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Entecavir Safe, Effective in Patients Unresponsive to Lamivudine MALDEN, Mass -- June 27, 2008 -- Patients with hepatitis B virus (HBV) who did not respond to lamivudine therapy had a better virological response after switching to entecavir for 1 year, according to a new study in the July issue of Hepatology. Continuing the drug for an additional year led to even more clinical improvement without significant side effects. Morris Sherman, PhD, Toronto General Hospital, Toronto, Ontario, and colleagues, studied 286 patients taking part in a double-blind, double-dummy, randomised, controlled trial comparing the safety and efficacy of entecavir 1 mg QD with lamivudine 100 mg QD. The results of the first year of this trial were previously reported. Of patients taking entecavir, 57% compared with 5% of those taking lamivudine were classified as virologic responders, and were offered continued therapy for an additional year. The researchers then assessed the efficacy, safety, and resistance profile of entecavir through 96 weeks of treatment. "The year 2 results demonstrated that patients continue to experience clinical benefit with entecavir therapy beyond 1 year, while the safety profile remained stable," the authors wrote. The additional year of treatment increased the proportion of patients with HBV DNA <300 copies/mL from 21% to 40%. Analysis showed that 7 patients in the total entecavir-treated cohort had baseline resistance to the drug. Another 10 became resistant in year 1, and 7 more in year 2. Virologic breakthrough lagged behind the development of resistance. "In summary, a second year of entecavir treatment in lamivudine-refractory patients with HbeAg-positive chronic hepatitis B resulted in continued virologic, serologic, and biochemical improvement and a safety profile that was comparable with the first year of therapy," the authors concluded. "A longer duration of treatment and continued treatment of patients with HbeAg loss may lead to higher rates of virologic response and seroconversion in lamivudine-refractory chronic hepatitis B patients." SOURCE: Wiley-Blackwell Publishing E-mail this page to a friend or colleague! To print, use this version