A DESIGN FOR THE EVALUATION OF ANTIVIRAL DRUGS IN HUMAN INFLUENZA1

Publisher Website
Google Scholar
Abstract
Bloomfield, S. S. (Div. of Clinical Pharmacology, Univ. of Gncinnati College of Medicine, Gndnnati, Ohio 45219), T. E Gaffney and G. M. Schiff. A design for the evaluation of antiviral drugs in human influenza. Amer. J. Epid., 1970, 97; 568–574.—The evaluation of antiviral drugs in experimental influenza has frequently involved hundreds of subjects to demonstrate prophylactic efficacy in reducing illness and antibody response. This report describes a double-blind study using only 18 highly susceptible volunteers in a matched-pairs design. Nine subjects randomly received amantadine 200 or 300 mg orally daily for 10 days; their partners, a placebo. On the 2nd day a challenge dose of 64, 000 TCID50 of Rockville A2 strain influenza virus was administered to the nasopharynx. Four of the placebo-treated subjects developed typical influenza; no cases occurred in the amantadine group. Illness scores were significantly higher (p =.05) in placebo-treated subjects than In the amantadine-treated partners. In addition, 14 and 21 days after viral challenge placebo subjects had a greater antibody rise than their amantadine partners (p <.01). Despite the attenuated antibody response to viral challenge in subjects treated with amantadine, a significant increase (p <.05) in titer did occur. A positive, significant correlation between illness score and antibody response suggested that the illness scoring technique could predict the degree of immunologic response to vims In highly susceptible subjects. These statistically significant differences in 18 volunteers confirmed investigations involving much larger numbers. Success was related in large part to 3 design features: a homogenous sample, accurate measurement techniques and matched pairing of subjects. This approach minimizes the number of subjects exposed to the risks of an investigational treatment and also may save time and money.

This publication has 0 references indexed in Scilit: