Gilead Sciences’ experimental drug Remdesivir has been used as a coronavirus treatment since the earliest days of the pandemic.
Ulrich Perry / Getty
For the latest corona virus pandemic news and information, visit WHO website.
Remdesivir, an experimental antiviral drug from the biotech company Gilead Sciences, was one of the most discussed treatment options for COVID-19, even in the face of conflicting reports of its potential. On Wednesday, the US National Institute of Allergy and Infectious Diseases said preliminary data from a U.S. clinical trial showed that it can help patients Recover faster from the corona virus.
The preliminary results were published by Dr. Anthony Fauci, the director of NIAID, announced during a press conference at the White House on Wednesday. Fauci said the initial results were “a very important proof-of-concept because it has been shown that a drug can block this virus.” However, full peer review data from the study is yet to be published, but will be available in an upcoming report, according to the NIAID.
Remdesivir is not specifically designed to destroy SARS-CoV-2, the virus that causes COVID-19. Instead, a particular machine that uses viruses for replication is switched off, known as “RNA polymerase”. It was originally developed as a drug to treat Ebola, but when tested, it turned out to be largely unsuccessful. In 2017, a study published in Science magazine showed that remdesivir is effective against human corona viruses in cells and mouse models.
The drug continued to show some benefit against coronaviruses in Rhesus monkeys and in smaller groups of patients with COVID-19However, larger human studies were required.
The NIAID study is the most comprehensive to date and involves more than 1,000 patients to test whether it will be a useful tool for patient care. There are two important findings from the preliminary results. Patients who received Remdesivir:
- had a 31% faster recovery time than patients who received the placebo
- had a slight but statistically insignificant improvement in survival – the mortality rate was 8% compared to 11.6% in patients receiving the placebo.
Remdesivir will likely receive approval for “emergency use” from the Food and Drug Administration. according to a report by the New York Times.
“The reason we’re making the announcement now is something that I don’t think people fully appreciate,” said Fauci during Wednesday’s briefing. “Whenever you have clear evidence that a drug is working, you are ethically required to immediately inform the people in the placebo group so they can have access.”
There are two groups of patients during a randomized, controlled clinical trial. One receives the experimental drug – in this case remdesivir – while the other receives a placebo, an inactive drug. Which patients receive the medication and which placebo is random and the patients do not know what they are receiving. If a drug is found to help patients improve, the health professionals who conduct the study can choose to give all patients access to the useful drug.
Gilead, the biotech company that manufactures remdesivir, is conducting its own clinical trial in patients with severe COVID-19. In response to the NIAID announcement Gilead published preliminary data in a cohort of nearly 400 patients. The study looked at how the patients felt when they were given a remdesivir infusion over five days and ten days. The longer treatment time had no added benefit, the company said.
“The study shows that some patients may be treated with a 5-day regime,” said Merdad Parsey, chief medical officer at Gilead Sciences, in a press release. Parsey suggests that “this could significantly increase the number of patients that could be treated with our current range of remdesivir.”
Gilead’s preliminary data also suggests that treating patients early (within 10 days of the onset of symptoms) can help them recover faster. However, Gilead’s study does not include a placebo group of patients, making it difficult to draw conclusions.
On the same day as the NIAID announcement, results from a placebo-controlled clinical trial in 237 patients in Hubei, China, were released published in the medical journal The Lancet. The peer review report compared 158 patients who received remdesivir with 79 patients on placebo. The process was stopped prematurely because the outbreak in China came to a halt.
In their small group of patients, the team found that remdesivir had no statistically significant clinical benefit. However, in patients treated with Remdesivir within 10 days of the onset of symptoms, Remdesivir was associated with a reduction in recovery time. However, the research team found that due to the early termination of the study, it was unable to adequately assess whether remdesivir COVID-19 patients had clinical benefits.
Mike Ryan, head of the WHO emergency program, declined to comment on the reports during a press conference on Wednesday. according to Reuters. “I don’t want to comment on this because I haven’t read these publications in detail,” he said.
Where’s Gilead’s experimental drug? Its a lot to do. Choosing data from the NIAID study provides a better picture of the potential of remdesivir as a treatment option for coronaviruses. Although the drug is promising, it does not appear to improve mortality significantly, and the clinical benefit data remain ambiguous.