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96 weeks combination of adefovir dipivoxil plus emtricitabine vs. adefovir dipivoxil monotherapy in the treatment of chronic hepatitis B.

Abstract

BACKGROUND/AIMS

In order to prevent the occurrence of drug-resistant mutants associated with treatment for chronic hepatitis B virus (HBV) infection, combination therapy is being developed. To determine the efficacy of adefovir dipivoxil (ADV) plus emtricitabine (FTC) combination therapy in chronic HBV infection.

METHODS

Thirty treatment-nai ve, HBeAg-positive patients were randomized to combination ADV plus FTC (n=14) or ADV plus placebo monotherapy (n=16) for 96 weeks. HBV DNA was measured by polymerase chain reaction. Treatment was stopped in those with HBeAg seroconversion.

RESULTS

The median decrease in HBV DNA at week 96 was higher in the combination group (-5.30 vs. -3.98 log(10)copies/ml, p=0.05). More patients in the combination group had normalization of alanine aminotransaminase and HBV DNA<300 copies/ml at week 96 when compared with the monotherapy group [11 of the 14 patients (78.6%) vs. 6 of the 16 patients (37.5%), p=0.03]. However, HBeAg seroconversion at week 96 was similar in the 2 groups [2/14 (14.3%) vs. 4/16 (25.0%), p=NS]. No ADV or FTC resistance was detected at week 96. In those with HBeAg seroconversion, 50.0% had post-treatment relapse.

CONCLUSIONS

Combination ADV plus FTC resulted in more potent suppression of HBV DNA over 96 weeks of therapy.

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  • Publisher Full Text
  • Authors

    , , , , , , , , , , ,

    Source

    Journal of hepatology 48:5 2008 May pg 714-20

    MeSH

    Adenine
    Adult
    Alanine Transaminase
    Antiviral Agents
    DNA, Viral
    Deoxycytidine
    Drug Resistance, Viral
    Drug Therapy, Combination
    Female
    Hepatitis B e Antigens
    Hepatitis B, Chronic
    Humans
    Male
    Middle Aged
    Organophosphonates

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    18207280

    Citation

    TY - JOUR T1 - 96 weeks combination of adefovir dipivoxil plus emtricitabine vs. adefovir dipivoxil monotherapy in the treatment of chronic hepatitis B. AU - Hui,Chee-Kin, AU - Zhang,Hai-Ying, AU - Bowden,Scott, AU - Locarnini,Stephen, AU - Luk,John M, AU - Leung,Kar-Wai, AU - Yueng,Yui-Hung, AU - Wong,April, AU - Rousseau,Frank, AU - Yuen,Kwok-Yung, AU - Naoumov,Nikolai N, AU - Lau,George K K, Y1 - 2007/12/31/ PY - 2007/7/23/received PY - 2007/10/8/revised PY - 2007/10/11/accepted PY - 2007/12/31/aheadofprint PY - 2008/1/22/pubmed PY - 2008/8/13/medline PY - 2008/1/22/entrez SP - 714 EP - 20 JF - Journal of hepatology JO - J. Hepatol. VL - 48 IS - 5 N2 - BACKGROUND/AIMS: In order to prevent the occurrence of drug-resistant mutants associated with treatment for chronic hepatitis B virus (HBV) infection, combination therapy is being developed. To determine the efficacy of adefovir dipivoxil (ADV) plus emtricitabine (FTC) combination therapy in chronic HBV infection. METHODS: Thirty treatment-nai ve, HBeAg-positive patients were randomized to combination ADV plus FTC (n=14) or ADV plus placebo monotherapy (n=16) for 96 weeks. HBV DNA was measured by polymerase chain reaction. Treatment was stopped in those with HBeAg seroconversion. RESULTS: The median decrease in HBV DNA at week 96 was higher in the combination group (-5.30 vs. -3.98 log(10)copies/ml, p=0.05). More patients in the combination group had normalization of alanine aminotransaminase and HBV DNA<300 copies/ml at week 96 when compared with the monotherapy group [11 of the 14 patients (78.6%) vs. 6 of the 16 patients (37.5%), p=0.03]. However, HBeAg seroconversion at week 96 was similar in the 2 groups [2/14 (14.3%) vs. 4/16 (25.0%), p=NS]. No ADV or FTC resistance was detected at week 96. In those with HBeAg seroconversion, 50.0% had post-treatment relapse. CONCLUSIONS: Combination ADV plus FTC resulted in more potent suppression of HBV DNA over 96 weeks of therapy. SN - 0168-8278 UR - https://www.unboundmedicine.com/medline/citation/18207280/96_weeks_combination_of_adefovir_dipivoxil_plus_emtricitabine_vs__adefovir_dipivoxil_monotherapy_in_the_treatment_of_chronic_hepatitis_B_ L2 - http://linkinghub.elsevier.com/retrieve/pii/S0168-8278(07)00653-8 ER -