Akhil Mohammed Shujauddin, Kirushnan Balaji, Martin Melvin, Arumugam Kanakaraj, Ganesh Prasad N K, Ravichandran Rajan
Department of Nephrology, MIOT International, Chennai, Tamilnadu, India.
Nephrology (Carlton). 2018 May;23(5):446-452. doi: 10.1111/nep.13050.
This study evaluates the safety and efficacy of direct-acting antivirals (DAAs) including sofosbuvir, ledipasvir and daclatasvir in patients with hepatitis C viraemia who were on maintenance haemodialysis.
Data on patients who received sofosbuvir and ribavirin were analysed. Patients who experienced treatment failure with the above regimen received sofosbuvir and ledipasvir for infection with hepatitis C virus (HCV) genotype 1. Those having HCV genotype 3 infection received sofosbuvir and daclatasvir. All treatment regimens were of 12 weeks duration. Side-effects were investigated. The HCV viral load was determined by RT-PCR at 4,16 and 24 weeks after the initiation of therapy; haemoglobin levels and liver function tests were monitored at regular intervals during therapy.
Of the 22 subjects initially treated with sofosbuvir and ribavirin, 72.72% attained sustained virologic response at 12 weeks (SVR12). Four patients experienced treatment failure and received genotype specific therapy. Patients with HCV genotype one received sofosbuvir with ledipasvir. One patient with HCV genotype 3 infection received sofosbuvir and daclatasvir. All of them attained SVR12. A statistically significant reduction in the median serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) were observed from the baseline until the end of treatment. Anaemia was observed in 45% of patients receiving ribavirin.
Our study demonstrates that sofosbuvir-based therapy is efficacious for HCV viraemia in patients on maintenance haemodialysis. The therapy was found to be reasonably safe with no major adverse effects noted with the use of sofosbuvir, ledipasvir or daclatasvir. However, larger studies are needed to validate our results.
本研究评估直接作用抗病毒药物（DAA），包括索磷布韦、来迪派韦和达卡他韦，在接受维持性血液透析的丙型肝炎病毒血症患者中的安全性和疗效。
分析接受索磷布韦和利巴韦林治疗的患者数据。使用上述方案治疗失败的患者，针对丙型肝炎病毒（HCV）基因1型感染接受索磷布韦和来迪派韦治疗。感染HCV基因3型的患者接受索磷布韦和达卡他韦治疗。所有治疗方案疗程均为12周。调查副作用。在治疗开始后4周、16周和24周通过逆转录聚合酶链反应（RT-PCR）测定HCV病毒载量；在治疗期间定期监测血红蛋白水平和肝功能检查。
最初接受索磷布韦和利巴韦林治疗的22名受试者中，72.72%在12周时达到持续病毒学应答（SVR12）。4名患者治疗失败并接受了基因特异性治疗。HCV基因1型患者接受索磷布韦和来迪派韦治疗。1名HCV基因3型感染患者接受索磷布韦和达卡他韦治疗。所有患者均达到SVR12。从基线到治疗结束，观察到血清谷草转氨酶（SGOT）和谷丙转氨酶（SGPT）中位数有统计学意义的降低。接受利巴韦林治疗的患者中有45%出现贫血。
我们的研究表明，基于索磷布韦的治疗方案对接受维持性血液透析的丙型肝炎病毒血症患者有效。该治疗方案被发现相当安全，使用索磷布韦、来迪派韦或达卡他韦未发现重大不良反应。然而，需要更大规模的研究来验证我们的结果。
