vs 4.2721 log copies/mL; P = 0.037).

• Thereafter, HBV DNA levels were comparable in the 2 groups.

• The improvement in serum bilirubin, ALT, and INR values was similar in the 2 groups.

• Results were similar when patients with severe acute hepatitis B were analyzed separately.

• After 12 months, 93.5% patients in the lamivudine group and 96.7% in the placebo group experienced HBsAg loss.

• After 18 months, the respective rates were 92.5% and 97.5%.

• After 1 year, 21 patients (67.7%) in the lamivudine group and 34 (85%) in the placebo group developed protective anti-HBs antibody titers (P = 0.096).

• All HBeAg-positive patients in both groups lost HBV "e" antigen, and 71.0% and 87.5% of patients in the lamivudine and placebo groups, respectively, developed anti-HBe antibodies (P = 0.132).

• There were no deaths in either group.

Conclusion

"Though lamivudine causes a greater decrease in levels of HBV DNA, it does not cause significantly greater biochemical and clinical improvement as compared to placebo in patients with acute hepatitis B," the authors concluded.

01/05/07

Reference
M Kumar, S Satapathy, R Monga, and others. A randomized controlled trial of lamivudine to treat acute hepatitis B. Hepatology 45(1): 97-101. January 2007.