A side-by-side comparative study on the efficacy of HBsAg clearance by PegIFN therapy for 48 weeks on NA-treated and treatment naive CHB patients with low baseline HBsAg levels
Objective This is a side by side comparative study(SSS)on the efficiency of functional cure(HBsAg clearance)by pegylated interferon alpha(PegIFNα)treatment between nucleos(t)ide analogue(NA)-treated and NA treatment-naive chronic hepatitis B(CHB)patients with low baseline HBsAg levels,and explored the related factors for HBsAg clearance.Methods Forty-nine CHB patients with serum HBsAg＜5000 IU/mL(especially＜1500 IU/mL)and HBV DNA＜104 IU/mL collected from 2018 to 2022 were divided into three groups,including group NP(NA treated-patients for more than one year in combination with PegIFNα-2b),group P(NA treatment-naïve patients with PegIFNα-2b monotherapy),and group C(patients without receiving any antiviral treatment).Serum HBV DNA,HBsAg,anti-HBs,HBeAg and liver function tests were measured and compared at baseline,week 12 and week 48.Results Twenty,seventeen and twelve patients were distributed into group NP,group P and group C respectively.The baseline HBsAg levels had no significant difference among the three groups(median,interquartile range:201.06,47.82～863.06 vs 184.15,50.79～386.17 vs 77.70,19.22～839.27,respectively,P=0.58).There were 19,15 and 11 patients with baseline HBsAg＜1500 IU/mL in group NP,P and C,respectively.After 48 weeks PegIFNα-2b therapy,a significant higher HBsAg clearance rate was observed in patients of NP and P groups than that of C group(35.00％vs 29.41％vs 0.00％,P＜0.017).A tendency of higher HBsAg clearance rate was found in patients of NP group compared with that of P group(P＞0.05).All the 12 patients who achieved HBsAg clearance had significant lower baseline HBsAg level(79.71,6.10～206.59)than that of patients without HBsAg clearance(202.09,115.73～9.81,H=224.00,P=0.02).They also had lower HBsAg levels at week 12(1.76,1.08～13.20 vs 107.99,H=224.00,P=0.02).Among the 12 patients who achieved HBsAg clearance,the highest baseline HBsAg level was 484.64 IU/mL.The Baseline level of serum HBV DNA(log10)in group NP were all＜50 IU/mL,while the levels were 2.66±0.61 IU/mL and 2.78±0.71 IU/mL in group P and C,respectively(t=-0.51,P=0.62).At week 48,serum HBV DNA level in all of the 17 patients in group P was＜50 IU/mL;however,only one patient in group C had HBV DNA＜50 IU/mL(P＜0.01).Four patients in group NP were HBeAg-positive(4.04,4.05,2.92 and 1.52 S/CO)at baseline.Only one of them had serum HBeAg-reversion at week 48.All of the patients in group P and C were HBeAg-negative.Conclusion Patients with PegIFNα-2b added on continuous NA treatment had a similar HBsAg clearance rate as that of patients with PegIFNα-2b monotherapy,but the former seemed to have higher HBsAg clearance potential.The lower the baseline HBsAg,the greater the likelihood of"functional cure"achieved by PegIFNα-2b treatment,especially when a baseline level of HBsAg was less than 500 IU/mL in both sides with or without NA treatment.
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