Roche Xofluza has increased drug resistance but is not good for children

an 11-year-old Japanese boy was diagnosed with the H3N2 flu virus and was later prescribed the Roche gene Tektronix flu drug Xofluza, which he stopped responding to a few days later. Soon after, the little boy's sister was infected with the virus, and genetic tests showed that she had a mutation in the flu known as H3N2, which made her resistant to Xofluza.The cases of the two children, including a clinical trial led by the University of Wisconsin-Madison, may be at the opposite conclusion of Roche's original intention to develop Xofluza. Xofluza may not be the best option for childhood flu prevention, the researchers report in the Journal of Natural Microbiology.Last fall, the FDA approved Xofluza for use in flu patients over the age of 12. Roche said it would continue to study the preventive effects of the drug in children under the age of 12.However, current trial data and the emergence of drug-resistant mutations have raised concerns about the effectiveness of the drug by Yoshihiro Kawaoka, a professor of pathology and biology at the University of Wisconsin. To do this, he designed a study to collect influenza virus samples from patients with H1N1 or H3N2 and sequence the genes of patients before and after Xofluza treatment.The team tested H3N2 samples from 40 adults and H3N2 samples from 101 children before treatment, and found that two of the flu patients with drug-resistant mutations were children. They also tested four adults and 12 children before and after treatment, four of whom developed drug-resistant mutations that were not found in adults. Although no mutations were found before treatment in the H1N1 group, 23% of patients, mostly children, had mutations after treatment.Researchers at the University of Wisconsin wanted to learn more about the role of resistance mutations, using mutant H1N1 and H3N2 viruses, which were tested in hamsters and ferrets. The study found that the mutant virus would continue to replicate, and that ferrets with mutant forms of influenza could transmit it to other healthy animals.Dr. Barry Clinch, Director of Clinical Sciences and Global Head of Influenza and Infectious Disease Product Development at Geneneck, said the company will work with its Japanese market partner, Yanoyi, and japan's National Institute of Infectious Diseases (NIID) to better understand and study the new findings.Clinch said the emergence of viral variants described in the study is a normal feature of antiviral drugs, and earlier antiviral drugs such as Roche Tamiflu have seen similar mutations, which are more common in children than in adults. He also revealed that Roche, Geneneck and Yannoyi are advancing a global Phase 3 study to understand the occurrence and potential clinical impact of viral variants that are less susceptible to strains resistant to Xofluza. In addition, the positive results of a global study of children under 12 years of age will be presented to the FDA in early 2020.Despite the increased resistance caused by genetic mutations, Xofluza has recently achieved some success in follow-up studies. A study published in September showed that Xofluza reduced the risk of infection in healthy people, with about 2 percent of people in the Xofluza group contracting the flu after exposure and 14 percent in the placebo group. Clinch said at the time that the data was crucial to establishing Xofluza as a preventive treatment and persuading payers. (Sina Pharmaceutical News)