Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year Prospective Field Practice Study in Germany.

Abstract

Multiple clinical trials have demonstrated the efficacy and safety of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB). However, long-term efficacy and safety data for TDF in real-life clinical practice are limited. Prospective German field practice study in CHB-mono-infected patients. Patients were TDF-naïve but could have been treated previously with other HBV antivirals. Efficacy analysis included 400 patients; 301 (75%) completed 36months of TDF treatment. Both treatment-naïve and treatment-experienced patients showed a rapid decline in HBV DNA within 3months of TDF initiation. After 36months, HBV DNA<69IU/mL was achieved by 91% of treatment-naïve patients (90 and 92% in hepatitis B "e" antigen [HBeAg]-positive and [HBeAg]-negative, respectively) and 96% of treatment-experienced patients (93 and 97%, respectively). Three patients experienced virologic breakthrough, all with reported non-compliance. Overall, 5.7% HBeAg-positive and 2.2% HBeAg-negative patients lost hepatitis B surface antigen. Safety data were consistent with the known TDF safety profile; the most commonly reported adverse events possibly related to TDF were fatigue (2.0%) and headache (2.0%). Few patients (1.3%) experienced renal-related adverse reactions. Creatinine clearance remained relatively stable over time; patients responded favorably where TDF was dose adjusted per label for decreased creatinine clearance. TDF showed a favorable tolerability profile and induced rapid and sustained suppression of HBV DNA in patients with CHB treated for up to 3years in routine clinical practice, irrespective of treatment history. Efficacy and safety in this heterogeneous patient population were consistent with data from clinical trials.