El-Shabrawi Mortada Hf, Sherief Laila M, Yakoot Mostafa, Kamal Naglaa M, Almalky Mohamed A, AbdElgawad Manal M, Mahfouz Aml A, Helmy Sherine, Kamal Enas M, Attia Dina, El-Khayat Hisham R
Paediatric Hepatology Department, Cairo Faculty of Medicine, Cairo 11559, Egypt.
Paediatric Hematology-Oncology Department, Zagazig Faculty of Medicine, Zagazig 21121, Egypt.
World J Clin Cases. 2019 Aug 26;7(16):2247-2255. doi: 10.12998/wjcc.v7.i16.2247.
Childhood cancer survivors are potentially at a higher risk of infection with hepatitis C virus (HCV). The effects of all-oral direct-acting antiviral therapy (DAA) on both the HCV infection as well as the state of cancer remission have not been well investigated in this population.
To test the effects of dual sofosbuvir/daclatasvir (SOF/DCV) therapy in the treatment of chronic HCV in survivors of hematologic malignancy in pediatric age group.
We conducted a prospective, uncontrolled, open-label multicenter study. A total of 20 eligible, chronic HCV, genotype-4, infected children who had been in continuous complete remission from hematologic cancer (leukemia/lymphoma) for at least one year were included in the study. All patients were treated with combined SOF/DCV for 12 wk. Patients were monitored throughout the study till 12 wk after end of treatment for safety and efficacy outcomes including the sustained virologic response 12 (SVR12) rate, hematological indices, liver and kidney functions.
The intent-to-treat SVR12 rate was 20 of 20 (100%; 95%CI: 84%-100%). All patients showed normalized liver enzymes from week-4. All hematological indices, liver and kidney functions were kept normal throughout the study. No fatalities or treatment-emergent serious or severe adverse events were reported throughout the study.
SOF/DCV combined therapy could be used safely and effectively in the treatment of chronic HCV genotype-4 infection in leukemia/lymphoma treated children. No relapses were detected during treatment and throughout the follow up period for either the original malignant disease or the HCV infection.
儿童癌症幸存者感染丙型肝炎病毒（HCV）的风险可能更高。全口服直接抗病毒疗法（DAA）对该人群中HCV感染以及癌症缓解状态的影响尚未得到充分研究。
测试索磷布韦/达卡他韦（SOF/DCV）联合疗法治疗小儿血液系统恶性肿瘤幸存者慢性HCV的效果。
我们开展了一项前瞻性、非对照、开放标签的多中心研究。共有20名符合条件的慢性HCV基因4型感染儿童纳入研究，这些儿童血液系统癌症（白血病/淋巴瘤）持续完全缓解至少一年。所有患者接受SOF/DCV联合治疗12周。在整个研究过程中对患者进行监测，直至治疗结束后12周，以观察安全性和有效性结果，包括持续病毒学应答12周（SVR12）率、血液学指标、肝肾功能。
意向性分析SVR12率为20/20（100%；95%CI：84%-100%）。所有患者从第4周起肝酶恢复正常。在整个研究过程中，所有血液学指标、肝肾功能均保持正常。在整个研究过程中未报告死亡或治疗中出现的严重或重度不良事件。
SOF/DCV联合疗法可安全有效地用于治疗白血病/淋巴瘤患儿的慢性HCV基因4型感染。在治疗期间以及整个随访期内，未检测到原发病或HCV感染复发。
