Abstract: Objective The aim of this study was to compare the antiviral efficacy of recombinant cytokine gene-derived protein (RCGDP) or human interferon α-2b and entecavir combination in the treatment of patients with serum HBeAg positive chronic hepatitis B (CHB). Methods 65 patients with serum HBeAg-positive CHB were recruited in our hospital between March 2019 and March 2021, and were divided into two groups. The interferon α-2b and entecavir combination were given in 33 patients and the RCGDP and entecavir combination were given in 32 patients with CHB. The regimen lasted for 48 weeks in both groups. Serum alanine aminotransferase (ALT) levels, HBV DNA loads and serum HBeAg seroconversion were recorded. Results At the end of 12 week treatment, serum HBeAg negative and HBeAg seroconversion rates in patients receiving entecavir and RCGDP combination were 34.4% and 25.0%, both significantly higher than 9.1% and 6.1% in patients receiving entecavir and interferon α-2b combination therapy (P<0.05); at the end of 48 week treatment, serum ALT normalization, serum HBeAg negative and HBeAg seroconversion rates in patients receiving entecavir and RCGDP combination were 87.5%, 62.5% and 40.6%, all significantly higher than 78.8%, 30.3% and 18.2% in patients receiving entecavir and interferon α-2b combination therapy (P<0.05); during the treatment period, the incidences of fatigue, and fever and headache in entecavir and interferon α-2b combination-treated patients were 21.2% and 84.9%, both significantly higher than 3.1% and 3.1%(P＜0.05)in entecavir and RCGDP combination–treated patients, while there were no significant differences as respect to the incidences of neutropenia, thrombocytopenia, decreased appetite, and hypocalcemia between the two groups (P>0.05) . Conclusion The administration of recombinant cytokine gene-derived protein and oral entecavir combination is efficacious in treatment of patients with serum HBeAg positive CHB, with a high HBeAg seroconversion and less untoward effects, as compared with interferon α-2b and entecavir combination therapy, which needs further multi-central clinical investigation.

Key words: Hepatitis B, HBeAg positive, Recombinant cytokine gene-derived protein, Human interferon α-2b, Entecavir, Therapy