The COVID super treatment Canadians can’t get
The case for monoclonal antibody treatments
Florida and other American states seeing record-setting surges in COVID-19 cases are ordering truckloads of labmade antibodies Canadian doctors say are being underused in Canada.
Data suggest monoclonal antibody therapies, one of the formulations famously used to rid then-u.s. President Donald Trump of COVID, can keep people with mild to moderate symptoms from ending up in hospital, or dead. Most recently, an early analysis of a Canadian-led study, a preprint not yet peer-reviewed, found a single dose of an antibody treatment developed by Glaxosmithkline and Vir Biotechnology reduced the risk of COVID progressing from mild to serious illness in high-risk people by 85 per cent compared with a placebo.
“Importantly, in the test tube, this antibody retains activity against multiple variants,” Dr. Anthony Fauci, U.S. President Joe Biden’s top infectious diseases doctor told a recent White House briefing. GSK’S antibody is a lab-engineered version of an antibody isolated from the blood of a survivor of the SARS outbreak two decades ago.
Vaccines offer the best hope of ultimately conquering COVID, but treatments are still needed to prevent severe disease in the infected, especially as the virus evolves. Ontario and other models are forecasting a “substantial” fall wave and while “we do not expect to see the same proportion of severely ill cases in the vaccinated,” Ontario’s COVID-19 science advisory table reported this week, not so for the unvaccinated. “Among the unvaccinated, we do expect to see a rapid increase in the number of seriously ill people needing hospital care as workplaces and education reopen in September.”
Despite the pricey costs attached (typically $2,000 per dose) and logistical challenges (the drugs, for the most part, are administered via intravenous infusion) when given within five to 10 days of testing positive for COVID, monoclonal antibodies can slow the disease by blocking the virus, once inside the body, from invading new cells and replicating.
“These are valuable tools not being used in Canada, and should be,” Dr. Andrew Morris, an infectious diseases specialist at Toronto’s Mount Sinai Health System said on social media.
In Florida, state-run monoclonal antibody infusion clinics have been swamped with unvaccinated COVID patients seeking the free treatments.
In the U.S., the drugs have also been authorized as a “post-exposure” prophylaxis for close contacts of people infected with COVID who don’t yet have symptoms, but who are at risk of getting infected, especially if they aren’t fully vaccinated or might not have mounted a strong immune response to the vaccine.
But the prophylactic question hasn’t been well studied. “Let’s say you’re at work and you find out that Bob down the hall is COVID positive and he’s been talking to everybody at the coffee break,” said infectious diseases specialist Dr. Donald Vinh, of Mcgill University Health Centre. Hypothetical Bob has symptoms, like sore throat and a fever. “In theory, you could say everybody who was talking to Bob is at high risk,” Vinh said. “Those people might benefit from prophylaxis. But those studies are hard and expensive to do.” It might make sense in principle, Vinh said, but the data are lacking.
GSK’S sotrovimab was granted Health Canada authorization in July. The company is now “in active discussions with the federal government to secure supply of sotrovimab by early fall 2021,” GSK said in an email to the National Post. The intent is that appropriate people will have access to it, with no out-of-pocket cost.
“Before somebody gets hospitalized with COVID, there isn’t all that much,” said Dr. Anil Gupta, a family doctor at William Osler Health System and lead investigator of the sotrovimab trial. By treating early, “we’re preventing the cascade of events that includes viral replication and the body’s inflammatory response. We’re attacking before we get to that inflammatory response stage.”
In the U.S. demand for sotrovimab has spiked almost 300 per cent over the past month, the Washington Post reported. Eli Lilly and Roche Canada also have been granted interim authorization for antibody cocktails.
The federal Liberals secured 26,000 doses of Lilly’s bamlanivimab last November. Five months later, the government issued a “failure” warning that the drug may not be effective against certain variants. It’s not known how many doses were used before the alert, but doctors say most of it sat on shelves, partly because there was no system to coordinate its use. Bamlanivimab,
Lilly said in an email this week, is not effective “against the variants currently at play in Canada.” The company has another monoclonal combination currently under review by Health Canada that is effective at neutralizing Delta.
What hasn’t proven effective against Delta are cow-sized doses of the dewormer ivermectin. In an Instagram video Wednesday, Covid-positive Joe Rogan said he threw “all kinds of meds” at the infection, including ivermectin, which conspiracy ideologues have been pushing as a “cure” for COVID. Health Canada issued an alert this week warning ivermectin, in livestock or human doses, has not been proven to treat COVID and that Canadians “should never consume health products intended for animals.”
“Honestly, it’s mind-boggling,” Morris said in an interview. “In a variety of settings people have so-called ‘drunk the Kool-aid.’ Ivermectin is the 2021 Kool-aid.”
Monoclonal antibodies aren’t a magic bullet that will treat all. While the drugs seem well-tolerated, they can cause side effects like diarrhea and rash, though in fairly small numbers. What’s more, bringing someone who has tested positive for
COVID into a medical space that has adequate ventilation, personal protective equipment and skilled staff to infuse the drug and watch people for possible reactions requires a lot of infrastructure in an already stretched system, said Dr. Zain Chagla, an infectious diseases specialist and associate professor of medicine at Mcmaster University. “But the payoff is huge. There is probably a big cost benefit here, in preventing ventilator days and ICU days and hospitalization, to really scale this up as much as possible to mitigate the spread of the fourth wave, especially among people that are unvaccinated.”
“This therapy is being used in the United States. It’s being used in places in Europe,” Chagla said. “It definitely can be done — I don’t think there’s anything to say we can’t do this.”
But with no national system, it’s very possible that each province will land in different places in terms of who gets a monoclonal antibody and who doesn’t, said Morris, a member of Ontario’s COVID-19 science advisory table. “Across the provinces, they’re looking at where and when to use them,” he said.
“How do you figure out who’s eligible and who is not? What are the criteria? How do you identify and notify them? We don’t really have great systems in place for that.”
Monoclonal antibodies shouldn’t be seen as a substitute for vaccination, he and others stressed. “Are there going to be some people who avoid vaccination and just get this? I anticipate there will be. It’s a shame,” Morris said. “It’s like the difference between quitting smoking and saying if I get lung cancer, I’ll get an operation.”
“The truth is that everyone who has forgone vaccination by now, the majority of them have no plans to get vaccinated in the near future. I’m not sure that they’re banking on a monoclonal as a way to avoid future vaccination.”
Still, experiences south of the border suggest some are unwisely putting their money on the treatments instead of the shots. “That is not a good thing,” said Vinh.
Monoclonal antibodies have proven beneficial for high-risk people (including those with obesity, asthma, heart failure or chronic kidney disease and people over age 55) who have mild to moderate disease. “If you have more than that — you start requiring oxygen or hospitalization — not only is there no benefit in terms of survival from these monoclonal antibodies, there may even be a signal of increased risk of death, though it’s hard to know if that’s simply because those people were already too sick to begin with,” Vinh said.
There’s also a finite treatment window. The antibodies have to be given within 10 days after symptoms begin. “The thing about COVID is that it can progress rapidly,” Vinh said. “You can literally go from sitting in your bed eating to, an hour or two later, requiring high amounts of oxygen. If you have to transport yourself to a setting where you have to wait in line and get triaged and get a monoclonal antibody, that window can close quickly.”
THESE ARE VALUABLE TOOLS NOT BEING USED IN CANADA.