- The Washington Times - Thursday, October 7, 2021

Vaccines are the focus of the global fight against COVID-19, but a flurry of therapeutic breakthroughs and fights over limited supplies of antibody drugs are returning treatments back to the spotlight.

Merck said this month that it would ask the Food and Drug Administration to authorize a course of pills that cut in half the risk of hospitalization or death from COVID-19 in clinical trials. Days later, AstraZeneca said it would seek emergency approval of a groundbreaking antibody drug that helps at-risk people avoid illness before they are exposed to the coronavirus.

The drugs add to a battery of treatments taken off the shelf or newly developed and deployed since the start of the pandemic. They include a common steroid that reels in wild immune responses to “monoclonal antibodies” that helped President Trump recover in October last year before this summer’s wave of delta variant cases drove demand across the Sun Belt.

Federal officials say therapeutics are no substitute for vaccines, which are cheaper than pioneering drugs and decrease the likelihood of infection or disease in the first place.

But treatments are still critical weapons against a virus that has upended the world and is likely to remain, especially as millions refuse the vaccines and some people fail to mount a robust immune response from the shots.



Antivirals old and new

Seated on a couch in the Oval Office, Dr. Anthony Fauci of the National Institutes of Health told Mr. Trump and reporters in April 2020 that the antiviral drug remdesivir showed promise in getting COVID-19 patients out of the hospital faster than those who did not receive the treatment.

Sold under the brand name Veklury, the drug was the first COVID-19 treatment to get full FDA approval last year and is the “antiviral standard of care” for treating hospitalized patients with COVID-19, said Chris Ridley, a spokesman for Gilead Sciences, which makes the drug.

Approved for patients ages 12 and older, a three-day regimen of intravenous therapy reduced the risk of hospitalization or death from COVID-19 by 87% after 28 days, Dr. Joshua Hill, an assistant professor at the Fred Hutchinson Cancer Research Center, told the Contagion Live website last month.

Mr. Ridley said remdesivir also was linked to a reduction in mortality in three real-world studies of more than 90,000 hospitalized patients.

Although it remains a standard treatment, experts say, the benefit is marginal if the timing isn’t right. Doctors said the same could be true of a groundbreaking antiviral pill from Merck.

Given too late, “then these will not be effective. Even remdesivir has fallen out of favor for use in the sickest patients,” said Dr. Panagis Galiatsatos, an assistant professor at Johns Hopkins School of Medicine in Baltimore.

Merck, based in New Jersey, announced on Oct. 1 that it would seek emergency approval of the pill treatment molnupiravir after it was shown to be 50% effective in staving off hospitalization or death in people with mild to moderate illness. The drugmaker said it stopped the trial early in consultation with the FDA because the results were positive.

If authorized for use, it would be a notable advancement. Pills are easier to administer than intravenous drugs and can reach a wider range of patients. If its product is authorized, Merck said, it can make 10 million courses of treatment by the end of this year and produce more next year. Earlier this year, the U.S. government pre-purchased 1.7 million courses for use once the FDA green-lights the treatment.

The company said it will provide “timely access” to the rest of the world based on a tiered pricing system under guidance from the World Bank.

A common steroid keeps patients alive

British researchers made a notable discovery in June 2020, when the pandemic was still in its relative infancy: Dexamethasone, a commonly used corticosteroid, reduced the rate of death in hospitalized patients who were either on a ventilator or required oxygen.
Scientists say COVID-19 patients often die from the immune system’s extreme reaction to the virus. The steroids help keep that reaction in check.

In other words, the steroid does not attack the virus itself but targets “the aberrant immune response the virus can cause — as can other infections,” Dr. Galiatsatos said. He said the drug remains key in treating moderate to severe COVID-19.

The World Health Organization says the steroid reduces mortality by 8.7% in critically ill patients and by 6.7% in severely ill patients. The FDA has authorized injections of the drug for use against COVID-19.

While prolonged use could lead to side effects, the treatment is short and “generally safe,” WHO says.

WHO recommends that only patients with severe COVID-19 take dexamethasone and advises against this treatment for those with mild illness.

Monoclonal antibodies

When Mr. Trump fell sick with COVID-19 one year ago, he received an investigational drug from a company called Regeneron Pharmaceuticals that uses “monoclonal antibodies” to mimic the body’s defenses as the patient mounts a natural response.

The treatment sparked cries of special treatment but shed light on a highly effective tool in keeping COVID-19 patients out of the hospital.

Regeneron’s product and a monoclonal antibody cocktail from Eli Lilly were approved for emergency use in November. The drugs likely have saved thousands of lives, but they are cumbersome to deploy. They are typically given intravenously, requiring supervision from overtaxed clinics and hospitals.

The FDA granted emergency authorization in June to another antibody treatment from GlaxoSmithKline that resulted in an 85% reduction in the risk of hospitalization or death among high-risk adult outpatients compared with a placebo group in trials. The company has entered agreements to provide 420,000 doses of the drug, sotrovimab, worldwide — including the U.S., Australia and parts of Asia and Europe.

A study from earlier this year found Regeneron’s cocktail of two monoclonal antibodies decreased the chances of hospitalization and death by 70% and cut the duration of symptoms by four days. The company said real-world studies by independent groups showed similar results.

The company delivered more than 1.5 million doses — one dose per patient — to the U.S. government and will deliver another 1.4 million doses by January.

Eli Lilly says its treatment combination of bamlanivimab and etesevimab reduced the risk of death and hospitalization by up to 87% in trials. So far, more than 535,000 treatment courses of bamlanivimab or both drugs together have been given to patients. The drugmaker estimates it has prevented more than 25,000 hospitalizations and 10,000 deaths in the U.S.

Regulators paused Eli Lilly’s emergency authorization for a period this year because of concerns that it was ineffective against variants that were common at the time but reissued the authorization in September, as studies showed it was effective against the delta variant.
Demand for antibody drugs soared as the delta wave slammed states across the Sun Belt this summer, flooding hospitals. Florida Gov. Ron DeSantis highlighted efforts to open monoclonal antibody clinics as a way to subdue the wave in his state.

The Biden administration in mid-September bought 1.4 million doses from Regeneron for $2.9 billion, or $2,100 per dose. Administration officials took over the distribution of the monoclonal antibodies, saying it wanted to ensure equal distribution. Several states in the South accounted for the majority of the drug’s use.

Mr. DeSantis and Republican lawmakers cried foul. They said the decision amounted to rationing and would put people’s lives at risk.

“Prior to this week, health care providers were able to obtain mAb therapies directly from distributors. With no warning, that changed, leaving Florida providers scrambling for information and a path forward for previously scheduled appointments of this life-saving therapy,” Sens. Marco Rubio and Rick Scott of Florida and House lawmakers said in a letter to Health and Human Services Secretary Xavier Becerra.

Preventive antibodies

AstraZeneca announced Tuesday that its long-acting antibody drug AZD7442 cut the risk of symptomatic disease by 77% in a trial that enrolled many people with underlying health conditions.

It is a notable development because it is a preventive measure that is given before exposure to COVID-19 — not afterward — and can help vulnerable people who don’t mount a response from vaccines.

The company is asking the FDA to authorize emergency use of the drug, which is given by infusion and can provide protection for up to a year.

“Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19. With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines,” said Mene Pangalos, the executive vice president of AstraZeneca’s biopharmaceutical research and development.

Ivermectin and company

Last year, it was hydroxychloroquine — a malaria medicine that some people called a game-changer against COVID-19 but never gained credence among the medical community as a worthwhile treatment.

This year, ivermectin is generating internet buzz as a treatment, even though it is used mainly to treat parasites in horses and cows.
Things have gotten messy. Some patients are angrily demanding ivermectin from doctors or asking the courts to intervene and order it as a treatment, while horse owners say they have faced shortages for their use.

The Food and Drug Administration says ivermectin is approved for human use for infections caused by some parasitic worms and head lice and skin conditions such as rosacea. Multiple clinical studies are underway abroad to test ivermectin against COVID-19, but the FDA says current data does not support its use against the coronavirus.

“There’s a lot of misinformation around, and you may have heard that it’s okay to take large doses of ivermectin. It is not okay,” the FDA’s website says. “Even the levels of ivermectin for approved human uses can interact with other medications, like blood-thinners. You can also overdose on ivermectin.”

Dr. Galiatsatos said one of his patients asked about ivermectin, so he pointed out the lack of randomized clinical trials that are considered the gold standard.

“At that moment, he understood and didn’t push forward,” he said.

Treatments vs. vaccines

Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases, has praised monoclonal antibody treatments in recent months and said they are “underutilized.”

He also hailed Merck’s pursuit of a pill treatment as “tremendously important” before adding a caveat: Promising treatments shouldn’t replace vaccination, which can reduce the risk of infection and disrupt chains of transmission to the vulnerable.

Doctors say vaccines also tend to offer the best protection against the worst outcomes from COVID-19.

“The vaccines are 90%-plus in their ability to reduce hospitalizations and death,” Dr. Galiatsatos said. “Still the best.”

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