No difference in HCC risk between tenofovir, entecavir for chronic HBV infection
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There was no clinically meaningful difference in the risk for hepatocellular carcinoma between patients taking tenofovir vs. entecavir to treat chronic hepatitis B virus infection, according to study results published in JAMA Network Open.
“The comparative risk of hepatocellular carcinoma between tenofovir and entecavir is a matter of ongoing controversy. Multiple meta-analyses on this topic yielded conflicting results, with some favoring tenofovir and others finding no significant difference between the two agents,” Daniel Q. Huang, MBBS, MCI, MMED, of the NAFLD Research Center at the University of California, San Diego, told Healio.
“All the previous meta-analyses relied on study-level data, and time-to-event data were not captured for individual patients. This led us to perform an individual patient data meta-analysis using reconstructed individual participant data, which accounts for censoring and addresses heterogeneity,” Huang, who also is affiliated with the National University of Singapore’s Yong Loo Lin School of Medicine, the National University Hospital’s division of gastroenterology and hepatology, and the National University Centre for Organ Transplantation, continued.
The reconstructed individual patient data meta-analysis included 24,269 patients (mean age, 49.86 years; 65.05% men) with chronic HBV infection being treated with tenofovir (n = 10,534) or entecavir (n = 13,735). Fourteen high-quality, propensity score-matched studies with time-to-event data were included.
Patients taking tenofovir vs. those taking entecavir had no statistically significant differences in baseline characteristics after propensity score matching. Median follow-up time was 3.46 years for tenofovir and 4.01 years for entecavir.
The incidence of HCC for patients taking tenofovir vs. patients taking entecavir was 3.08% vs. 3.51% at 1 year, 6.71% vs. 7.85% at 3 years and 8.26% vs. 10.87% at 5 years.
While the incidence of HCC in the overall cohort at 5 years was lower for tenofovir vs. entecavir (stratified Cox HR = 0.85; 95% CI, 0.76-0.94), the researchers found no significant difference when looking at subanalysis of clinical cohort studies at the same time point (stratified Cox HR = 0.92; 95% CI, 0.8-1.06).
“Although tenofovir was associated with a statistically lower hepatocellular carcinoma incidence in the overall analysis, there were no differences among clinical cohort studies that likely provided better balancing of baseline characteristics between groups,” Huang said.
“The mean time to hepatocellular carcinoma development was less than 3 weeks longer in the tenofovir group than in the entecavir group at year 5 among administrative database studies,” Huang continued. “Hence, our study suggests that there is no clinically meaningful difference in hepatocellular carcinoma incidence between tenofovir and entecavir.”
Based on these findings, the researchers recommended the choice of antiviral treatment for chronic HBV infection be based on “drug availability, patient convenience and tolerability, rather than the perception that one drug is better than the other,” Huang said.
While these data could be validated in a large, prospective, multicenter randomized trial, Huang cautioned the low rate of HCC development would mean such a trial would require an “extremely large number of patients” and a long follow-up duration.
“The current study provides the highest level of evidence available to date evaluating the comparative risk of hepatocellular carcinoma between tenofovir and entecavir,” Huang said.
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