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Some clinicians are confused about the best dosage for Eli Lilly’s new Covid-19 treatment, which the Food and Drug Administration approved on Monday for emergency use.
The drug is a monoclonal antibody, a lab-cooked version of what our bodies produce to fight the novel coronavirus. The FDA has given doctors the green light to give bamlanivimab to people 12 years of age or older whose Covid-19 is not yet severe enough to require hospitalization, but who are at high risk of getting it.
Reducing the number of people who get sick enough to require admission would be a huge benefit, as it could help prevent medical centers from being overwhelmed. Preliminary results showed that the drug could potentially have this effect if administered early enough.
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Some clinicians have questioned, however, whether the decision to allow doses of 700 milligrams – rather than more – was made in part because the drug was in short supply.
In data first published in September, researchers tried three different doses, but only the average dose – 2,800 milligrams – achieved the primary goal the study set out to reduce the amount of the virus. found in patients. Considering that this was not the case for patients who got either 700 milligrams or 7,000 milligrams, it seemed like this finding could be fluke. After all, most patients, even those who were given a placebo, had virtually no viruses in them after 11 days, anyway.
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“What we understand with Covid is that the viral load is highest at the very beginning and it drops by seven or eight days,” explained Helen Boucher, chief of geographic medicine and infectious diseases at Tufts Medical Center in Boston, which was not involved in the research. “By day 11, almost everyone’s viral load was better – we can’t get too much of it. There is no biological plausibility as to why you would only see this at the medium dose and not at the lowest or highest dose. “
But it left people wondering if the FDA had cleared the best possible dose.
“This is not an ideal situation, because the dose discrepancies confused people,” Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, wrote in an email to STAT. “Also, the government has already bought 700 mg vials, which may be relevant here, and a 2800 mg dose would mean a lot less doses.”
A spokesperson for Eli Lilly said the company was “confident in the growing body of evidence” supporting a 700 mg dose and that the most significant results were that 10% of those who received the placebo ended up in the hospital or emergency room, while only 3% of those who received the drug did so.
At a press conference on Tuesday, Janet Woodcock, the therapeutics lead for Operation Warp Speed - the federal government’s initiative to boost the development of Covid-19 drugs and vaccines – acknowledged that only the 2,800 milligrams hit that particular target, but said it didn’t. does not compromise the effectiveness of the dose of 700 milligrams. “If you look at the hospitalizations… there was a decrease in each of the subgroups,” she says. She asked the FDA about it, but said, “The lower dose is a rational choice in this situation. You don’t want to give more medicine than you need. … I think you could probably go lower, frankly.
The Department of Health and Human Services plans to start dispensing vials this week, using the weekly count of Covid-19 cases and hospitalizations to determine how much of the supply needs to go where. Each state and territory health department will then allocate its share to the treatment centers.
Officials anticipate logistical challenges, as the drug has to be given as an hour-long infusion and is only allowed for ambulatory patients infected with coronavirus.
Given the limited amount of drug available, thorny ethical questions also arise. To be eligible, for example, you must be at high risk of developing severe Covid-19. “This includes a lot of people who are traditionally underserved by the health care system,” Boucher said. “The challenge I face as a clinician is, how do you use it fairly if your supply is so low?”
As for questions about the dose, she hopes those will be answered as studies continue and new data is released. “We don’t have all the data the FDA has,” she said. For now, she warned, of the results released so far, “The key is that the numbers are quite small, and that can’t be emphasized enough.”
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