Efficacy and tolerance of a combination of tenofovir disoproxil fumarate plus emtricitabine in patients with chronic hepatitis B: A European multicenter study

Background and aims: The combination of tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) is used extensively to treat HIV infection and also has potent activity against hepatitis B virus (HBV) infection. The aim of this study was to assess the efficacy and tolerance of TDF. +. FTC in patients with chronic hepatitis B (CHB). Methods: Seventy eight consecutive CHB patients from five European centers were included. All started a TDF. +. FTC combination between October 2005 and March 2010. Virological, biochemical, and clinical data were recorded during follow-up. Tolerance was also monitored. Patients were classified into either treatment simplification (TS), where efficacy of the previous treatment was obtained at TDF. +. FTC initiation, and treatment intensification (TI), where the previous line of therapy had failed. Results: TDF+FTC was given as a TI to 54 patients (69%) and as a TS to 24 (31%). Among patients with TI, 83% were males. The median baseline HBV-DNA was 4.4log10IU/mL, and median alanine-transaminase (ALT) was 1.10×ULN. Sixty percent were HBeAg positive, 47% had significant fibrosis (≥F3 Metavir equivalent), and 29% had confirmed cirrhosis. Median treatment duration was 76weeks (interquartile range 60-116). Kaplan-Meier analysis showed that, 48weeks after TI, the probability of being HBV-DNA becoming undetectable was 76%, and reached 94% at week 96. No viral breakthrough occurred. Patients with TS (87% males, median baseline HBV-DNA 1.1log10IU/mL, median ALT 0.79×ULN, 33% HBeAg positive, 61% with significant fibrosis) were treated for a median duration of 76weeks. In this subgroup, all patients but one remained HBV-DNA undetectable and no ALT flare-up occurred during follow-up. Creatinine levels did not show kidney-function deterioration in either group of patients. Conclusions: After a median follow-up of >76. weeks, the TDF. +. FTC combination showed encouraging antiviral efficacy and a good safety profile in all patients with CHB. TDF. +. FTC may represent an interesting clinical option to simplify therapy and increase the barrier to resistance, which should be assessed in the long term.

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