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

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 4.4 log10 IU/mL, and median alanine-transaminase (ALT) was 1.10 ¡Á ULN. Sixty percent were HBeAg positive, 47 % had significant fibrosis (?F3 Metavir equivalent), and 29 % had confirmed cirrhosis. Median treatment duration was 76 weeks (interquartile range 60?16). Kaplan¨CMeier analysis showed that, 48 weeks 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 1.1 log10 IU/mL, median ALT 0.79 ¡Á ULN, 33 % HBeAg positive, 61 % with significant fibrosis) were treated for a median duration of 76 weeks. 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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