Department of Nephrology Jinnah Hospital & Allama Iqbal Medical College, Lahore, Pakistan.
Department of Gastroenterology Jinnah Hospital & Allama Iqbal Medical College, Lahore, Pakistan.
BMC Nephrol. 2019 Nov 28;20(1):438. doi: 10.1186/s12882-019-1631-4.
There is paucity of data using direct anti-viral agents (DAA) in patients on maintenance hemodialysis (MHD) infected with HCV-genotype 1 & 3. Aim of the study was to evaluate DAA therapy in patients infected with HCV-genotype 1 & 3 on MHD.
A prospective open label, parallel, non-randomized interventional trial was conducted in patients with Hepatitis-C on maintenance hemodialysis. Total of Sixty two (62) patients with hepatitis-C on maintenance hemodialysis were screened and 36 patients were enrolled and then equally allocated in 1:1 ratio to group 1 who received 400 mg daily sofosbuvir/ 60 mg daily daclatasvir and group 2 who received thrice a week 400 mg Sofosbuvir and daily 60 mg daclatasvir for 12 weeks. Patients with compensated cirrhosis received therapy for 24 weeks. Relevant data was obtained before, during and after therapy. HCV viral load was assessed at week 4, 8, at end of therapy and 12 weeks after treatment.
Eighteen (18) patients were allocated in each group. Three patients in group 1 withdrawn from the study after 2 weeks due to refusal to participate, while one withdrawn in group 2 due to development of adverse effect. Mean age of patients was 47.22 + 14.17 in group 1 and 53.89 + 14.11 in group 2. Genotype 3 was most common in group 1 patients, n = 12 (66.6%), and n = 11 (61.1%) in group 2. All patients in both groups achieved undetectable viral load at 12th week. As per intention to treat analysis overall 29/36 (80.55%) patients achieved SVR (group 1 = 15/18; group 2 = 14/18) and as per-protocol analysis overall 29/32 (90.62%) patients achieved SVR (group 1 = 15/15; group 2 = 14/17).
Direct acting antiviral therapy using sofosbuvir and declatsavir is highly effective and tolerable in patients with HCV genotype 1 & 3 undergoing maintenance hemodialysis, especially when given daily.
This trial is registered in WHO, International Clinical Trial Registry Platform, through Iranian Registry of Clinical Trials (IRCT) having IRCT ID: IRCT20170614034526N3, registered retrospectively on 2019-03-08.
目前关于接受维持性血液透析（MHD）治疗的丙型肝炎病毒（HCV）基因型 1 和 3 感染者使用直接抗病毒药物（DAA）的数据较少。本研究旨在评估接受 MHD 治疗的 HCV 基因型 1 和 3 感染者的 DAA 治疗效果。
对正在接受 MHD 的丙型肝炎患者进行了一项前瞻性、开放标签、平行、非随机干预性试验。对 62 例正在接受 MHD 的丙型肝炎患者进行了筛选，其中 36 例患者被纳入研究，并以 1:1 的比例分为两组，每组 18 例。组 1 患者每日接受 400mg 索磷布韦和 60mg 达卡他韦治疗，组 2 患者每周接受 3 次 400mg 索磷布韦和每日 60mg 达卡他韦治疗，疗程均为 12 周。代偿性肝硬化患者的治疗疗程为 24 周。在治疗前、治疗期间和治疗后获得相关数据。分别在第 4、8、治疗结束和治疗后 12 周评估 HCV 病毒载量。
两组各有 18 例患者。由于拒绝参与，组 1 中有 3 例患者在治疗 2 周后退出研究，而组 2 中有 1 例患者因发生不良反应而退出。组 1 患者的平均年龄为 47.22 ± 14.17 岁，组 2 为 53.89 ± 14.11 岁。组 1 中最常见的基因型为 3 型，n=12（66.6%），组 2 中 n=11（61.1%）。两组患者在第 12 周均达到病毒载量不可检测。根据意向治疗分析，36 例患者中有 29 例（80.55%）实现 SVR（组 1：15/18；组 2：14/18），根据方案分析，32 例患者中有 29 例（90.62%）实现 SVR（组 1：15/15；组 2：14/17）。
索磷布韦和达卡他韦联合直接抗病毒治疗对接受维持性血液透析的 HCV 基因型 1 和 3 患者非常有效且耐受良好，尤其是每日用药时。
本试验在世界卫生组织（WHO）、国际临床试验注册平台（通过伊朗临床试验注册平台 IRCT）注册，注册号为 IRCT20170614034526N3，于 2019 年 3 月 8 日进行了回顾性注册。
