title: 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.
abstract: 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.
authors.affiliation: Department of Transplantation Medicine and Nephrology, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Olga
authors.initials: O
authors.lastname: Tronina
authors.affiliation: Department of Transplantation Medicine and Nephrology, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Durlik
authors.affiliation: Clinic of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland.
authors.forename: Marta
authors.initials: M
authors.lastname: Wawrzynowicz-Syczewska
authors.affiliation: Clinic of Gastroenterology, Nephrourology and Surgery, Center of Hepatology, Gastroenterology and Dietetics, Vilnius University, Vilnius, Lithuania.
authors.forename: Arida
authors.initials: A
authors.lastname: Buivydiene
authors.affiliation: Department of Gastroenterology, Hepato-Pancreato-Biliary (HPB) Surgery and Transplantology, Military Medical Academy, Sofia, Bulgaria.
authors.forename: Krum
authors.initials: K
authors.lastname: Katzarov
authors.affiliation: Department of Gastroenterology and Institute for Digestive Research, Lithuanian University, Kaunas, Lithuania.
authors.forename: Limas
authors.initials: L
authors.lastname: Kupcinskas
authors.affiliation: Department of Hepatology, Riga East University Hospital, Infectology Center of Latvia, Latvian University, Faculty of Medicine, Riga, Latvia.
authors.forename: Ieva
authors.initials: I
authors.lastname: Tolmane
authors.affiliation: Clinic of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland.
authors.forename: Ewa
authors.initials: E
authors.lastname: Karpińska
authors.affiliation: ID Clinic, Mysłowice, Poland.
authors.forename: Arkadiusz
authors.initials: A
authors.lastname: Pisula
authors.affiliation: Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University in Toruń, Bydgoszcz, Poland.
authors.forename: Kornelia Magdalena
authors.initials: KM
authors.lastname: Karwowska
authors.affiliation: Chair and Department of Infectious Diseases, Karol Marcinkowski University of Medical Sciences, Poznań, Poland.
authors.forename: Beata
authors.initials: B
authors.lastname: Bolewska
authors.affiliation: Department of Infectious and Liver Diseases, Medical University of Łódź, Łódź, Poland.
authors.forename: Maciej
authors.initials: M
authors.lastname: Jabłkowski
authors.affiliation: Division of Infectious Diseases and Hepatology, Faculty of Medicine and Dentistry, Wrocław Medical University, Wrocław, Poland.
authors.forename: Karolina
authors.initials: K
authors.lastname: Rostkowska
authors.affiliation: Clinic of Gastroenterology, Nephrourology and Surgery, Center of Hepatology, Gastroenterology and Dietetics, Vilnius University, Vilnius, Lithuania.
authors.forename: Jolita
authors.initials: J
authors.lastname: Jakutiene
authors.affiliation: Department of Gastroenterology, Hepato-Pancreato-Biliary (HPB) Surgery and Transplantology, Military Medical Academy, Sofia, Bulgaria.
authors.forename: Marieta
authors.initials: M
authors.lastname: Simonova
authors.affiliation: Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland.
authors.forename: Robert
authors.initials: R
authors.lastname: Flisiak
mesh_terms: D015081:2-Naphthylamine; D000328:Adult; D000368:Aged; D000813:Anilides / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002219:Carbamates / Q000009:adverse effects / Q000627:therapeutic use*; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus; D006526:Hepatitis C / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D047029:Lactams, Macrocyclic; D016031:Liver Transplantation / Q000009:adverse effects*; D047028:Macrocyclic Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000188:drug therapy / Q000209:etiology; D011392:Proline / Q000031:analogs & derivatives; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D019438:Ritonavir / Q000009:adverse effects / Q000627:therapeutic use*; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D014498:Uracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014633:Valine
chemical_list: D000813:Anilides; D000998:Antiviral Agents; D002219:Carbamates; D003521:Cyclopropanes; D047029:Lactams, Macrocyclic; D047028:Macrocyclic Compounds; D013449:Sulfonamides; C586094:ombitasvir; D012254:Ribavirin; D014498:Uracil; D011392:Proline; D015081:2-Naphthylamine; C588260:dasabuvir; D014633:Valine; D019438:Ritonavir; C585405:paritaprevir