期刊
BMC GASTROENTEROLOGY
卷 21, 期 1, 页码 -出版社
BMC
DOI: 10.1186/s12876-021-02008-9
关键词
Tenofovir disoproxil fumarate; Chronic hepatitis B; HBsAg; HBeAg-positive; Entecavir
资金
- GlaxoSmithKline (GSK)
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.
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