RELEASE ON RECEIPT Embargoed for release per JAMA Tuesday, Jan. 23, 1996, 4 p.m., EST CONTACT: Marguerite Beck NEW ANTIVIRAL DRUG FIGHTS THE FLU Both A and B Types Targeted CHARLOTTESVILLE, VA., Jan. 23 --A new antiviral drug that fights both A and B types of the influenza virus has proved effective in a laboratory setting, according to a study published in the Journal of the American Medical Association, Jan. 24 issue. Other antiviral drugs currently on the market are active only against type A. Researchers at the University of Virginia and the University of Rochester medical schools found that intranasal administration of the experimental drug was 82 percent effective in preventing laboratory evidence of infection and 95 percent effective in preventing the fever associated with experimental influenza. It reduced other respiratory symptoms by 50 to 80 percent. "These results are very encouraging, but it is important to bear in mind that these studies were done in experimentally infected volunteers," said Dr. Frederick Hayden, head of the study and professor of internal medicine at the University of Virginia. "Additional studies in naturally occurring influenza are needed to test this drug's effectiveness as a preventive agent and as a treatment for people who already are ill. In an average year, five to 15 percent of adults in this country get the flu, so clearly we need additional, effective treatments." When a person is infected with the flu virus, it invades cells in the respiratory tract, where hundreds of new virus particles are produced. These particles, in turn, invade other cells. The drug, labeled GG167 by its developer, GlaxoWellcome Inc. of North Carolina, targets a part of influenza virus, the neuraminidase, one of two major surface proteins of both type A and B viruses. Neuraminidase (nur-ah-min-ah-daze) is important in the spreading of viruses from infected cells. GG167 was designed to inhibit this function of the protein, and thus inhibit viral growth, Hayden said. The drug was tested in four randomized, double-blind placebo controlled trials with 166 participants over a six month period. The trials evaluated preventive treatment -- dosing four hours before viral inoculation; early treatment -- dosing 26 or 32 hours after inoculation; and delayed treatment -- dosing begun 50 hours after inoculation. The drug was administered two or six times daily via nasal drops or spray. The drug's effectiveness for prevention was measured by determining the frequency of infection and the frequency of fever. For all dose groups combined, GG167 was 82 percent effective in preventing laboratory evidence of infection and 95 percent effective in preventing fever. Researchers found that two doses a day were as effective as six. The drug's effectiveness for early treatment was measured by determining the duration of viral growth in the nose and the occurrence of illness. GG167 reduced peak viral growth by a factor of about 100-fold and reduced risk of developing fever by 84 percent. The results of these studies indicate that the protein neuraminidase is likely to be essential for influenza growth in humans. Antiviral drugs like GG167 that inhibit this protein's activity offer promise for treating and preventing influenza, Hayden said. Further clinical trials are being conducted at the University of Virginia and other centers in North America, Europe and Japan during this year's influenza season. ### January 23, 1996