背景血液透析(HD)患者最有可能感染丙型肝炎(HCV)感染,这与显著的发病率和疾病进展有关。直接作用抗病毒药物(DAA)在慢性肾脏病(CKD)中是安全和可耐受的,治愈率为90-100%,关于它们在终末期肾病(ESRD)中的疗效的数据有限,特别是南亚的HD患者。该研究旨在评估12周的sofosbuvir(SOF)和velpatasvir(VEL)治疗方案对巴基斯坦亚洲人群中慢性HCV感染的ESRD患者进行HD治疗的结果。方法这项前瞻性队列研究于2022年1月至2023年1月在SheikhZayed医学院和医院的门诊肾脏病和胃肠病学诊所进行,RahimYarKhan,巴基斯坦。本研究共纳入220例符合纳入标准的ESRD患者,20-55岁,他们已经接受每周一次的高清课程至少两年了,获得性HCV感染。通过患者访谈收集有关人口统计学和临床特征的数据。进行实验室和透析分析以评估ESRD并发现超声腹部的根本原因。血压计测量血压,糖尿病随机血糖,并注意透析的持续时间和频率。在选定的时间间隔进行HCVRNAPCR以评估对治疗的病毒学应答。持续病毒学应答(SVR),肝硬化状态,在SOF/VEL方案治疗1年时,比较每周一次的HD治疗次数.结果ESRD患者平均年龄为41.8岁,标准差(SD)为9.3岁,HCV诊断为1.3年,SD为0.4年;52.7%(n=116)为男性,47.3%(n=104)为女性,75%(n=165)是城市居民,93.6%(n=206)已婚。需要透析的CKD主要由高血压引起(78,35%),2型糖尿病(52,24%),双侧小肾脏病(40,18%),和其他(34,16%)。一百一十六(48.2%)每周接受三次透析,83(37.7%)两次,和31(14.1%)每周一次。该研究监测了89.5%的ESRD患者在SOF/VEL方案治疗4周时的快速病毒学应答(RVR),在12周时观察到的治疗结束反应(ETR)为93.2%,并注意到一年时SVR反应为91.4%。在研究中只观察到四次(1.8%)复发,这在统计上是微不足道的。肝硬化的状态显示了50%的改善,从40%下降到20%。每周HD会话的频率从每周三次减少到每周两次三次。结论CKD和透析型ESRD患者感染HCV的患病率较高。全口服DAA疗法彻底改变了HCV治疗的合并症。在接受HD的ESRD患者中,使用SOF/VEL方案治疗慢性HCV感染后肾功能得到改善,每周透析次数减少,SVR达到91.4%。因此,一个平板电脑,SOF/VEL的泛基因型DAA方案12周是安全的,有效,无论ESRD的潜在病因如何,都可以耐受,肝硬化并发症,HCV基因型,或先前的治疗暴露。成功治疗HCV并实现SVR可降低ESRD并发症的风险,改善肝外表现,大大提高了生存。在获得其他DAA后,有必要进行进一步的研究,以确认没有限制的发现。
Background Patients on hemodialysis (HD) are most likely to contract hepatitis C (HCV) infection, which is associated with significant morbidity and disease progression. Direct-acting antivirals (DAAs) are safe and tolerable in chronic kidney disease (CKD) with a 90-100% cure rate, and limited data exist regarding their efficacy in end-stage renal disease (ESRD), particularly for HD patients in South Asia. The study aimed to assess the outcome of a 12-week sofosbuvir (SOF) and velpatasvir (VEL) treatment regimen on ESRD patients with chronic HCV infection undergoing HD in the Pakistani Asian population. Methodology This prospective cohort study was conducted between January 2022 and January 2023 at the outpatient nephrology and gastroenterology clinic of Sheikh Zayed Medical College and Hospital, Rahim Yar Khan, Pakistan. This study included a total of 220 ESRD patients fulfilling the inclusion criteria, aged 20-55 years, who had been undergoing weekly HD sessions for at least two years, with acquired HCV infection. Data on demographic and clinical characteristics were collected through patient interviews. Laboratory and dialysis profiling was executed to assess ESRD and discover the underlying cause by ultrasound abdomen, blood pressure measurement by sphygmomanometer, random blood sugar for diabetes, and taking note of the duration and frequency of dialysis. HCV RNA PCR was done at selected intervals to evaluate the virological response to treatment. Sustained virological response (SVR), liver cirrhosis status, and number of weekly HD sessions were compared at one year of SOF/VEL regimen. Results The mean age of patients with ESRD was 41.8 with a standard deviation (SD) of 9.3 years, and HCV diagnosis was 1.3 years with SD of 0.4 years; 52.7% (n=116) were males, 47.3% (n=104) were females, 75% (n=165) were urban dwellers, and 93.6% (n=206) were married. CKD that requires dialysis was caused mainly by hypertension (78, 35%), diabetes mellitus type 2 (52, 24%), bilateral small kidney disease (40, 18%), and others (34, 16%). One hundred and six (48.2%) received dialysis thrice weekly, 83 (37.7%) twice, and 31 (14.1%) once weekly. The study monitored the rapid virological response (RVR) at four weeks of SOF/VEL regimen in 89.5% of ESRD patients, observed end-of-treatment response (ETR) at 12 weeks in 93.2%, and noted 91.4% SVR response at one year. Only four (1.8%) relapses were observed in the study, which was statistically insignificant. The status of liver cirrhosis showed a 50% improvement, decreasing from 40% to 20%. The frequency of weekly HD sessions decreased from thrice to twice-thrice a week. Conclusion The prevalence of contracting HCV is high among CKD and dialysis ESRD patients. All-oral DAA therapy has revolutionized HCV treatment with co-morbidities. Renal functions improved after the SOF/VEL regimen for chronic HCV infection in ESRD patients undergoing HD, with the number of weekly dialysis sessions reduced and SVR reaching 91.4%. Thus, a single-tablet, pan-genotypic DAA regimen of SOF/VEL for 12 weeks is safe, effective, and tolerable regardless of the underlying etiology of ESRD, complications of cirrhosis, HCV genotype, or previous treatment exposure. The successful treatment of HCV and achieving SVR lowers the risk of ESRD complications, improves extra-hepatic manifestations, and greatly enhances survival. Further studies are warranted after the availability of other DAAs to confirm findings with no limitations.