Tenofovir alafenamide prevents HBV reactivation in anticancer/immunosuppression: 24-month multicentre prospective study

OBJECTIVE: Our prior interim report remains the only prospective study evaluating tenofovir alafenamide (TAF) for HBV reactivation prevention, with prophylaxis assessed up to 12 months. Herein, we report the final 24-month follow-up results. METHODS: This multicentre prospective-study enrolled HBV carriers who received prophylactic TAF before antineoplastic or immunosuppressive therapy and patients with resolved HBV infection who developed reactivation and received TAF as reactivation-related hepatitis prophylaxis. We examined TAF effectiveness at 12 and 24 months. The primary endpoints were HBV reactivation and reactivation-related hepatitis. RESULTS: Of 191 enrolled patients, 150 and 127 were evaluable at 12 and 24 months, respectively. At 12 months, no HBV reactivation, HBV reactivation-related hepatitis, or therapy interruption occurred. Between months 12-24, four patients discontinued TAF. None of the remaining patients experienced HBV reactivation, HBV reactivation-related-hepatitis, or treatment interruption. Virologic relapse occurred in one of two patients with TAF discontinuation after anticancer/immunosuppressive therapy completion; TAF re-initiation enabled biochemical hepatitis prevention and viral suppression. Neither patient who switched to entecavir experienced reactivation. No patients on high-risk regimens developed reactivation, reactivation-related hepatitis, or treatment interruption. No patient discontinued therapy for TAF-related adverse events. CONCLUSIONS: Over 24 months, TAF demonstrated effectiveness in preventing HBV reactivation and reactivation-related hepatitis.