Tag Archives: steroids

Exclusive: WHO-led COVID drug scheme doubles down on antibodies, steroids and shuns remdesivir

By Francesco Guarascio

BRUSSELS (Reuters) – A World Health Organization-led scheme to supply COVID-19 drugs to poor countries is betting on experimental monoclonal antibody treatments and steroids but is shunning Gilead’s remdesivir blockbuster therapy, an internal document shows.

The WHO draft document, seen by Reuters and dated Oct. 30, says the priorities are to secure monoclonal antibodies in a tight market and to boost purchases and distribution of cheap steroid dexamethasone, of which it has already booked nearly 3 million courses of treatment for poorer countries.

Monoclonal antibodies are manufactured copies of antibodies created by the body to fight an infection.

The paper, which for the first time outlines how the scheme would spend donors’ money, does not cite remdesivir among priority drugs – a significant omission as the antiviral is the only other medication alongside dexamethasone approved across the world for treating COVID-19.

Gilead Science, the U.S. company that developed remdesivir, said the WHO scheme had not funded its COVID-19 trials and had never approached the firm for the possible inclusion of the drug in its portfolio.

The drug-supply scheme is one of the four pillars of the so-called ACT Accelerator, a WHO-led project which also seeks to secure COVID-19 vaccines, diagnostics and protective gear for poorer countries by raising more than $38 billion by the beginning of 2022.

“Immediate priorities for the (therapeutics) pillar are intensifying efforts on monoclonal antibodies while scaling up dexamethasone use,” says the WHO document, still subject to changes and expected to be published on Friday or next week.

The drug-supply scheme, co-led by the Wellcome Trust, a charity, and Unitaid, a health partnership hosted by the WHO, urgently needs $6.1 billion, $750 million of which by February, out of a total ask of $7.2 billion.

More than half the money needed urgently would be used to procure and distribute monoclonal antibodies, the document shows, saying these therapeutics could have a “game-changing” impact but are in short supply.

No drug based on monoclonal antibodies has yet been approved against COVID-19, but the WHO scheme has already invested in research on the new technology and has secured production capacity at a plant of Fujifilm Diosynth Biotechnologies in Denmark.

Fujifilm was not immediately available for a comment.

The scheme wants to spend $320 million to produce antibodies in that facility, the document says, estimating that would be enough to secure at least 4 million antibody courses assuming upper-range procurement costs of $80 per course.

A spokeswoman for Unitaid, speaking on behalf of the co-leaders of the scheme, confirmed that it wanted to raise and invest $320 million in securing monoclonal antibodies but declined to comment on potential commercial deals citing confidential agreements.

Another $110 million would be used for regulatory approval and other market preparation procedures for monoclonal antibodies in poorer countries, the document shows, while $220 million would fund clinical trials of monoclonal antibodies and COVID-19 drugs projects in poorer countries.

Among companies developing monoclonal antibodies against COVID-19 are U.S. pharmaceutical giant Eli Lilly, Switzerland’s Novartis and U.S. firm Regeneron, whose antibodies were administered together with remdesivir to U.S. President Donald Trump in October when he tested positive for the coronavirus.

Eli Lilly has already agreed to produce antibodies at the Fujifilm plant from April and make them available at “an affordable price” to poorer countries, a company spokeswoman said.

Lilly’s drug is being trialed and is seeking emergency authorization in the United States.

A U.S. government-run trial of the drug was paused in mid-October over safety concerns, but other trials continue. In spite of the suspension, the U.S. administration said last week it had sealed a $375-million supply deal.

It is unclear how and whether the WHO scheme will raise the money needed for the supply of antibodies and other projects.

Regeneron was not immediately available for comment.

Novartis, which expects results soon from a trial of its arthritis treatment canakinumab against COVID-19, said on Thursday that it received a request several days ago from the WHO scheme seeking information about medicines to tackle the coronavirus. Novartis also makes dexamethasone.

REMDESIVIR? NO, THANKS

Despite being short of funds, the WHO drugs-supply scheme wants to “transform the treatment landscape”, the document says, and distribute hundreds of millions of courses of COVID-19 drugs to poorer countries by 2022.

Apart from monoclonal antibodies and dexamethasone, it is also planning to develop and secure experimental drugs, including new antivirals and repurposed drugs.

The scheme wants to spend another $100 million to seal deals with unspecified drugmakers from mid-2021, the document says, and next year plans to invest another $4.4 billion to secure drugs showing positive results in clinical trials.

The Unitaid spokeswoman said that among repurposed therapeutics, dexamethasone and its alternative, hydrocortisone, were the most promising.

Remdesivir, alternatively known as Veklury, is also a repurposed antiviral which was initially trialed against Ebola.

Unitaid confirmed the scheme had not procured or funded remdesivir. It did not comment on whether it may buy the drug in future or on why remdesivir did not appear among priority treatments in the document.

Remdesivir has been authorized in dozens of countries around the world to treat COVID-19. However, preliminary findings of a major WHO-sponsored trial revealed in October the antiviral had little or no benefit for COVID-19 patients, contradicting previous positive trials.

Governments however continue to buy it, with Germany this week announcing the purchase of more than 150,000 doses for the next six months.

(Reporting by Francesco Guarascio @fraguarascio; additional reporting by John Miller in Zurich and Caroline Humer; editing by Nick Macfie)

Steroids cut death rates among critically ill COVID-19 patients, major study finds

By Kate Kelland

LONDON (Reuters) – Treating critically ill COVID-19 patients with corticosteroid drugs reduces the risk of death by 20%, an analysis of seven international trials found on Wednesday, prompting the World Health Organisation to update its advice on treatment.

The analysis – which pooled data from separate trials of low dose hydrocortisone, dexamethasone and methylprednisolone – found that steroids improve survival rates of COVID-19 patients sick enough to be in intensive care in hospital.

“This is equivalent to around 68% of (the sickest COVID-19) patients surviving after treatment with corticosteroids, compared to around 60% surviving in the absence of corticosteroids,” the researchers said in a statement.

The WHO’s clinical care lead, Janet Diaz, said the agency had updated its advice to include a “strong recommendation” for use of steroids in patients with severe and critical COVID-19.

“The evidence shows that if you give corticosteroids …(there are) 87 fewer deaths per 1,000 patients,” she told a WHO social media live event. “Those are lives … saved.”

“Steroids are a cheap and readily available medication, and our analysis has confirmed that they are effective in reducing deaths amongst the people most severely affected by COVID-19,” Jonathan Sterne, a professor of medical statistics and epidemiology at Britain’s Bristol University who worked on the analysis, told the briefing.

He said the trials – conducted by researchers in Britain, Brazil, Canada, China, France, Spain, and the United States – gave a consistent message throughout, showing the drugs were beneficial in the sickest patients regardless of age or sex or how long patients had been ill.

The findings, published in the Journal of the American Medical Association, reinforce results that were hailed as a major breakthrough and announced in June, when dexamethasone became the first drug shown to be able to reduce death rates among severely sick COVID-19 patients.

Dexamethasone has been in widespread use in intensive care wards treating COVID-19 patients in some countries since then.

Martin Landray, a professor of medicine and epidemiology at the University of Oxford who worked on the dexamethasone trial that was a key part of the pooled analysis published on Wednesday, said the results mean doctors in hospitals across the world can safely switch to using the drugs to save lives.

CLEAR BENEFITS

“These results are clear, and instantly usable in clinical practice,” he told reporters. “Among critically ill patients with COVID-19, low-dose corticosteroids … significantly reduce the risk of death.”

Researchers said the benefit was shown regardless of whether patients were on ventilation at the time they started treatment. They said the WHO would update its guidelines immediately to reflect the fresh results.

Until the June findings on dexamethasone, no effective treatment had been shown to reduce death rates in patients with COVID-19, the respiratory disease caused by the new coronavirus.

More than 25 million people have been infected with COVID-19 and 856,876​ have died, according to a Reuters tally.

Gilead Sciences Inc’s remdesivir was authorized by United States regulators in May for use in patients with severe COVID-19 after trial data showed the antiviral drug helped shorten hospital recovery time.

Anthony Gordon, an Imperial College London professor who also worked on the analysis, said its results were good news for patients who become critically ill with COVID-19, but would not be enough to end outbreaks or ease infection control measures.

“Impressive as these results are, this is not a cure. We now have something that will help, but it is not a cure, so it’s vital that we keep up all the prevention strategies.”

(Reporting by Kate Kelland; Editing by Mark Heinrich and Catherine Evans)

London attacker took steroids before deadly rampage, inquest told

Police officers and forensics investigators and police officers work on Westminster Bridge the morning after an attack by a man driving a car and weilding a knife left five people dead and dozens injured, in London, Britain, March 23, 2017.

LONDON (Reuters) – The man who mowed down pedestrians on London’s Westminster Bridge before killing a police officer outside Britain’s parliament last year had taken steroids beforehand, a London court heard on Monday.

Last March Khalid Masood, 52, killed four people on the bridge before, armed with two carving knives, he stabbed to death an unarmed police officer in the grounds of parliament. He was shot dead at the scene.

It was the first of five attacks on Britain last year which police blamed on terrorism.

A submission to a pre-inquest hearing into the fatalities at London’s Old Bailey Court said there was evidence that Masood had taken anabolic steroids in the hours or days before his death.

“A more specialist pharmaceutical toxicologist … has been instructed to prepare a report addressing how steroid use may have affected Khalid Masood,” the submission by the inquiry’s lawyer Jonathan Hough said.

The hearing also heard from Gareth Patterson, a lawyer representing relatives of four of the victims, who lambasted tech firms over their stance on encryption and failing to remove radicalizing material from websites.

Patterson said families wanted answers about how Masood, who was known to the UK security service MI5, was radicalized and why shortly before his attack, he was able to share an extremist document via WhatsApp.

He said victims’ relatives could not understand “why it is that radicalizing material continues to be freely available on the internet”.

“We do not understand why it’s necessary for WhatsApp, Telegram and these sort of media applications to have end-to-end encryption,” he told the hearing at London’s Old Bailey court.

Patterson told Reuters following the hearing that he was “fed up” of prosecuting terrorism cases which featured encryption and particularly the WhatsApp messaging service.

“How many times do we have to have this?” he said.

The British government has been pressurizing companies to do more to remove extremist content and rein in encryption which they say allows terrorists and criminals to communicate without being monitored by police and spies, while also making it hard for the authorities to track them down.

However, it has met quiet resistance from tech leaders like Facebook, Google and Twitter and critics say ending encryption will weaken security for legitimate actions and open a back door for government snooping.

Samantha Leek, the British government’s lawyer, said the issues over encryption and radicalization were a matter of public policy and too wide for an inquest to consider.

Police say Masood had planned and carried out his attack alone, despite claims of responsibility from Islamic State, although a report in December confirmed he was known to MI5 for associating with extremists, particularly between 2010 and 2012, but not considered a threat.

Coroner Mark Lucraft said the inquest, which will begin in September, would seek to answer “obvious and understandable questions” the families might have.

(Reporting by Michael Holden; editing by Guy Faulconbridge)