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Drug Demonstrates Efficacy in Chronic Hepatitis B Patients

Entecavir-treated patients show greater improvement compared to continued lamivudine in patients with lamivudine-resistance

WEDNESDAY, July 2 (HealthDay News) -- Entecavir improved multiple efficacy endpoints compared to continued lamivudine in patients with chronic hepatitis B with resistance to lamivudine, according to an article published in the July issue of Hepatology.

Morris Sherman, M.D., Ph.D., from the Toronto General Hospital in Ontario, Canada, and colleagues assessed the efficacy and safety profile of 286 patients with chronic hepatitis B who were refractory to lamivudine and were randomized to receive either entecavir 1 mg/day or lamivudine 100 mg/day for 52 weeks. Entecavir responders were then given an additional 44 weeks of treatment.

Of the 141 patients treated with entecavir, 133 completed the 52-week dosing protocol, the report indicates. Among 77 responders continuing blinded treatment in the second year, the proportion of patients with decreasing viral load below 300 copies/mL increased from 21 percent to 40 percent, and the percentage of patients with ALT less than 1 times the upper limit of normal increased from 65 percent to 81 percent during the second year. The researchers note that 10 percent of patients achieved HBeAg seroconversion at 96 weeks of treatment, and there was no increased safety risk during the second year of treatment.

"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," according to the authors. "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."

The study received funding from Bristol-Myers Squibb. Several of the study authors report financial relationships with the pharmaceutical industry.

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