| Background Hepatitis B virus(HBV) infection is an epidemic disease worldwide and it is also an major infectious disease threatening human health globally. As a front-line drug of antiviral therapy, interferon(IFN), however, its therapeutic effect is limited with more side-effects. Moreover, the treatment expenses are rather expensive. Its is apparently important to predict the efficacy of IFN therapy in chronic hepatitis B prior to treatment and during the treatment. Factors associated with a favorable response to Peg IFN-α therapy include serum alanine aminotransferase(ALT) levels, serum HBV DNA levels, serum Hepatitis B surface antigen(HBs Ag) and Hepatitis B e antigen(HBe Ag) levels, antibody to hepatitis B core antigen(Anti-HBc), and HBV genotype, however, few studies on IFN-α. This paper aims at studying and analyzing the influencing factors and its predictive value on efficacy of common IFN-α, building prediction models, thereby providing the theoretical basis and clinical guidance for clinical IFN individualized treatment of chronic hepatitis B(CHB).Methods A total of 147 patients with HBe Ag positive chronic hepatitis B who received the initial common IFN(IFN-α1b) at our hospital Outpatient or Inpatient Department from January 2008 to June 2014 were enrolled this study to investigate at week 0, week 12, week 24 and week 52 liver function, hepatitis B five-item quantitative analysis and HBV DNA, etc.; observe the IFN users’ virology response rate, HBe Ag seroconversion rate and HBs Ag seroconversion rates; evaluate the possible influencing factors and predictive value to antiviral efficacy of IFN-α1b; and set up prediction models with multi-point-in-time via analyzing various factors of predictive value ofHBe Ag seroconversion.Result 1. Levels of ALT, HBV DNA and HBs Ag at baseline, levels and reduced levels of HBV DNA, HBs Ag and HBe Ag at Week 12, reduced levels of ALT and HBV DNA at Week 24 and levels and reduced levels of HBs Ag and HBe Ag at Week 24, the differences of levels in those patients with HBe Ag chronic hepatitis B in IFN-α initial treatment had statistical significance between virology response group and non-response group. Levels of ALT, HBV DNA and HBe Ag and Anti-HBc at baseline, levels and reduced levels of HBV DNA, HBs Ag and HBe Ag at Week 12, level of Anti-HBc at Week 12, levels and reduced levels of ALT, HBV DNA, HBs Ag and HBe Ag at Week 24, level of Anti-HBc at Week 24, the differences of levels in those patients with HBe Ag chronic hepatitis B in IFN-α initial treatment had statistical significance between HBe Ag seroconversion response group and non-response group. Reduced level of HBV DNA at Week 12, level and reduced level of HBs Ag at Week 12, level and reduced level of HBs Ag at Week 24, the differences of levels in those patients with HBe Ag chronic hepatitis B in IFN-α initial treatment had statistical significance between HBe Ag seroconversion rate response group and non-response group.2. By using single factor and multiple-factor analysis, discoveries of ALT > 4 ×ULN(OR = 2.44,95% CI = 1.10-5.42,P = 0.028), HBe Ag ≤ 500 S/CO(OR = 2.12,95% CI = 0.97-4.64,P = 0.060) and Anti-HBc ≥ 11.4 S/CO(OR=3.02,95% CI=1.39-6.57,P=0.005) at baseline; HBe Ag ≤ 250 S/CO(OR = 10.90,95% CI = 2.63-45.27,P = 0.001), HBe Ag decline > 1 log10 S/CO(OR = 4.53,95% CI = 1.59-12.91,P = 0.005) and Anti-HBc ≥ 11.8 S/CO(OR = 3.72,95% CI = 1.41-9.84,P = 0.008) at Week 12; HBe Ag ≤ 5 S/CO(OR = 16.82,95% CI = 5.07-55.79,P < 0.001) and Anti-HBc ≥ 11.4 S/CO(OR = 3.01,95% CI = 1.20-7.56,P = 0.019) at Week 24 can effectively predict the HBe Ag seroconversion of IFN therapy in patientswith HBe Ag positive chronic hepatitis B.3. Baseline scoring model were obtained by using baseline levels of ALT, we found that there were 34(23.13%) patients scored as 0 of which only 1(2.9%) patient obtained the HBe Ag seroconversion; 26(17.7%) patients scored as 3 of which 15(57.7%) patients obtained the response. Week 12 scoring prediction model were obtained by using level and reduced level of HBe Ag and level of Anti-HBc at Week 12, we found that there were 50(34.0%) patients scored as 0 of which zero patient obtained the HBe Ag seroconversion; 18(12.2 %) patients scored as 3 of which 15(83.3%) patients obtained the response. Week 24 scoring prediction model was obtained by using level and reduced level of HBe Ag and level of Anti-HBc at Week 24., we found that there were 48(32.7%) patients scored as 0 of which 1(2.1%) patient obtained the HBe Ag seroconversion; 25(17 %) patients scored as 3 of which 21(84.0%) patients obtained the response.Conclusion 1. Levels or reduced levels of ALT, HBV DNA, HBs Ag, HBe Ag, Anti-HBc at Baseline or during the treatment had a better predictive value to efficacy of initial IFN therapy in patients with HBe Ag positive chronic hepatitis B. It is necessary to regularly monitor the serum levels of ALT, HBV DNA, HBs Ag, HBe Ag and Anti-HBc.2. A simple scoring model was set up at baseline, Week 12 and Week 24, respectively via single factor and multiple-factor analysis prior to treatment and after 12- and 24-weeks treatment. These series models have a better negative predictive value and positive predictive value for HBe Ag seroconversion to IFN-α initial therapy in patients with HBe Ag positive chronic hepatitis B. It is a better introducing individualized optimal treatment schedules and efficacy evaluation during the treatment. |
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