The National Institute of Infectious Diseases Evandro Chagas of the Oswaldo Cruz Foundation (INI/Fiocruz) suspended the search for volunteers who would test the drug Paxlovid for patients at low risk for covid-19.
According to the institute, Pfizer, which developed the drug, decided to suspend clinical studies in the group of people under 65 years of age without comorbidities because it did not find, in a preliminary analysis, a significant decrease in the duration of symptoms and hospitalization of these patients.
On Tuesday (14), the institute announced that it was looking for volunteers to carry out the tests in Rio de Janeiro in partnership with the pharmaceutical company, as part of a survey carried out in different parts of the world with 1,980 volunteers.
INI also participated in the previous trials of Paxlovid, which showed that the drug is safe and effective in treating patients at high risk (people over 65 and with comorbidities) for the development of more severe conditions of the disease, which remains valid. .
These data allowed the emergency use of the drug against covid-19 to be released by regulatory agencies such as the FDA, of the United States, and the National Health Surveillance Agency (Anvisa) only for risk groups.
In the call for volunteers published on Tuesday, Fiocruz mentioned that the results in high-risk patients showed that the drug, which combines the antivirals nirmatrelvir and ritonavir, reduced hospitalization for the disease and deaths by 89%.
Reply
Pfizer Brasil clarified that in response to inquiries about the paxlovid EPIC-SR (Evaluation of Protease Inhibition for Covid-19 in Standard-Risk Patients) study, the company decided to terminate the study’s enrollment because of the low hospitalization or death rate. in the standard risk patient population. However, it will continue to evaluate treatment in populations with high unmet medical need.
The drugmaker said it believes the EPIC-SR study data “support the efficacy and safety profile of paxlovid for the treatment of mild to moderate COVID-19 in patients with at least one risk factor for progressing to the form serious, regardless of vaccination status.”
According to Pfizer, one of the study’s findings was that “self-reported sustained relief of all symptoms for four consecutive days, the clinical endpoint used as the study’s primary endpoint, showed no statistically significant difference.”
In addition, he informed that other data analyzed in the study with the participation of standard risk patients, for vaccinated and unvaccinated, although not all statistically significant, “reinforce the safety and efficacy data observed in the EPIC-HR study (use of paxlovid in patients with mild-to-moderate COVID with at least one risk factor for progression to severe form) and will be included in the forthcoming definitive registration submission to the US FDA for high-risk patients.”
The company ended the note by noting that the safety data available for paxlovid has been consistent across more than 3,500 participants in the EPIC-HR, EPIC-SR, and EPIC-PEP studies, “as well as reported post-authorization safety experience until the moment”.
*Collaborated with reporter Cristina Indio do Brasil.
