Why it’s so hard to make antiviral drugs for Covid and other diseases

‘Antibiotics abound, but virus-fighting drugs are harder to come by. Fortunately, scientists are getting better at making and finding them...

‘The pandemic has sent scientists scrambling to find treatments. Heise [virologist Mark Heise of the University of North Carolina at Chapel Hill], for one, is testing a wide range of drugs—not just standard antivirals—against SARS-CoV-2 in lab dishes, as part of the Rapidly Emerging Antiviral Drug Discovery Initiative (READDI). The idea is that, because the virus depends on many processes in human cells, a variety of medications that act on human proteins might give doctors an edge by hurting the virus more than the patient. That throws the doors open to considering medications that were originally designed for cancer, psychosis, inflammatory conditions and autoimmune disease, to see if they might have a shot against Covid-19.

‘But the READDI collaborators—including academic centers, pharmaceutical companies and nongovernmental organizations—are aiming for more than a Covid-19 treatment. READDI hopes to identify and test potential medications for as-yet-unknown infections that may crop up in the future.

‘By getting early human safety testing done ahead of time, they’ll be ready to spring into action when those future outbreaks happen. As Heise says, “We don’t want to repeat what we’ve just been through.”

Read here (Scientific American, Feb 11, 2021)

WHO advises against remdesivir for COVID-19 treatment

‘The anti-viral drug remdesivir should not be used to treat COVID-19 patients no matter how severe their illness as it has "no important effect" on survival chances, the World Health Organization said on Friday (Nov 20).

‘Scratching one of the few treatments that had shown some initial promise in severe patients, a WHO Guideline Development Group (GDG) of international experts said there was "no evidence based on currently available data that it does improve patient-important outcomes".’

Read here (Channel News Asia, Nov 20, 2020) 

World's top intensive care body advises against remdesivir for sickest Covid patients

‘Antiviral remdesivir should not be used as a routine treatment for COVID-19 patients in critical care wards, the head of one of the world's top bodies representing intensive care doctors said, in a blow to the drug developed by U.S. firm Gilead GILD.O.

‘Remdesivir, also known as Veklury, and steroid dexamethasone are the only drugs authorised to treat COVID-19 patients across the world. But the largest study on remdesivir’s efficacy, run by the World Health Organization (WHO), showed on Oct. 15 it had little or no impact, contradicting previous trials.

‘In light of the new interim data from the WHO’s Solidarity trial “remdesivir is now classified as a drug you should not use routinely in COVID-19 patients,” the President of the European Society of Intensive Care Medicine (ESICM), Jozef Kesecioglu, said in an interview with Reuters.’

Read here (Reuters, Nov 13, 2020) 

WHO study says remdesivir did not cut hospital stay or mortality in Covid-19 patients. Same with hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon

‘Gilead Sciences Inc's GILD.O remdesivir had little or no effect on COVID-19 patients' length of hospital stay or chances of survival, a clinical trial by the World Health Organization (WHO) has found. The antiviral medication, among the first to be used as a treatment for COVID-19, was one of the drugs recently used to treat U.S. President Donald Trump’s coronavirus infection.

‘The results are from WHO’s “Solidarity” trial, which evaluated the effects of four potential drug regimens, including remdesivir, hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon, in 11,266 adult patients across more than 30 countries. The study found the regimens appeared to have little or no effect on 28-day mortality or the length of the in-hospital course among patients hospitalized with COVID-19, the WHO said on Thursday.’

Read here (Reuters, Oct 16, 2020)

Donald Trump’s oxygen levels dropped and he has been treated with steroids, doctors say

‘US President Donald Trump remained in a military hospital on Sunday for a third day amid ­conflicting reports about his ­condition even as doctors reported steady progress adding that he could be released as soon as Monday... Doctors added that Trump was on the second day of a planned five-day course of Remdesivir, an antiviral medicine, and is being treated with the powerful steroid dexamethasone amid indications that his lungs may have suffered some damage.’

Read here (South China Morning Post, Oct 4, 2020)

Steroids can be lifesaving for Covid-19 patients, scientists report: New data in hand, the WHO recommended that doctors give the drugs to critically ill patients worldwide

‘International clinical trials published on Wednesday confirm the hope that cheap, widely available steroid drugs can help seriously ill patients survive Covid-19, the illness caused by the coronavirus. Based on the new evidence, the World Health Organization issued new treatment guidance, strongly recommending steroids to treat severely and critically ill patients, but not to those with mild disease...

‘JAMA published that paper and three related studies, along with an editorial describing the research as an “important step forward in the treatment of patients with Covid-19.” Corticosteroids should now be the first-line treatment for critically ill patients, the authors said. The only other drug shown to be effective in seriously ill patients, and only modestly at that, is remdesivir. Steroids like dexamethasone, hydrocortisone and methylprednisolone are often used by doctors to tamp down the body’s immune system, alleviating inflammation, swelling and pain. Many Covid-19 patients die not of the virus, but of the body’s overreaction to the infection.’

Read here (New York Times, Sept 2, 2020)

WHO ‘living guidance' on corticosteroids for Covid-19:

Download here (WHO)

Why steroids are a Covid-19 game changer

This video provides clear information on how Covid-19 affects our bodies adversely, e.g. via inflammation and over-reaction of the immune system (cytokine storm); why anti-viral remdesivir and drug hydroxychloroquine have been found to be relatively ineffective; and how a low-cost steroid dexamethasone produced quite dramatic positive results in severely affected patients. Although well-produced, this video is a means by the producers Real Science to advertise services like Nebula and CuriosityStream.

View here (Real Science, July 11, 2020)

Covid-19: Are we being misled again by Big Pharma?

This Third World Network article examines the parallels between the production, marketing and distribution strategies of (1) antiviral medicine oseltamivir (Tamiflu) by Roche for H1N1 in the years 2005 and 2009 and (2) remdesivir by Gilead Sciences for Covid-19 during this pandemic.

Read here (Third World Network, July 10, 2020)

US buys up world stock of key Covid-19 drug remdesivir

‘The US has bought up virtually all the stocks for the next three months of one of the two drugs proven to work against Covid-19, leaving none for the UK, Europe or most of the rest of the world. Experts and campaigners are alarmed both by the US unilateral action on remdesivir and the wider implications, for instance in the event of a vaccine becoming available. The Trump administration has already shown that it is prepared to outbid and outmanoeuvre all other countries to secure the medical supplies it needs for the US.’

Read here (The Guardian, June 30, 2020)

Remdesivir, the first coronavirus drug, gets a price tag

‘Remdesivir will be sold for US$520 (S$724) per vial, or US$3,120 per treatment course, to hospitals for treatment of patients with private insurance, according to the Department of Health and Human Services and Gilead Sciences, the drug's manufacturer.’

Read here (Straits Times, June 30, 2020)

Gilead to start testing an inhaled version of remdesivir, making it available to vastly more patients

‘The biotech giant that developed the first effective coronavirus treatment is now looking to expand its impact. Gilead Sciences CEO Daniel O'Day said Monday that the company would start testing an inhaled version of the antiviral drug remdesivir in August. Currently, the drug is given as an intravenous infusion. If remdesivir is effective when given through a nebulizer, that "could have significant implications in helping to stem the tide of the pandemic," O'Day wrote in an open letter.’

Read here (Business Insider, June 22, 2020)

Government researchers changed metric to measure coronavirus drug remdesivir during clinical trial

‘Government clinical trial investigators changed the primary metric for measuring the success of Gilead’s experimental drug remdesivir as a coronavirus treatment two weeks before Anthony S. Fauci’s announcement that the drug would be the new “standard of care.”

‘Instead of counting how many people taking the drug were kept alive on ventilators or died, among other measures, the National Institute of Allergy and Infectious Diseases said it would judge the drug primarily on a different outcome: how long it took surviving patients to recover.’

Read here (The Washington Post, May 1, 2020)

Dr Anthony Fauci says Gilead’s remdesivir will set a new ‘standard of care’ for coronavirus treatment

• White House health advisor Dr. Anthony Fauci said Wednesday that data from a coronavirus drug trial testing Gilead Sciences’ antiviral drug remdesivir showed “quite good news” and sets a new standard of care for Covid-19 patients.
• Fauci said the median time of recovery for patients taking the drug was 11 days, compared with 15 days in the placebo group. 
• The results suggested a survival benefit, with a mortality rate of 8% for the group receiving remdesivir versus 11.6% for the placebo group, according to a statement from the National Institutes of Health released later Wednesday.

Read here (CNBC, April 29, 2020)

Leaked study data finds no benefits of Remdesivir on coronavirus patients, sending Gilead stock tumbling

‘The World Health Organisation prematurely posted a draft summary of the China-based trial that was seen by STAT News before it was removed, with a WHO spokesperson telling the publication it's still being peer reviewed and finalised.

‘Gilead challenged the results in an emailed statement, however, deeming them "inconclusive" given the clinical trial was ended early resulting in low enrollment, though it noted there were trends suggesting potential benefit for patients who received treatment early.

‘That didn't stop Gilead's stock from diving down 8% to $75.37 a share in the afternoon before recovering slightly to $77.78.’

Read here (Forbes, April 22, 2020)

Dow futures rally 700 points after Gilead drug reported shows effectiveness. There are reservations about the report and clinical trials funded by Gilead

Dow futures rally. Read here (CNBC, April 16, 2020)

‘Gilead’s severe Covid-19 study includes 2,400 participants from 152 different clinical trial sites all over the world. Its moderate Covid-19 study includes 1,600 patients in 169 different centers, also all over the world.

‘The trial is investigating five- and 10-day treatment courses of remdesivir. The primary goal is a statistical comparison of patient improvement between the two treatment arms. Improvement is measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between.

‘The lack of a control arm in the study could make interpreting the results more challenging.’

Read here (STAT News, April 16, 2020)

Drugmaker Gilead Sciences funds study on "compassionate use of Remdesivir for patients with severe Covid-19" showing positive results

‘In this cohort of patients hospitalised for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomised, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.)’

In this short conclusion in its introduction, the paper published by the New England Journal of Medicine, mentions specifically who funded it.

Read here (New England Journal of Medicine, April 10, 2020)