What is the difference in clinical outcomes of patients with chronic hepatitis B after discontinuation of tenofovir or entecavir? | High Score Study

Not yet knownEntecavir (ETV) )and tenofovir disoproxil fumarate (TDF)whether different patients Subgroupsrelapse and outcomes after discontinuation of treatment have different effects. Recently, a study published by Clin Gastroenterol Hepatol (impact factor 13.576) compared hepatitis B surface antigen (HBsAg) clearance, Virological and clinical recurrence and retreatment rates. The results showed that the HBsAg clearance rate and retreatment rate of the two groups were similar, indicating that the two groups had similar clinical outcomes after stopping treatment.

Research Methods

A total of 1402 patients with virally suppressed CHB who discontinued ETV (n=981) or TDF (n=421) treatment between 2001 and 2020 from 13 participating centers in Asia were included in this study. All patients were negative for hepatitis B e antigen (HBeAg) and had undetectable serum HBV DNA levels at the time of treatment discontinuation. Use the inverse probability of the treatment weights to balance the treatment groups. Patient outcomes were analyzed using survival methods.

Study Results

1. HBsAg clearance rate

During a median follow-up of 18 months after treatment discontinuation, a total of 96 patients ( 6.8%) achieved HBsAg clearance, of which 61 received ETV and 35 received TDF. The cumulative incidence of HBsAg clearance at 6, 12, and 24 months was 1.2%, 3.0%, and 6.4% in the TDF group, and 0.7%, 1.9%, and 6.7% in the ETV group, respectively.

In the unweighted population, the TDF group was associated with higher HBsAg clearance than the ETV group (p=0.03), but after statistical correction, this association was no longer significant (p=0.61) (Fig. 1).

Figure 1 Comparison of two groups Cumulative incidence of HBsAg clearance in patients

2. Virological and clinical recurrence rates

A total of 1097 patients (78%) experienced virological relapse during treatment discontinuation. The cumulative incidence of virological relapse at 6, 12, and 24 months was 65%, 76%, and 83%, respectively, in the TDF group and 42%, 69%, and 79%, respectively, in the ETV group. Virological recurrence occurred earlier in the TDF group (p<0.01), but virological recurrence occurred in both groups after the first year of discontinuation of treatment rate was comparable (p=0.49).

A total of 598 patients (43%) developed clinical recurrence. The cumulative incidence of clinical recurrence at 6, 12, and 24 months was 31%, 42%, and 58%, respectively, in the TDF group and 11%, 29%, and 44%, respectively, in the ETV group. During the entire follow-up period, the clinical recurrence rate in the TDF group was significantly higher than that in the ETV group (p<0.01). Among patients with clinical relapse, peak alanine aminotransferase (ALT) levels were higher in the TDF group than in the ETV group (p<0.01). ALT levels were comparable between the two groups at 6 months (p=0.63) and 12 months (p=0.97) after the onset of clinical relapse. The occurrence of virological or clinical relapse did not affect the HBsAg clearance rate.

There was no significant difference in retreatment rates between the two groups.


TDF and ETV Patients had different relapse patterns, and although early relapse rates were higher after TDF discontinuation, HBsAg clearance and retreatment rates were similar between the two groups, suggesting that the two groups had similar clinical outcomes after discontinuation of therapy. Therefore, patients with CHB may be considered for finite therapy with TDF or ETV.

However, virological relapse with ALT elevation occurred earlier in patients who discontinued TDF therapy, and clinical relapse occurred earlier.Higher peak ALT levels were seen during this period. In this regard, closer discontinuation monitoring early after TDF discontinuation may be required to ensure continued safety, and for patients with a history of advanced fibrosis or current advanced fibrosis, ETV prior to discontinuation may be an option.

References: Choi HSJ, Hirode G, Chen CH, Hirode G et al. Differential relapse patterns after discontinuation of entecavir vs tenofovir disoproxil fumarate in chronic hepatitis B[J]. Clin Gastroenterol Hepatol. 2022 Jul 18:S1542-3565(22)00672-3. doi: 10.1016/j.cgh.2022.07. 005.

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