4.3 Article

Switching from entecavir to tenofovir disoproxil fumarate for HBeAg-positive chronic hepatitis B patients: a phase 4, prospective study

Journal

BMC GASTROENTEROLOGY
Volume 21, Issue 1, Pages -

Publisher

BMC
DOI: 10.1186/s12876-021-02008-9

Keywords

Tenofovir disoproxil fumarate; Chronic hepatitis B; HBsAg; HBeAg-positive; Entecavir

Funding

  1. GlaxoSmithKline (GSK)

Ask authors/readers for more resources

This study aimed to evaluate the potential of switching from entecavir (ETV) to tenofovir disoproxil fumarate (TDF) for reducing HBsAg levels in HBeAg-positive chronic hepatitis B patients at 48 weeks. Results showed limited HBsAg reduction after switching, with a numerical increase in reduction for participants with higher alanine aminotransferase levels. Further investigation is needed to understand the clinical impact of this switch.
Background: Tenofovir disoproxil fumarate (TDF) is widely used and recommended as first-line treatment for patients infected with the hepatitis B virus (HBV). However, current data are limited regarding the efficacy and safety of switching to TDF for the treatment of chronic hepatitis B in hepatitis B e-antigen (HBeAg)-positive patients who are virologically suppressed with another nucleos(t)ide analogue. The primary objective of this study was to evaluate the hepatitis B surface antigen (HBsAg) reduction potential of switching from entecavir (ETV) to TDF at week 48 in HBeAg-positive chronic hepatitis B patients with undetectable serum HBV-DNA. Methods: In this multicenter, single-arm, open-label, phase 4 clinical study, 75 participants currently treated with ETV 0.5 mg once daily were switched to TDF 300 mg once daily for 96 weeks. Results: At week 48, 3/74 participants (4%) achieved 0.25 log(10) reduction of HBsAg levels from baseline (the primary endpoint). Mean HBsAg reduction was -0.14 log(10) IU/mL and 12% (9/74) achieved 0.25 log(10) reduction by 96 weeks. No participants achieved HBsAg seroclearance. HBsAg reduction at weeks 48 and 96 was numerically greater in participants with higher alanine aminotransferase levels (>= 60 U/L). Seventeen participants (25%) achieved HBeAg seroclearance up to week 96. No participants experienced viral breakthrough. All drug-related adverse events (18 participants [24%]) were mild in intensity, including an increase in urine beta-2-microglobulin (15 participants [20%]). Conclusions: In conclusion, HBsAg reduction was limited after switching from ETV to TDF in this study population. Further investigation is warranted to better understand the clinical impact of switching from ETV to TDF.

Authors

I am an author on this paper
Click your name to claim this paper and add it to your profile.

Reviews

Primary Rating

4.3
Not enough ratings

Secondary Ratings

Novelty
-
Significance
-
Scientific rigor
-
Rate this paper

Recommended

No Data Available
No Data Available