Muñoz-Gómez R, Rincón D, Ahumada A, Hernández E, Devesa M J, Izquierdo S, Ortiz M, Hernández-Albujar A, Fernández-Rodríguez C, Calvo M, González R, Lozano M, Castellano G, Fernández-Vázquez I
Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.
Unit of Hepatology, Hospital Universitario Gregorio Marañón, CIBERehd , Madrid, Spain.
J Viral Hepat. 2017 Jun;24(6):464-471. doi: 10.1111/jvh.12664. Epub 2017 Jan 20.
Limited data are available on direct-acting antivirals for treating hepatitis C virus (HCV) infection in patients with severe renal impairment. The aim of this study was to evaluate the effectiveness and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) in patients with stage 4 or 5 chronic kidney disease (CKD) and HCV genotype 1 or 4 infection in real clinical practice, and to investigate pharmacological interactions. This retrospective study included patients treated with OBV/PTV/r+DSV±RBV or OBV/PTV/r+RBV with CKD stage 4 (eGFR: 15-29 mL/min/1.73m ) or 5 (eGFR<15 mL/min/1.73m or requiring dialysis) and HCV infection by genotypes 1 and 4 between April 2015 and October 2015 in nine Spanish centres. Sustained virological response at 12 weeks (SVR12) was assessed, and clinical and laboratory data, fibrosis stage, adverse events and pharmacological interactions were reported. Forty-six patients were included: 10 (21.7%) had CKD stage 4 and 36 (78.2%) CKD stage 5. Seventeen (36.9%) had cirrhosis. SVR12 rate in the intention-to-treat population was 95.7%. Twenty-one (45.6%) received RBV, which was discontinued in two (9.5%) patients. Anaemia (haemoglobin <10 g/dl) occurred in 12 patients (57.1%) with RBV vs 10 (40.0%) without RBV (P=.246). Renal function remained stable during antiviral therapy. Nine patients (19.5%) experienced serious adverse events unrelated to antiviral therapy. Concomitant medication was discontinued or modified in 41.3% of patients. In conclusion, the effectiveness of OBV/PTV/r±DSV±RBV in patients with CKD 4-5 was similar to that observed in those with normal renal function and was not associated with severe adverse events.
关于直接作用抗病毒药物治疗严重肾功能损害患者丙型肝炎病毒（HCV）感染的数据有限。本研究的目的是在实际临床实践中评估ombitasvir/paritaprevir/ritonavir（OBV/PTV/r）±达沙布韦（DSV）±利巴韦林（RBV）治疗4期或5期慢性肾脏病（CKD）且感染HCV 1型或4型的患者的有效性和安全性，并研究药物相互作用。这项回顾性研究纳入了2015年4月至2015年10月在西班牙九个中心接受OBV/PTV/r+DSV±RBV或OBV/PTV/r+RBV治疗的CKD 4期（估算肾小球滤过率：15 - 29 mL/min/1.73m²）或5期（估算肾小球滤过率<15 mL/min/1.73m²或需要透析）且感染HCV 1型和4型的患者。评估了12周持续病毒学应答（SVR12），并报告了临床和实验室数据、纤维化分期、不良事件及药物相互作用。共纳入46例患者：10例（21.7%）为CKD 4期，36例（78.2%）为CKD 5期。17例（36.9%）有肝硬化。意向性治疗人群的SVR12率为95.7%。21例（45.6%）接受了RBV，其中2例（9.5%）患者停用了RBV。接受RBV的患者中有12例（57.1%）发生贫血（血红蛋白<10 g/dl），未接受RBV的患者中有10例（40.0%）发生贫血（P = 0.246）。抗病毒治疗期间肾功能保持稳定。9例患者（19.5%）发生了与抗病毒治疗无关的严重不良事件。41.3%的患者停用或调整了伴随用药。总之，OBV/PTV/r±DSV±RBV在CKD 4 - 5期患者中的有效性与肾功能正常患者相似，且未发生严重不良事件。
