Remdesivir is the only approved antiviral drug used in SARS-CoV-2 infections. Although world health organizations have alternately recommended it or not recognized its effectiveness, it is available in over forty countries. The drug was developed long before the COVID-19 epidemic began to treat another disease. What do you need to know about it?
The Society of Epidemiologists and Doctors of Infectious Diseases recommends the administration of remdesivir for full-blown COVID-19 in hospitalized patients with saturation below 95% The drug is administered intravenously over 5 days in the following schedule: on the first day loading dose – 200 mg, then maintenance dose – 100 mg. Remdesiwir is not new to the pharmaceutical market. Research on its application began in 2009. in the treatment of hepatitis C and RSV infections. Unfortunately, this research failed.
Remdesivir and Ebola – a research failure
So remdesivir was only returned to in 2014, when the Ebola virus epidemic was spreading in West Africa and an effective antiviral drug was sought. Gilead, the biotechnology company that developed remdesivir, has partnered with other institutions for this purpose, including the CDC and the U.S. Army’s Infectious Disease Research Institute. Analyzes of studies conducted in the Democratic Republic of Congo showed that remdesivir underperformed the antibody-based drugs and although the study was discontinued for this reason, it provided preliminary information on the safety profile in patients. During the studies, serious adverse events were noted, including cases of hypotension, along with increased plasma creatinine and aspartate aminotransferase levels, indicating impaired renal and hepatic function.
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Impact studies were conducted in parallel with the work on EBOV remdesivir or coronavirusincluding SARS and MERS. Studies have confirmed the activity of remdesivir against these coronaviruses in in vitro laboratory tests and in vivo animal models.
Despite the positive preclinical data, it was not possible to verify the actual efficacy due to the lack of an adequate number of study participants. Clinical MERS infections were limited in number, with an almost exclusive location in the Kingdom of Saudi Arabia, and there was no SARS infection at all during this period. But the data obtained then contributed to the rapid approval of the drug during the COVID-19 pandemic. The speed with which the authorization for the use of the drug was granted initially caused a stir in the scientific world due to contradictory reports on the effectiveness, especially in the light of the high price of the drug – treatment with remdesivir costs about PLN 9.
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Let’s follow the path to introducing this drug to the market, which is now available in at least 40 countries.
April 8 2020
Gilead has applied to the Food and Drug Administration for authorization to use remdesivir to treat COVID-19.
April 29 2020
The first results of clinical trials with the use of the drug in COVID-19 patients are published. Between February 6, 2020 and March 12, 2020, 237 patients in ten hospitals in Hubei were enrolled and randomly assigned to the study: 158 received remdesivir and 79 placebo. This Lancet study found no significant difference between remdesivir and placebo in hospitalized patients.
1 May 2020
Although a study in China did not show a benefit of remdesivir, in early May, the FDA approved it for hospitalized patients with severe COVID-19.
The FDA acknowledged that information on the safety and efficacy of remdesivir in treating patients is limited, but in their statement, they cited promising preliminary results from the ACCT-1 study by the National Institutes of Health. The study found that a 10-day treatment with remdesivir reduces time to recovery by five days compared to placebo, but has no significant effect on mortality.
7 May 2020
Immediately after approval of the drug in the US, the Japanese Ministry of Health, Labor and Welfare authorized the use of remdesivir in hospitalized patients.
27 May 2020
The Gilead sponsored Simple-Severe study published in NEJM showed that remdesivir shortens the time to clinical improvement in patients with severe COVID-19 in both the 5-day and 10-day regimens.
July 3 2020
The European Commission has granted a conditional marketing authorization to remdesivir for use in COVID-19 patients requiring oxygen.
August 21 2020
A Gilead sponsored study published in JAMA found that remdesivir shortens the time to clinical improvement in average COVID-19 patients on a 5-day treatment regimen, but not on a 10-day regimen.
SEPTEMBER 15, 2020
The WHO sponsored study, Solidarity, showed that remdesivir had little or no effect on overall mortality, onset of ventilation, or length of hospital stay.
The 2750 patients who received the drug came from the overall study population of 11 hospitalized adults in 266 hospitals in 405 countries. Although the WHO study was much larger than the previous studies, Gilead tried to undermine the Solidarity attempt, inter alia, due to the study design which did not include a placebo control group.
SEPTEMBER 15, 2020
The Polish Society of Epidemiologists and Doctors of Infectious Diseases and the National Consultant in the field of infectious diseases issued a joint statement on the Solidarity study conducted by WHO:
“The results of the Solidarity study in the currently available form cannot provide evidence of the effectiveness or ineffectiveness of remdesivir, as well as of other analyzed drugs, due to imprecise stratification, as well as limiting itself to all-cause mortality, disregarding a number of factors affecting it. The study also omitted many endpoints that should be taken into account, as they may significantly affect the speed of recovery, the quality of life of patients and the economic aspects related to the duration of the disease. “
SEPTEMBER 22, 2020
The FDA has officially approved remdesivir for use in patients hospitalized for COVID-19, regardless of the severity of the disease.
November 20 2020
WHO has issued a statement advising against the use of remdesivir. The data reviewed by the expert panel included the results of 7000 patients from the Solidarity study, as well as from 3 other randomized trials. The evidence was considered to indicate no significant effect on mortality, need for mechanical ventilation, time to clinical improvement, and other outcomes of importance. The guideline development group considered that more research was needed, especially to provide more certainty of the evidence for specific patient groups.
24 March 2021
A recent study published in JAMA confirmed the effectiveness of remdesivir. The study lasted from March 4 to August 29, 2020. in the United States and involved 2483 patients. Patients receiving remdesivir had a shorter time to clinical improvement than the matched control group without remdesivir treatment (median, 5,0 days).
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