Assessing the Benefits and Costs of New Therapies for Hepatitis B Virus Infection

In recent years, hepatitis B has taken a backseat to hepatitis C because of the increased prevalence of hepatitis C in the United States and western Europe. However, hepatitis B has reclaimed the attention of gastroenterologists and other health care professionals because of 3 developments: the introduction of polymerase chain reaction (PCR)–based hepatitis B virus (HBV) DNA testing; the improved understanding of the nature of HBV-related disease; and the introduction of potent, orally administered new antiviral agents. In our editorial, we discuss the treatment of HBV, which has evolved rapidly, and then comment on the cost-effectiveness of HBV therapies.

The renewed interest in hepatitis B has led to the publication of 2 treatment guidelines authored by 2 expert groups of hepatologists (1, 2). While differing slightly in criteria for offering treatment, both guidelines emphasize that treatment with current antiviral regimens can achieve 2 long-term goals. First, treatment can reverse decompensated cirrhosis (thereby allowing many patients with seemingly end-stage disease to be removed from transplantation lists). Second, treatment reduces the risk for developing hepatocellular carcinoma. Although some clinical issues relating to HBV therapy are still unsettled, enough evidence exists to justify antiviral therapy for a substantial proportion of chronically infected individuals. However, treatment is usually prolonged, and some of the drugs are expensive. Placed in this context, the contribution of Kanwal and colleagues' analysis in this issue (3) is timely.

During the early days of HBV treatment when interferon was the only available therapy, the most frequently used criterion for treatment was the presence of hepatitis B e antigen (HBeAg) in the serum. Introduction of PCR-based assay methods …