Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Alimentary Tract Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
J Gastroenterol Hepatol. 2020 Sep;35(9):1590-1594. doi: 10.1111/jgh.14994. Epub 2020 Feb 5.
Many of the treatment regimens available for hepatitis C include sofosbuvir. Unfortunately, sofosbuvir has not been recommended for use in patients with severe renal impairment leaving these group of patients with very few options. Nevertheless, there are many reports in which these patients have been treated with sofosbuvir-containing regiments without important adverse events. This study aims at determining the safety and effectiveness of a sofosbuvir-based treatment in patients with severe renal impairment, including those on hemodialysis.
We enrolled subjects with hepatitis C and estimated glomerular filtration rate under ml/min/1.73m from 13 centers in Iran. Patients were treated for 12 weeks with a single daily pill containing 400-mg sofosbuvir and 60-mg daclatasvir. Patients with cirrhosis were treated for 24 weeks. Response to treatment was evaluated 12 weeks after end of treatment (sustained viral response [SVR]). ClinicalTrials.gov identifier: NCT03063879.
A total of 103 patients were enrolled from 13 centers. Seventy-five patients were on hemodialysis. Thirty-nine had cirrhosis and eight were decompensated. Fifty-three were Genotype 1, and 27 Genotype 3. Twenty-seven patients had history of previous failed interferon-based treatment. Three patients died in which cause of death was not related to treatment. Six patients were lost to follow-up. The remaining 94 patients all achieved SVR. No adverse events leading to discontinuation of medicine was observed.
The combination of sofosbuvir and daclatasvir is an effective and safe treatment for patients infected with all genotypes of hepatitis C who have severe renal impairment, including patients on hemodialysis.
许多现有的丙型肝炎治疗方案都包含索非布韦。遗憾的是，严重肾功能损害患者并未推荐使用索非布韦，这使得该类患者的治疗选择非常有限。然而，有许多报道表明，这些患者使用含索非布韦的方案治疗并未出现重要的不良事件。本研究旨在确定包含索非布韦的方案治疗伴有严重肾功能损害（包括接受血液透析的患者）的安全性和有效性。
我们从伊朗的 13 个中心纳入肾小球滤过率估计值<30ml/min/1.73m2的丙型肝炎患者。所有患者接受为期 12 周的治疗，方案为每日服用一片包含 400mg 索非布韦和 60mg 达卡他韦的单一片剂。肝硬化患者的治疗疗程为 24 周。治疗结束后 12 周评估治疗应答（持续病毒学应答[SVR]）。临床试验注册编号：NCT03063879。
从 13 个中心共纳入 103 例患者。75 例患者正在接受血液透析。39 例患者患有肝硬化，8 例患者为失代偿性肝硬化。53 例患者为基因型 1，27 例患者为基因型 3。27 例患者既往干扰素治疗失败。3 例患者死亡，死亡原因与治疗无关。6 例患者失访。其余 94 例患者均获得 SVR。未观察到因不良事件而停药的病例。
索非布韦和达卡他韦联合方案治疗所有基因型丙型肝炎且伴有严重肾功能损害（包括接受血液透析的患者）的疗效确切且安全性良好。
