No effect of baseline cirrhosis on long-term TDF treatment outcomes
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.â€
“Therefore, surveillance for HCC should be performed regardless of HBV DNA suppressionâ€, they recommend in Hepatology International.
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