TY - JOUR
T1 - Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir With or Without Ribavirin in Patients With Kidney Disease
AU - Bernstein, David E.
AU - Tran, Albert
AU - Martin, Paul
AU - Kowdley, Kris V.
AU - Bourliere, Marc
AU - Sulkowski, Mark S.
AU - Pockros, Paul J.
AU - Renjifo, Boris
AU - Wang, Deli
AU - Shuster, Diana L.
AU - Cohen, Daniel E.
AU - Jacobson, Ira M.
N1 - Publisher Copyright:
© 2018 International Society of Nephrology
PY - 2019/2
Y1 - 2019/2
N2 - 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 m 2 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.
AB - 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 m 2 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.
KW - chronic hepatitis C
KW - chronic kidney disease
KW - direct-acting antiviral
KW - hepatitis C virus
UR - http://www.scopus.com/inward/record.url?scp=85057369772&partnerID=8YFLogxK
U2 - 10.1016/j.ekir.2018.10.005
DO - 10.1016/j.ekir.2018.10.005
M3 - Article
AN - SCOPUS:85057369772
SN - 2468-0249
VL - 4
SP - 245
EP - 256
JO - Kidney International Reports
JF - Kidney International Reports
IS - 2
ER -