AGI – Paxlovid, the oral antiviral treatment against Covid-19 developed by the pharmaceutical giant Pfizer, seems to be able to reduce the risk of hospitalization or death from SARS-CoV-2 by 89% in subjects considered most vulnerable. Antivirals are medicines used to treat influenza and, if taken promptly, can reduce the symptoms, duration of illness and complications of influenza. Paxlovid counteracts an enzyme the coronavirus needs to replicate, slowing down the activity of the SARS-CoV-2-3CL protease.
Co-administration with a low dose of ritonavir, an antiretroviral drug, helps slow down the metabolism of the active ingredient in Paxlovid, allowing it to stay active in the body for longer periods of time. Pfizer reported the results of the Phase 2/3 clinical trial of the drug. The study, EPIC-HR (Evaluation of Protease Inhibition for Covid-19 in High-Risk Patients), was conducted on a sample of non-hospitalized adult patients who tested positive for new coronavirus infection and considered to be at high risk for a severe course. of the disease. The analysis showed an 89% decreased risk of hospitalization and death from any cause related to Covid-19 in the subjects who received Paxlovid compared to the control group.
0.8% of participants who received the drug were hospitalized within 28 days of administration, versus 7% found among those who took placebo. As of day 28, the scientists report, no deaths were reported among those who received Paxlovid, while 10 placebo-associated patients died as a result of complications. The company’s top management underline the commitment to provide all job data to the Food and Drug Administration to apply for approval of the oral antiCovid drug.
Started in September 2021, the clinical trial evaluated data from 1,219 adults, from North and South America, Europe, Africa and Asia, who tested positive for new coronavirus infection and characterized by at least one condition associated with a higher risk of develop complications. Participants received either Paxlovid or a placebo orally every 12 hours for five days. 19 and 21 percent of those taking the drug or placebo, respectively, reported side effects, most of which were mild.
Paxlovid, the experts explain, is an experimental antiviral therapy with a SARS-CoV-2 protease inhibitor, designed to be administered orally so that it can be prescribed at the first sign of infection or with known exposure to the pathogen.
This could limit the risk of serious courses that could lead to hospitalization or death. In fact, the drug counteracts the activity of the SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir, an antiretroviral drug, helps slow down the metabolism of the active ingredient in Paxlovid, allowing it to stay active in the body for longer periods of time. Pfizer has initiated Phase 2/3 to evaluate the efficacy and safety of treatment in patients with a confirmed diagnosis of SARS-CoV-2 infection.
“The risks and uncertainties of these data – the scientists write – could alter the final results, like the efficacy, safety and tolerability profile observed to date, but for now the preliminary data are very encouraging. “” Today’s news is a real turning point in global efforts to counter the pandemic – says Albert Bourla, President and CEO of Pfizer – our oral antiviral candidate, if approved or cleared by regulatory bodies, could save lives, reduce the severity of infections and limit the number of hospitalizations and hospitalizations. “