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Remdesivir shows success in large COVID-19 trial. Will become 'new standard of care,' Fauci says.
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"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in an interview with NBC News today (April 29). Patients treated with remdesivir took an average of 11 days to recover as compared with 15 days for those who received a placebo, he said.
"Although a 31% improvement doesn't seem like a knockout 100%, it is a very important proof of concept," Fauci said. "What it has proven is that a drug can block this virus."
he so-called primary endpoint of the study was patients' time to recovery, and more specifically, their "ability to be discharged" from the hospital, he said. The researchers used different metrics to measure improvement, depending on how sick a given patient was at the start of treatment
In addition to recovering more quickly, on average, fewer people in the remdesivir group than the placebo group died, though the result wasn't statistically significant. The mortality rate "trended toward" 8% in the treatment group as compared with 11% in the placebo, although the data still requires further analysis, Fauci said. Normally, the NIAID would wait several days to announce the results of the study, so that the final analyses could be completed.
But "whenever you have clear-cut evidence that a drug works, you have an ethical obligation to immediately let the people who are in the placebo group know so that they can have access," Fauci said. "And all of the other trials that are taking place now have a new standard of care."
As the research groups continue to finalize the data, "some of the numbers may change a little, but the conclusion will not change," he added.
Prior to Fauci's interview, Gilead Sciences, the company that produces remdesivir, announced it was "aware of positive data emerging" from the trial, according to a statement published April 29.
Gilead originally designed remdesivir to treat patients with Ebola, but the drug proved ineffective when tested for that purpose, Live Science previously reported. When tested in animal models of coronavirus infection, however, remdesivir showed efficacy in treating both severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).
When SARS-CoV-2 emerged, scientists found the virus stopped replicating in a lab dish when exposed to the drug. Remdesivir also prevented the virus from infecting human cells in a petri dish, according to a letter published in the journal Nature in February. These preliminary data compelled the U.S. Food and Drug Administration to approve remdesivir for "compassionate use" in COVID-19 patients. Another trial showed the drug stopped SARS-CoV-2 infections in monkeys.
Since then, several research groups have launched clinical trials to test the drug's safety and efficacy. Several small studies suggested that remdesivir alleviated COVID-19 symptoms, including fever and breathing difficulties, but these studies did not include a control group that did not receive the drug, Live Science reported. Without a control group, doctors cannot determine that remdesivir actually caused patients to improve, as opposed to a strong placebo effect or some other, unknown factor.
In including a placebo group, the NIAID trial avoided that problem.
Remdesivir works by mimicking a nucleotide, one of the molecular building blocks of RNA, Live Science previously reported. Thus disguised, the drug can infiltrate viral RNA, disrupt its genetic sequence and render whole sections useless. "This drug happens to be blocking an enzyme that the virus uses" known as an RNA polymerase, which enables the virus to make copies of its genetic material, Fauci said.
Looking forward, the NIAID and its collaborators plan to test remdesivir in combination with other drugs, including anti-inflammatory treatments, to see if its positive effects can be amplified. In the meantime, the original remdesivir study will be finalized and submitted to a peer-reviewed journal, Fauci said.
"This will be the standard of care."
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Antiviral treatments were mentioned in a recent interview with Ray Peat;Pol&Sci. Part 3. Coronavirus, Immunity, & Vaccines. 4/7/2020
RP:"One of the common practices when people come in with respiratory infections, even before they go on a ventilator, they might get aerosolized antiviral, such as Ribavirin, even though there's no published evidence showing that reduces mortality. Since they know it work in vitro it will reduce the virus in cells in a culture dish but there's no proven evidence it protects a person against the virus in the living state. That's still a common practice in hospitals. that and several other viruses and these viruses-
JB: Is that antivirals you mean?
RP: So called, yeah. They're classified. hydroxyquinoline is classified as an antimalarial and anti-inflammatory for rheumatoid arthritis and such, but these, the nucleoside analogues or nucleotide analogues or the hydroxyquinoline categories, these are all recognized as hazardous, mutagenic, possibly carcinogenic drugs. They damage the RNA or DNA of the virus, but they also damage the human DNA and RNA. And so they're known to be very toxic and if they are figuring that the person is beyond reproductive age then they minimize the effects of mutating their DNA. But especially in people who might reproduce its not good to give mutagens."
Pol&Sci. Part 3. Coronavirus, Immunity, & Vaccines. 4/7/2020
--
"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in an interview with NBC News today (April 29). Patients treated with remdesivir took an average of 11 days to recover as compared with 15 days for those who received a placebo, he said.
"Although a 31% improvement doesn't seem like a knockout 100%, it is a very important proof of concept," Fauci said. "What it has proven is that a drug can block this virus."
he so-called primary endpoint of the study was patients' time to recovery, and more specifically, their "ability to be discharged" from the hospital, he said. The researchers used different metrics to measure improvement, depending on how sick a given patient was at the start of treatment
In addition to recovering more quickly, on average, fewer people in the remdesivir group than the placebo group died, though the result wasn't statistically significant. The mortality rate "trended toward" 8% in the treatment group as compared with 11% in the placebo, although the data still requires further analysis, Fauci said. Normally, the NIAID would wait several days to announce the results of the study, so that the final analyses could be completed.
But "whenever you have clear-cut evidence that a drug works, you have an ethical obligation to immediately let the people who are in the placebo group know so that they can have access," Fauci said. "And all of the other trials that are taking place now have a new standard of care."
As the research groups continue to finalize the data, "some of the numbers may change a little, but the conclusion will not change," he added.
Prior to Fauci's interview, Gilead Sciences, the company that produces remdesivir, announced it was "aware of positive data emerging" from the trial, according to a statement published April 29.
Gilead originally designed remdesivir to treat patients with Ebola, but the drug proved ineffective when tested for that purpose, Live Science previously reported. When tested in animal models of coronavirus infection, however, remdesivir showed efficacy in treating both severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).
When SARS-CoV-2 emerged, scientists found the virus stopped replicating in a lab dish when exposed to the drug. Remdesivir also prevented the virus from infecting human cells in a petri dish, according to a letter published in the journal Nature in February. These preliminary data compelled the U.S. Food and Drug Administration to approve remdesivir for "compassionate use" in COVID-19 patients. Another trial showed the drug stopped SARS-CoV-2 infections in monkeys.
Since then, several research groups have launched clinical trials to test the drug's safety and efficacy. Several small studies suggested that remdesivir alleviated COVID-19 symptoms, including fever and breathing difficulties, but these studies did not include a control group that did not receive the drug, Live Science reported. Without a control group, doctors cannot determine that remdesivir actually caused patients to improve, as opposed to a strong placebo effect or some other, unknown factor.
In including a placebo group, the NIAID trial avoided that problem.
Remdesivir works by mimicking a nucleotide, one of the molecular building blocks of RNA, Live Science previously reported. Thus disguised, the drug can infiltrate viral RNA, disrupt its genetic sequence and render whole sections useless. "This drug happens to be blocking an enzyme that the virus uses" known as an RNA polymerase, which enables the virus to make copies of its genetic material, Fauci said.
Looking forward, the NIAID and its collaborators plan to test remdesivir in combination with other drugs, including anti-inflammatory treatments, to see if its positive effects can be amplified. In the meantime, the original remdesivir study will be finalized and submitted to a peer-reviewed journal, Fauci said.
"This will be the standard of care."
--
Antiviral treatments were mentioned in a recent interview with Ray Peat;Pol&Sci. Part 3. Coronavirus, Immunity, & Vaccines. 4/7/2020
RP:"One of the common practices when people come in with respiratory infections, even before they go on a ventilator, they might get aerosolized antiviral, such as Ribavirin, even though there's no published evidence showing that reduces mortality. Since they know it work in vitro it will reduce the virus in cells in a culture dish but there's no proven evidence it protects a person against the virus in the living state. That's still a common practice in hospitals. that and several other viruses and these viruses-
JB: Is that antivirals you mean?
RP: So called, yeah. They're classified. hydroxyquinoline is classified as an antimalarial and anti-inflammatory for rheumatoid arthritis and such, but these, the nucleoside analogues or nucleotide analogues or the hydroxyquinoline categories, these are all recognized as hazardous, mutagenic, possibly carcinogenic drugs. They damage the RNA or DNA of the virus, but they also damage the human DNA and RNA. And so they're known to be very toxic and if they are figuring that the person is beyond reproductive age then they minimize the effects of mutating their DNA. But especially in people who might reproduce its not good to give mutagens."
Pol&Sci. Part 3. Coronavirus, Immunity, & Vaccines. 4/7/2020
