Eight-year survival in chronic HBV patients under long-term entecavir or tenofovir therapy is similar to the general population

The Journal of Hepatology
Eight-year survival in chronic HBV patients under long-term entecavir or tenofovir therapy is similar to the general population

George V. Papatheodoridis, Vana Sypsa, George Dalekos, Cihan Yurdaydin, Florian Van Boemmel, Maria Buti, John Goulis, Jose Luis Calleja, Heng Chi, Spilios Manolakopoulos, Alessandro Loglio, Spyros Siakavellas, Nikolaos Gatselis, Onur Keskın, Maria Lehretz, Savvoula Savvidou, Juan de la Revilla, Bettina E. Hansen, Anastasia Kourikou, Ioannis Vlachogiannakos, Kostantinos Galanis, Ramazan Idilman, Massimo Colombo, Rafael Esteban, Harry L.A. Janssen, Thomas Berg, Pietro Lampertico

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Highlights

•Chronic hepatitis B patients under entecavir/tenofovir have excellent 8-year survival.
•Mortality of non-cirrhotics seems to be lower than that of the general population.
•Mortality of cirrhotics is similar to that of the general population.
•Hepatocellular carcinoma is the main factor affecting their mortality.

Abstract
Background/Aims
The effects of long-term antiviral therapy on survival have not been adequately assessed in chronic hepatitis B (CHB). In this 10-center, ongoing cohort study, we evaluated the probability of survival and factors affecting survival in Caucasian CHB patients treated with long-term entecavir/tenofovir therapy.

Methods
We included 1951 adult Caucasians with CHB with or without compensated cirrhosis and no hepatocellular carcinoma (HCC) at baseline who received entecavir/tenofovir for ≥12 months (median: 6 years). Kaplan-Meier estimates of cumulative survival over time were obtained. Standardized mortality ratios (SMR) were calculated by comparing death rates with the Human Mortality Databases.

Results
The 1-, 5- and 8-year cumulative probabilities were 99.7%, 95.9% and 94.1% for overall survival, 99.9%, 98.3% and 97.4% for liver related survival and 99.9%, 97.8% and 95.8% for transplantation free liver related survival. Overall mortality was independently associated with older age and HCC development, liver related mortality with HCC development only and transplantation free liver related mortality with HCC development and lower platelets at baseline. Baseline cirrhosis was not independently associated with any type of mortality. Compared to general population, mortality was not significantly different in all CHB patients (SMR: 0.82), while it was lower in patients without HCC regardless of baseline cirrhosis (SMR: 0.58) and higher in patients who developed HCC (SMR: 3.09).

Conclusion
Caucasian patients with CHB and compensated liver disease treated with long-term entecavir/tenofovir therapy have excellent overall and liver related 8-year survival, which is similar to that of the general population. HCC is the main factor affecting their overall mortality and the only factor affecting their liver related mortality.

Lay summary
Caucasian chronic hepatitis B patients with or without compensated cirrhosis treated with long-term entecavir or tenofovir therapy have an excellent overall 8-year survival which is similar to that of the general population.

Hepatocellular carcinoma is the main factor affecting their overall mortality and the only factor affecting liver related mortality in this setting.

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