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Annals of Transplantation
Article . 2017 . Peer-reviewed
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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

Authors: Olga, Tronina; Magdalena, Durlik; Marta, Wawrzynowicz-Syczewska; Arida, Buivydiene; Krum, Katzarov; Limas, Kupcinskas; Ieva, Tolmane; +9 Authors

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.

Country
Poland
Keywords

Adult, Cyclopropanes, Male, Macrocyclic Compounds, Anilides - adverse effects, Genotype, Proline, Antiviral agents - therapeutic use, Lactams, Macrocyclic, Antiviral agents - adverse effects, Postoperative complications - etiology, Hepacivirus, Antiviral Agents, Uracil - analogs & derivatives, Hepatitis C - etiology, Macrocyclic compounds - therapeutic use, Postoperative Complications, Sulfonamides - therapeutic use, 2-Naphthylamine, Sulfonamides - adverse effects, Ritonavir - therapeutic use, Humans, Anilides, Ritonavir - adverse effects, Middle aged, Macrocyclic compounds - adverse effects, Aged, combination, Postoperative complications - drug therapy, Middle Aged, Hepatitis C, Liver Transplantation, Ribavirin - therapeutic use, Carbamates - adverse effects, Carbamates - therapeutic use, Antiviral Agents; Hepacivirus; Hepatitis C; Liver Transplantation, Anilides - therapeutic use, Uracil - adverse effects, Liver transplantation - adverse effects, Drug Therapy, Combination, Female, Drug therapy, Hepatitis C - drug therapy, Carbamates, Ribavirin - adverse effects, Uracil - therapeutic use

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
12
Average
Top 10%
Top 10%
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