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ABSTRACT: Introduction
Patients with hepatitis C virus (HCV) infection and chronic kidney disease (CKD) are a high-priority population for treatment.Methods
We performed a post hoc pooled 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.Results
SVR12 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 m2 were baseline proteinuria, body mass index, nonblack race, and history of diabetes.Conclusion
OBV/PTV/r + DSV ± RBV achieved high SVR rates and was generally well tolerated irrespective of CKD stage.
SUBMITTER: Bernstein DE
PROVIDER: S-EPMC6365509 | biostudies-literature | 2019 Feb
REPOSITORIES: biostudies-literature
Bernstein David E DE Tran Albert A Martin Paul P Kowdley Kris V KV Bourliere Marc M Sulkowski Mark S MS Pockros Paul J PJ Renjifo Boris B Wang Deli D Shuster Diana L DL Cohen Daniel E DE Jacobson Ira M IM
Kidney international reports 20181016 2
<h4>Introduction</h4>Patients with hepatitis C virus (HCV) infection and chronic kidney disease (CKD) are a high-priority population for treatment.<h4>Methods</h4>We performed a <i>post hoc</i> pooled 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 clinic ...[more]