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Pegylated interferon alpha-2b plus ribavirin in patients with genotype 4 chronic hepatitis C: Some issues

✍ Scribed by Ming-Lung Yu; Chia-Yen Dai; Jee-Fu Huang; Ming-Yen Hsieh; Wan-Long Chuang


Publisher
John Wiley and Sons
Year
2008
Tongue
English
Weight
63 KB
Volume
47
Category
Article
ISSN
0270-9139

No coin nor oath required. For personal study only.

✦ Synopsis


accurate representation of the data is given in Table 1. 7. The major conclusion of this paper was that monitoring hepatitis C virus RNA levels and varying the duration of therapy can save resources without sacrificing rates of SVR. The authors used the Blackwelder test to test the noninferiority of the variable-duration approach, stating that equivalence "was defined as SVR percentages within 1%". This degree of accuracy is impossible in a study of this size. The authors claim that the groups were comparable (P Ο­ 0.024), but it is unclear how this P value was obtained or what statistical test was used. Table 1 demonstrates no differences in response rates (P Ο­ 0.24) and an overall higher response rate with fixed duration of treatment. However, the study was far too small to demonstrate noninferiority.

In summary, the failure of randomization to achieve comparable groups in this study renders it impossible to support its conclusions. The lack of consistency in presentation of results and statistical analyses and the numerous errors in addition and division do not build confidence in a careful reader.


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## Abstract The safety and efficacy of pegylated interferon (PEG‐IFN) alfa‐2a and ribavirin were studied among patients treated for genotype 4 chronic hepatitis C. Ninety‐five patients with chronic hepatitis C genotype 4 were treated with PEG‐IFN alfa‐2a (180 ¡g/week) plus ribavirin (β‰₯11 mg/kg/day)