Therapy with ombitasvir/paritaprevir/ritonavir plus dasabuvir is effective and safe for the treatment of genotypes 1 and 4 hepatitis C virus ( HCV HCV ) infection in patients with severe renal impairment: A multicentre experience

摘要

Summary 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 2 ) or 5 ( eGFR 15 mL /min/1.73m 2 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 ( SVR 12) 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. SVR 12 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.