AstraZeneca Evusheld reveals prophylaxis for at least 6 months prior to exposure to COVID-19 under a Phase 3 Provent study in a high-risk population.
AstraZeneca’s Evusheld (formerly known as AZD7442 antibody mixture) today (April 21) results from a phase 3 study on prophylaxis before exposure to the pathogenic virus. Two long-acting tixagevimab and cilgavimab) can reduce the risk of developing COVID-19. The symptomatic group was 77% in the initial analysis and 83% from the median analysis at 6 months compared to the placebo group. The trial found no patients had serious symptoms or death from COVID-19. throughout the 6-month follow-up More than 75% of the participants in the PROVENT study had underlying disease. This poses a high risk of contracting severe COVID-19, including those who are immunocompromised and may not have an inadequate immune response to vaccination.
Additional information from pharmacokinetics (Pharmacokinetics) also showed that Evusheld concentrations remained high for 6 months following administration. This supports that a single injection can provide at least six months of protection once morest COVID-19 infection. These data were published April 20, 2022 in the New England Journal of Medicine.
Dr. Myron J. Levin, professor of pediatrics and internal medicine Faculty of Medicine University of Colorado united states and Principal Investigator of the PROVENT trial said, “While the COVID-19 vaccine It is highly effective in reducing the number of hospitalizations and deaths. But the number of new infections continues to increase. And many of them are still at high risk. This includes those who are immunocompromised and those who cannot be vaccinated. These data, published in the New England Journal of Medicine, can help ensure that a single intramuscular dose of Evusheld can provide long-term protection for vulnerable people. Not only that, Evusheld was also able to eradicate the BA.2 subtype that is currently the main epidemic.”
Mene Pangalos, Executive Vice President of Research and Development for Biopharmaceuticals AstraZeneca’s Biopharmaceuticals said: “The data is evidence supporting the use of Evusheld for the prevention of COVID-19. Symptoms and incidence of COVID-19 with severe symptoms This is especially true in people whose immune response is inadequate to vaccination and in need of increased protection. Evusheld is now used in many countries around the world. Registration is progressing for both the drug for pre-exposure prophylaxis and for the treatment of COVID-19 patients. with mild to moderate symptoms.”
In a preliminary efficacy analysis, Evusheld for intramuscular injection 300 mg reduced the risk of developing symptomatic COVID-19 infection by 77% compared to the placebo group ( 95% confidence interval (CI) 46-90; p
Compared to the preliminary results analysis An analysis of longer follow-up shows that Evusheld can reduce the incidence of COVID-19. even more There was an 83% reduction in relative risk reduction (RRR) in symptomatic COVID-19 infection (95% confidence interval (CI) 66, 91) compared to the placebo group. The median follow-up period was 196 days following drug exposure, with confirmed cases of COVID-19. The symptomatic proportions were 11/3,441 (0.3%) and 31/1731 (1.8%) in the Evusheld and placebo groups, respectively. These performance were consistent with those assessed among the smaller participants.
At a six-month follow-up among participants taking Evusheld, no patients with severe symptoms of COVID-19 were found. There were no cases of infection at the level that required hospitalization or COVID-19-related deaths. The placebo group Have a patient with COVID-19 Of the five severe symptoms, seven had to be hospitalized, and two had died from COVID-19.
Evusheld had well-tolerated side effects in the PROVENT study, and no safety issues were identified from the early analysis or even at 6 months. similar in both groups The most frequent adverse events were reactions at the vaccination site. This occurred in 2.4% of participants taking Evusheld and 2.1% of participants taking placebo.
Approximately 2% of the global population is at increased risk of having an inadequate immune response to the COVID-19 vaccine and may benefit from Evusheld in pre-exposure prophylaxis once morest the covid-19 virus. 192,3 This population also includes people with immunodeficiency states, such as cancer patients. organ transplant patients Patients receiving immunosuppressants Besides that People at increased risk of contracting SARS-CoV-2 can also benefit from prophylaxis with Evusheld.
AstraZeneca previously announced good results from the TACKLE trial, a phase 3 study to treat COVID-19 patients. with mild to moderate symptoms The full study results will be presented at the upcoming European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). It has also been published in peer-reviewed medical journals.