Evaluation of the safety and antiviral efficacy of the tenofovir alafenamide fumarate molecule in immunosuppressed patients

Abstract

Aim: Patients with chronic or prior hepatitis B virus (HBV) infection may experience HBV reactivation during immunosuppressive therapy. The objective of this study was to evaluate the safety and antiviral efficacy of tenofovir alafenamide fumarate (TAF) for prophylaxis of HBV reactivation in patients on immunosuppressive therapy.
 Material and Method: This study included patients who were started on immunosuppressive treatment due to hematologic/solid malignancy, autoimmune disease, or inflammatory disease and were treated with TAF for at least six months due to HBsAg and/or total anti-HBc positivity at Karadeniz Technical University Farabi Hospital between January 2018 and February 2021. Electronic medical records were retrospectively reviewed and the adverse event profile was analyzed. 
 Results: Of the 94 patients enrolled in the study, 70.2% (n=66) were male. The mean age of the patients was 60.37±14.56 years. The reasons for initiation of immunosuppressive drug treatment were hematologic malignancies in 48.9% (n=46), solid tumors in 27.7% (n=26), and other causes (autoimmune/inflammatory) in 23.4% (n=22). There was no statistically significant difference in creatinine, phosphorus, glucose, and LDL profile between baseline and 6-12 months of TAF treatment (p=0.861, p=0.136, p=0.323, p=0.304, respectively). All patients in whom HBV DNA was detectable at baseline became negative at the last follow-up visit. None of the patients developed HBV reactivation and there was no need to discontinue antiviral/immunosuppressive treatment due to side effects.
 Conclusion: TAF is a safe and effective short-term option to prevent HBV reactivation in patients receiving immunosuppressive therapy.