Milwaukee Journal Sentinel

New drugs could alter virus’ path

But none considered a substitute for vaccines

- Karen Weintraub MERCK & CO, INC./AFP VIA GETTY IMAGES

Several new COVID-19 treatments are expected to become available within the next few months.

Each drug fills a slightly different role, but they could change the course of the illness, at least in the United States.

An experiment­al antiviral from Merck and a monoclonal antibody from AstraZenec­a, along with a handful of other drugs under developmen­t, could make COVID-19 a much less fearsome disease.

“We’re at the point where if we could use these medication­s all to their interlocki­ng benefits ... we could really begin to control the impact this virus has on us, and in particular on the health care system,” said Dr. William Schaffner, an infectious disease physician at the Vanderbilt University School of Medicine.

COVID-19 won’t go away, Schaffner said, but we could make an uneasy peace with it, just as we do with the flu, which in sme years kills as many as 52,000 people, most of them children and seniors. More than 700,000 Americans have died of COVID-19 in the past 20 months.

The drugs could be taken in sequence, offering layers of protection, to prevent disease and then, if someone falls ill, to reduce the risk of a severe case of COVID-19.

Most drugs to be taken early in the course of infection, which makes it even more important for people to be able to get tested quickly, said Dr. Rajesh Gandhi, an infectious disease physician at Massachuse­tts General Hospital and Harvard Medical School.

Additional coronaviru­s testing, recently provided by the government, should alert people sooner that they are infected.

“If you’re in a situation where you are not able to get tested or or it takes too long to get the result back,” the drugs won’t work, Gandhi said. “Testing and treatment go hand in glove.”

Other drugs under developmen­t are aimed at reducing deaths among those who require hospitaliz­ation.

None of the drugs is a substitute for vaccinatio­n, Gandhi said, noting that vaccines cost less than $12 a shot (funded by the U.S. government) and provide excellent protection against severe disease.

But vaccines don’t work perfectly, and they don’t provide strong protection for people who are immunocomp­romised or whose allergies prevent them from getting the shots.

“These are essentiall­y backups to vaccines; they’re not a substitute for vaccines,” Gandhi said. “Having these (drugs) in our armamentar­ium is helpful.”

The Merck antiviral, molnupirav­ir, when taken at the first sign of COVID-19 symptoms, reduces the risk of severe disease by half, the company said this month.

The drug is delivered by pill.

“It’s going to be huge,” said Dr. Daniel Griffin, chief of the division of Infectious Disease for ProHEALTH, a health care provider in the New York City region.

Though the antiviral is most effective if given within two to three days of symptoms, the fact that it reduced symptoms by half up to five days later is “pretty exciting,” Griffin said. It often takes people a few days to realize they are infected.

AstraZenec­a on Monday released new trial data about its monoclonal antibody that showed the double shot, when given within a week of the onset of symptoms, can reduce the likelihood of severe disease by half in people at high risk; if given within five days, the chance of severe disease is cut by more than 67%.

It also offers long-term protection, up to 12 months, the company predicts, meaning it could dramatical­ly improve the lives of people who are immunocomp­romised and can’t get adequate protection from a vaccine.

“Not only have you treated them right then, but you’ve treated them for the next year,” Griffin said.

Dr. Hugh Montgomery, a professor of Intensive Care Medicine at University College London, who helped lead the AstraZenec­a trial, said his sister is being treated for breast cancer. Chemothera­py weakens her immune response and makes it unlikely a COVID-19 vaccine will protect her.

As countries open up and return to something like normal, people like her are even more isolated, he said, because they are more likely to encounter the virus than when everyone was home or masked.

The long-lasting protection provided by the monoclonal antibody, AZD7442, could allow her to see her family and leave home again, Montgomery said.

The people in the AstraZenec­a trial were not vaccinated before receiving the drug. Gandhi said he’d like to know if the combinatio­n of the vaccine and the antibody will have extra benefits.

“I would be thrilled if they could show that the antibodies add to the protection immunocomp­romised people receive from vaccines,” he said.

What remains unclear, Gandhi said, is if the antibody would prevent someone from passing on the virus and if it would shorten the duration of illness.

AstraZenec­a has already requested emergency authorizat­ion from the Food and Drug Administra­tion to use AZD7442 to prevent infection in someone exposed to the virus. Merck also has applied for emergency use for its antiviral.

Another drug combinatio­n of two monoclonal antibodies, REGEN-COV from Regeneron, has long been available as an infusion but is now authorized as a four-shot sequence, which is easier to deliver.

Lilly, which also has an authorized two-monoclonal-antibody drug, says that it can be used either for prevention or treatment and that its protection lasts about three months.

The U.S. government is pre-buying the antiviral and monoclonal antibodies to provide at no cost within the country.

The government recently purchased 388,000 doses of one of the two Lilly antibodies, etesevimab, for $850 a dose, adding to the $1,250 a dose it had spent on bamlanivim­ab, which was determined not to be effective on its own. The government paid the same $2,100 per dose for Regeneron’s REGEN-COV.

It has also preordered 1.7 million courses of Merck’s molnupirav­ir for $1.2 billion, or $706 per dose, pending its receipt of FDA authorizat­ion.

Though the drugs probably will be prohibitiv­ely expensive for some parts of the world, Lilly aims to make its monoclonal antibody affordable.

 ?? ?? Earlier this month, Merck said the experiment­al antiviral drug molnupirav­ir showed “compelling results” in a clinical trial.
Earlier this month, Merck said the experiment­al antiviral drug molnupirav­ir showed “compelling results” in a clinical trial.

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