PMID- 34465694
OWN - NLM
STAT- MEDLINE
DCOM- 20210913
LR  - 20230718
IS  - 1572-0241 (Electronic)
IS  - 0002-9270 (Linking)
VI  - 116
IP  - 9
DP  - 2021 Sep 1
TI  - Ledipasvir/Sofosbuvir for 8, 12, or 24 Weeks in Hepatitis C Patients Undergoing 
      Dialysis for End-Stage Renal Disease.
PG  - 1924-1928
LID - 10.14309/ajg.0000000000001281 [doi]
AB  - INTRODUCTION: We evaluated 8, 12, or 24 weeks of ledipasvir/sofosbuvir in 
      patients with hepatitis C virus and end-stage renal disease undergoing dialysis. 
      METHODS: Primary efficacy end point was sustained virologic response 12 weeks 
      after treatment. Primary safety end point was treatment discontinuation because 
      of adverse events (AEs). RESULTS: Ninety-four percent (89/95) achieved sustained 
      virologic response 12 weeks after treatment. Six patients died during treatment 
      (n = 4) or before study completion (n = 2); no deaths were related to treatment. 
      No patients discontinued treatment because of AEs. Thirteen percent had serious 
      AEs; none were related to treatment. DISCUSSION: Treatment with 
      ledipasvir/sofosbuvir was safe and effective in patients with end-stage renal 
      disease undergoing dialysis.
CI  - Copyright (c) 2021 by The American College of Gastroenterology.
FAU - Chuang, Wan-Long
AU  - Chuang WL
AD  - Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, 
      Taiwan.
FAU - Hu, Tsung-Hui
AU  - Hu TH
AD  - Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan.
FAU - Buggisch, Peter
AU  - Buggisch P
AD  - Ifi-Institut fur Interdisziplinare Medizin, Liver-Centre Hamburg, Hamburg, 
      Germany.
FAU - Moreno, Christophe
AU  - Moreno C
AD  - CUB Hopital Erasme, Universite Libre de Bruxelles, Brussels, Belgium.
FAU - Su, Wei-Wen
AU  - Su WW
AD  - Changhua Christian Hospital, Changhua City, Taiwan.
FAU - Biancone, Luigi
AU  - Biancone L
AD  - Universita Degli Studi di Torino, Turin, Italy.
FAU - Camargo, Marianne
AU  - Camargo M
AD  - Gilead Sciences, Foster City, California, USA.
FAU - Hyland, Robert
AU  - Hyland R
AD  - Gilead Sciences, Foster City, California, USA.
FAU - Lu, Sophia
AU  - Lu S
AD  - Gilead Sciences, Foster City, California, USA.
FAU - Kirby, Brian J
AU  - Kirby BJ
AD  - Gilead Sciences, Foster City, California, USA.
FAU - Dvory-Sobol, Hadas
AU  - Dvory-Sobol H
AD  - Gilead Sciences, Foster City, California, USA.
FAU - Osinusi, Anu
AU  - Osinusi A
AD  - Gilead Sciences, Foster City, California, USA.
FAU - Gaggar, Anuj
AU  - Gaggar A
AD  - Gilead Sciences, Foster City, California, USA.
FAU - Peng, Cheng-Yuan
AU  - Peng CY
AD  - China Medical University Hospital, Taichung City, Taiwan.
FAU - Liu, Chen-Hua
AU  - Liu CH
AD  - National Taiwan University Hospital, Taipei City, Taiwan.
FAU - Sise, Meghan E
AU  - Sise ME
AD  - Massachusetts General Hospital, Boston, Massachusetts, USA.
FAU - Mangia, Alessandra
AU  - Mangia A
AD  - Casa Sollievo Della Sofferenza, San Giovanni Rotondo, Italy .
LA  - eng
SI  - EudraCT/2016-003489-25
SI  - ClinicalTrials.gov/NCT03036839
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Gastroenterol
JT  - The American journal of gastroenterology
JID - 0421030
RN  - 0 (Antiviral Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Fluorenes)
RN  - 013TE6E4WV (ledipasvir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antiviral Agents/administration & dosage/*therapeutic use
MH  - Benzimidazoles/administration & dosage/*therapeutic use
MH  - Drug Administration Schedule
MH  - Female
MH  - Fluorenes/administration & dosage/*therapeutic use
MH  - Hepatitis C/complications/*drug therapy
MH  - Humans
MH  - Kidney Failure, Chronic/complications/*therapy
MH  - Male
MH  - Middle Aged
MH  - Sofosbuvir/administration & dosage/*therapeutic use
MH  - Sustained Virologic Response
MH  - Treatment Outcome
EDAT- 2021/09/02 06:00
MHDA- 2021/09/14 06:00
CRDT- 2021/09/01 06:42
PHST- 2020/10/22 00:00 [received]
PHST- 2021/03/18 00:00 [accepted]
PHST- 2021/09/01 06:42 [entrez]
PHST- 2021/09/02 06:00 [pubmed]
PHST- 2021/09/14 06:00 [medline]
AID - 00000434-202109000-00023 [pii]
AID - 10.14309/ajg.0000000000001281 [doi]
PST - ppublish
SO  - Am J Gastroenterol. 2021 Sep 1;116(9):1924-1928. doi: 
      10.14309/ajg.0000000000001281.