Interferon antibodies in patients with infectious diseases
Interferons (IFNs) are generally recognized as the most important therapeutic agent in some infectious diseases such as chronic hepatitis B and C. Since the early clinical trials it was documented that the therapeutic use of IFNs could be complicated by the development of antibodies able to neutralize or to bind to the IFN molecule.After several years of research it is now widely accepted that the presence of circulating anti-IFN antibodies may affect the response to IFN.Here we summarize what is currently know on the clinical significance of antibodies to IFN in IFN-treated viral diseases patients.
This article is to introduce FDA's(Food and Drug Administration,FDA)considerations of non-inferiority design used in anti-bacterial drug clinical trial.Non-inferiority study designs may be appropriate when there is adequate evidence of a defined effect size for the control treatment,so that the proposed non-inferiority margin can be supported.