Long-Term Entecavir Therapy Improves Histology in HBV

Three years' therapy reverses fibrosis, cirrhosis in patients with chronic disease

THURSDAY, Aug. 19 (HealthDay News) -- Long-term treatment (at least three years) with entecavir appears to result in histologic improvements and regression of fibrosis or cirrhosis in people with chronic hepatitis B virus, according to research published in the September issue of Hepatology.

Ting-Tsung Chang, M.D., of the National Cheng Kung University Medical College in Tainan, Taiwan, and colleagues evaluated 69 nucleoside-naive patients from two Phase III entecavir studies -- hepatitis B e antigen (HBeAg)-positive and HBeAg-negative. The patients had subsequently entered an open-label rollover study and received entecavir for at least three years. The patients had a long-term liver biopsy, and 57 patients who had adequate baseline biopsy were analyzed for histologic improvement.

The researchers found that 96 percent of the patients had a decrease in Knodell necroinflammatory score of at least two points and no worsening in their Knodell fibrosis score, indicating histologic improvement; 88 percent, including the 10 patients with advanced fibrosis or cirrhosis at Phase III baseline, were found to have an improvement in Ishak fibrosis score of at least one point.

"The majority of nucleoside-naive chronic hepatitis B patients treated with entecavir in this long-term cohort achieved substantial histologic improvement and regression of fibrosis or cirrhosis," the authors write.

The research was sponsored by Bristol-Myers Squibb Pharmaceutical Research Institute; study authors disclosed financial relationships with medical device and/or pharmaceutical companies, including Bristol-Myers Squibb.

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