The role of antivirals in patients with acute viral hepatitis B (AVH-B) has not been evaluated in controlled trials. The aim of this study was to evaluate the efficacy of lamivudine in patients with AVH-B. AVH-B patients with serum bilirubin of more than 5 mg/dL were randomized to receive either 100 mg of lamivudine daily for 3 months (group 1, n ‫؍‬ 31) or placebo (group 2, n ‫؍‬ 40). Patients were considered to have severe AVH-B if they fulfilled 2 of 3 criteria: (1) hepatic encephalopathy; (2) serum bilirubin > 10.0 mg/dL; and (3) international normalized ratio (INR) > 1.6. At week 4, HBV DNA levels were significantly lower (P ‫؍‬ 0.037) in group 1 (median: 3.6721 log copies/mL) than group 2 (median: 4.2721 log copies/mL). 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. Twenty-two patients (71%) in group 1 and 25 patients (62.5%) in group 2 had severe AVH-B. Results were similar when patients with severe AVH-B were analyzed separately. After 12 and 18 months, 93.5% and 92.5%, respectively, of patients in the lamivudine group and 96.7% and 97.5%, respectively, of patients in the placebo group lost HBsAg. There were no deaths in either group. After 1 year, 21 patients (67.7%) in group 1 and 34 patients (85%) in group 2 developed protective anti-HBs titers (P ‫؍‬ 0.096). All HBeAg-positive patients in both groups lost e antigen and anti-HBe developed in 71% and 87.5% of patients in groups 1 and 2, respectively (P ‫؍‬ 0.132). A cute viral hepatitis B (AVH-B) is successfully cleared in more than 95% of immunocompetent patients. The remainder of patients may develop either chronic HBV infection or, in a small proportion, fulminant hepatitis.The accepted criteria for defining clinical and serologic recovery from acute hepatitis B are clearance of circulating hepatitis B surface antigen (HBsAg) and appearance of the antibodies to HBsAg (anti-HBs), with normalization of serum aminotransferases. Nevertheless, a recent longterm study noted that occult HBV infection might persist in the liver up to 10 years after clinical resolution. 1Lamivudine is a potent inhibitor of HBV replication that works by causing chain termination of an RNA-dependent HBV polymerase. 2 It has been administered successfully to immunocompromised patients with 4 Since a proportion of patients with AVH-B develop severe hepatitis and fulminant hepatic failure, a logical hypothesis is that rapid reduction in the HBV DNA levels through the use of antiviral agents could result in a less intense host response against the hepatitis B virus. However, the experience with lamivudine treatment of immunocompetent patients with AVH-B has been limited to only a few case reports, 5,6 a published abstract of a larger series 7 and a pilot study. 8 The aim of this study was to evaluate the efficacy, utility, and safety of lamivudine in treating immunocompetent patients with AVH-B.

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