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Gut doi:10.1136/gut.2005.089722

Predicting response to peginterferon alfa-2a, lamivudine and the two combined for HBeAg-negative chronic hepatitis B

  1. Ferruccio Bonino (bonino{at}med-club.com)
  1. Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Italy
    1. P Marcellin
    1. INSERM Unite 481, France
      1. G KK Lau
      1. The University of Hong Kong, China
        1. S Hadziyannis
        1. Henry Dunant Hospital, Greece
          1. R Jin
          1. Beijing You An Hospital, China
            1. T Piratvisuth
            1. Prince of Songkla University, Thailand
              1. G Germanidis
              1. Papageorgiou General Hospital, Greece
                1. C Yurdaydin
                1. University of Ankara, Turkey
                  1. M Diago
                  1. Hospital General Universitario de Valencia, Spain
                    1. S Gurel
                    1. University of Uludag, Turkey
                      1. M-Y Lai
                      1. National Taiwan University Hospital, Taiwan
                        1. M Brunetto
                        1. Azienda Ospedaliera Universitaria Pisana, Italy
                          1. P Farci
                          1. Universita di Cagliari, Italy
                            1. M Popescu
                            1. Roche, Switzerland
                              1. P McCloud
                              1. Roche, Australia
                                • Published Online First 24 November 2006

                                Abstract

                                Background and aims: In a trial of patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B, 24-week post-treatment biochemical and virologic response rates with peginterferon alfa-2a ± lamivudine were significantly higher than with lamivudine alone. The effect of pre-treatment factors on post-treatment responses has been investigated.

                                Patients and methods: Multivariate analyses were performed using available data from 518 patients treated with peginterferon alfa-2a monotherapy ± lamivudine, or lamivudine monotherapy. A post-treatment response was defined as alanine aminotransferase (ALT) normalisation and hepatitis B virus (HBV) DNA <20,000 copies/mL.

                                Results: In logistic regression analyses across all treatment arms, peginterferon alfa-2a (± lamivudine) therapy, younger age, female gender, high baseline ALT, low baseline HBV DNA and HBV genotype were identified as significant predictors of combined response 24 weeks post-treatment. In the peginterferon alfa-2a and lamivudine monotherapy arms, patients infected with genotypes B or C had a higher chance of response than genotype D infected patients (p<0.001), the latter responding better to combination than peginterferon alfa-2a monotherapy (p=0.015). At 1 year post-treatment, response rates by intention-to-treat analysis were 19.2% for peginterferon alfa-2a, 19.0% for combination, and 10.0% for lamivudine-treatment groups, with genotypes B or C associated with a sustained combined response to peginterferon alfa-2a ±lamivudine therapy.

                                Conclusions: Baseline ALT and HBV DNA levels, patient age, gender, and infecting HBV genotype significantly influenced combined response 24 weeks post-treatment, in patients treated with peginterferon alfa-2a and/or lamivudine. At 1 year post-treatment HBV genotype was significantly predictive of efficacy for patients treated with peginterferon alfa-2a ±lamivudine.

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                                  1. gut.2005.089722v1
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