Annagiulia Gramenzi, Carmela Cursaro, Marzia Margotti, Clara Balsano, Alessandra Spaziani, Simona Anticoli, Elisabetta Loggi, Maddalena Salerno, Silvia Galli, Giuliano Furlini, Mauro Bernardi, Pietro Andreone
Journal: World journal of gastroenterology 2010;15(47):5946-52
PMID: 20014458
AIM
To evaluate the safety of adding ketoprofen to pegylated-interferon (PEG-IFN) with or without ribavirin and the effect on viral kinetics, STAT1 activity and expression of 2'-5'-oligoadenylate synthetase (2'-5'OAS) in genotype 1 chronic hepatitis C in a phase II study.
METHODS
Forty-five patients were studied: fifteen were randomized to PEG-IFN plus ribavirin (PR), 16 to PEG-IFN plus ketoprofen and 14 to PR and ketoprofen. The molecular study of IFN-dependent signal transduction was conducted in 9 patients from each group.
RESULTS
The combination of ketoprofen and PEG-IFN with or without ribavirin was safe and well tolerated. An early activation of STAT1 was observed in ketoprofen-treated patients, but this activation was less sustained over time. Conversely, ketoprofen plus PEG-IFN and ribavirin induced an early and sustained increase of 2'-5'OAS transcription starting 24 h after the first dose until the 36th wk. These data are consistent with the clinical results, showing a better sustained virological response and a lower relapse rate in patients receiving ketoprofen plus PEG-IFN and ribavirin.
CONCLUSION
The addition of ketoprofen to the standard therapy of chronic hepatitis C should be explored in larger randomized clinical studies.
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