Tenofovir alafenamide for prevention and treatment of hepatitis B virus reactivation and de novo hepatitis

Abstract

Background and Aim Administration of tenofovir alafenamide (TAF) as prevention or treatment of hepatitis B virus (HBV) reactivation is not well known. The aim of this study is to reveal the efficacy and safety of TAF against HBV reactivation. Methods Entecavir (ETV) and TAF were given to 66 and 11 patients, respectively, as prophylaxis against or treatment of HBV reactivation during chemotherapy or immune suppression therapy from January 2010 to June 2020. The antiviral effects and safety were assessed. Results At week 24, the antiviral effects on patients receiving ETV and TAF were similar in terms of reduction of HBV DNA (−2.83 ± 1.45log IU/mL vs −3.05 ± 2.47log IU/mL; P = 0.857) and achieving undetectable levels of HBV DNA (78.8 vs 90.9%; P = 0.681). There was no significant difference in the decrease in the estimated glomerular filtration rate (eGFR) between the two groups (−0.62 ± 11.2 mL/min/1.73 m2 vs −3.67 ± 13.2 mL/min/1.73 m2; P = 0.291). Conclusion TAF is safe and effective against HBV reactivation.

KASL clinical practice guidelines for management of chronic hepatitis B

“…Considering the failure rate and tolerance rate, entecavir and tenofovir are expected to be relatively safe options. In a retrospective study evaluating patients receiving chemotherapy or immunosuppressant treatment for solid cancers, lymphoma, or rheumatic diseases, the tenofovir AF group (n=11) had similar effects compared to the entecavir group (n=66) in terms of HBV DNA reduction effect (-2.83±1.45 log IU/mL vs. -3.05±2.47 log IU/mL; P =0.86), HBV non-detection rate (78.8 vs. 90.9%; P =0.68), and renal function decline rate (-0.62±11.2 mL/min/1.73 m2 vs. -3.67±13.2 mL/min/1.73 m2; P =0.29), respectively [ 401 ]. Therefore, tenofovir AF can also be considered as a safe drug with good preventive effects.…”

Antiviral Prophylaxis With Tenofovir for Patients With History of Hepatitis B Receiving Oncology Drug Treatment

“…The 4 included primary clinical studies comprised 2 RCTs 17,18 and 2 retrospective cohort studies. 19,20 The RCTs were published in 2021 17 and 2017, 18 while the 2 retrospective cohort studies were published in 2021 19 and 2018. 20 One RCT 17 was parallel and from a single centre (a university).…”

“…One RCT 18 analyzed the data using the intention-to-treat (ITT) approach, while the other 17 analyzed the data as per protocol. The 2 retrospective cohort studies 19,20 did not perform sample size calculation and did not identify and adjust for confounding variables in the analyses.…”

“…The primary clinical studies were conducted by authors from Turkey, 17 Spain, 18 Japan, 19 and Taiwan. 20 The guidelines were conducted by authors from Australia, 21,24 Germany, 22 Brazil, 23 India, 25 US, 26 Canada, 27 and Italy.…”

“…One retrospective cohort study 19 involved patients undergoing chemotherapy or immunosuppressive therapy for cancer who had previous HBV infection or were HBV carriers.…”