So, registration certificates for domestic and imported remdesivirs have been issued. We recall the background and understand what benefits a patient with coronavirus infection can get when using this direct-acting antiviral drug.
Let us recall the results of randomized, placebo-controlled clinical trials of remdesivir. Such studies are called the gold standard for studying drug efficacy. In these, one group of patients receives conventional treatment, and the other receives the test drug along with standard therapy for the disease. Patients are randomly assigned to groups, no one needs to know which drugs they are receiving.
The first study found the drug didn't work
The first study of remdesivir in COVID-19 was conducted by a group of Chinese scientists, its results were published in the journal Lancet at the end of April 2020. It involved 237 patients with a severe course of the disease. The study did not show any efficacy for the drug and was completed ahead of schedule due to serious side effects in the remdesivir group.
In the findings of this study, the scientists indicated that the forced reduction in study time and the small number of participants could distort its results.
Despite a failed study, remdesivir received an emergency approval for the treatment of hospitalized patients with COVID-19 in the United States on May 1
The second trial of remdesivir was conducted on 1,063 patients in 13 countries, with preliminary results published on May 22, and final results on October 8 in New England Journal of Medicine... Among its sponsors was the drug manufacturer, Gilead Sciences.
Preliminary data showed that a ten-day course of the drug was more effective than a placebo. Severely ill patients who received remdesivir improved in 11 days, while those in the placebo group improved in 15 days. The drug was effective in patients who did not require mechanical ventilation. However, the difference in mortality among patients from different groups was insignificant.
The final data showed that remdesivir accelerated recovery by 5 days and slightly improved survival. On the 29th day after the onset of the disease, 11.4% of the drug group and 15.2% of the placebo group died.
Gilead conducted a study comparing five- and ten-day courses of medication. Their effectiveness was similar. However, it was impossible to objectively assess this effectiveness, because the study did not have a group of patients who did not receive the drug, for comparison.
No effect in moderate disease
International study published in JAMA at the end of August, found no effect on the mortality of patients with moderate COVID-19 in remdesivir. The ten-day course of the drug had no effect on the course of the disease. The five-day period accelerated recovery slightly, but the scientists did not indicate how much. In an editorial in the same journal, scientists from the University of Pittsburgh School of Medicine pointed out that these results could be questionable.
Not everyone believes in its effectiveness
The effectiveness of remdesivir is questioned by some scientists. For example, Professor James M Brophy of McGill University Medical Center on pages BMJ stated that the most successful drug study involved data manipulation that could lead to favorable conclusions. He recalled that the only study that was not sponsored by the manufacturer found no effect on the drug.
Severe patients with COVID-19 can only hope that Gilead is a decent company, the research data is correct, and remdesivir will help them survive and win back an additional five days without symptoms of the disease.