低剂量索磷布韦治疗严重肾功能损害或终末期肾病慢性丙型肝炎患者安全有效。
Low-Dose Sofosbuvir Is Safe and Effective in Treating Chronic Hepatitis C in Patients with Severe Renal Impairment or End-Stage Renal Disease.
机构信息
Department of Hepatology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India.
Department of Nephrology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
出版信息
Dig Dis Sci. 2018 May;63(5):1334-1340. doi: 10.1007/s10620-018-4979-6. Epub 2018 Feb 26.
BACKGROUND AND AIMS
There is sparse data on the use of Sofosbuvir based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m. We evaluated the safety and efficacy of low-dose Sofosbuvir plus full-dose Daclatasvir in CHC patients with CKD.
METHODS
Sixty-five CHC patients with CKD with eGFR less than 30 mL/min/1.73 m [54 (83%) patients with ESRD on hemodialysis] were included. All patients irrespective of genotype were treated with half-dose Sofosbuvir [200 mg (half tablet of 400 mg)] plus full-dose Daclatasvir (60 mg) given daily for either 12 or 24 weeks given in patients with genotype 3 cirrhosis. The efficacy was assessed by the sustained virological response (SVR12) with negative HCV RNA 12 weeks after the end of treatment (ETR).
RESULTS
The median HCV RNA level in 65 patients (Males 40, mean age 42.9 ± 13 years) was 1.65 × 10 (1.2 × 10-1.73 × 10) IU/mL with 42 (64.6%) patients having HCV genotype 1, followed by genotype 3 and 2 in 22 (34%) and 1 (1.4%) patients, respectively. Twenty-one (32%) patients had evidence of cirrhosis, and ten (15.4%) patients were treatment experienced. Sixty-four (98.5%) patients achieved ETR, and 65 (100%) patients attained SVR12. All patients tolerated the DAAs well with none of the patients reporting any serious adverse events. Minor side effects noted were nausea seen in five (7.7%) patients, insomnia and headache in four (6.2%) patients each, and pruritus in one (1.5%) patient.
CONCLUSION
Low-dose Sofosbuvir and full-dose Daclatasvir are safe and effective in treating CHC in patients with CKD with eGFR less than 30 mL/min/1.73 m.
背景和目的
目前关于肾小球滤过率（eGFR）<30 ml/min/1.73 m 的慢性肾脏病（CKD）合并慢性丙型肝炎（CHC）患者应用直接作用抗病毒（DAA）药物 Sofosbuvir 方案的数据较少。我们评估了低剂量 Sofosbuvir 联合全剂量 Daclatasvir 在 CKD 合并 CHC 患者中的安全性和疗效。
方法
纳入 65 例 eGFR<30 ml/min/1.73 m 的 CKD 合并 CHC 患者[54 例（83%）为接受血液透析的终末期肾病（ESRD）患者]。所有患者无论基因型如何，均接受 Sofosbuvir 半剂量[200mg（400mg 半片）]联合全剂量 Daclatasvir（60mg）治疗，基因型 3 肝硬化患者治疗 12 或 24 周。治疗结束后 12 周（ETR）时，通过持续病毒学应答（SVR12）评估疗效，即 HCV RNA 阴性。
结果
65 例患者（男性 40 例，平均年龄 42.9±13 岁）的中位 HCV RNA 水平为 1.65×10（1.2×10-1.73×10）IU/ml，其中 42 例（64.6%）患者为 HCV 基因型 1，其次是基因型 3 和 2，分别为 22 例（34%）和 1 例（1.4%）。21 例（32%）患者有肝硬化证据，10 例（15.4%）患者为治疗经验丰富。64 例（98.5%）患者达到 ETR，65 例（100%）患者达到 SVR12。所有患者均耐受 DAA 治疗，无患者报告任何严重不良事件。少数患者出现不良反应，包括 5 例（7.7%）患者恶心，4 例（6.2%）患者失眠和头痛，1 例（1.5%）患者瘙痒。
结论
低剂量 Sofosbuvir 联合全剂量 Daclatasvir 治疗 eGFR<30 ml/min/1.73 m 的 CKD 合并 CHC 患者安全有效。
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