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| |  Entecavir Has Low Resistance Rates After 5-Year Treatment of Chronic Hepatitis B PRINCETON, NJ -- March 25, 2008 -- Patients with nucleoside-naive chronic hepatitis B treated with entecavir have a continued low incidence of resistance through 5 years of treatment. Results from a new study -- announced at the 18th Conference of the Asia-Pacific Association for the Study of the Liver in Seoul, South Korea -- showed no additional patients developing resistance in the fifth year (n = 108). Through 5 years of treatment, the cumulative probability of developing mutations in the virus that confer genotypic resistance to entecavir was 1.2%. Among lamivudine-refractory patients who received entecavir after failed treatment with lamivudine, the cumulative probability of genotypic resistance to entecavir was 51% through the fifth year. This finding is consistent with prior observations that the pre-existence of lamivudine-resistant mutations results in an increase in the rate of entecavir resistance. "Many chronic hepatitis B patients require long-term treatment. Unfortunately, the initial benefits of therapy can be lost after the development of resistance," reported Professor Ching-Lung Lai, Chief, Division of Gastroenterology and Hepatology, University of Hong Kong, Hong Kong, People's Republic of China. Dr. Lai noted that "long-term minimal resistance at 1.2% in nucleoside-naive patients can be of great importance for patients." Drug resistance, which occurs when the hepatitis B virus mutates, can both decrease the efficacy of the current medication and compromise future treatment options. To date, studies have shown that multiple mutations are required to develop entecavir resistance. In this study, more than 700 patients across 6 studies initiated therapy on entecavir and were monitored for treatment response and resistance. This new report adds information on patients who received treatment with entecavir during the fifth year of follow-up (n = 108 patients in nucleoside-naive studies and n = 33 patients in lamivudine-refractory studies). All patients enrolled in clinical trials who experienced a virologic breakthrough (defined as a >= 1 log increase in hepatitis B DNA from nadir, as measured by the polymerase chain reaction [PCR] or PCR assay) or whose virus had not yet reached undetectable levels (defined as hepatitis B DNA levels <300 copies/mL, as measured by PCR assay) at weeks 48, 96, 144, 192, 240, or end of dosing, were sequenced to determine if any changes occurred in the genetic code of the virus that would result in resistance or loss of effectiveness of entecavir.
SOURCE: Bristol-Myers Squibb
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