PMID- 30775621
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220331
IS  - 2468-0249 (Electronic)
IS  - 2468-0249 (Linking)
VI  - 4
IP  - 2
DP  - 2019 Feb
TI  - Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir With or Without Ribavirin 
      in Patients With Kidney Disease.
PG  - 245-256
LID - 10.1016/j.ekir.2018.10.005 [doi]
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.
FAU - Bernstein, David E
AU  - Bernstein DE
AD  - Division of Hepatology, Hofstra Northwell School of Medicine, Manhasset, New 
      York, USA.
FAU - Tran, Albert
AU  - Tran A
AD  - Institut National de la Sante et de la Recherche Medicale (INSERM), U1065, Team 
      8, "Hepatic Complications in Obesity," Nice, F-06204, Cedex 3, France and 
      University Hospital of Nice, Digestive Centre, Nice, F-06202, Cedex 3, France.
FAU - Martin, Paul
AU  - Martin P
AD  - Division of Hepatology, School of Medicine, University of Miami, Miami, Florida, 
      USA.
FAU - Kowdley, Kris V
AU  - Kowdley KV
AD  - Swedish Medical Center, Seattle, Washington, USA.
FAU - Bourliere, Marc
AU  - Bourliere M
AD  - Hopital Saint Joseph, Marseilles, France.
FAU - Sulkowski, Mark S
AU  - Sulkowski MS
AD  - Viral Hepatitis Center, Johns Hopkins University, Baltimore, Maryland, USA.
FAU - Pockros, Paul J
AU  - Pockros PJ
AD  - Division of Gastroenterology/Hepatology, Scripps Clinic, La Jolla, California, 
      USA.
FAU - Renjifo, Boris
AU  - Renjifo B
AD  - AbbVie Inc., North Chicago, Illinois, USA.
FAU - Wang, Deli
AU  - Wang D
AD  - AbbVie Inc., North Chicago, Illinois, USA.
FAU - Shuster, Diana L
AU  - Shuster DL
AD  - AbbVie Inc., North Chicago, Illinois, USA.
FAU - Cohen, Daniel E
AU  - Cohen DE
AD  - AbbVie Inc., North Chicago, Illinois, USA.
FAU - Jacobson, Ira M
AU  - Jacobson IM
AD  - Mount Sinai Beth Israel, New York, New York, USA.
LA  - eng
PT  - Journal Article
DEP - 20181016
PL  - United States
TA  - Kidney Int Rep
JT  - Kidney international reports
JID - 101684752
PMC - PMC6365509
OTO - NOTNLM
OT  - chronic hepatitis C
OT  - chronic kidney disease
OT  - direct-acting antiviral
OT  - hepatitis C virus
EDAT- 2019/02/19 06:00
MHDA- 2019/02/19 06:01
PMCR- 2018/10/16
CRDT- 2019/02/19 06:00
PHST- 2018/09/05 00:00 [received]
PHST- 2018/10/08 00:00 [accepted]
PHST- 2019/02/19 06:00 [entrez]
PHST- 2019/02/19 06:00 [pubmed]
PHST- 2019/02/19 06:01 [medline]
PHST- 2018/10/16 00:00 [pmc-release]
AID - S2468-0249(18)30227-4 [pii]
AID - 10.1016/j.ekir.2018.10.005 [doi]
PST - epublish
SO  - Kidney Int Rep. 2018 Oct 16;4(2):245-256. doi: 10.1016/j.ekir.2018.10.005. 
      eCollection 2019 Feb.