The likelihood of treatment success of 48 wk peg-interferon (PEG-IFN) plus ribavirin (RBV) therapy for chronic hepatitis C may be predicted by viral kinetics on therapy. In particular, recent studies have shown that sustained virological response (SVR) can be predicted by a rapid virological response (RVR), and an early virological response (EVR). Nevertheless, the current dosing regimens could potentially under-treat some patients and additional measurements of viral response is needed to facilitate individualization of therapy. Among predictive factors already reported, many are not readily available from daily clinical assessment, because they require genomic analyses and/or advanced experimental methods. The prediction with simply available data may be useful.
A Clinical research article to be published on January 7 , 2010 in the World Journal of Gastroenterology suggested a novel but easily available on-treatment formula, which predicted SVR of patients who received PEG-IFN/RBV for 48 wk better than viral kinetics. The analysis was performed using the data of 176 patients with chronic hepatitis and hepatitis C virus genotype 1 who received 48 wk standard therapy. The formula was constructed using data from the first 100 patients enrolled and validated using data from the remaining 76 patients.
The predictive potential was very high, as judged by area under the curve of receiver operating characteristic (AUC) analysis, which was more than 0.8 from week 4. In particular, the validity at week 24 was more than 0.85 of AUC. The positive predictive value (PPV) of the formulae were better at weeks 12 and 24 than the prediction with viral kinetics, and the negative predictive value (NPV) of the formulae were better at weeks 4 and 12. Evaluation of the formulae using data from the test patients revealed a very high AUC value of more than 0.85. These results suggest that formulae based on simple clinical data are superior to prediction by viral kinetics.
The formula can be made with a personal computer using statistical software to create a logistic regression model. The formula was made for every cohort of patients affiliated to a hospital, and the prediction made is suitable for every cohort. The concept that extension of treatment duration can reduce relapse rates should be adopted only for a limited proportion of type 1-infected patients. The formulae we suggest might be helpful for patients who are expected to achieve SVR but do not do so. For those individuals, the method based on logistic regression analysis will show a clear direction of therapy in each case and enable the best tailored treatment. Further prospective studies should be performed to determine whether this approach really increases the SVR rate by selection of patients and extension of treatment duration up to week 72.
Reference: Saito H, Ebinuma H, Ojiro K, Wakabayashi K, Inoue M, Tada S, Hibi T. On-treatment predictions of success in peginterferon/ribavirin treatment using a novel formula. World J Gastroenterol 2010; 16(1): 89-97 http://www.
Correspondence to: Hidetsugu Saito, MD, PhD, Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo 1608582, Japan. firstname.lastname@example.org Telephone: +81-3-33531211 Fax: +81-3-33518705
About World Journal of Gastroenterology
World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection and provides a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2008 IF: 2.081. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th day of every month. WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the name of China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.
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