PMID- 28012215
OWN - NLM
STAT- MEDLINE
DCOM- 20170724
LR  - 20211204
IS  - 1432-2277 (Electronic)
IS  - 0934-0874 (Linking)
VI  - 30
IP  - 3
DP  - 2017 Mar
TI  - Real-world experience with daclatasvir plus sofosbuvir +/- ribavirin for post-liver 
      transplant HCV recurrence and severe liver disease.
PG  - 243-255
LID - 10.1111/tri.12910 [doi]
AB  - Optimizing therapy of post-transplant HCV recurrence remains important, 
      especially in advanced liver disease. We evaluated daclatasvir (DCV) plus 
      sofosbuvir (SOF), with or without ribavirin (RBV), in patients with post-liver 
      transplant recurrence in a real-world European cohort at high risk of 
      decompensation or death within 12 months. Recommended treatment was DCV 60 mg 
      plus SOF 400 mg once daily for 24 weeks; RBV use/shorter treatment duration was 
      at physicians' discretion. Patients (N = 87) were 70% male, 93% white, and mostly 
      infected with HCV genotypes 1b (48%), 1a (32%), or 3 (9%); 37 (43%) had cirrhosis 
      (16 decompensated), five had fibrosing cholestatic hepatitis. Sustained virologic 
      response at post-treatment week 12 (SVR12) was 94% (80/85) in a modified 
      intention-to-treat analysis: 95% (58/61) without RBV and 92% (22/24) with RBV, 
      with no virologic failures. SVR12 was 100% (80/80) in an as-observed analysis 
      excluding five nonvirologic failures. Four patients (5%) discontinued therapy for 
      adverse events (AEs); 16 (18%) experienced serious AEs. One patient died on 
      treatment and five during follow-up. Most AEs were associated with advanced liver 
      disease and unrelated to therapy. No clinically significant drug-drug 
      interactions were observed. DCV + SOF +/- RBV was well tolerated and achieved high 
      SVR12 (94%) in patients with post-transplant HCV recurrence, including patients 
      with severe liver disease.
CI  - (c) 2016 The Authors. Transplant International published by John Wiley & Sons Ltd 
      on behalf of Steunstichting ESOT.
FAU - Herzer, Kerstin
AU  - Herzer K
AD  - Universitatsklinikum Essen, Essen, Germany.
FAU - Welzel, Tania M
AU  - Welzel TM
AD  - Universitatsklinikum der Johann Wolfgang Goethe Universitat, Frankfurt, Germany.
FAU - Spengler, Ulrich
AU  - Spengler U
AD  - Universitatsklinikum Bonn, Bonn, Germany.
FAU - Hinrichsen, Holger
AU  - Hinrichsen H
AD  - Gastroenterologisch-Hepatologisches Zentrum Kiel, Kiel, Germany.
FAU - Klinker, Hartwig
AU  - Klinker H
AD  - Universitatsklinikum Wurzburg, Wurzburg, Germany.
FAU - Berg, Thomas
AU  - Berg T
AD  - Universitatsklinikum Leipzig, Leipzig, Germany.
FAU - Ferenci, Peter
AU  - Ferenci P
AD  - Medical University of Vienna, Vienna, Austria.
FAU - Peck-Radosavljevic, Markus
AU  - Peck-Radosavljevic M
AD  - Medical University of Vienna, Vienna, Austria.
AD  - Klinikum Klagenfurt am Worthersee, Klagenfurt, Austria.
FAU - Inderson, Akin
AU  - Inderson A
AD  - Leiden University Medical Center, Leiden, The Netherlands.
FAU - Zhao, Yue
AU  - Zhao Y
AD  - Bristol-Myers Squibb, Princeton, NJ, USA.
FAU - Jimenez-Exposito, Maria Jesus
AU  - Jimenez-Exposito MJ
AD  - Bristol-Myers Squibb, Princeton, NJ, USA.
FAU - Zeuzem, Stefan
AU  - Zeuzem S
AD  - Universitatsklinikum der Johann Wolfgang Goethe Universitat, Frankfurt, Germany.
LA  - eng
PT  - Journal Article
PL  - Switzerland
TA  - Transpl Int
JT  - Transplant international : official journal of the European Society for Organ 
      Transplantation
JID - 8908516
RN  - 0 (Antiviral Agents)
RN  - 0 (Carbamates)
RN  - 0 (Imidazoles)
RN  - 0 (Pyrrolidines)
RN  - 49717AWG6K (Ribavirin)
RN  - HG18B9YRS7 (Valine)
RN  - LI2427F9CI (daclatasvir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
CIN - Transpl Int. 2017 Mar;30(3):239-242. PMID: 28102906
MH  - Adult
MH  - Aged
MH  - Antiviral Agents/*administration & dosage/adverse effects
MH  - Carbamates
MH  - Cohort Studies
MH  - Drug Therapy, Combination
MH  - End Stage Liver Disease/etiology/*surgery
MH  - Female
MH  - Hepatitis C, Chronic/complications/*drug therapy/*surgery
MH  - Humans
MH  - Imidazoles/administration & dosage
MH  - Liver Transplantation/*adverse effects
MH  - Male
MH  - Middle Aged
MH  - Pyrrolidines
MH  - Recurrence
MH  - Ribavirin/administration & dosage
MH  - Sofosbuvir/administration & dosage
MH  - Treatment Outcome
MH  - Valine/analogs & derivatives
OTO - NOTNLM
OT  - Decompensated
OT  - HCV therapy
OT  - fibrosing cholestatic hepatitis
OT  - liver transplant
EDAT- 2016/12/25 06:00
MHDA- 2017/07/25 06:00
CRDT- 2016/12/25 06:00
PHST- 2016/09/23 00:00 [received]
PHST- 2016/11/18 00:00 [revised]
PHST- 2016/12/13 00:00 [accepted]
PHST- 2016/12/25 06:00 [pubmed]
PHST- 2017/07/25 06:00 [medline]
PHST- 2016/12/25 06:00 [entrez]
AID - 10.1111/tri.12910 [doi]
PST - ppublish
SO  - Transpl Int. 2017 Mar;30(3):243-255. doi: 10.1111/tri.12910.