South Carolina doctors now able to use ‘groundbreaking’ experimental COVID-19 drug

Tidelands Health announced Monday that it had received approval to begin offering a “groundbreaking,” albeit experimental, new treatment for COVID-19 patients.

The new drug is called bamlanivimab and works to prevent the coronavirus from spreading further in a person’s body. Bamlanivimab is only meant for people who don’t yet have advanced symptoms of COVID-19, but who could develop such symptoms if the virus were allowed to progress.

Tidelands Health is one of 15 health care providers in South Carolina approved to offer the first treatments of the new drug. A spokesperson for the South Carolina Department of Health and Environmental Control, the state agency playing a role in the distribution of bamlanivimab, declined to name the other health care providers able to offer the treatment, saying it was up to the providers to self-identify.

“This new treatment shows tremendous promise in helping high-risk patients with COVID-19 avoid hospitalization,” Dr. Gerald Harmon, Tideland Health’s vice president of medical affairs, said in a statement Monday. “Our team is aggressively fighting COVID-19 with every approved treatment available with the goal of helping our patients recover and have the best outcome.”

According to federal health officials, only patients older than 12 years old and weighing over 88 pounds are advised to take the drug. COVID-19 patients who are receiving additional oxygen or who are hospitalized are not advised to take the drug.

The FDA approved bamlanivimab for emergency use Nov. 9, and South Carolina hospitals are now beginning to offer the treatment to patients. According to the U.S. Dept. of Health and Human Services, South Carolina hospitals have received 1,570 doses of the drug to date and could receive more in coming weeks. Nationwide, 169,280 doses have been distributed to date.

The news of the new treatment comes as cases of COVID-19 have risen steadily in the Grand Strand. Horry County has seen more than 2,200 new cases of COVID-19 since the beginning of November and Georgetown County has seen more than 360 new cases. In that same time frame, 33 people have died from COVID-19 in Horry County and 11 people have died in Georgetown County.

The news also comes as the Myrtle Beach area saw a record number of visitors during the Thanksgiving holiday. According to data kept by Coastal Carolina University, nearly two-thirds of rental properties were booked last week, a 20% increase from 2019.

Distribution and use of the new treatment

As the new drug enters the scene as a possible COVID-19 treatment, how its used and distributed are big questions.

Tidelands Health spokesperson Dawn Bryant said that the health care provider wanted to use bamlanivimab as “another tool” to help patients recover from COVID-19. Bryant said Tidelands previously embraced the experimental treatment remdesivir and found success with that medicine.

Tidelands received its first shipment of bamlanivimab last week, Bryant said, and one person so far has been treated with the new drug. Per FDA guidelines, Bryant said Tidelands offers patients all needed information about the treatment and has patients monitored after they’ve completed the treatment.

According to a spokesperson for the HHS Assistant Secretary for Preparedness and Response, the federal government is currently handling distribution of the treatment as the drug maker Eli Lilly seeks FDA approval. That means patients who receive the treatment now will not be charged for the drug, because the federal government has purchased the initial doses and is distributing them to states and U.S. territories.

The spokesperson said the distribution is based on the number of COVID-19 cases and hospitalizations reported in a given state per week. For example, if South Carolina reports a spike in COVID-19 cases one week, it will likely receive additional doses of bamlanivimab the following week.

The federal government is already beginning to distribute the drug more widely. The initial doses of bamlanivimab were only available to out-patient facilities associated with a hospital. The doses the federal government is distributing now can go to out-patient facilities not associated with a hospital, and nursing homes.

Laura Renwick, the spokesperson for DHEC, said 14 other health care providers besides Tidelands Health are currently able to offer bamlanivimab, though she declined to name the providers, citing security concerns.

“Individual facilities may choose to comment on their bamlanivimad status but DHEC isn’t public announcing that information at this time out of an abundance of caution toward security concerns about the location of this limited supply of treatment,” she said in an email.

How bamlanivimab worked in clinical trials

Bamlanivimab is a monoclonal antibody that mimicks real antibodies that humans produce naturally. The drug is a man-made protein that attaches to the little spikes on the outside of the coronavirus, preventing it from spreading further in the body.

Clinical trials showed that 10% of patients who tested positive for COVID-19 and did not take bamlanivimab ended up in the hospital. But only 3% of patients who tested positive and did take bamlanivimab were hospitalized.

In the clinical trials, drug maker Eli Lilly gave varying doses of bamlanivimab to 309 people who had tested positive for COVID-19 but who hadn’t been hospitalized. More than 150 others received a placebo drug. The study found that after 11 days, most of the patients had gotten rid of COVID-19 in their bodies. Importantly, though, after 28 days, only 3% of the patients who had taken bamlanivimab, about nine people, were hospitalized for COVID-19. About 15 people who didn’t take bamlanivimab were hospitalized after that 28 day mark.

For COVID-19 patients who could now take bamlanivimab, the treatment will take more than two hours. According to guidance issued by the Food and Drug Administration, the federal agency that evaluates and approves new drugs, patients should receive 700 milligrams of bamlanivimab through an IV over the course of an hour. A doctor or nurse should monitor the patient for at least another hour after the IV is completed. Patients should still self-isolate, wear a mask and social distance after receiving the treatment, according to the FDA.

More information about the new drug for patients and caregivers can be found here.

“This gives us another tool as we continue to battle COVID-19 on multiple fronts and work continuously to help patients recover from this virus,” Tideland Health’s Harmon said in the statement. “Bamlanivimab gives us another treatment option in our arsenal.”

This story was originally published November 30, 2020 at 6:03 PM with the headline "South Carolina doctors now able to use ‘groundbreaking’ experimental COVID-19 drug."