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Adefovir plus lamivudine are more effective than adefovir alone in lamivudine-resistant HBeAg- chronic hepatitis B patients: a 4-year study.

Abstract

BACKGROUND AND AIM

Adefovir dipivoxil (ADV) is effective in lamivudine (LAM)-resistant hepatitis B e antigen-negative (HBeAg(-)) chronic hepatitis B (CHB). However, it is unclear whether LAM treatment should be continued in these patients. We aimed to compare the long-term efficacy of adding ADV to ongoing LAM treatment versus switching to ADV monotherapy in LAM-resistant HBeAg(-) CHB.

METHODS

Sixty LAM-resistant patients with HBeAg(-) CHB were randomly assigned (3:1) to combination therapy (10 mg ADV once daily plus ongoing LAM at 100 mg once daily [n = 45]) or 10 mg ADV monotherapy once daily (n = 15). Virological and biochemical responses were defined as hepatitis B virus (HBV)-DNA <400 copies/mL and as normalization of alanine aminotransferase levels, respectively.

RESULTS

The median follow-up time was 53 months (range 20-60 months). A virological response was observed in 38/45 (84.4%) and 11/15 (73.3%) patients in the ADV/LAM and ADV monotherapy groups, respectively (P = 0.56). Biochemical response rates were higher in the ADV/LAM group than in the ADV monotherapy group (90.9% vs 57.1%, respectively; P = 0.01). In the ADV/LAM group, serum HBV-DNA remained undetectable in all patients who achieved a virological response (n = 38). In the ADV monotherapy group, virological breakthrough occurred in four of the 11 patients who achieved a virological response (36.4%; P < 0.001 vs the ADV/LAM group, log-rank test). In addition, two patients in each group who did not achieve a virological response eventually developed ADV resistance.

CONCLUSIONS

Adding ADV to LAM is more effective than switching to ADV monotherapy in LAM-resistant patients with HBeAg(-) CHB.

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  • Authors+Show Affiliations

    ,

    Gastroenterology and Hepatology Division, Second Propedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.

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    Source

    MeSH

    Adenine
    Adult
    Aged
    Alanine Transaminase
    Antiviral Agents
    Biological Markers
    DNA, Viral
    Drug Resistance, Multiple, Viral
    Drug Therapy, Combination
    Female
    Genotype
    Hepatitis B
    Hepatitis B e Antigens
    Hepatitis B, Chronic
    Humans
    Lamivudine
    Male
    Middle Aged
    Organophosphonates
    Time Factors
    Treatment Outcome
    Viral Load
    Young Adult

    Pub Type(s)

    Comparative Study
    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    19780875