Superiority of tenofovir alafenamide fumarate over entecavir for serum HBsAg level reduction in patients with chronic HBV infection: A 144-week outcome study after switching of the nucleos(t)ide analog.

Yoshihito Uchida,Kayoko Sugawara,Yukinori Imai,Shunsuke Yamada,Nobuaki Nakayama,Jun-Ichi Kouyama,Shohei Tsuji,Kayoko Naiki,Tomoaki Tomiya,Hayato Uemura,Satoshi Mochida,Masamitsu Nakao,Jee-Fu Huang

doi:10.1371/journal.pone.0262764

Abstract

BackgroundTo evaluate the long-term efficacy of switching of the nucleos(t)ide analog used for treatment from entecavir (ETV) to tenofovir alafenamide fumarate (TAF) in patients with chronic HBV infection.MethodsA total of 103 patients with serum HBsAg levels of ≥100 IU/mL who had received ETV were enrolled. The nucleos(t)ide analog used for the treatment was switched from ETV to TAF, and the changes in serum HBsAg levels during the 144-week period before and after the drug switching were compared in 74 patients who had received ETV at least for 192 weeks.ResultsSignificant decreases of serum HBsAg levels were observed during both the ETV and the TAF administration period, although the degree of reduction was greater during the latter period than during the former period (P<0.001). Significant decreases of serum HBsAg levels were seen in both patients with genotype B HBV infection and genotype C HBV infection, irrespective of the serum HBsAg and HBcrAg levels at the time of the drug switching.ConclusionSwitching of the nucleos(t)ide analog used for treatment from ETV to TAF merits consideration in patients with chronic HBV infection, since the extent of reduction of the serum HBsAg level was greater during the TAF treatment period than during the ETV treatment period.

Highlights

According to the Cancer Information Service of the National Cancer Center in Japan [1], Japanese patients dying of hepatocellular carcinoma (HCC) have been decreasing year-onyear after 2003
Significant decreases of serum HBsAg levels were observed during both the ETV and the tenofovir alafenamide fumarate (TAF) administration period, the degree of reduction was greater during the latter period than during the former period (P
Significant decreases of serum HBsAg levels were seen in both patients with genotype B hepatitis B virus (HBV) infection and genotype C HBV infection, irrespective of the serum HBsAg and HBcrAg levels at the time of the drug switching

Summary

Introduction

According to the Cancer Information Service of the National Cancer Center in Japan [1], Japanese patients dying of hepatocellular carcinoma (HCC) have been decreasing year-onyear after 2003. TDF, cannot utilized for prolonged periods of time in patients, since tenofovir, derived from TDF following intestinal absorption, may cause renal tubular damage, leading to the development of hypophosphatemia, renal impairment, and bone mineral deficiency [8,9,10] These adverse events have not yet been known to occur in patients receiving TAF [8,9,10], which is a prodrug converted to tenofovir exclusively in the hepatocytes, the antiviral effects of TAF, especially in relation to its efficacy of reducing the serum HBsAg level in patients with chronic HBV infection, still remain to be precisely elucidated. To evaluate the long-term efficacy of switching of the nucleos(t)ide analog used for treatment from entecavir (ETV) to tenofovir alafenamide fumarate (TAF) in patients with chronic HBV infection

Methods

Discussion

Conclusion