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EASL 2015: HBV Patients on Long-term Entecavir or Tenofovir Have Low Mortality, HCC Still a Risk

More than 95% of people with chronic hepatitis B were still alive after 5 years on antiviral therapy with entecavir (Baraclude) or tenofovir (Viread), and most deaths were due to non-liver-related causes, but hepatocellular carcinoma was still a major factor affecting mortality, researchers reported presented at the European Association for the Study of the Liver (EASL) 50th International Liver Congress last month in Vienna. 

Antiviral therapy using nucleoside/nucleotide analogs such as lamivudine (Epivir), entecavir (Baraclude), or tenofovir (Viread) is the mainstay of chronic hepatitis B treatment. While these drugs can effectively suppress hepatitis B virus(HBV) replication during therapy, they usually do not lead to a cure and long-term treatment may be needed.

Over years or decades chronic HBV infection can lead to advanced liver disease including cirrhosis and liver cancer. Research indicates that maintaining viral suppression on treatment can help prevent disease progression. But as entecavir and tenofovir were approved for hepatitis B treatment in 2005 and 2008, respectively, long-term data are still needed.

George Papatheodoridis from Athens University Medical School in Greece and colleagues evaluated outcomes and survival among Caucasian chronic hepatitis B patients treated with entecavir or tenofovir. Hepatitis B is endemic in Asia and much of the research to date has involved Asian patients, so less is known about Caucasians with HBV.

This ongoing cohort study included 1815 chronic hepatitis B patients with or without liver cirrhosis, all Caucasian, at 9 centers in Europe, Turkey, and Canada. About 70% were men and the mean age was 53 years. 28% had compensated cirrhosis at baseline, but none had hepatocellular carcinoma (HCC).

All participants received either entecavir or tenofovir for at least 12 months. A majority (60%) has not previously used antiviral therapy before this study.

Results

• Among the total patient population, survival rates without liver transplantation were high overall: 99.5% at 1 year, 98.5% at 2 years, 97.5% at 3 years, and 95.0% at 5 years.
• Survival rates were significantly higher among non-cirrhotic patients (100%, 99.0%, 98.5%, and 97.0%, respectively), compared to those with cirrhosis (98%, 96.5%, 95.0%, and 92.0%).
• When only liver-related deaths or liver transplantation were taken into account, survival rates were even higher: 99.7%, 99.4%, 99.0%, and 97.5%, respectively.
• Again, survival was significantly higher among non-cirrhotics (100%, 100%, 100%, and 99.0%) compared to people with cirrhosis (99.0%, 98.0%, 97.0%, and 95.0%).
• Excluding patients who developed HCC, survival rates were 99.5%, 99.0%, 98.0%, and 96.5%, respectively.
• Here again, survival was higher for non-cirrhotics (100%, 99.0%, 99.0%, and 98.0%) compared to cirrhotics (98.0%, 97.5%, 96.5%, and 94.0%).
• Among the 85 patients who developed HCC, survival rates after liver cancer diagnosis were much lower: 76.0% at 1 year and 56.0% at 3 years.
• Among patients with HCC, there was no longer a survival difference between non-cirrhotic and cirrhotic patients.
• In a multivariate analysis, higher overall survival was independently associated with absence of HCC (HR 6.45) and younger age (HR 1.04 per year), but not with sex or cirrhosis.
• Considering only liver-related deaths, higher survival was independently associated only with absence of HCC (HR 22.45).

"The survival of Caucasian chronic hepatitis B patients treated with [entecavir or tenofovir] is excellent with >95% of cases surviving at 5 years and a significant proportion of deaths coming from liver unrelated causes," the researchers concluded.

However, they continued, "HCC development is a major factor affecting the overall mortality and the only factor affecting liver-related mortality in such patients."

5/28/15

Reference

G Papatheodoridis, G Dalekos, C Yurdaydin, P Lampertico, et al. Excellent 5-Year Survival in Caucasian Chronic Hepatitis B (CHB) Patients with or without Cirrhosis under Long-term Entecavir (ETV) or Tenofovir (TDF) Therapy and the Impact of Hepatocellular Carcinoma (HCC). 2015 International Liver Congress: 50th Annual Meeting of the European Association for the Study of the Liver (EASL). Vienna, April 22-26, 2015. Abstract P0641.

Other Source

EASL. Long-term therapy with entecavir or tenofovir demonstrates positive 5-year survival in patients with chronic hepatitis B. Press release. April 23, 2015.