Long-term entecavir, TDF effective in chronic HBV in real-world setting

Mar 13 2015

By Shreeya Nanda, Senior medwireNews Reporter

A Turkish clinical practice study shows that entecavir and tenofovir disoproxil fumarate (TDF) can effectively maintain long-term virological and biochemical responses in patients with chronic hepatitis B virus (HBV) infection, both in those with and without cirrhosis.

Hepatocellular carcinoma (HCC) did develop in a proportion of patients, but the rate was lower than that reported in previous studies, say the researchers, adding that owing to the lack of a control group, they “cannot prove” that HCC prevention was a consequence of antiviral therapy.

Virological response, defined as a serum HBV DNA level below 20 IU/mL, and normalisation of alanine aminotransferase (ALT) levels were achieved by a similar proportion of the 183 entecavir- and the 172 TDF-treated patients who were followed up for a minimum of 6 months. And the presence of cirrhosis did not adversely affect viral suppression.

The loss of hepatitis B e antigen (HBeAg) was also comparable between the treatment groups, achieved by 25.5% of the 105 HBeAg-positive patients in the entecavir group and 33.3% of the 54 HBeAg-positive participants in the TDF group.

Hepatitis B surface antigen loss occurred in one entecavir-treated and three TDF-treated participants.

A total of 17 patients, seven and 10 in the entecavir and TDF groups, respectively, were diagnosed with HCC during the course of the study, with 13 diagnosed in the first 2 years of treatment and the remaining in the third and fourth years.

The 1-year cumulative probability of HCC development was 3.3% at 1 year, and 4.2%, 5.9% and 7.3% at 2, 3 and 4 years, respectively, with no significant difference between patients receiving entecavir or TDF.

But HCC was diagnosed in 11.5% of the 139 cirrhotic patients and in 0.05% of the 216 patients without cirrhosis, a difference that was statistically significant. And multivariate analysis established cirrhosis and older age (≥50 years) as factors significantly associated with the development of HCC, with adjusted odds ratios of 20.66 and 4.16, respectively.

The team led by Ramazan Idilman (Ankara University School of Medicine) reports in the Journal of Viral Hepatitis that both entecavir and TDF were “well tolerated”, with no safety-related drug discontinuations or dose reductions in either group.

Additionally, serum creatinine levels and creatinine clearance remained stable during the study, leading the researchers to conclude that long-term entecavir or TDF treatment can be “safely maintained” in chronic HBV patients who do or do not have cirrhosis.

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