Clinical study of IFNα-2b alone or in combination with lamivudine for HBeAg positive chronic hepatitis B

Objective To compare the efficacy of combination therapy of rh interferon α-2b(Kinferon) lamivudine,mono-therapy of Kinferon and mono-therapy of lamivudine,in the treatment of patients with hepatitis B e antigen(HBeAg) positive chronic hepatitis B(CHB).Methods Total 344 HBeAg positive CHB patients were enrolled and randomly divided into three groups: mono-therapy of Kinferon(Group A,n=116);combination therapy of Kinferon lamivudine(Group B,n=103);mono-therapy of lamivudine(group C,n=125).Changes of serum ALT normalization rate,no detection rate of HBV DNA and HBV virus serum marker were compared at week 12,24,36,48 and week 72(during follow-up visit).Adverse reactions and drug resistance were also observed.Results(1) Serum ALT normalization rates in all three groups were not statistically significant.(P0.05);(2) In group B,negative conversion ratio of HBeAg and seroconversion rate were 39.67% and 31.59% respectively at week 48,which had significant difference with group A C(P0.05);(3) In group A,negative conversion ratio of HBeAg and seroconversion rate were 30.29% and 29.27% respectively at week 48,comparing with 6.74% and 5.62% in group C(P0.05);(4) Both group B and C acquired high HBV DNA detection limit at week 12.But at week 48,the drug resistance rate in group C reached 12.21% while it was only 3.23% in group B;(5) During the treatment,some patients had mild leukopenia,but no severe ADR happened.All patients completed their therapy.Conclusion Anti-HBV effect is observed in all three groups but combined use of rh Interferon α-2b and lamivudine has better efficacy than mono-therapy of either interferon or lamivudine.Appropriate extension of the treatment course will help the patients acquire comparatively higher negative conversion ratio and seroconversion rate of HBeAg.Combination therapy of rh interferon α-2b and lamivudine also reduces patients' drug resistance rate.