Gut and Gastroenterology

Abstract

Real life study of ombitasvir/paritaprevir/ritonavir in chronic kidney disease Egyptian patients infected with HCV genotype 4

Author(s): Hanno A, Elwazzan D, Ibrahim M and Abdeen N

Background: The availability of new direct acting antiviral drugs for HCV allow for treatment of HCV infection associated with renal impairment by interferon free regimens, but the choice of the suitable drug is important because some of these drugs can accumulate to a toxic level due to renal impairment. 
Aims: The aim of this work was to confirm the efficacy and safety of ombitasvir/ paritaprevir/ ritonavir (OBV/PTV/r) and ribavirin in the treatment of HCV genotype 4 infected Egyptian patients with impaired renal functions. 
Methods: The study enrolled 50 HCV infected patients with impaired renal functions. Pre-treatment assessment included complete liver functions with calculation of Child-Pugh score (patients with Child A only were included), renal function tests with calculation of estimated glomerular filtration rate (eGFR), HCV RNA, complete blood picture (CBC) and ultrasound abdomen. The patients were given OBV/PTV/r two tablets daily, each tablet contains paritaprevir 75 mg/ ombitasvir 12.5 mg/ ritonavir 50 mg± ribavirin (the dose was decided according to the body weight, eGFR and heamoglobin level follow up during treatment) for 12 weeks. Patients were followed up during treatment by routine laboratory investigations, HCV RNA was done at end of treatment, 12 and 24 weeks post- treatment. 
Results: According to eGFR; 15 (30%) patients had chronic kidney disease CKD stage 2 (eGFR 60-89 ml/min/1.73m2), 22 (44%) patients were CKD stage 3(eGFR 30-59 ml/min/1.73m2), two (4%) patients were CKD stage 4 (eGFR 15-29 ml/min/1.73m2) and 11 (22%) patients were on dialysis; CKD stage 5 (eGFR <15 ml/min/1.73m2). No serious side effects were detected during treatment except for pruritis and GIT disturbances which were detected in 12 (24%), jaundice (total serum bilirubin >2 mg/dl) was found in 7 patients (14%),anemia was observed in 8 patients (16%), which necessitated stoppage of ribavirin in five (10%) patients. SVR was achieved in 48(96%) patients. 
Conclusions: The use of paritaprevir 150 mg/ombitasvir 25 mg/ ritonavir100 mg ± ribavirin for 12 weeks provided high rate of sustained virological response among chronic HCV genotype 4 infected patients with renal impairment without serious side effects.

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