Lamivudine for the treatment of chronic hepatitis B.

Lamivudine (Zeffix) is the first of a new class of antiviral agents to become available for the treatment of chronic hepatitis B. The results of controlled clinical trials indicate that in most patients, lamivudine improves necro-inflammatory liver disease, reduces the progression of hepatic fibrosis, normalises serum alanine aminotransferase, and enhances hepatitis B e antigen (HBeAg) seroconversion. For patients with HBeAg-positive chronic hepatitis B, one year of lamivudine therapy results in HBeAg seroconversion rates similar to those obtained with a standard course of interferon-alpha. Moreover, results from two and three years of lamivudine therapy show that the cumulative HBeAg seroconversion rate continues to increase with extended lamivudine therapy. Even in the absence of HBeAg seroconversion, lamivudine therapy leads to improvements in liver disease in many patients. HBV strains (YMDD variants) with reduced in vitro sensitivity to lamivudine were detected in some patients after at least 9 months therapy. Although the clinical benefits to lamivudine were greatest for those patients who remained free of YMDD variants, one year of lamivudine therapy led to improvements in most response parameters compared with placebo, regardless of whether YMDD variants were detected. Controlled and open-label studies show that lamivudine may provide similar benefits to other important groups of patients with chronic hepatitis B, including those with pre-core mutant disease and those with hepatic decompensation. Lamivudine was well tolerated in all patient groups studied. The incidence of adverse events was consistently similar in patients who received lamivudine compared with those given placebo. In conclusion, extensive clinical data provide evidence that lamivudine is a well-tolerated, effective, and convenient medicine for patients with chronic hepatitis B.