Comparison of efficacy and safety of entecavir and switching from entecavir to tenofovir alafenamide fumarate in chronic hepatitis B: Long‐term effects from a prospective study

Abstract

Aim: Both entecavir (ETV) and tenofovir alafenamide fumarate (TAF) are widely used to treat chronic hepatitis B (CHB) in Japan. However, it remains unclear whether the efficacy of TAF in decreasing the hepatitis B surface antigen (HBsAg) level, and its safety, are superior to those of ETV. This study aimed to report the long-term effects and safety of 96-week ETV and TAF treatment in patients with CHB.Methods: A prospective comparative observational study was undertaken on the following two groups: patients with CHB who received continuous ETV (n = 32) and patients with CHB who were switched from ETV to TAF upon request (n = 48). The HBsAg, urinary β2-microglobulin (β2MG)/creatinine (Cr), urinary N-acetyl-β-Dglucosaminidase (NAG)/Cr, and serum alanine aminotransferase (ALT) levels, estimated glomerular filtration rate (eGFR), and bone mineral density (lumbar spine and femur) at 96 weeks were compared. Results:The two groups did not significantly differ with respect to mean age, male / female patient ratio, or rate of hepatitis B e antigen-positive status. The mean changes in serum HBsAg level and eGFR at 96 weeks were not significantly different between the two groups. The β2MG/Cr and NAG/Cr levels at 96 weeks were similar between the two groups. Additionally, the bone mineral density of the lumbar spine and femur as well as the serum ALT did not significantly differ. Conclusions:When compared with patients who received continuous ETV, those who were introduced to TAF after ETV showed similar effects in terms of the decrease in HBsAg level and safety.

Comparison of Tenofovir Alafenamide and Entecavir Therapy in Patients with Chronic Hepatitis B Initially Treated with Tenofovir Disoproxil: A Retrospective Observational Survey

“…Half of the patients with ETV experience were switched to TAF in a study, and the groups were compared. No significant difference was found between the two groups after 24, 48, and 96 weeks in serum HBsAg levels (22,23). In our study, the median duration of TDF treatment for those with detectable HBV-DNA at baseline was 12 months.…”

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

“…Similar results were also reported by Itokawa et al [20], Li ZB et al [21], and Tamaki N, et al [22]. There were limitations of these studies, e.g., small study sample sizes [18,19,21,22], short TAF administration period (24 weeks) [21], and different sites of measurement of the serum HBsAg levels [17,20]. Thus, in the present study, we compared the degrees of reduction of the serum HBsAg levels over the long term (144 weeks) in the same cohort of patients as in our previous study [11], by comparison of the level between the 144-week ETV treatment period prior to switching of the nucleos(t)de analog from ETV to TAF and the 144-week TAF treatment period after the drug switching.…”

“…Kumada T, et al reported results similar to ours [11] in patients in whom the nucleos(t)ide analog used for treatment was switched from ETV to TAF [16]; on the other hand, Ogawa E, et al [17] did not find any superiority of TAF over ETV, in terms of the efficacy of the drugs in reducing the serum HBsAg levels. Moreover, Hagiwara et al reported similar degrees of reduction of the serum HBsAg level between patients in whom the nucleos(t)de analog was switched from ETV to TAF and those who had received ETV monotherapy [18,19]. Similar results were also reported by Itokawa et al [20], Li ZB et al [21], and Tamaki N, et al [22].…”

“…Moreover, the McNemar test revealed that the antiviral efficacy of TAF was superior to that of ETV when increase and decrease of the serum HBsAg level by 0.08 Log IU/mL/48 weeks or more were defined as "increase" and "decrease," respectively (P = 0.022) [11]. Controversy exists, however, as to whether TAF exerts superior efficacy to ETV in reducing the serum HBsAg level [16][17][18][19][20][21]. Kumada T, et al reported results similar to ours [11] in patients in whom the nucleos(t)ide analog used for treatment was switched from ETV to TAF [16]; on the other hand, Ogawa E, et al [17] did not find any superiority of TAF over ETV, in terms of the efficacy of the drugs in reducing the serum HBsAg levels.…”

Patients with liver cirrhosis due to nonalcoholic steatohepatitis have lesser chances for liver transplantation

“…In the past decade, the etiologies of liver cirrhosis have changed 4 . The contribution of viral hepatitis as an etiology of liver cirrhosis has decreased due to advances in antiviral therapies 5–8 . In contrast, alcohol‐related liver disease and nonalcoholic steatohepatitis (NASH) have increased due to lifestyle changes 9–11 .…”