Solari Joaquín, Galdame Omar, Rezzonico Lucrecia, Frider Bernardo, Villamil Alejandra, Casciato Paola, Reig María, Bandi Juan Carlos, Alessio Analía, Gadano Adrían
Sección de Hepatología, Servicio de Clínica Médica, Departamento de Medicina, Hospital Italiano de Buenos Aires. CABA, Argentina.
Acta Gastroenterol Latinoam. 2009 Dec;39(4):254-60.
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.
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.
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.
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.
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.
聚乙二醇化干扰素α-2a进行48周治疗已证明对约三分之一的HBeAg阳性慢性乙型肝炎患者有效。尽管这些患者的推荐治疗疗程为48周，但尚无足够数据支持48周治疗优于24周治疗。对于有良好疗效预测指标的患者，治疗疗程可能会缩短。
比较聚乙二醇化干扰素α-2a治疗48周与24周对有良好疗效预测指标的慢性乙型肝炎患者的疗效。
19例基线ALT水平高（>3倍正常上限）且病毒载量低（HBV DNA<10⁹拷贝/ml）的患者接受聚乙二醇化干扰素α-2a 180μg/周治疗，疗程48周。将其病毒学、生化和血清学反应与16例具有相似基线特征并接受聚乙二醇化干扰素α-2a治疗24周的患者进行比较。所有患者在治疗结束后有24周的随访期。
随访结束时，48周治疗的患者中有7/19（36.8%）出现HBeAg血清学转换，24周治疗的患者中有6/16（37.5%）出现HBeAg血清学转换（无统计学差异）。48周治疗的患者在治疗结束时HBV DNA下降幅度明显高于24周治疗的患者（分别为-4.8 log vs -3.6 log，p<0.05）。然而，随访结束时两组中HBV DNA<100,000拷贝/ml的患者百分比相似（42.1% vs 43.7%，无统计学差异）。两组在ALT正常化、HBsAg消失或血清学转换方面未观察到显著差异。两组不良事件发生率相似。
这项初步研究结果表明，对于有良好疗效预测指标的HBeAg阳性慢性乙型肝炎患者，聚乙二醇化干扰素α-2a治疗24周可能与48周治疗效果相似。
