Antiviral Regimens for Chronic Hepatitis B Virus Infection

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The summary below is from the full report titled "Treatment Alternatives for Chronic Hepatitis B Virus Infection: A Cost-Effectiveness Analysis." It is in the 17 May 2005 issue of Annals of Internal Medicine (volume 142, pages 821-831). The authors are F. Kanwal, I.M. Gralnek, P. Martin, G.S. Dulai, M. Farid, and B.M.R. Spiegel.

What is the problem and what is known about it so far?

Hepatitis B is an inflammation of the liver that is caused by a virus. The virus spreads through contact with infected body fluids. Most people who get hepatitis B recover within a few months, but some develop chronic infection. Chronic infection increases the risk for liver failure and liver cancer. Persons with chronic infection often have virus-related protein substances in their blood (called hepatitis B surface antigens and e antigens) for many years. Persons with hepatitis B e antigens may have very active liver disease and a high level of hepatitis B virus.

Doctors often treat patients with chronic hepatitis B virus infections with powerful antiviral drugs. Several antiviral drugs are available that have different benefits, adverse effects, and costs. Some patients develop viral forms (mutants) that are resistant to 1 or more drugs. If this occurs, doctors may switch or add drugs. We do not know which of the many antiviral regimens is most cost-effective or whether cost-effectiveness varies depending on hepatitis B e antigen status.

Why did the researchers do this particular study?

To compare the cost-effectiveness of different antiviral regimens for chronic hepatitis B virus infection.

Who was studied?

Instead of studying actual patients, the researchers used computer models to combine evidence about the benefits, adverse effects, and costs of different regimens.

How was the study done?

The researchers compared the following 5 strategies: no treatment, interferon, lamivudine, adefovir, and lamivudine followed by adefovir if drug resistance developed (adefovir salvage). They reviewed medical literature to find information about the benefits and adverse effects of each approach. They also calculated the costs of each regimen, including its potential complications, and the health care costs of caring for patients with chronic liver disease. They then used a computer model to combine these data and estimate the cost-effectiveness of different treatment approaches over a patient's expected lifetime.

What did the researchers find?

Both interferon and adefovir salvage were cost-effective. Interferon was less expensive than adefovir salvage. No treatment, lamivudine, and adefovir were not cost-effective compared with either interferon or adefovir salvage. Interferon seemed most cost-effective for health care systems with tight budgetary constraints that treat many patients without hepatitis B e antigens.

What are the limitations of the study?

The authors based some estimates in the model on data from few studies. The results apply only to patients who have abnormal liver test results (elevated aminotransferase levels) and no evidence of liver scarring (cirrhosis). The authors did not model the cost-effectiveness of some newer salvage regimens after interferon treatment failure.

What are the implications of the study?

Interferon and adefovir salvage probably are cost-effective regimens for patients with chronic hepatitis B virus infection who have abnormal liver test results and no cirrhosis.