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Tenofovir delivers better protection against HCC than entecavir in HBV patients

Jairia Dela Cruz
28 May 2020

Persistent hepatitis B virus (HBV) replication contributes to an increased risk of hepatocellular carcinoma (HCC), and suppressing this replication with tenofovir disoproxil fumarate (TDF) yields greater HCC risk reduction than with entecavir (ETV), according to the results of a meta-analysis.

Such finding was consistently observed in the sensitivity analyses consisting of propensity-score matched (PSM) and cirrhosis subcohorts, as well as in meta-regression analyses, the researchers said.

The meta-analysis included 15 nonrandomized comparative studies evaluating the effect of the two nucleos(t)ide analogues on the risk of HCC, with a total population of 61,787 chronic HBV patients (TDF: n=16,101; ETV: n=45,686) aged 40–60 years.

Nine of the studies included only treatment-naïve patients, whereas the remaining six also involved treatment-experienced patients and those with unknown treatment status. Baseline characteristics of patients were comparable across the studies. However, the follow-up duration was longer for the ETV than the TDF arm in most of the studies.

Pooled data showed that HCC risk was 20-percent lower with TDF than with ETV (hazard ratio [HR], 0.80, 95 percent confidence interval [CI], 0.69–0.93; p=0.003; I2, 13 percent). [Clin Gastroenterol Hepatol 2020;doi:10.1016/j.cgh.2020.05.008]

The lower risk of HCC in patients given TDF persisted in sensitivity and subcohort analyses of (1) PSM cohorts with 15,387 patients (5,750 and 9,637 in TDF and ETV arms, respectively; HR, 0.75, 95 percent CI, 0.58–0.97; p=0.028) and (2) cirrhosis cohorts with 7,260 patients (2,452 and 4,808, respectively; HR, 0.74, 95 percent CI, 0.62–0.88; p=0.001).

Subsequent subgroup analyses revealed no significant between-group differences in the incidence of death or transplantation (HR, 0.93, 95 percent CI, 0.73–1.17; p=0.519; I2, 6 percent).

“Inclusion of patients with decompensated cirrhosis and the sample size were the factors with the largest effects on between-study heterogeneity in meta-regression analyses,” according to the researchers. “[As such], a special caution would be required in interpreting whether TDF may provide better reduction in risk of HCC than ETV in patients who do not have decompensated cirrhosis.”

The present data support the findings of previous meta-analyses reporting that nucleos(t)ide analogues substantially cut the incidence of HCC compared with no treatment. Use of such drugs have been shown to confer benefits for recurrence as well as disease-free and overall survival of chronic HBV patients with HCC after curative therapy. [Can J Gastroenterol Hepatol 2016;2016:5234969; Hepatology 2016;63:284-306; PLoS One 2014;9:e102761]

“Taken together, it has been consistently reported that nucleos(t)ide analogue treatment improves long-term clinical outcomes, such as HCC incidence, decompensation, and death, as well as intermediate surrogate endpoints, such as virologic, biochemical, and histologic responses,” the researchers said.

There were several limitations to the meta-analysis. For the most part, it did not include randomized controlled trials, and the majority of the patients were derived from an Asian chronic HBV cohort (eg, Korea, Taiwan, Hong Kong, India), which could limit the generalizability of the results.

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