Background: 48 week therapy with peginterferon alfa-2a has demonstrated to be effective in about one third of patients with HBeAg-positive chronic hepatitis B. Although the recommended treatment duration for these patients is 48 weeks, there are no enough data supporting 48 weeks of therapy over 24 weeks of therapy. Treatment might be shortened particularly in patients with good predictors of response.
Aim: To compare the efficacy of 48 weeks vs 24 weeks of therapy with peginterferon alfa-2a, in patients with chronic hepatitis B who had good predictors of response.
Patients and methods: Nineteen patients with high baseline ALT levels (> 3 ULN) and low viral load (HBV DNA < 10(9) copies/ml) were treated with peginterferon alfa-2a 180 mcg/week, during 48 weeks. Virological, biochemical and serological responses were compared with those obtained in 16 patients with similar baseline characteristics treated with peginterferon alfa-2a for 24 weeks. All patients had a followup period of 24 weeks after the end of therapy.
Results: At end of follow-up, HBeAg seroconversion was observed in 7/19 (36.8%) of patients treated for 48 weeks and in 6/16 (37.5%) of patients treated for 24 weeks (NS). Patients treated for 48 weeks evidenced a significantly higher decrease in HBV DNA at the end of therapy than patients treated for 24 weeks (-4.8 logs vs -3.6 logs respectively, p < 0.05). However, the percentage of patients with HBV DNA < 100.000 copies/ml was similar in both groups at the end of follow up (42.1% vs 43.7%, NS). No significant differences between both groups were observed regarding ALT normalization, HBsAg loss or seroconversion. The incidence of aderse events was similar in both groups.
Conclusion: The results from this pilot study indicate that 24 weeks of therapy with peginterferon alfa-2a could be similar to 48 weeks therapy in patients with HBeAg positive chronic hepatitis B who have good predictors of response.