Friday, May 01, 2020

Gilead trial reveals more than half of life-threateningly ill coronavirus patients treated with Ebola drug remdesivir go from relying on oxygen to leaving hospital in two weeks

A trial of the antiviral drug remdesivir has produced 'positive data' for treating coronavirus patients, its maker, Gilead Sciences, said Wednesday.

Gilead announced the results of a clinical trial testing the drug, which was originally developed to treat Ebola patients, in people severely ill with coronavirus.

Half of the 397 patients, who were sick enough to need additional oxygen, but not to be placed on ventilators, improved within 10 days of a five-day treatment course and those who were on a 10-day regimen were better by the eleventh day.

More than half of the patients were discharged from the hospital within two weeks, Gilead announced in a press release.

Meanwhile, Dr Anthony Fauci addressed reports of 'positive data' from the National Institutes of Health's (NIH) own trial of remdesivir in a pool meeting with President Donald Trump and Louisiana Governor John Bel Edwards, calling the findings 'very optimistic'.

The NIH trial is separate from Gilead's own, and details have not yet been officially released, though Dr Fauci said that eight percent in the remdesivir group died, compared to 11 percent in the placebo group. 

Fauci added that the trial was proof 'that a drug can block this virus', and compared the finding to the arrival of the first antiretrovirals that worked against HIV in the 1980s, albeit with modest success at first.

The announcement of promising preliminary remdesivir results sent the Dow soaring by more than 500 points, though Gilead's own stocks were halted pre-trading ahead of the announcement of the trial's findings.

Remdesivir was developed by Gilead Sciences to treat Ebola, the deadly hemorrhagic fever that emerged in West Africa in 2014.

Remdesivir produced encouraging results earlier this year when it showed promise for both preventing and treating MERS - another coronavirus - in macaque monkeys.

The drug appears to help stop the replication of viruses like coronavirus and Ebola alike.

It's not entirely clear how the drug accomplishes this feat, but it seems to stop the genetic material of the virus, RNA, from being able to copy itself.

That, in turn, stops the virus from being able to proliferate further inside the patient's body. 

NIH researchers in charge of the macaque study recommended that it move ahead to human trials with the new coronavirus.

Scientists have listened, and human trials for remdesivir first began in Nebraska.

Most recently, researchers trialing the drug at the University of Chicago reported that most of the 125 COVID-19 patients they'd treated with the drug had been discharged from the hospital, according to Stat News. Two patients died over the course of the trial.

Remdesivir has been among the top contenders of existing drugs being trialed for treating coronavirus, although World Health Organization documents leaked last week suggested it had failed to help patients in a more than 200-person trial recover.

Gilead defended the trial, saying it believed the leaked data was a 'mischaracterization' of the study's results. It's unclear whether the newly-announced results are from the same trial.

The NIH is also studying remdesivir in a randomized controlled trial of 400 patients, meaning about half of the group would take the Ebola antiviral, and the others would get a placebo drug.

In addition to the results of its own trial (which did not have a placebo arm, making its data less informative), Gilead hinted at promising results from the NIH trial.

Addressing these reports in a pool meeting at the White House, Dr Fauci said: 'So that's something that will go with 31 percent improvement, doesn't seem like a knock out, 100 percent, it is a very important proof of concept.

'This is very optimistic, the mortality rate trended towards being better in the sense of less deaths in the REM designate group. Eight percent versus eleven percent in the placebo group.

'So bottom line. You're going to hear more details about this this will be submitted to a peer reviewed journal, and will be peer reviewed appropriately.'

Timing mattered as well. People who were treated early - within 10 days of their first symptoms - fared better, with 62 percent being discharged from the hospital within 14 days.

But the trial's results suggest the drug may still be beneficial, even if given relatively late. Nearly half of those who received remdesivir 10 or more days after they developed symptoms were also released from the hospital by day 14.

Generally speaking, the drug appeared safe in the trial, regardless of the duration of the treatment course.

More than 10 percent of patients treated with the antiviral became nauseous, and six percent of the five-day treatment group and 10.7 percent of the 10-day treatment group were in acute respiratory failure (also a complication of the infection itself).

The greatest risk posed to the coronavirus patients treated with remdesivir was liver damage. Lab work showed enzyme build up in 7.3 percent of the patients. the risk of liver damage became great enough that three percent were removed from the trial. 



How Close Is US to Herd Immunity for COVID-19? What the Numbers Show

There has been considerable interest lately in Sweden’s response to the COVID-19 pandemic. According to Sweden’s top epidemiologist, Dr. Anders Tegnell, Sweden is expected to achieve herd immunity in several weeks’ time.

Sweden pursued a much more relaxed mitigation strategy, practicing social distancing while avoiding a national lockdown, and approximately 20% of Swedes may have been infected and may now be immune to the virus.

Herd immunity is the point at which a large enough percentage of the population is immune to a disease that new cases are not likely to spread to others.

In other words, it’s when there are enough people who are immune to the disease that the disease has nowhere to go and eventually dies off. Therefore, every person who has been infected and recovered, or infected and remained asymptomatic, will help contribute to herd immunity.

But how close are we to achieving this? Although several studies are suggesting that there are far more people with antibodies to the virus than we know of, it’s not clear that we are very close.

An earlier study of pregnant women found that 29 out of 33 women who tested positive for SARS-CoV-2 were asymptomatic at the time of the test, and 26 of them never developed any symptoms at all. That finding suggests that for every pregnant woman with symptomatic COVID-19, there were seven who were infected with the virus, but never developed the disease.

That also suggests that for every woman with symptomatic COVID-19, there may be up to four other women who were infected, but don’t show symptoms.

The study is difficult to generalize because the sample was small and because the study took place in New York City, where incidences are expected to be very high. Furthermore, women seem to be less susceptible to the COVID-19 disease, which would cause the numbers to overestimate the asymptomatic prevalence of SARS-CoV-2.

To get a better idea, the state of New York has been conducting antibody tests and announced preliminary results on April 23, which found that 13.9% of New York residents had the virus and recovered.

In New York City, that rate was up to 21.2%. In upstate New York, away from the metropolitan centers, the rate was much lower at 3.6%.

If those numbers bear out, approximately 2.6 million people have been infected in the state, including 1.7 million people in New York City.

As of this writing, the state’s health department is reporting that it has had 288,045 positive test results. Initial testing has focused on symptomatic patients, so the majority of the positive cases reported by the health department likely indicate a symptomatic case of COVID-19.

If that’s the case, there would be approximately nine asymptomatic infections for every symptomatic case of COVID-19. Granted, those are suppositions based on preliminary data that hasn’t been released in its entirety.

In one of the first complete antibody studies on prevalence, researchers from the Stanford University School of Medicine tested a representative sample of 3,330 people in Santa Clara County, California.

When adjusted by demographics to represent the county, it found that the estimated prevalence of the virus ranged from 2.49% to 4.16%, which would represent between 48,000 and 81,000 people.

If those estimates prove true, the actual prevalence in Santa Clara County would be 50 to 85 times greater than the number of confirmed cases.

However, some have raised issues with this study. The raw, unadjusted prevalence found in the study was 1.5%, representing 50 people testing positive for the antibody out of 3,330 study participants.

According to the manufacturer of the test, the false-positive rate for the test is 0.5%, which would correspond to 17 false-positives in this study. Based on that, a third of the positive results may in fact be false-positives, which would greatly inflate the estimated prevalence.

Still, the study of Santa Clara County echoes the studies from New York that suggest that actual prevalence of SARS-CoV-2 is likely much higher than the number of confirmed cases would lead us to believe (albeit likely not 50 to 85 times higher).

While Sweden’s 20% immunity corresponds to New York City’s estimated 21.2% immunity, the same is not true for the rest of the country.

There are nearly 1 million cases in the United States at this time, so even with the greatest estimated prevalence from the Santa Clara County study, there would be 85 million actual cases, each of which would result in a person being immune to the virus.

The obvious problem is that there are approximately 245 million Americans left to be infected.

Given that the Santa Clara County numbers are likely overstated even for the COVID-19 hot spot of Santa Clara, the actual number of Americans left to be infected is many tens of millions more than that.

Herd immunity is an unrealistic goal for the United States until there is a vaccine. Even if the virus proves to spread much faster than previously thought, that would only require a much larger proportion of Americans to get infected and develop immunity.

That’s not to say that we should hunker down until a vaccine comes, but rather that we should proceed with the assumption that we will not have herd immunity. That will require careful planning and deliberate steps, but it’s certainly possible.




Andrew Cuomo's malfeasance: New York refused to send nursing home's COVID-19 patients to nearly empty and underutilized USNS Comfort, which is returning to Virginia (New York Post)

Senate Democrats — the same ones who feverishly castigated Brett Kavanaugh — refuse to acknowledge sexual-assault accusations against Joe Biden (The Daily Caller)

Former Hillary Clinton adviser calls on Biden to drop out: "We lose all moral authority" if we don't take Tara Reade seriously (The Daily Caller)

This week, Colorado, Mississippi, Minnesota, Montana, and Tennessee will get their economies rolling again, Reuters reports. Last week, it was Georgia, Oklahoma, Alaska, and South Carolina.

Better late than never (but still maybe too late for her political career): Michigan Gov. Gretchen Whitmer extends stay-at-home order while liberating state of draconian bans (The Federalist)

States face $500 billion shortfalls as Congress debates aid (Washington Examiner)

Trump calls reports he may fire HHS Secretary Alex Azar "fake news" (The Washington Post)

Navy recommends reinstating Brett Crozier, who was ousted as commander of the USS Theodore Roosevelt (Fox News)

How noble of them: Saudi Arabia bans flogging as criminal punishment (New York Daily News)


For more blog postings from me, see  TONGUE-TIED, EDUCATION WATCH INTERNATIONAL, GREENIE WATCHPOLITICAL CORRECTNESS WATCH, AUSTRALIAN POLITICS, and Paralipomena (Occasionally updated), A Coral reef compendium and an IQ compendium. (Both updated as news items come in).  GUN WATCH is now mainly put together by Dean Weingarten. I also put up occasional updates on my Personal blog and each day I gather together my most substantial current writings on THE PSYCHOLOGIST.

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