REAL-WORLD DATA OF TENOFOVIR ALAFENAMIDE IN TREATMENT-NAIVE AND EXPERIENCED PATIENTS WITH CHRONIC HEPATITIS B: MORE EFFICACY, LESS SIDE EFFECTS

Abstract

Background: Tenofovir alafenamide (TAF) has fewer safety concerns and similar antiviral efficacy compared to entecavir (ETV) and tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB). We aim to pres-ent efficacy and safety data of TAF in the real-world patients. Methods: This is a retrospective study of patients (aged above 18 years) with CHB (HBeAg +/-) who have used TAF for at least 6 months. Longitudinal virological and biochemical tests were performed at intervals. HBV DNA level <31.6 IU/mL for virologicalresponse, serum phosphorus (Pi) level <2.5 mg/dl for hypophosphatemia, eGFR <60 mL/min/1.73m2 for azotemia, ALT level <35 in men and <25 IU/mL in women as normalization were accepted. Results: 225 patients were included in this study [age 57 years (IQR 48-65) , male 158 (70.2%), follow-up period 22 months (IQR 12-30), cirrhotic 43 (19.1%), decompensated 25/43 (58.1%), 72 post-liver transplant, 41 prophylaxis against reactivation]. 39 patients were treatment naive, 186 patients were switched to TAF from various anti-virals [TDF 164 (88%), ETV 18 (10%), others 4 (2%)]. Hypophosphatemia, azotemia and ostoporosis were the most common causes (67%) of switching to TAF. The viral load of anti- viral naive patients was sup-pressed significantly (p=0.011) and virologic response improved significantly in switch to TAF group (p=0.003) (fig1). HBsAg loss did not occur in any patient. eGFR levels before and after TAF treatment did not change significantly in total group unlike low baseline eGFR level group, eGFR levels increased significantly 6-12 months after TAF (p<0.001). After 6-12 months of TAF therapy, phosphorus levels improved significantly in both the total group and the low phosphorus group (p<0.001, fig1). Renal toxicity did not occur in naive group. LDL and triglyceride levels did not change sig-nificantly in the total group after TAF treatment. 33 pa-tients had abnormal ALT levels in switch to TAF group, 29 of them have normalized after treatment. There was no need to give up treatment due to adverse reactions. Conclusion: TAF has a potent viral suppressive effect in treatment-naive and experienced patients with CHB. Patients switched to TAF have improved renal function (characterized by elevated eGFR and Pi levels). TAF provided ALT normalization of patients and did not af-fect their lipid profiles. In CHB patients, TAF was safe, well-tolerated and effective in this real-world cohort.