Drug & Device Development

Long-term entecavir effective for chronic HBV

Last Updated: 2012-07-13 18:10:30 -0400 (Reuters Health)

By Gabriel Miller

NEW YORK (Reuters Health) - Japanese researchers have found that long-term entecavir therapy reduces chronic hepatitis B to undetectable levels in 96% of patients, with only 1.1% experiencing viral breakthrough and less than 0.5% developing resistance.

In addition, there were no serious side effects in a group of patients who received entecavir for four years, according to the new results, published online June 1 in the Journal of Hepatology.

The study included 474 patients with chronic hepatitis B who received the recommended dose of entecavir -- 0.5 mg/day -- for a median of 2.4 years. Seventy-three of these patients were followed for at least four years.

All of the patients were nucleoside-na�ve and 336 had genotype C, which is common in Asian populations; 67 had genotype B and 12 had genotype A. Among these genotypes, 148, 57 and eight patients, respectively, were hepatitis B e antigen (HBeAg)-positive.

At the end of one year, 88% had undetectable hepatitis B virus DNA (HBV-DNA) levels, and this increased to 96% at four years. Among only HBeAg-positive patients, the figure rose from 75% at year one to 93% at year four.

Treatment failed in five patients, including two who developed entecavir-resistance. All of these patients were positive for HBeAg at baseline and had HBV-DNA serum levels >6 log10 IU/ml.

The investigators, led by Dr. Atsushi Ono at Toranomon Hospital in Tokyo, also did a multivariate analysis to see which factors helped predict response to therapy.

Although multiple factors appeared prognostic at years 1 and 2, only HBV-DNA level was a significant predictor of response at year 3 (<7.6 log10 copies/ml: odds ratio, 15.8; p=0.001).

"The most important factor of long-term entecavir therapy therefore was low HBV-DNA level," the researchers say.

SOURCE: http://bit.ly/N6v8dc

J Hepatol 2012.