Introduction of lamivudine for the treatment of chronic hepatitis B: expected clinical and economic outcomes based on 4-year clinical trial data

J Gastroenterol Hepatol. 2002 Feb;17(2):153-64. doi: 10.1046/j.1440-1746.2002.02673.x.

Abstract

Background: Chronic hepatitis B (CHB) is associated with a significant burden of illness and treatment involves substantial health-care costs. This study estimates clinical outcomes and cost-effectiveness of lamivudine compared with other treatment scenarios for CHB, from an Australian health-care provider perspective.

Methods: A two-step modeling approach depicted clinical progression of hepatitis B in hypothetical patient cohorts using three different treatment scenarios: scenario A, lamivudine and alpha-interferon (IFN-alpha) available; scenario B, IFN-alpha available only; and scenario C, no treatment available. Assumptions were based on clinical trials, published studies, a hepatologist's questionnaire and an expert panel follow up. One-year clinical outcomes and costs were estimated using a decision tree, while lifetime costs and outcomes were estimated using available clinical trial data for lamivudine (up to 4 years therapy duration) and a Markov model.

Results: The analysis considered only patients with pretreatment elevated alanine aminotransferase levels > or = 2 x upper limit of normal. In the short term, the introduction of lamivudine is expected to result in almost 3.5 times more CHB patients receiving therapy (lamivudine or IFN-alpha) compared to IFN-alpha only (67% compared to 20%, respectively). Hence, scenario A subsequently doubled the seroconversion rate. The incremental cost-effectiveness ratio was $3341 Australian per additional seroconversion. Also, non-seroconverted lamivudine patients are less likely to progress to cirrhosis than those receiving IFN-alpha/no treatment. One-year progression to cirrhosis was estimated at 5.1% with scenario A, compared to 12.2% and 12.7%, scenarios B and C, respectively. From the long-term analysis, lamivudine is expected to increase life expectancy by years and reduce the lifetime risk of compensated cirrhosis, decompensated cirrhosis and hepatocellular carcinoma by 6%, 12% and 12%, respectively. Additionally, the introduction of lamivudine decreases lifetime costs by $548, thus making it a cost-saving and life-extending strategy. In both short- and long-term models, worst case scenarios in sensitivity analyses still associate lamivudine with a favorable cost-effectiveness ratio.

Conclusion: Introduction of lamivudine is expected to improve health outcomes in CHB patients, resulting in overall savings in health-care costs. In this model, compared with IFN-alpha only and no treatment, lamivudine allowed more CHB patients to be treated, increased the seroconversion rate, delayed disease progression and prolonged life expectancy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antiviral Agents / economics
  • Antiviral Agents / therapeutic use*
  • Australia
  • Clinical Trials as Topic
  • Cost-Benefit Analysis
  • Decision Support Techniques
  • Disease Progression
  • Health Care Costs
  • Hepatitis B, Chronic / drug therapy*
  • Hepatitis B, Chronic / economics
  • Humans
  • Interferon-alpha / economics
  • Interferon-alpha / therapeutic use
  • Lamivudine / economics
  • Lamivudine / therapeutic use*
  • Markov Chains
  • Models, Economic
  • Models, Statistical

Substances

  • Antiviral Agents
  • Interferon-alpha
  • Lamivudine