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Long-Term Efficacy of Tenofovir Disoproxil Fumarate Therapy in Nucleos(t)ide-Experienced Chronic Hepatitis B Patients

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Abstract

Background and Objectives

Tenofovir disoproxil fumarate (TDF) therapy is a therapeutic option for nucleos(t)ide analogue (NA)-experienced chronic hepatitis B (CHB) patients infected with hepatitis B virus (HBV). In this study, we evaluated the efficacy of TDF alone compared with the efficacy of TDF plus additional NA combinations in NA-experienced CHB patients.

Methods

This retrospective cohort study included 108 patients with a serum HBV DNA level above 5.0 log10 IU/ml who were treated with TDF alone (monotherapy group) or TDF combined with additional NAs (combination therapy group) for 30 months.

Results

At month 30, both therapies resulted in the suppression of HBV DNA levels: 66 of 66 patients (100 %) in the monotherapy group and 40 of 42 patients (95.23 %) in the combination therapy group achieved virologic suppression. Kaplan–Meier curves revealed median times for virologic suppression of 3.12 months in the monotherapy group and 5.23 months in the combination therapy group (p = 0.699). The probability of virologic suppression was comparable between treatment groups. At month 6, more patients achieved normal alanine aminotransferase (ALT) levels in the monotherapy group (p = 0.029). During the treatment period, no patients experienced severe renal dysfunction.

Conclusion

TDF monotherapy and TDF plus additional NAs have comparable antiviral efficacy in CHB patients after NA treatment failure.

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Author notes

    Authors and Affiliations

    1. Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-Sen University, No. 600, Tianhe Road, Guangzhou, Guangdong, 510630, China

      Mingxing Huang, Yusheng Jie, Guoli Lin, Hong Shi, Xinhua Li, Xiangyong Li, Yuankai Wu & Yutian Chong

    2. Department of Infectious Diseases, Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong, China

      Mingxing Huang

    Authors
    1. Mingxing Huang
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    2. Yusheng Jie
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    3. Guoli Lin
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    4. Hong Shi
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    5. Xinhua Li
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    6. Xiangyong Li
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    8. Yutian Chong
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    Corresponding author

    Correspondence to Yutian Chong.

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    Funding

    None declared.

    Conflicts of interest

    MH, YJ, GL, HS, XL, XL, YW and YC declared no conflicts of interest.

    Ethical approval

    This study was approved by the Medical Ethics Committee of The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China. All procedures in this study were in accordance with the 1964 Helsinki declaration (and its amendments).

    Informed consent

    Signed informed consent was received from each patient prior to commencement of the study.

    Additional information

    M. Huang and Y. Jie contributed equally to this paper.

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    Huang, M., Jie, Y., Lin, G. et al. Long-Term Efficacy of Tenofovir Disoproxil Fumarate Therapy in Nucleos(t)ide-Experienced Chronic Hepatitis B Patients. Clin Drug Investig 36, 471–478 (2016). https://doi.org/10.1007/s40261-016-0392-0

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    • DOI: https://doi.org/10.1007/s40261-016-0392-0

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