Efficacy of ombitasvir/paritaprevir/ritonavir/ribavirin in management of HCV genotype 4 and end-stage kidney disease.

Abstract

BACKGROUND\nTill now, pooled data about the safety and efficacy of different direct-acting antiviral (DAAs) regimens in different renal situations are still under evaluation.\n\n\nAIM\nTo evaluate a real-life experience of the efficacy and safety of ombitasvir/paritaprevir/ritonavir plus ribavirin (OBV/PTV/r plus RIB) in patients with end-stage kidney disease (ESKD).\n\n\nPATIENTS AND METHODS\nBetween January 2017 and January 2018, an open-label multicenter prospective study was designed to enroll all consecutive patients with proven CHC genotype 4 infections and concomitant ESKD based on estimated glomerular filtration rate (eGFR) with (HD group) or without hemodialysis (non-HD group). Patients were given a co-formula of OBV/PTV/r (25/150/100\u2009mg) once-daily plus RIB was given for 12\u2009weeks. Sustained virologic response (SVR 12) was the primary endpoint.\n\n\nRESULTS\nA total of 110 patients were enrolled. An overall SVR 12 was reported in 104 (94.5%) patients, and treatment failure were reported in 6 patients [2 patients (1.8%) were relapsed, and 4 patients (3.6%) patients were non-responders]. SVR12 was 96% in HD and 91.4% in non-HD patients (P\u2009=\u20090.286). There were no reported serious adverse events. Anemia was reported in 66.6% (n\u2009=\u200950) in HD group and in 31.4% (n\u2009=\u200911) in non-HD group.\n\n\nCONCLUSION\nAlthough it is still challenging, achievement of SVR12 in patients with chronic HCV and concomitant end-stage kidney disease in the era of DAAs became possible with a 12\u2009weeks course of a co-formula of ombitasvir/paritaprevir /ritonavir plus ribavirin. CLINICALTRIALS.\n\n\nGOV ID\nNCT03341988.