Clinical Efficacy Observation Of Antiviral/immunomodulatory Therapy In Naive Patients With Chronic Hepatitis B With HBeAg Positive

BackgroundChronic HBV infection is a global public health problem that seriously endangers human health.15～25%of patients with chronic HBV occur cirrhosis or hepatocellular carcinoma,and even liver failure.About 650 thousand people died of chronic hepatitis B(CHB)related diseases each year.Studies have shown that HBsAg clearance is the most close to clinical cure of CHB,and can significantly reduce the incidence of liver cirrhosis,hepatocellular carcinoma and liver failure.In order to effectively remove HBsAg,combined therapy has become a main direction of study.ObjectiveTo compare the clinical efficacy(HBsAg serological rate,HBeAg serological rate,DNA negative conversion rate,ALT recovery rate and histological response rate)of different antiviral/immunomodulatory therapies in the initial treatment of patients with chronic hepatitis B with e antigen(HBeAg)positive.Methods240 patients with HBeAg positive CHB were enrolled in this study.They were randomly divided into 4 groups:Group A was treated with interferon alpha 2b(IFNα-2b)alone(60 cases);Group B was treated with IFNα-2b,combined with adefovir dipivoxil(ADV)(60 cases);Group C was treated with IFNα-2b,ADV combined with Granulocyte macrophage colony-stimulating factor(GM-CSF)(60 cases);Group D was treated with IFNα-2b,ADV combined with GM-CSF and hepatitis B vaccine(HBV Vaccine)(60 cases).All patients were treated for 48 weeks and then followed up for 24 weeks.We compared the efficacy between these 4 groups.ResultsAfter the treatment of 48 weeks,HBsAg loss rate of Group D was significantly higher than that of Group A,B(Χ2=8.634 and 8.634.P<0.01).HBsAg seroconversion rate of Group D was significantly higher than that of Group A,B(Χ2=7.149 and 7.149,P<0.01).HBsAg decrease rate from baseline of Group D was significantly higher than that of Group A,B(t=4.194 and 4.508,P<0.01).Up to 24 weeks after the treatment,HBsAg loss rate was as same as before.HBsAg seroconversion rate of Group D was significantly higher than that of Group A,B(Χ2=7.149 and 7.149,P<0.01).HBsAg decrease rates from baseline of Group C,D was significantly higher than that of Group A(t=4.546 and 4.969,P<0.01).After the treatment of 48 weeks,HBeAg loss rate of Group D was significantly higher than that of Group A(Χ2=8.792,P<0.01).HBeAg seroconversion rate of Group C,D had a significant difference compared with Group A(Χ2=7.064 and 10.159,P<0.01).Up to 24 weeks after the treatment,HBeAg loss rate of Group C,D was significantly higher than that of Group A(Χ2=10.159 and 13.713,P<0.01).HBeAg loss rate of Group D was significantly higher than that of Group B(Χ2=8.155,P<0.01).HBeAg seroconversion rate of Group C,D had a significant difference compared with Group A(Χ2=10.506 and 12.857,P<0.01).After the treatment of 48 weeks,DNA negative conversion rate of Group B,C,D was significantly higher than that of group A(Χ2=12.452,17.062 and 20.670,P<0.01);Up to 24 weeks after the treatment,DNA negative conversion rate of Group B,C,D was significantly higher than that of group A(Χ2=21.121,26.880 and 33.611,P<0.01).After the treatment of 48 weeks,ALT recovery rate of Group C,D were significantly higher than that of Group A(Χ2=8.711 and 8.711,P=0.003);Up to 24 weeks after the treatment,ALT recovery rate of Group C,D were significantly higher than that of Group A(Χ2=8.076 and 9.624,P<0.01).After the treatment of 48 weeks,histological response rate of Group B,C,D was sigjnificantly higher than those of group A(Χ2=8.543,13.348 and 16.205,P<0.01).There were no half-way withdrawal and no serious adverse reaction.ConclusionA greater and more effective treatment of naive patients with HBeAg positive chronic hepatitis B is the new antiviral/immunomodulatory therapy:IFNa-2b,ADV combined with GM-CSF and HBV Vaccine.