‘Excellent’ survival with long-term TDF, entecavir treatment of chronic HBV
medwireNews: Caucasian patients with chronic hepatitis B virus (HBV) infection who receive long-term therapy with tenofovir disoproxil fumarate (TDF) or entecavir have “excellent” survival, which is comparable to that of the general population, say researchers.
This finding in “patients with diagnosed and appropriately treated [chronic HBV] suggests that the targets set by the World Health Organization for reductions in mortality are feasible at least in European countries,” they add.
The cohort included 1951 chronic HBV patients aged at least 16 years who were treated for 12 months or more with TDF and/or entecavir at one of 10 participating centers in Greece, Spain, Germany, Italy, the Netherlands, or Turkey. Just over a quarter (27%) of participants had compensated cirrhosis at baseline.
As reported in the Journal of Hepatology, 84 patients died of any cause over a median follow-up of 6 years, equating to a cumulative likelihood of survival at 1, 5, and 8 years of 99.7%, 95.9%, and 94.1%, respectively.
The corresponding rates for liver-related survival were 99.9%, 98.3%, and 97.4%, while the cumulative rates of transplantation-free liver-related survival at these timepoints were 99.9%, 97.8%, and 95.8%.
The mortality rate for this cohort of treated chronic HBV patients was comparable to that of the general population matched by country, age, sex, and calendar year of diagnosis, with a standardized mortality ratio (SMR) of 0.82.
George Papatheodoridis (Medical School of National and Kapodistrian University of Athens, Greece) and fellow researchers describe this finding as “reassuring” given the reports of increased all-cause mortality in untreated patients with chronic HBV and inactive carriers living in European countries.
Of note, chronic HBV patients without cirrhosis and those who did not develop hepatocellular carcinoma (HCC), regardless of baseline cirrhotic status, had mortality rates that were lower than those of the general population (SMR=0.58 for both comparisons).
The study authors point out that only the subgroup of patients who developed HCC had a mortality rate higher than that of the general population (SMR=3.09).
And in multivariable analysis, the presence of HCC was associated with a significantly increased risk for all-cause mortality (hazard ratio [HR]=35.95, p<0.001), liver-related mortality (HR=139.20, p<0.001), and transplantations or liver-related death (HR=163.13, p<0.001).
“Given that existing patients with [chronic HBV], particularly those whose liver disease remains undiagnosed, are becoming older and perhaps are progressing to more advanced stages of liver disease, the incidence of, and mortality related to, HBV-related HCC are expected to increase soon,” write Papatheodoridis et al.
“Thus, effective screening programmes should be implemented for diagnosis and treatment of existing [chronic HBV] patients at younger ages and earlier stages. Since HCC may also develop in effectively treated patients, careful evaluation of the patients’ HCC risk and HCC surveillance are mandatory.”
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