Ombitasvir, Paritaprevir, Ritonavir, and?Dasabuvir With or Without Ribavirin in?Patients With Kidney Disease

摘要

IntroductionPatients with hepatitis C virus (HCV) infection and chronic kidney disease (CKD) are a high-priority population for treatment.MethodsWe performed apost hocpooled efficacy and safety analysis that included HCV genotype 1–infected patients with compensated liver disease and CKD stages 1 to 3 who received the all-oral 3–direct-acting antiviral regimen of ombitasvir, paritaprevir, ritonavir, and dasabuvir ± ribavirin (OBV/PTV/r?+ DSV ± RBV) in 11 phase 3 clinical trials. Sustained virologic response rates at posttreatment week 12 (SVR12) and treatment-related adverse events (AEs), serious AEs, and renal-associated AEs are reported. Mean changes from baseline in serum creatinine and estimated glomerular filtration rate (eGFR) were calculated to assess changes in renal function. Factors associated with improved eGFR were assessed by stepwise logistic regression analysis of data from 7 trials in which baseline urinalysis was collected.ResultsSVR12 rates in patients with stage 1, 2, and 3 CKD were 97% (439/453), 98% (536/547), and 97% (32/33), respectively, with OBV/PTV/r?+ DSV; and, 96% (1172/1221), 96% (1208/1254), and 93% (55/59), respectively, with OBV/PTV/r?+ DSV?+ RBV. Overall rates of serious AEs and renal AEs were 3% (95/3567) and 2% (56/3567), respectively. Factors associated with an eGFR increase of?≥10 ml/min per 1.73 m2were baseline proteinuria, body mass index, nonblack race, and history of diabetes.ConclusionOBV/PTV/r?+ DSV ± RBV achieved high SVR rates and was generally well tolerated irrespective of CKD stage.