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Efficacy of 2years of entecavir plus adefovir therapy in patients with chronic hepatitis B who had failed on prior nucleos(t)ide analog treatment.

Abstract

Entecavir (ETV) plus adefovir (ADV) combination therapy may be a promising option for chronic hepatitis B (CHB) patients who have failed on prior nucleos(t)ide analog (NA) treatment. However, the long-term efficacy and safety of this combination are not well-defined. In a single-center, retrospective study, 104 patients (mean age 31.7 years; 88.5% male) with HBV DNA >10(3)IU/mL who had received one or multiple prior NAs for ⩾ 6 months (median 44.5 months) were treated for ⩾ 24 months with ETV (0.5mg/day) plus ADV (10mg/day). Among patients with available samples, 44/90 (48.9%) had drug-resistant mutations. At 2 years, HBV DNA levels were undetectable (<12 IU/mL) in 52/104 (50.0%) patients. The mean HBV DNA level was 2.0 ± 1.2 log 10 IU/mL, and it was decreased by 3.2 ± 2.0 log 10 IU/mL from the pre-combination treatment (V0) value. The 2-year HBeAg loss rate was 14.4% (13/90), HBeAg seroconversion rate was 10.0% (9/90), and ALT normalization rate was 75%. In multivariate analyses, the prior NA treatment duration, the V0 HBV DNA level, and the HBV DNA reduction at 1 year after ETV+ADV therapy were associated with the virological response after 2 years. No patients developed renal impairment, clinical decompensation or new HCC, and no relapses of HCC or deaths occurred. Thus, 2-year rescue therapy with ETV+ADV was effective and well-tolerated in CHB patients who had previously failed on multiple NA treatments. The HBV DNA level just before ETV+ADV combination therapy and the decrease of HBV DNA at 1 year could predict the efficacy of 2 years of ETV+ADV treatment.

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  • Authors+Show Affiliations

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    Department of Infectious Diseases, Southwest Hospital, The Third Military Medical University, Chongqing, China. Electronic address: wangxhke@126.com.

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    Department of Infectious Diseases, Southwest Hospital, The Third Military Medical University, Chongqing, China.

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    Department of Infectious Diseases, Southwest Hospital, The Third Military Medical University, Chongqing, China.

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    Department of Infectious Diseases, Southwest Hospital, The Third Military Medical University, Chongqing, China.

    Department of Infectious Diseases, Southwest Hospital, The Third Military Medical University, Chongqing, China.

    Source

    Antiviral research 103: 2014 Mar pg 71-7

    MeSH

    Adenine
    Adult
    Alanine Transaminase
    Antiviral Agents
    Cohort Studies
    DNA, Viral
    Drug Therapy, Combination
    Drug-Related Side Effects and Adverse Reactions
    Female
    Guanine
    Hepatitis B e Antigens
    Hepatitis B, Chronic
    Humans
    Male
    Organophosphonates
    Retrospective Studies
    Salvage Therapy
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    24462954