Efficacy and Safety of Peginterferon a-2a in Patients of Chronic Hepatitis B With Spontaneous Decline of HBV DNA
Efficacy and Safety of Peginterferon a-2a in Patients of Chronic Hepatitis B With Spontaneous Decline of HBV DNA
Patients with spontaneous decline of HBV DNA were non-randomly assigned to accept
 peginterferon alfa-2a or entecavir therapy, or didn't accept any antiviral regiment.
It was a prospective, non-randomized, open-label study that evaluated the efficacy and safety
 of pegasys treatment in chronic hepatitis B patients with spontaneous HBVDNA decline after
 acute exacerbation.Patients with spontaneous decline of HBV DNA(a decrease of HBV DNA levels
 of more than 2 log(10) IU/mL as compared to baseline before antiviral treatment) after acute
 exacerbation (ALT was 10-30ULN，TBIL was 2-20mg/ml，PTA>60%)were non-randomly divided into 3
 groups: group A, B and C. Before treatment, the patients were counselled on the advantages
 and disadvantages of taking peginterferon or nucleos(t)ide analogue, and the subsequential
 treatment were decided by themselves. Cases in group A receive 180µg of peginterferon alfa-2a
 (Pegasys,Roche) once weekly for 48 weeks. Group B and C were control group, cases in group B
 received an continual entecavir therapy(0.5 mg orally once daily) and those in group C didn't
 accept any antiviral regiment.
This study focused on the subsequential antiviral therapeutic strategies for chronic
 hepatitis B patients with spontaneous decline of HBV DNA after acute exacerbation. Patients
 fullfilled the following criterias were chosen for screening: They were antiviral treatment
 naı¨ve and had been positive for hepatitis B surface antigen (HBsAg) for at least 6 months,
 were positive for HBeAg and had an HBV DNA Level of more than 500,000IU/ml. Their serum
 alanine aminotransferase level was greater than 2 but less than or equal to 30 times the
 upper limit of the normal range, their peak value of total bililubin ranged from 2mg/ml to
 20mg/ml and the prothrombin time activity was greater than 60%.

 ALL of these patients were hospitalized and pretreated with anti-inflammation and liver
 protection agents such as Stronger Neo-Minophagen C, Polyunsaturated phosphatidylcholine
 (Essentiale), Ursodeoxycholic Acid and L-Glutathione reduced, without any nuclutide of
 nucleoside. Their ALT、TBIL and PTA were monitor weekly and HBVDNA level were measured every
 two weeks. Patients were eligible if their HBVDNA declined spontaneously by 2 log(10) IU/mL
 while their ALT falled below 10 ULN and TBIL falled below 2mg/ml within 8 weeks of
 pretreatment.

 Patients with advanced fibrosis, cirrhosis and hepatoma were excluded. Other cause of
 chronic liver disease should be systematically checked to exclude co-infection with HDV,
 HCV and HIV, comorbidities with alcoholism, autoimmune and metabolic liver disease. Serious
 medical or psychiatric illnesses that had usage of corticosteroid or immunosup-pressive
 agents at the time of study were excluded. All patients in this study lived in Guangdong, a
 province of 100,000,000 populations, with same demographics. Owing to patients fear or
 refusal of liver biopsy, no patients had the liver biopsy and the rest relied on other
 clinical methods to obtain equivalent information of patient conditions. In our cases,
 ultrasonorgraphy helped to filter out patients with advanced fibrosis.The liver sonar
 examination was performed by two experi-enced hepatologists at least three times on each
 patient.