No effect of baseline cirrhosis on long-term TDF treatment outcomes

Apr 13 2015

By Shreeya Nanda, Senior medwireNews Reporter

Research suggests that virological, serological and histological outcomes are comparable between cirrhotic and noncirrhotic patients with chronic hepatitis B virus (HBV) infection undergoing long-term tenofovir disoproxil fumarate (TDF) treatment.

The team used data from two randomised controlled trials that assigned 641 patients to receive either adefovir dipivoxil (n=215) or TDF (n=426) for a year followed by open-label TDF for up to a further 9 years. But only the 634 patients for whom baseline liver biopsy samples were available were included in this analysis.

After 5 years of treatment, virological response, defined as plasma HBV DNA levels below 69 IU/mL, was achieved by 99.2% of the 152 participants with cirrhosis at baseline and by 98.0% of the 482 noncirrhotic participants, a difference that was not significant.

Of the patients positive for serum hepatitis B e antigen (HBeAg) at intake, a similar proportion experienced HBeAg loss in the cirrhosis and noncirrhosis groups, at 61.9% and 45.4%, respectively. The rate of serum hepatitis B surface antigen loss in the HBeAg-positive cohort was comparable too, at 14.4% in patients with cirrhosis and 8.3% in those without.

Normalisation of alanine aminotransferase levels at 5 years was achieved by 79.7% of cirrhotic patients and by a comparable 81.9% of noncirrhotic patients.

And comparison of the liver biopsy samples at intake with the available 5-year samples (n=96 in the cirrhosis and n=252 in the noncirrhosis group) showed that both sets of patients achieved a histological response, with 93.8% and 90.5% of patients with and without cirrhosis, respectively, achieving a minimum 1 unit improvement in the Knodell necroinflammatory score.

However, the cirrhosis and noncirrhosis groups did vary significantly in terms of the rate of development of hepatocellular carcinoma (HCC), at 4.0% versus 1.2%.

Noting the comparable rates of virological response, Maria Buti (Hospital General Universitari Vall d’Hebron, Barcelona, Spain) and co-investigators propose that “the presence of cirrhosis at baseline may contribute more to the development of HCC during the study timeframe than viral load on therapy does.”

“Therefore, surveillance for HCC should be performed regardless of HBV DNA suppression”, they recommend in Hepatology International.

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