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Entecavir plus adefovir rescue therapy for chronic hepatitis B patients after multiple treatment failures in real-life practice.

Abstract

AimTo evaluate the efficacy and safety of Entecavir (ETV) plus adefovir (ADV) for chronic hepatitis B (CHB) patients after multiple nucleos(t)ide analogue (NAs) failure treatment.

METHODS:

Hepatitis B e antigen (HBeAg)-positive patients who had a suboptimal response or developed resistance to two or more previous NAs treatments were included, and all subjects were treated with ETV in combination with ADV for >= 24 months. Complete virologic response (CVR) was defined as an undetectability of serum hepatitis B virus (HBV) DNA level during treatment. Safety assessment was based on the increasing of serum creatinine and creatine kinase levels.

RESULTS:

A total of 45 eligible patients were included. Twenty-five patients had been treated with lamivudine (LAM) or telbivudine (LdT) and developed genotypic resistance. Resistance to ADV was present in 18 patients and 4 patients had a suboptimal response to ETV. Two patients had a resistance to both LAM and ADV. The cumulative probabilities of CVR at 12 and 24 months of ETV + ADV treatment were 88.9% (40/45) and 97.8% (44/45), respectively. Although one patient failed to achieve CVR, its serum HBV DNA level decreased by 3.3 log copies/mL after 24 months of combination therapy. The cumulative probability of HBeAg seroconversion was 15.6% (7/45) and 26.7% (12/45) at 12 and 24 months of treatment, respectively. History of prior exposure to specific NAs did not make a difference to ETV + ADV treatment outcome. There were no significant adverse events related to ETV + ADV therapy observed in the study subjects.

CONCLUSION:

ETV + ADV can be used as an effective and safe rescue therapy in patients after multiple NA therapy failures, especially in the areas where tenofovir is not yet available.

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  • Authors

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    Source

    Virology journal 10:1 2013 May 25 pg 162

    Pub Type(s)

    JOURNAL ARTICLE

    Language

    ENG

    PubMed ID

    23706010

    Citation

    TY - JOUR T1 - Entecavir plus adefovir rescue therapy for chronic hepatitis B patients after multiple treatment failures in real-life practice. A1 - Xu,Xian-Hua, AU - Li,Gai-Li, AU - Qin,Yang, AU - Li,Qiang, AU - He,Fa-Qun, AU - Li,Jin-Ye, AU - Pan,Quan-Rong, AU - Deng,Jie-Yin, Y1 - 2013/5/25/ PY - 2013/3/26/received PY - 2013/5/25/accepted PY - 2013/5/25/aheadofprint PY - 2013/5/28/entrez PY - 2013/5/28/pubmed PY - 2013/5/28/medline SP - 162 EP - 162 JF - Virology journal JO - Virol. J. VL - 10 IS - 1 N2 - AimTo evaluate the efficacy and safety of Entecavir (ETV) plus adefovir (ADV) for chronic hepatitis B (CHB) patients after multiple nucleos(t)ide analogue (NAs) failure treatment. METHODS: Hepatitis B e antigen (HBeAg)-positive patients who had a suboptimal response or developed resistance to two or more previous NAs treatments were included, and all subjects were treated with ETV in combination with ADV for >= 24 months. Complete virologic response (CVR) was defined as an undetectability of serum hepatitis B virus (HBV) DNA level during treatment. Safety assessment was based on the increasing of serum creatinine and creatine kinase levels. RESULTS: A total of 45 eligible patients were included. Twenty-five patients had been treated with lamivudine (LAM) or telbivudine (LdT) and developed genotypic resistance. Resistance to ADV was present in 18 patients and 4 patients had a suboptimal response to ETV. Two patients had a resistance to both LAM and ADV. The cumulative probabilities of CVR at 12 and 24 months of ETV + ADV treatment were 88.9% (40/45) and 97.8% (44/45), respectively. Although one patient failed to achieve CVR, its serum HBV DNA level decreased by 3.3 log copies/mL after 24 months of combination therapy. The cumulative probability of HBeAg seroconversion was 15.6% (7/45) and 26.7% (12/45) at 12 and 24 months of treatment, respectively. History of prior exposure to specific NAs did not make a difference to ETV + ADV treatment outcome. There were no significant adverse events related to ETV + ADV therapy observed in the study subjects. CONCLUSION: ETV + ADV can be used as an effective and safe rescue therapy in patients after multiple NA therapy failures, especially in the areas where tenofovir is not yet available. SN - 1743-422X UR - https://www.unboundmedicine.com/medline/citation/23706010/Entecavir_plus_adefovir_rescue_therapy_for_chronic_hepatitis_B_patients_after_multiple_treatment_failures_in_real_life_practice_ L2 - http://www.virologyj.com/content/10/1/162 ER -