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Coronavirus

Doctors in Maryland see COVID treatments aiding return to more normal life, once the public can get them

As patience with the seemingly endless pandemic wears thin, the scientific community has turned its attention to finding ways for us to live with the coronavirus.

The focus is increasingly on preventing hospitalizations and deaths, rather than stopping all COVID-19 infections, by using new therapies.

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Vaccinations and boosters remain the preferred method of protection, along with masking and testing, to stem transmission or keep infections on the mild side. But the toolbox is growing with monoclonal antibodies, antiviral pills and infusions, and maybe soon, even simple plasma taken from survivors’ blood.

The U.S. Food and Drug Administration expanded approvals Jan. 21 for the antiviral drug remdesivir for use in newly infected adults and children, not just those already hospitalized with more severe disease.

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The FDA also recently authorized — gave temporary approvals — to two antiviral pills from pharmaceutical giants Pfizer and Merck.

The actions, “bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement.

On remdesivir, she added, the approvals “provide adults and pediatric patients, with mild-to-moderate COVID-19 who are at high risk of severe COVID-19, with a treatment option they could receive outside of a traditional inpatient hospital setting, including at skilled nursing facilities, home health care settings and outpatient facilities such as infusion centers.”

Doctors warn that most of the therapies are just trickling out and nearly all are in short supply. They also say none are cure-alls, rather they give the body time to battle the virus. Some work better than others.

Nonetheless, doctors and scientists in Maryland are pleased with the pipeline of possible treatments that could continue pushing down hospitalizations.

Now considered a leading indicator of the pandemic’s severity, hospitalizations peaked in the last week or so in many states. Maryland peaked Jan. 11 at 3,462 in a hospital with COVID-19, but has since dropped to 2,234, still above last winter’s high mark of 1,952. Deaths surpassed 13,000 in the state and thousands continue to test positive each day.

No one can say when the latest omicron-fueled wave will pass and when another variant may arrive, said Dr. Shyam Kottilil, director of the division of clinical care and research in the University of Maryland School of Medicine’s Institute of Human Virology.

But over time, he said, doctors have gotten better at treating critically ill patients, knowing when to use existing tools such as ventilators and steroids and when to put patients in the prone position, on their stomachs, to aid breathing.

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“We’ve gotten better in managing critically ill patients for sure,” Kottilil said. “Some are getting better sooner. There is a big difference I see now.”

He said the new drugs will help further, but he saw specific hurdles.

Maryland is providing hundreds of doses of remdesivir, also known as Veklury, to at-risk residents of nursing homes, according to several health care groups. That could limit its availability elsewhere.

Kottilil noted remdesivir, as well as most monoclonal antibodies, are administered by infusion that requires specialized locations and staff to administer. Further, not all monoclonal antibodies appear to work against the omicron variant.

GlaxoSmithKline’s sotrovimabis, also known as Xevudy, is the one that studies suggest works best. Maryland’s federal allocation has been limited to 816 doses a week for the next several weeks, according to the Maryland Department of Health.

States have been advised to use it for those most at risk from severe cases of COVID-19 after infection. Republican Gov. Larry Hogan, a cancer survivor, was given a dose when he tested positive in December.

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The supply isn’t likely to last long. The state reported 2,900 new cases of COVID-19 on Wednesday alone, though many cases are mild and will resolve on their own.

In mid-January, Maryland also received 1,320 doses of AstraZeneca’s Evusheld, but it’s authorized for use only in people with compromised immune systems who don’t respond well to vaccines and are at risk from COVID-19.

Regeneron said its monoclonal antibody was “unlikely” to be effective against omicron. Eli Lilly’s version also has proven ineffective against that variant. On Monday, the FDA limited their use to cases of the delta variant or others where they’ve been shown to work.

The new antiviral pills, Merck’s molnupiravir and Pfizer’s Paxlovid, authorized by the FDA in late December, can lessen the duration and severity of an infection and are easier for patients to access and take. But they have varying efficacy and also remain in short supply.

The state gets new stock every other week. Doctors can prescribe the medications, which are delivered to a small number of Walgreens pharmacies in Maryland. A list of allocations can be found on the website of MedChi, the physicians’ association.

“In order to avoid sending prescriptions and patients to a pharmacy that has depleted its stock, the state will provide an estimate of inventory by site posted on the MedChi website, which will be updated regularly,” said Andy Owen, a state health department spokesman.

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Dr. Kinjal Sheth, chief of critical care medicine at LifeBridge Health’s Northwest Hospital, said the Pfizer pill has been shown to be the most effective.

“But it has to be given in the five days after symptoms arise and there is a positive COVID test,” he said. “There are a lot of barriers. Patients may fall outside the window. And because of a limited supply we won’t be able to give it to everybody.”

Sheth also warned that none of the drugs are actually treatments, rather they “just make the body feel better and buy time to let the body heal.”

More devastating to him, however, is that even as hospitals are overrun and staffs are exhausted from nearly two years of providing care, some patients don’t want the therapies, he said. Like vaccines, he said, the science related to medications has been “heavily politicized, and it’s trickled out to all areas of care.”

Still Sheth is committed to the hospital and providing care to COVID-19 patients, and he’s optimistic about the therapeutic pipeline.

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He pointed to one new, or rather old, therapy. Convalescent plasma doesn’t need to be made in a lab like monoclonal antibodies. It’s taken from survivors’ blood and contains antibodies against whatever variant is circulating at the time.

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“It has tremendous promise,” he said, as new variants emerge that evade existing vaccines or drugs.

Studies on plasma until now have been mixed, and Sheth said more studies are needed. But he pointed to the latest study from Johns Hopkins Medicine and university researchers, the largest trial to date, that showed more promise in preventing hospitalizations in people newly infected with the virus.

The findings, posted in December on MedRxiv, a website used to quickly post the latest COVID studies, could help make the therapy more accessible to patients who can’t access lab-made monoclonal antibodies or antiviral pills or they become ineffective.

The researchers found that the early administration of plasma with high levels of antibodies reduced hospitalizations by more than 50%.

”Our findings suggest that this is another effective treatment for COVID-19 with the advantages being low cost, wide availability and rapid resilience to the evolving” virus, said study colead author Dr. Kelly Gebo, professor of medicine in Hopkins’ School of Medicine, in a statement.

Researchers would need to ask FDA to authorize its use before it could become a treatment option.


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