摘要
Background： Until now, various types of combined therapy with nucleotide analogs and pegylated interferon （Peg-INF） in patients with hepatitis B patients have been tried. Howe6ver, studies regarding the benefits of de novo combination, late-add on, and sequential treatmentare very limited. The objective of the current study was to identify the efficacy of sequential treatment of Peg-INF after short-term antiviral treatment. Methods： Between June 2010 and June 2015, hepatitis 13 e antigen （HBeAg）-positive patients （n = 162） received Peg-IFN for 48 weeks （mono-treatment group, n = 81） and entecavir （ETV） for 12 weeks with a 48-week course of Peg-IFN starting at week 5 of ETV therapy （sequential treatment group, n = 81）. The primary endpoint was HBeAg seroconversion at the end of follow-up period after the 24-week treatment. The primary endpoint was analyzed using Chi-square test, Fisher＇s exact test, and regression analysis.Results： HBeAg seroconversion rate （18.2% vs. 18.2%, t = 0.03, P = 1.000） and seroclearance rate （19.7% vs. 19.7%, t = 0.03, P = 1.000） were same in both mono-treatment and sequential treatment groups. The rate of alanine aminotransferase （ALT） normalization （45.5% vs. 54.5%, t = 1.12, P = 0.296） and serum hepatitis B virus （HBV）-DNA 〈2000 U/L （28.8% vs. 28.8%, t = 0.10, P = 1.000） was not different in sequential and mono-treatment groups at 24 weeks of Peg-INF. Viral response rate （HBeAg seroconversion and serum HBV-DNA 〈2000 U/L） was not different in the two groups （12.1% vs. 16.7%, t = 1.83, P = 0.457）. Baseline HBV-DNA level （7 log10 U/ml vs. 7.5 log10 U/ml, t = 1.70, P = 0.019） and hepatitis B surface antigen titer （3.6 log10 U/ml vs. 4.0 log10 U/ml, t = 2.19, P = 0.020） were lower and predictors of responder in mono-treatment and sequential treatment groups, respectively. Conclusions： The current study shows no differences in HBeAg seroconversion rate, ALT normalization, and HBV-DNA levels between mono-therapy and sequential therapy regimens.
Background： Until now, various types of combined therapy with nucleotide analogs and pegylated interferon （Peg-INF） in patients with hepatitis B patients have been tried. Howe6ver, studies regarding the benefits of de novo combination, late-add on, and sequential treatmentare very limited. The objective of the current study was to identify the efficacy of sequential treatment of Peg-INF after short-term antiviral treatment. Methods： Between June 2010 and June 2015, hepatitis 13 e antigen （HBeAg）-positive patients （n = 162） received Peg-IFN for 48 weeks （mono-treatment group, n = 81） and entecavir （ETV） for 12 weeks with a 48-week course of Peg-IFN starting at week 5 of ETV therapy （sequential treatment group, n = 81）. The primary endpoint was HBeAg seroconversion at the end of follow-up period after the 24-week treatment. The primary endpoint was analyzed using Chi-square test, Fisher＇s exact test, and regression analysis.Results： HBeAg seroconversion rate （18.2% vs. 18.2%, t = 0.03, P = 1.000） and seroclearance rate （19.7% vs. 19.7%, t = 0.03, P = 1.000） were same in both mono-treatment and sequential treatment groups. The rate of alanine aminotransferase （ALT） normalization （45.5% vs. 54.5%, t = 1.12, P = 0.296） and serum hepatitis B virus （HBV）-DNA 〈2000 U/L （28.8% vs. 28.8%, t = 0.10, P = 1.000） was not different in sequential and mono-treatment groups at 24 weeks of Peg-INF. Viral response rate （HBeAg seroconversion and serum HBV-DNA 〈2000 U/L） was not different in the two groups （12.1% vs. 16.7%, t = 1.83, P = 0.457）. Baseline HBV-DNA level （7 log10 U/ml vs. 7.5 log10 U/ml, t = 1.70, P = 0.019） and hepatitis B surface antigen titer （3.6 log10 U/ml vs. 4.0 log10 U/ml, t = 2.19, P = 0.020） were lower and predictors of responder in mono-treatment and sequential treatment groups, respectively. Conclusions： The current study shows no differences in HBeAg seroconversion rate, ALT normalization, and HBV-DNA levels between mono-therapy and sequential therapy regimens.
