FDA limits use of monoclonal antibodies but oral Covid treatment is available locally

·3 min read

Jan. 25—As the Omicron variant continues to infect record numbers of West Virginians, two new oral therapies are available in southern West Virginia but the Food and Drug Administration has limited use of two monoclonal antibodies that are in regular use in the region, Dr. Kyle Muscari of Access Health reported.

Vaccinations, according to Dr. Clay Marsh, the state's leading pandemic advisor, still offer the greatest level of protection against the variant, which accounted for 94 percent of West Virginia cases on Monday.

The Food and Drug Administration (FDA) announced on Monday that two monoclonal antibodies, made by Eli Lilly and Regeneron, will be limited because the medicines seem to be ineffective against the Omicron variant of the Covid virus.

Although the drugs were highly effective at treating earlier variants, the FDA announced that they have been shown not to work well against the Omicron variant.

"There are two new oral treatments (Paxlovid and Molnupiravir) for COVID-19," said Muscari. "It is recommended to start an oral therapy within the first 5 days of symptoms."

Covid patients may ask their primary care provider for a prescription. Both pills must be started within five days of developing symptoms.

FDA has authorized Molnupiravir, from Merck and Ridgebac Biotherapeutics, as a last resort, due to lower efficacy and potential risks.

Muscari reported National Institutes of Health (NIH) statistics that show Paxlovid, a five-day oral treatment that was developed by Pfizer, reduces risk of hospitalization and death by 89 percent, while a five-day treatment of Molnupiravir reduces the rate by 30 percent.

Walgreens is the only pharmacy in southern West Virginia that carries the oral treatments.

The pills are available for patients with mild to moderate symptoms of Covid-19 who have a higher risk of disease progression.

"You will need to present a copy of your Positive COVID-19 test result to obtain this prescription," Muscari noted.

Paxlovid may not be taken in conjunction with a list of certain drugs that could lower its effectiveness or be fatal. Health care providers are able to advise patients who have tested positive for Covid but who are taking those drugs.

Muscari reported that a third monoclonal antibody, Sotrovimab, is effective against the Omnicron variant, with NIH reporting that Sotrovimab reduces the death and hospitalization risk by 85 percent.

"Unfortunately, it has a very limited supply," Muscari reported.

On Saturday, the number of hospitalized Covid patients across the state was reported at 990, the highest that metric had been since Sept. 24 when it set a record of 1,012 patients.

West Virginia Department of Health and Human Resources (WVDHHR) counted 21,717 current active cases in its Monday report, with the state showing a daily positivity rate of 18.93 percent.

"We're in the midst of another surge that is caused by the Omicron variant," said Dr. Clay Marsh, the state's leading pandemic adviser, who described the latest sequencing that shows 94 percent of West Virginia cases are now Omicron.

"It is so infectious that it can even infect people who have been vaccinated but are over four to six months after their primary vaccination series or people who are vaccinated and boosted who are greater than three months after their booster dose."

Marsh added that the vaccines still provide greater protection against serious cases which are more likely to result in hospitalization or death.