Efficiency and safety of sofosbuvir in Bangladeshi children with chronic hepatitis C virus infection

Salahuddin Mahmud , Jahida Gulshan , Md. Belayet Hossain , Madhabi Baidya , Rafia Rashid , Farhana Tasneem , Ahmed Rashidul Hasan , Tanzila Farhana , Mohammed Reaz Mobarak , Md. Jahangir Alam , Syed Shafi Ahmed
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Abstract

Background and aims

Currently, treatment with oral direct-acting antivirals is recommended for all hepatitis C virus (HCV)-infected pediatric patients. The aim of this study was to evaluate the efficacy and safety of sofosbuvir and ribavirin combination therapy for children and adolescents in Bangladesh who are living with chronic HCV infection.

Methods

An experimental study was performed from January 2021 to December 2022. HCV polymerase chain reaction (PCR)-positive thalassemic children, who were 6–18 years of age, were enrolled by consecutive nonprobability sampling. Clinical features were recorded, and investigations were performed. All patients were initially treated with sofosbuvir (200 mg for 6- to 11-year-olds and 400 mg for 12- to 18-year-olds) and ribavirin (10–15 mg/kg/day) and were assessed clinically on a four-weekly basis, along with liver-function testing. The total duration of therapy was 24 weeks. HCV PCR was done at the end of treatment and 12 weeks after the completion of treatment to see the sustained virological response.

Results

There were 26 cases in total, with a mean age of 9.26 ± 2.82 years; 14 were males (53.8%), and 12 females (46.2%). Twenty-five (96.15%) patients achieved a sustained virological response, and the end-of-treatment PCR was negative. One patient (3.85%) was a nonresponder even after 24 weeks of treatment. The medication was well received, with only four patients (15.3%) reporting headaches that were reported untreated.

Conclusion

The combination of sofosbuvir and ribavirin is effective in treating chronic HCV infection and is not accompanied by any major negative side effects.

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索非布韦治疗孟加拉国慢性丙型肝炎病毒感染儿童的有效性和安全性
背景和目的目前,建议所有丙型肝炎病毒(HCV)感染的儿童患者使用口服直接作用抗病毒药物进行治疗。本研究的目的是评估索非布韦和利巴韦林联合治疗孟加拉国慢性丙型肝炎感染儿童和青少年的疗效和安全性。方法于2021年1月至2022年12月进行实验研究。HCV聚合酶链式反应(PCR)阳性的地中海贫血儿童,年龄为6-18岁,通过连续的非概率抽样进行登记。记录临床特征,并进行调查。所有患者最初接受索非布韦(6至11岁患者200 mg,12至18岁患者400 mg)和利巴韦林(10至15 mg/kg/天)治疗,并每四周进行临床评估和肝功能测试。治疗总持续时间为24周。在治疗结束和治疗结束后12周进行HCV PCR,以观察持续的病毒学反应。结果26例,平均年龄9.26±2.82岁;14例为男性(53.8%),12例为女性(46.2%)。25例(96.15%)患者获得了持续的病毒学应答,治疗结束时PCR呈阴性。一名患者(3.85%)在治疗24周后仍无反应。该药物治疗效果良好,只有四名患者(15.3%)报告头痛未经治疗。结论索非布韦联合利巴韦林治疗慢性丙型肝炎病毒感染疗效确切,无明显副作用。
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