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Treatment Alternatives for Chronic Hepatitis B Virus Infection: A Cost-Effectiveness Analysis
abstract & commentary
By Malcolm Robinson, MD, FACP, FACG
Emeritus Clinical Professor of Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK
Dr. Robinson serves as a consultant for TAP, Pfizer, Janssen, Eisai, J&J-Merck, and Procter & Gamble, is on the speaker's bureau of Janssen, Eli Lilly, Solvay, TAP, and Aventis, and does research for Forest Labs, Wyeth-Ayerst, AstraZeneca, and Centocor.
Synopsis: Despite controversy as to the precise regimen that should be used for treating chronic hepatitis B infection, the most cost-effective alternative seems to be first-line use of the anti-viral drug lamivudine.
Source: Kanwal F, et al. Treatment alternatives for chronic hepatitis B virus infection: a cost-effectiveness analysis. Ann Intern Med. 2005;142:821-831.
Chronic hepatitis b infection (HBV) is extremely common worldwide, affecting an estimated 350 million people. In the United States, this disease is much less common, but there are still about 1.25 million infected people in this country (estimated cost of more than $700 million a year). Hepatitis B has a range of serious complications including cirrhosis, hepatic failure, and hepatocellular carcinoma. Interferon has been used for therapy, but efficacy is limited at 15-30% virologic response. Interferon is also associated with unpleasant and limiting side effects. Oral drugs such as lamivudine and adefovir are better tolerated but require long-term administration. Neither interferon nor lamivudine are very effective in patients negative for hepatitis B antigen (up to half of United States patients). Adefovir is effective regardless of HBV e antigen status, but it is much more expensive than lamivudine. Using decision analysis software, Kanwal and colleagues worked out the relative costs/benefits of various HBV therapy options. They took into consideration the costs of treatment vs the expenses associated with predictable complications of the disease with various therapies and with no therapy. The analysis done by Kanwal et al is very complex and considers several different patient groupings and all of the foreseeable response patterns to the therapies. Despite the relatively poor response and side effects associated with interferon, monotherapy with this agent was found to be cost effective. Adefovir was too expensive to be cost effective in any HBV infection cohort ($90,000 per quality-of-life year gained). Lamivudine therapy was also not deemed cost effective due to the frequent development of viral resistance. However, the authors do believe that there may be a role for initiation of lamivudine therapy followed by adefovir rescue for patients who become unresponsive. The only major potential defect in this analysis is mentioned by the authors: ie, they did not consider an additional arm that would have treated interferon failures with either lamivudine or adefovir.
For non-hepatologists, this paper does provide some useful information. First, it considers many of the current options for HBV infection management. This information can be valuable for primary care physicians whose patients may require one or more of these treatments and who might ask about such options. Second, it reminds us all that we have a long way to go to perfect anti-viral therapies. Nevertheless, many patients with chronic HBV infection can lessen or eliminate their viral burden and avoid the otherwise likely development of hepatic decompensation and hepatocellular carcinoma.