Gastroenterology Update Newsletter
April 11, 2012
Kate Aubusson
Doctors cannot assume results from clinical trials are transferable to their clinical practice, conclude the authors of a study showing hepatatis C treatments in some patients are less effective than suggested by trial data.
The retrospective study compared the results of pegylated interferon and ribavirin therapy in pharmaceutical trials to those of over 400 patients treated in a tertiary hospital and found that though results for patients with genotypes 1 and 2 infections were comparable, the results for genotype 3 patients were “inferior” in a clinical setting.
Of the 187 genotype 3 patients included in the hospital cohort 72% achieve a sustained virological response (SVR) compared to 76-84% in pharmaceutical trials, the researchers reported in Internal Medicine Journal.
The authors from Flinders Medical Centre in Adelaide said the reason for the genotype 3 group’s poorer performance in the clinical setting was unclear, considering the SVR results for genotype 1 and 2 were within the range of trial results at 55% and 82% respectively.
But overall the authors suggested the differences in outcomes between pharmaceutical trials and day-to-day practice “are likely to relate to differences in treatment and patient support, and inclusion of subjects who may not meet trial inclusion criteria”.
The findings are particularly relevant as dual anti-viral therapy with pegylated interferon and ribavirin begins to be phased out and replaced by more complicated triple therapy regimens, they said.
“Whether impressive results from pharmaceutical trials containing direct anti-virals regimens can be replicated in real life situations will be important to confirm.”
The authors advised clinicians to be aware of outcomes in their own practice and provide patients with accurate local SVR data.
Internal Medicine Journal,
Online First April 2012. DOI:
10.1111/j.1445-5994.2012.02798.x
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