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Comparison of entecavir monotherapy and de novo lamivudine and adefovir combination therapy in HBeAg-positive chronic hepatitis B with high viral load: 48-week result.

Abstract

This study compared virologic response to entecavir monotherapy and de novo lamivudine plus adefovir (LAM + ADV) combination therapy in patients with chronic hepatitis B (CHB) with high viral load (HVL). Hepatitis B e antigen (HBeAg)-positive patients [hepatitis B virus (HBV) DNA levels >1 × 10(7) copies/ml] were assigned to LAM + ADV or entecavir treatment. The primary efficacy endpoint measure of the multicenter prospective cohort study was proportion of patients with CHB with virologic response, defined as HBV DNA <300 copies/ml at week 48. During treatment, 39.1 % (18/46) of patients in the LAM + ADV group and 48.1 % (25/52) of those in the entecavir group achieved virologic response in week 48 (P = 0.37). A baseline alanine aminotransferase (ALT) level ≥5 × ULN (upper limit of normal) or baseline serum HBV DNA level <8 log10 IU/ml could predict virologic response at week 48 (P = 0.025). The mean reduction in HBV DNA was comparable (P = 0.45); no significant difference was found in the proportion of ALT normalization (P = 0.46) or HBeAg seroconversion (P = 0.88). Two cases of genotypic resistance were found (rtM204 V + rtL180 M and rtA181T/V) in the LAM + ADV group, with a resistance rate of 4.3 %; there was no genotypic resistance in the entecavir group (P = 0.13). De novo LAM + ADV combination therapy is as effective as entecavir monotherapy in HBeAg-positive patients with CHB with HVL. Moreover, genotypic resistance was only found in the LAM + ADV group at week 48. Baseline ALT levels ≥5 ULN or baseline serum HBV DNA levels <8 log10 IU/ml were favorable predictors of virologic response in CHB with HVL.

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  • Authors+Show Affiliations

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    Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong Province, China. First Affiliated Hospital of Xiamen University, Xiamen, Fujian Province, China.

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    Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong Province, China.

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    Southwest Hospital, Third Military Medical University, Chongqing, China.

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    Second Xiangya Hospital, Central South University, Changsha, Hunan Province, China.

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    Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, Zhejiang Province, China.

    Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong Province, China. pjie138@163.com.

    Source

    Clinical and experimental medicine 16:3 2016 Aug pg 429-36

    MeSH

    Adenine
    Adolescent
    Adult
    Alanine Transaminase
    Antiviral Agents
    Blood
    DNA, Viral
    Female
    Guanine
    Hepatitis B e Antigens
    Hepatitis B virus
    Hepatitis B, Chronic
    Humans
    Lamivudine
    Male
    Middle Aged
    Organophosphonates
    Prospective Studies
    Treatment Outcome
    Viral Load
    Young Adult

    Pub Type(s)

    Clinical Study
    Comparative Study
    Journal Article
    Multicenter Study

    Language

    eng

    PubMed ID

    26164128