PMID- 30400729
OWN - NLM
STAT- MEDLINE
DCOM- 20190812
LR  - 20211204
IS  - 2005-1212 (Electronic)
IS  - 1976-2283 (Print)
IS  - 1976-2283 (Linking)
VI  - 13
IP  - 2
DP  - 2019 Mar 15
TI  - Efficacy and Safety of Daclatasvir and Asunaprevir in Patients with Hepatitis C 
      Virus Genotype 1b Infection on Hemodialysis.
PG  - 191-196
LID - 10.5009/gnl18240 [doi]
AB  - BACKGROUND/AIMS: We evaluated the efficacy and safety of daclatasvir (DCV) and 
      asunaprevir (ASV) in patients with chronic hepatitis C virus (HCV) infection on 
      hemodialysis. METHODS; We performed a single-arm, multicenter prospective study. 
      Twenty-one chronic hemodialysis patients with HCV infection were prospectively 
      enrolled from February 2016 to April 2017. We evaluated the virological responses 
      at weeks 4, 12, and 24 (end of treatment [EOT]) and the sustained virological 
      response at 12 weeks after the EOT (SVR12). The tolerability and safety of the 
      drugs were also assessed. RESULTS: None of the 20 patients had the NS5A 
      resistance-associated variant (NS5A RAV), and one patient was indeterminate for 
      the NS5A RAV. Seventeen patients (80%) completed the 24 weeks of treatment with 
      DCV and ASV. Four patients discontinued the study prior to week 12. In an 
      intention-to-treat analysis, the SVR12 was 76.1%. In a per-protocol analysis, 
      patients who completed DCV and ASV treatment achieved an SVR12 of 100%. DCV and 
      ASV were well tolerated by the majority of patients. Three patients discontinued 
      treatment due to adverse events (AEs) including dizziness, dyspnea, and 
      neutropenia. The patient with indeterminate NS5A RAV showed viral breakthrough 
      and discontinued treatment. CONCLUSIONS: DCV and ASV combination therapy in 
      chronic hemodialysis patients with HCV infection achieved a high SVR12 rate with 
      few AEs. To maximize the SVR12 rate, it is important to identify candidates by 
      baseline RAV testing. Close monitoring of the safety and tolerability of DCV and 
      ASV may be necessary in HCV-infected patients on hemodialysis. 
      (ClinicalTrials.gov ID NCT02580474).
FAU - Lee, Byung Seok
AU  - Lee BS
AD  - Department of Internal Medicine, Chungnam University College of Medicine, 
      Daejeon, Korea.
FAU - Song, Myeong Jun
AU  - Song MJ
AD  - Division of Hepatology, Department of Internal Medicine, Daejeon St. Mary's 
      Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
FAU - Kwon, Jung Hyun
AU  - Kwon JH
AD  - Division of Hepatology, Department of Internal Medicine, Incheon St. Mary's 
      Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
FAU - Lee, Tae Hee
AU  - Lee TH
AD  - Department of Internal Medicine, Konyang University College of Medicine, Daejeon, 
      Korea.
FAU - Jang, Ji Woong
AU  - Jang JW
AD  - Department of Internal Medicine, Eulji University Hospital, Eulji University 
      College of Medicine, Daejeon, Korea.
FAU - Kim, Seok Hyun
AU  - Kim SH
AD  - Department of Internal Medicine, Chungnam University College of Medicine, 
      Daejeon, Korea.
FAU - Lee, Sae Hwan
AU  - Lee SH
AD  - Department of Internal Medicine, Soonchunhyang University Hospital, Soonchunhyang 
      University College of Medicine, Cheonan, Korea.
FAU - Kim, Hong Soo
AU  - Kim HS
AD  - Department of Internal Medicine, Soonchunhyang University Hospital, Soonchunhyang 
      University College of Medicine, Cheonan, Korea.
FAU - Kim, Ji Hoon
AU  - Kim JH
AD  - Department of Internal Medicine, Korea University Guro Hospital, Korea University 
      College of Medicine, Seoul, Korea.
FAU - Kim, Seok Bae
AU  - Kim SB
AD  - Department of Internal Medicine, Dankook University Hospital, Dankook University 
      College of Medicine, Cheonan, Korea.
FAU - Ko, Soon Young
AU  - Ko SY
AD  - Department of Internal Medicine, Konkuk University School of Medicine, Seoul, 
      Korea.
FAU - Song, Do Seon
AU  - Song DS
AD  - Division of Hepatology, Department of Internal Medicine, St. Vincent's Hospital, 
      College of Medicine, The Catholic University of Korea, Seoul, Korea.
LA  - eng
SI  - ClinicalTrials.gov/NCT02580474
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - Korea (South)
TA  - Gut Liver
JT  - Gut and liver
JID - 101316452
RN  - 0 (Antiviral Agents)
RN  - 0 (Carbamates)
RN  - 0 (Imidazoles)
RN  - 0 (Isoquinolines)
RN  - 0 (Pyrrolidines)
RN  - 0 (RNA, Viral)
RN  - 0 (Sulfonamides)
RN  - HG18B9YRS7 (Valine)
RN  - LI2427F9CI (daclatasvir)
RN  - S9X0KRJ00S (asunaprevir)
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antiviral Agents/*administration & dosage
MH  - Carbamates
MH  - Drug Therapy, Combination
MH  - Female
MH  - Genotype
MH  - Hepacivirus/*drug effects/genetics
MH  - Hepatitis C, Chronic/*drug therapy/virology
MH  - Humans
MH  - Imidazoles/*administration & dosage
MH  - Isoquinolines/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Pyrrolidines
MH  - RNA, Viral/drug effects
MH  - Renal Dialysis
MH  - Sulfonamides/*administration & dosage
MH  - Sustained Virologic Response
MH  - Valine/analogs & derivatives
PMC - PMC6430432
OTO - NOTNLM
OT  - Asunaprevir
OT  - Chronic hepatitis C virus
OT  - Daclatasvir
OT  - Hemodialysis
OT  - Sustained virologic response
COIS- CONFLICTS OF INTEREST No potential conflict of interest relevant to this article 
      was reported.
EDAT- 2018/11/08 06:00
MHDA- 2019/08/14 06:00
PMCR- 2019/03/01
CRDT- 2018/11/08 06:00
PHST- 2018/05/28 00:00 [received]
PHST- 2018/07/09 00:00 [revised]
PHST- 2018/08/13 00:00 [accepted]
PHST- 2018/11/08 06:00 [pubmed]
PHST- 2019/08/14 06:00 [medline]
PHST- 2018/11/08 06:00 [entrez]
PHST- 2019/03/01 00:00 [pmc-release]
AID - gnl18240 [pii]
AID - gnl-13-191 [pii]
AID - 10.5009/gnl18240 [doi]
PST - ppublish
SO  - Gut Liver. 2019 Mar 15;13(2):191-196. doi: 10.5009/gnl18240.