The analysis of early virologic response in combination treatment with pegylated interferon and necleos (t)ide analogue in patients with chronic hepatitis B

Abstract

Background: The aims of this study were to compare the effi cacy of treatment between pegylated interferon monotherapy and pegylated inter-feron, entecavir combination therapy in patients with chronic hepatitis B. Methods: A total of 25 naive patients with chronic hepatitis B (all geno-type C, HBe Ag positive n = 21, HBe Ag negative n = 4) were included in this prospective study and randomly divided into a monotherapy (group A, n = 13) and a combination therapy (group B, n = 12). Results: Baseline HBV DNA in group B was decreased after 2 weeks entecavir treatment (8.8 × 108→ 2.2 × 108 copy/mL, p = 0.004). On-treatment virologic response (reduction of HBV DNA more than 2 log copies/ml) was signifi cantly higher in group B than in group A at 4 weeks (15.3% vs 77.8%, p = 0.007), at 12 weeks (23.1% vs 75%, p = 0.017), at 24 weeks (23.1% vs 66.7%, p = 0.047). However, end of treatment response (HBV DNA levels of <50 copies/mL) was not signifi cantly dif-ferent between group A and group B at 48 weeks (15.3% vs 25%, p =0.459), at 72 weeks (0% and 10%). HBV DNA levels of <10,000 copies/mL was also not signifi cant in two groups at 48 weeks (30.8% vs 58.3%, p = 0.238), at 72 weeks (20% and 60%, p = 0.085). The virologic break-through (1 log IU/ml increase in HBV DNA from nadir of initial response during therapy) were observed in group A (0%, 0/3) and group B (33.3%, 3/9). The HBe Ag seroconversion rates at 48 weeks were only observed in group B (27.3%, 3/11). Conclusion: Early virologic response was higher in the patients of com-bination therapy of pegylated interferon and entecavir. But because the virologic breakthrough frequently occurred in group B, early virologic response can not refl ect HBe seroconversions and virologic response at end of treatment.