Exploration of the characteristics of chronic hepatitis B patients clinically cured by interferon therapy
Objective To analyze the characteristics of chronic hepatitis B(CHB)patients clinically cured,and to explore the advantageous population and regimen of pegylated interferon-α-2b(Peg-IFN-α-2b)treatment.Methods A total of 188 CHB patients who were treated with Peg-IFN-α-2b in the Department of Infectious Diseases of the First Hospital of Shanxi Medical University from February 2018 to January 2024 and enrolled in the"China research(Oasis)project on reducing the incidence of hepatocellular carcinoma in hepatitis B patients"in Shanxi Province from September 2020 to January 2024 with clinically cured by Peg-IFN-α-2b therapy were selected as subjects.The basic information and efficacy indicators of patients were collected and analyzed,and the levels of hepatitis B surface antigen(HBsAg)and hepatitis B surface antibody(HBsAb)at baseline,12 weeks,24 weeks,36 weeks,48 weeks,72 weeks and 96 weeks of treatment were counted.Patients were divided into negative conversion group and non-negative conversion group according to the status of HBsAg at week 48,and HBsAg levels were compared between the two groups at 12 weeks of treatment.Patients were grouped according to the treatment plan and treatment duration,and the proportions of patients who achieved clinical cure at each monitoring point were compared between groups of sequential combination therapy of nucleo(s)tide analogues(NAs)with Peg-IFN-α-2b and Peg-IFN-α-2b alone,among groups of patients with combination treatment of NAs＜5 years,5 to＜10 years and≥10 years,and among groups of patients with NAs treatment duration＜5 years,5 to＜10 years and ≥ 10 years before the application of Peg-IFN-α-2b.Statistical analysis was performed using chi-square test or Mann-Whitney U test.Results The age of 188 patients was(43.7±9.9)years old,including 126 males(67.02％)and 62 females(32.98％).There were 150 patients(79.79％)treated with sequential combination therapy of NAs with Peg-IFN-α-2b,and 38 patients(20.21％)treated with Peg-IFN-α-2b alone.The baseline HBsAg level of 188 patients was 51.99(3.26,250.00)IU/mL,and there were 169 cases(89.89％)with negative hepatitis B e antigen(HBeAg).There were 93 patients(49.47％)with HBsAg＜50 IU/mL and 162 cases(86.17％)with negative hepatitis B virus(HBV)DNA at baseline.After 12 weeks,24 weeks,36 weeks,48 weeks,72 weeks and 96 weeks of treatment,there were 47 cases(25.00％),47 cases(25.00％),41 cases(21.81％),35 cases(18.61％),14 cases(7.45％)and four cases(2.13％)of HBsAg loss,respectively,and there were 28 cases(14.89％),33 cases(17.55％),35 cases(18.62％),24 cases(12.77％),nine cases(4.79％)and four cases(2.13％)of HBsAg seroconversion,respectively.The levels of HBsAb were 0.63(0.20,2.08)IU/mL,3.69(0.68,19.00)IU/mL,8.47(1.43,54.98)IU/mL,10.96(2.93,63.42)IU/mL,15.55(1.10,82.17)IU/mL and 23.45(2.30,129.50)IU/mL,respectively.The HBsAg levels at week 12 in the HBsAg negative group(170 cases)and the non-negative group(18 cases)according to the status of HBsAg at week 48 were 0.67(0.03,36.09)IU/mL and 18.31(5.99,162.19)IU/mL,respectively.The difference was statistically significant(Z=2.71,P=0.007).There was no significant difference in the proportion of patients who achieved clinical cure at each monitoring point between patients treated with NAs sequential combined with Peg-IFN-α-2b and patients treated with Peg-IFN-α-2b alone(x2=1.60,P=0.918).The total duration of NAs treatment and the duration of NAs treatment before the application of Peg-IFN-α-2b had no significant difference in the proportion of patients achieving clinical cure at each monitoring point(x2=5.67 and 5.47,respectively,P=0.854 and 0.857,respectively).Conclusions For young and middle-aged CHB patients,baseline HBsAg＜50 IU/mL,HBeAg and HBV DNA negative are the characteristics of clinical cure.These patients have a high probability of clinical cure with 12 weeks to 48 weeks of Peg-IFN-α-2b treatment.HBsAg decline to a low level at 12 weeks of treatment can be used as a reference index for good efficacy at 48 weeks of treatment.Some patients can achieve clinical cure after a short course of treatment with Peg-IFN-α-2b(12 weeks or 24 weeks),and even produce high levels of HBsAb.The course of Peg-IFN-α-2b treatment can be personalized.
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