Clinical–Liver, Pancreas, and Biliary TractAdherence to combination therapy enhances sustained response in genotype-1–infected patients with chronic hepatitis C☆,☆☆,★
Section snippets
Patient selection
Data for patients from 3 previously published clinical trials of interferon α-2b or peginterferon α-2b and ribavirin combination therapy were evaluated retrospectively to determine the effect of dose reduction on sustained response (Figure 1).3, 4, 7
Results
Of the 1010 patients evaluated who received interferon α-2b plus ribavirin, 218 were excluded from further analysis because the duration of therapy was <80% of the assigned treatment regimen. Most of the remaining patients who were treated for longer than 80% of the planned duration, 631 of 792 (80%), also received >80% of both their interferon α-2b and ribavirin doses. Similarly, for the 511 patients receiving peginterferon α-2b 1.5 μg · kg−1 · wk−1 plus ribavirin, 88 were excluded from the
Discussion
This retrospective analysis indicates that adherence to therapy with interferon α-2b or peginterferon α-2b plus ribavirin for patients with chronic hepatitis C is important and enhances sustained response rates. This observation was apparent only for HCV-1–infected patients, those most difficult to treat. Moreover, the fact that results obtained with 2 different approaches—subgroup analysis of observed data and modeling—produced similar results strengthens the premise that adherent patients are
Acknowledgements
The authors thank Elvia Nunez of the Scripps Clinic for preparing this manuscript. The authors also thank all participating investigators in these randomized controlled trials. Their individual names and sites appear in the appendices attached to each of the separate publications.
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Address requests for reprints to: John G. McHutchison, M.D., Duke Clinical Research Institute, Duke University Medical Center, P.O. Box 17969, Durham, North Carolina 27715. e-mail: [email protected]; fax: (919) 668-7164.
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Supported in part by research grants from the Schering-Plough Research Institute, Kenilworth, New Jersey, and clinical research center grants from Massachusetts General Hospital (MO1-RR01066), the Scripps Clinic (MO1-RR00833), and Los Angeles County–University of Southern California Medical Center (M01-RR00043).
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Dr. McHutchison is an advisor and consultant and has received research support from Schering-Plough. Dr. Manns is an ad hoc consultant to and a recipient of research grants from Schering-Plough. Dr. Poynard works on the Principal Investigator and Speaker Bureau for Schering-Plough. Dr. Lindsay is a speaker for Schering-Plough and has received research support from Schering-Plough, Glaxo Wellcome, Hoffman-Rodel, Scripps Liver Research Consortium, and Triangle Pharmaceuticals. Dr. Dienstag has received research support and has served on an adjudication board for Schering-Plough. Drs. Mak and Albrecht are employees of Schering-Plough and own stock in the corporation.