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Subject Area

Clinical Pathology

Article Type

Original Study

Abstract

Objective To evaluate efficacy and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) and ribavirin (RBV) therapy in hepatitis C virus (HCV)-infected patients with chronic kidney disease (CKD). Background In the era of new direct-acting antiviral drugs for HCV, data about their efficacy and safety in different renal situations are still under evaluation especially in Egypt. Patients and methods Between June 2017 and August 2018, a prospective study at Damanhour Medical National Institute was designed to enroll 50 patients with chronic HCV and CKD grades 4, 5, and 5D. Patients were given OBV/PTV/r (25/150/100 mg) plus RBV (200 mg) once daily for 12 weeks. Sustained virologic response (SVR12) was the primary end point. Results All patients achieved SVR12 (100%). Hemoglobin levels were significantly reduced during treatment (P < 0.001), with partial improvement 12 weeks after treatment; however, they were significantly lower than the baseline levels (P < 0.001). Serum bilirubin and liver enzymes levels were significantly increased during treatment (P = 0.046 and 0.021, respectively). After 12 weeks, bilirubin levels were normalized, whereas liver enzymes were significantly reduced (P < 0.001). Following a nonsignificant deterioration in serum creatinine and estimated glomerular filtration rates during treatment, a significant improvement was achieved 12 weeks after treatment in nonhemodialysis patients (P = 0.010). No serious adverse events occurred. Only three patients discontinued treatment; however, they achieved SVR12. Conclusion This study concluded that the combination of OBV/PTV/r and RBV for 12 weeks is an effective and relatively safe option for patients with HCV and CKD grades 4, 5, and 5D, which was even associated with improved estimated glomerular filtration rates after treatment in nonhemodialysis patients.

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