Jara Paloma, Hierro Loreto, de la Vega Angela, Díaz Carmen, Camarena Carmen, Frauca Esteban, Miños-Bartolo Gema, Díez-Dorado Ruth, de Guevara Concepción Ladrón, Larrauri Javier, Rueda Magdalena
Pediatric Liver Service, La Paz University Hospital, Madrid, Spain.
Pediatr Infect Dis J. 2008 Feb;27(2):142-8. doi: 10.1097/INF.0b013e318159836c.
Interferon (IFN)-alpha2b plus ribavirin is approved for treatment of hepatitis C in children; however, little is known about efficacy and tolerability of pegylated IFN (PEG-IFN)-alpha2b in this population. The objective of this study was to test the efficacy and safety of PEG-IFN-alpha2b plus ribavirin in children with chronic hepatitis C.
Thirty children 3-16 years of age who had detectable hepatitis C virus (HCV) RNA for >or=3 years after exposure and elevated alanine aminotransferase values received PEG-IFN-alpha2b 1.0 microg/kg/wk plus ribavirin 15 mg/kg/d for 24 weeks (genotype 2/3) or 48 weeks (genotype 1/4). The primary endpoint was sustained virologic response (SVR), defined as undetectable HCV RNA (<50 IU/mL) at week 24 of follow-up.
SVR was achieved in 50% of patients (3/3 genotype 3; 12/27 genotype 1/4). At week 12, 52% of patients were HCV RNA negative and 72% had a >2 log10 decrease in viral load, compared with baseline; 87% and 71% of these patients, respectively, attained an SVR. Therapy was discontinued in 3 patients as a result of adverse events. No patient required ribavirin dose reduction; PEG-IFN-alpha2b dose was reduced in 23% of patients to manage neutropenia.
Combination therapy with PEG-IFN-alpha2b and ribavirin treatment was effective in children with chronic hepatitis C. Virologic status at week 12 identified future responders and nonresponders. PEG-IFN-alpha2b and ribavirin were reasonably well tolerated, with no unexpected or permanent adverse effects. Further studies are needed to identify the optimum treatment regimen for this patient population.
干扰素（IFN）-α2b联合利巴韦林已被批准用于治疗儿童丙型肝炎；然而，关于聚乙二醇化干扰素（PEG-IFN）-α2b在该人群中的疗效和耐受性知之甚少。本研究的目的是测试PEG-IFN-α2b联合利巴韦林治疗慢性丙型肝炎儿童的疗效和安全性。
30名3至16岁的儿童，在接触病毒后丙型肝炎病毒（HCV）RNA可检测到≥3年且丙氨酸转氨酶值升高，接受PEG-IFN-α2b 1.0μg/kg/周联合利巴韦林15mg/kg/天治疗24周（基因2/3型）或48周（基因1/4型）。主要终点是持续病毒学应答（SVR），定义为随访第24周时HCV RNA检测不到（<50 IU/mL）。
50%的患者实现了SVR（基因3型3/3；基因1/4型12/27）。在第12周时，52%的患者HCV RNA呈阴性，72%的患者病毒载量较基线下降>2 log10；这些患者中分别有87%和71%实现了SVR。3名患者因不良事件停药。没有患者需要降低利巴韦林剂量；23%的患者降低了PEG-IFN-α2b剂量以处理中性粒细胞减少症。
PEG-IFN-α2b和利巴韦林联合治疗对慢性丙型肝炎儿童有效。第12周时的病毒学状态可识别未来的应答者和无应答者。PEG-IFN-α2b和利巴韦林耐受性良好，没有意外或永久性不良反应。需要进一步研究以确定该患者群体的最佳治疗方案。
