Gil Weitzman, MD; Ira Jacobson, MD
Potential Financial Conflicts of Interest: Consultancies: I. Jacobson (Gilead Sciences, Bristol-Myers Squibb).
Weitzman G., Jacobson I.; Cost-Effectiveness in Hepatitis B. Ann Intern Med. 2005;143:757-758. doi: 10.7326/0003-4819-143-10-200511150-00021
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Published: Ann Intern Med. 2005;143(10):757-758.
TO THE EDITOR:
In the cost-effectiveness analysis by Kanwal and colleagues (1), the authors conclude that a hybrid salvage strategy for chronic hepatitis B (HBV) infection (lamivudine with crossover to adefovir on resistance) is more cost-effective than adefovir monotherapy. This assessment does not sufficiently take into account the consequences of lamivudine resistance. Entecavir (Bristol-Myers Squibb, New York, New York) is a newly approved nucleoside analogue with greater antiviral potency than lamivudine in large comparative trials (2); in 48-week trials in treatment-naive patients, no resistance has been demonstrated. However, its potency is diminished in the presence of lamivudine-resistant HBV infection. Only 22% of lamivudine-refractory patients experienced complete suppression of HBV DNA (by polymerase chain reaction) compared with 83% of treatment-naive patients (3). In addition, the presence of preexisting lamivudine-induced mutations has been associated with the emergence of several additional signature mutations in patients receiving entecavir therapy, resulting in still further loss of potency. Given that more than 70% of patients will develop lamivudine resistance after 4 years of therapy, we contend that any strategy that uses lamivudine as a first-line drug has the potential to undermine the future efficacy of an entire class of potent nucleoside analogues that are already available (entecavir) or in the late phases of development (such as telbivudine). Adefovir is a nucleotide analogue without cross-resistance to lamivudine, but a recent study reported an increase in resistance to adefovir from 0% to 2% at 1 and 2 years, respectively, to 18% after 4 years in HBeAg–negative patients (4). This finding underscores the need for our therapeutic choices to preserve the maximum possible potency of alternative drugs.
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