scholarly journals First experience of off-label use GLE/PIB+SOF in treating a patient with relapse of RNA HCV 1b viremia and RAS R117H in the NS3 region after NS3/4A PI + NS5AI + NS5BI failure of 3D-therapy PTV/R/OBV+DSV in Russia (case report)

2021 ◽  
Vol 13 (1) ◽  
pp. 59-69
Author(s):  
D. L. Sulima ◽  
A. A. Yakovlev ◽  
V. N. Koryagin ◽  
V. A. Larionov ◽  
O. V. Gorchakova ◽  
...  

For the first time in Russia, a description of a case of full application in clinical practice of a completely interferon-free mode of the 3D-mode GLE/PIB + SOF for the treatment of recurrence of HCV 1b RNA viremia after a primary course of interferonfree therapy in the PTV/r/OBV + DSV mode, which included inhibitors of NS3/4A PI, NS5Ai and NS5Bi, in a patient with combined HCV syndrome is presented. The target result of the repeated course of interferon-free therapy — SVR12 — was achieved despite the presence of significant RAS R117H in the NS3 region of the HCV genome and multiple RASs in the NS3 and NS5A regions, the nature of resistance of which to the corresponding inhibitors of GLE and PIB was unknown. Along with a complete virological response, the treatment also achieved a complete immunological response, which lasted for 12 weeks after the end of the repeated course of interferon-free therapy.

2015 ◽  
Vol 22 (Suppl 1) ◽  
pp. A13.3-A14
Author(s):  
MH García Lagunar ◽  
M Gutiérrez Cívicos ◽  
R Guerrero Bautista ◽  
E Ferris Villanueva ◽  
A García Márquez ◽  
...  

2020 ◽  
Vol 120 (09) ◽  
pp. 1323-1329 ◽  
Author(s):  
Tim A. C. de Vries ◽  
Jack Hirsh ◽  
Ke Xu ◽  
Imaad Mallick ◽  
Vinai C. Bhagirath ◽  
...  

Abstract Background Recent reports suggest an important contribution from frequent off-label use of apixaban 2.5 mg twice daily to the higher rates of thromboembolic events observed in observational studies (OSs) relative to in randomized controlled trials (RCTs), and consequently, advocate against such use in all patients. Objectives To examine factors contributing to the higher thromboembolic event rates, we estimated the prevalence of off-label use in contemporary practice, and compared patient characteristics and rates of stroke/systemic embolism, major bleeding, and mortality by apixaban dose and by study design in a systematic review and meta-analysis. Results and Discussion We identified 18 OSs and 2 RCTs that included 155,228 and 11,928 patients, respectively. Patients in OSs more often received apixaban 2.5 mg twice daily (31.3% vs. 5.1%), were older (mean age 73.8 vs. 69.8 years), and had higher CHA2DS2-VASc scores (mean 3.6 vs. 2.9) versus those in RCTs. We observed a consistent pattern of higher rates of thromboembolic events, bleeding, and mortality in patients treated with 2.5 versus 5 mg twice daily apixaban in both OSs and RCTs. Conclusion The higher risk profiles of patients in OSs versus RCTs, and higher rates of both bleeding and mortality not attributable to thromboembolism in patients treated with apixaban 2.5 versus 5 mg twice daily suggest that differences in patient characteristics are additional important contributors to the higher than expected thromboembolic event rates in clinical practice.


2019 ◽  
Vol 28 ◽  
pp. S108
Author(s):  
J. Martinelli Nadal ◽  
Fabiano Viana

2020 ◽  
Vol 75 ◽  
pp. 398-402
Author(s):  
Fatima Barhoum ◽  
Klaus Tschaikowsky ◽  
Michael Koch ◽  
Markus Kapsreiter ◽  
Matti Sievert ◽  
...  

2020 ◽  
Vol 22 (3) ◽  
pp. 208-215 ◽  
Author(s):  
Ane Bayona Cebada ◽  
Lía Nattero-Chávez ◽  
Sara Alonso Díaz ◽  
Héctor F. Escobar-Morreale ◽  
Manuel Luque-Ramírez

2018 ◽  
Author(s):  
F Barhoum ◽  
M Koch ◽  
K Tschaikowsy ◽  
M Sievert ◽  
H Iro ◽  
...  

2019 ◽  
Vol 44 (5) ◽  
pp. 805-808
Author(s):  
Bellal B. Jubran ◽  
Jocelyn Bolduc ◽  
Amy Eng ◽  
Melanie Stapleton ◽  
Ben J. Wilson

Author(s):  
A Ganfornina Andrades ◽  
MDC Jiménez De-Juan ◽  
A Salguero Olid ◽  
MJ Fernández Anguita

2013 ◽  
Vol 69 (9) ◽  
pp. 1689-1699 ◽  
Author(s):  
I. Danés ◽  
A. Agustí ◽  
A. Vallano ◽  
J. Martínez ◽  
C. Alerany ◽  
...  

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