PMID- 28386057
OWN - NLM
STAT- MEDLINE
DCOM- 20170926
LR  - 20211204
IS  - 2329-0358 (Electronic)
IS  - 1425-9524 (Linking)
VI  - 22
DP  - 2017 Apr 7
TI  - Real-World Safety and Efficacy of 
      Ombitasvir/Paritaprevir/Ritonavir/+Dasabuvir+/-Ribavirin (OBV/PTV/r/+DSV+/-RBV) 
      Therapy in Recurrent Hepatitis C Virus (HCV) Genotype 1 Infection Post-Liver 
      Transplant: AMBER-CEE Study.
PG  - 199-207
AB  - BACKGROUND The introduction of direct-acting antivirals (DAAs) has considerably 
      improved therapeutic outcomes for patients with chronic hepatitis C virus (HCV) 
      infections. The AMBER-CEE study aimed to assess real-world efficacy and safety of 
      ombitasvir/paritaprevir/ritonavir/+ dasabuvir +/-ribavirin (OBV/PTV/r/ +DSV+/-RBV) in 
      the treatment of post-transplant recurrence of HCV infection. MATERIAL AND 
      METHODS Liver transplant recipients with recurrent HCV genotype 1 infection, 
      scheduled for OBV/PTV/r/+DSV+/-RBV according to therapeutic guidelines, were 
      eligible. The primary efficacy endpoint was sustained virologic response (SVR) 12 
      weeks after the end of treatment (FU12). Clinical and laboratory adverse events 
      (AEs) were recorded from baseline to FU12. RESULTS A total of 35 patients were 
      included: 91.4% genotype 1b-infected, 94.3% treatment-experienced, and 77.1% at 
      fibrosis stage >/=F2. SVR12 was achieved by all patients (35/35, 100%) including 
      one patient with genotype 1a, one patient with detectable HCV RNA at the end of 
      treatment, two patients with a history of first-generation DAA therapy, and two 
      patients who prematurely discontinued the regimen. AEs were experienced by 22 
      patients (62.9%) and were mostly mild. No death, graft loss, or acute graft 
      rejections were reported during the therapy. On-treatment hepatic decompensation 
      occurred in three patients (8.6%). Anemia was observed in 29 patients (83.9%), 
      with 21 (60%) requiring RBV dose reduction or discontinuation. CONCLUSIONS 
      OBV/PTV/r/+DSV+/-RBV has excellent efficacy in post-transplant recurrence of HCV 
      genotype 1-infection treated under real-world conditions. Excellent virologic 
      outcomes were observed irrespective of prior treatment history or the degree of 
      fibrosis, and AEs were mostly mild and transient.
FAU - Tronina, Olga
AU  - Tronina O
AD  - Department of Transplantation Medicine and Nephrology, Medical University of 
      Warsaw, Warsaw, Poland.
FAU - Durlik, Magdalena
AU  - Durlik M
AD  - Department of Transplantation Medicine and Nephrology, Medical University of 
      Warsaw, Warsaw, Poland.
FAU - Wawrzynowicz-Syczewska, Marta
AU  - Wawrzynowicz-Syczewska M
AD  - Clinic of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian 
      Medical University, Szczecin, Poland.
FAU - Buivydiene, Arida
AU  - Buivydiene A
AD  - Clinic of Gastroenterology, Nephrourology and Surgery, Center of Hepatology, 
      Gastroenterology and Dietetics, Vilnius University, Vilnius, Lithuania.
FAU - Katzarov, Krum
AU  - Katzarov K
AD  - Department of Gastroenterology, Hepato-Pancreato-Biliary (HPB) Surgery and 
      Transplantology, Military Medical Academy, Sofia, Bulgaria.
FAU - Kupcinskas, Limas
AU  - Kupcinskas L
AD  - Department of Gastroenterology and Institute for Digestive Research, Lithuanian 
      University, Kaunas, Lithuania.
FAU - Tolmane, Ieva
AU  - Tolmane I
AD  - Department of Hepatology, Riga East University Hospital, Infectology Center of 
      Latvia, Latvian University, Faculty of Medicine, Riga, Latvia.
FAU - Karpinska, Ewa
AU  - Karpinska E
AD  - Clinic of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian 
      Medical University, Szczecin, Poland.
FAU - Pisula, Arkadiusz
AU  - Pisula A
AD  - ID Clinic, Myslowice, Poland.
FAU - Karwowska, Kornelia Magdalena
AU  - Karwowska KM
AD  - Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus 
      Copernicus University in Torun, Bydgoszcz, Poland.
FAU - Bolewska, Beata
AU  - Bolewska B
AD  - Chair and Department of Infectious Diseases, Karol Marcinkowski University of 
      Medical Sciences, Poznan, Poland.
FAU - Jablkowski, Maciej
AU  - Jablkowski M
AD  - Department of Infectious and Liver Diseases, Medical University of Lodz, Lodz, 
      Poland.
FAU - Rostkowska, Karolina
AU  - Rostkowska K
AD  - Division of Infectious Diseases and Hepatology, Faculty of Medicine and 
      Dentistry, Wroclaw Medical University, Wroclaw, Poland.
FAU - Jakutiene, Jolita
AU  - Jakutiene J
AD  - Clinic of Gastroenterology, Nephrourology and Surgery, Center of Hepatology, 
      Gastroenterology and Dietetics, Vilnius University, Vilnius, Lithuania.
FAU - Simonova, Marieta
AU  - Simonova M
AD  - Department of Gastroenterology, Hepato-Pancreato-Biliary (HPB) Surgery and 
      Transplantology, Military Medical Academy, Sofia, Bulgaria.
FAU - Flisiak, Robert
AU  - Flisiak R
AD  - Department of Infectious Diseases and Hepatology, Medical University of 
      Bialystok, Bialystok, Poland.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20170407
PL  - United States
TA  - Ann Transplant
JT  - Annals of transplantation
JID - 9802544
RN  - 0 (Anilides)
RN  - 0 (Antiviral Agents)
RN  - 0 (Carbamates)
RN  - 0 (Cyclopropanes)
RN  - 0 (Lactams, Macrocyclic)
RN  - 0 (Macrocyclic Compounds)
RN  - 0 (Sulfonamides)
RN  - 2302768XJ8 (ombitasvir)
RN  - 49717AWG6K (Ribavirin)
RN  - 56HH86ZVCT (Uracil)
RN  - 9DLQ4CIU6V (Proline)
RN  - CKR7XL41N4 (2-Naphthylamine)
RN  - DE54EQW8T1 (dasabuvir)
RN  - HG18B9YRS7 (Valine)
RN  - O3J8G9O825 (Ritonavir)
RN  - OU2YM37K86 (paritaprevir)
SB  - IM
MH  - 2-Naphthylamine
MH  - Adult
MH  - Aged
MH  - Anilides/adverse effects/*therapeutic use
MH  - Antiviral Agents/adverse effects/*therapeutic use
MH  - Carbamates/adverse effects/*therapeutic use
MH  - Cyclopropanes
MH  - Drug Therapy, Combination
MH  - Female
MH  - Genotype
MH  - Hepacivirus
MH  - Hepatitis C/*drug therapy/etiology
MH  - Humans
MH  - Lactams, Macrocyclic
MH  - Liver Transplantation/*adverse effects
MH  - Macrocyclic Compounds/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Postoperative Complications/drug therapy/etiology
MH  - Proline/analogs & derivatives
MH  - Ribavirin/adverse effects/*therapeutic use
MH  - Ritonavir/adverse effects/*therapeutic use
MH  - Sulfonamides/adverse effects/*therapeutic use
MH  - Uracil/adverse effects/*analogs & derivatives/therapeutic use
MH  - Valine
EDAT- 2017/04/08 06:00
MHDA- 2017/09/28 06:00
CRDT- 2017/04/08 06:00
PHST- 2017/04/08 06:00 [entrez]
PHST- 2017/04/08 06:00 [pubmed]
PHST- 2017/09/28 06:00 [medline]
AID - 903535 [pii]
AID - 10.12659/aot.903535 [doi]
PST - epublish
SO  - Ann Transplant. 2017 Apr 7;22:199-207. doi: 10.12659/aot.903535.