Stanislaus County wants to boost access for COVID-19 treatment that could save lives
There’s an effort to expand access to monoclonal antibody treatment against COVID-19 in Stanislaus County.
But the prospects for more patients getting the outpatient infusion treatment have run into issues of limited supply. In addition, coronavirus variants have become more resistant to some of the lab-produced antibodies.
Monoclonal antibodies are a treatment for people with mild to moderate COVID-19. The treatment aims to keep the disease from progressing to severe illness, hospitalization or even worse.
County public health officials said this week they are trying to work with the medical community to make the outpatient therapy more available to people meeting the criteria.
“There is a shortage of supply and the federal government is on an allocation basis, but hopefully that is a temporary situation,” said Mary Ann Lilly, managing director of the county Health Services Agency, speaking to county supervisors this week.
Monoclonal antibodies have been pushed in states like Kentucky that are hard-hit by the COVID delta variant. Stanislaus County and its neighbors are hard-hit, as well.
The county has recorded 214 additional deaths since the delta surge began in July. Another option to keep COVID-infected people out of hospitals could save lives this fall and lessen the severity of a potential winter surge looming around the holidays.
One health system in the Northern San Joaquin Valley announced in March its monoclonal antibody therapy for COVID was put on hold, citing state and federal concerns that some treatments were less effective against coronavirus variants. Golden Valley Health Centers, serving patients in Merced, Stanislaus and San Joaquin counties, held a meeting Wednesday to discuss restarting monoclonal therapy but didn’t have details to share yet, a spokesman said.
Monoclonal antibodies are proteins made in laboratories to act like the natural antibodies in the bloodstream that combat viruses. The treatment designed for COVID-19 targets the spike protein of SARS-CoV-2 to keep the virus from entering human cells and replicating.
The FDA in April revoked an emergency use authorization for a monoclonal therapy that used a single antibody, bamlanivimab, and the federal government in June halted distribution of a treatment combining two antibodies, because COVID variants were increasingly resistant to the therapies.
The FDA endorses the REGEN-COV monoclonal antibody treatment, using casirivimab and imdevimab, for health care providers in California, according to the state Department of Public Health.
Monoclonal therapies are backed by some studies showing they reduce the risk of COVID disease progression and hospitalization by 60% to 70%. It’s not considered a substitute for vaccination.
The eligibility includes adults and young people 12 years and older (minimum 88 pounds) who test positive for COVID-19 and are within 10 days of the onset of symptoms. The person must be high risk for getting severely ill or needing hospitalization.
Lilly said county residents who may be eligible should seek advice from their doctor.
The Centers for Disease Control and Prevention also allows it as a preventative measure for people in congregate living facilities who are exposed to COVID-19, Lilly said.
The monoclonal antibody therapy is not authorized for hospitalized patients or the critically ill, and may actually result in worse outcomes for hospital patients who are on high-flow oxygen or ventilation.
The FDA’s emergency authorization said the intravenous infusion can only be done in health centers or clinics with the ability to treat an infusion reaction such as anaphylaxis. Other possible side effects of the therapy are fever, chills, hives, itching and flushing.
Before approving the emergency authorization, the FDA considered the results of a clinical trial including 799 participants. Among the COVID patients vulnerable to disease progression, only 3% receiving the monoclonal therapy were hospitalized or visited the emergency room, compared to 9% of untreated patients. In addition, the patients getting monoclonal antibody treatment had a larger reduction in viral load.
Where is the treatment available?
Kaiser Permanente said it offers the FDA’s recommended monoclonal treatment to patients with mild to moderate COVID-19.
“The monoclonal antibody treatment is an option for our patients,” Kaiser spokesman Jordan Scott said by email. “As with all the care we provide, individual treatment decisions are made jointly by physicians and their patients, and patients can ask their doctors if this is a suitable option.”
A spokesperson said Sutter Gould Medical Foundation, serving patients in Stanislaus, Merced and San Joaquin counties, is exploring the use of REGEN-COV as a monoclonal treatment option for the appropriate patients, but “supply issues affecting health systems across the U.S. have impacted those efforts.”
Sutter Health said it continues to support communities with a wide range of COVID-19 health-related needs, from vaccination to treatment.
A receptionist said this week that Elite Urgent Care, at 1524 McHenry Ave., offers monoclonal antibody treatment for those eligible. The doctor screens the patient first for eligibility. The infusion is done during an appointment lasting one or two hours. The patient’s cost depends on insurance coverage.
The National Infusion Center Association has a locator showing local health providers and clinics that received monoclonal antibody supplies, though it does not mean the site is currently providing the treatment.
Doctors Medical Center is one of the centers identified in Modesto. A hospital spokesperson said monoclonal antibodies are a treatment used at the facility.
The Oak Valley Hospital emergency department in Oakdale is also one of the sites in Stanislaus County. The hospital didn’t return a message from The Modesto Bee.
Another treatment is mostly dismissed
Convalescent plasma, an antibody treatment that showed promise early in the coronavirus pandemic, seems to have taken a back seat.
A concept that goes back to the Spanish flu epidemic of 1918, convalescent plasma uses the antibodies of COVID-19 survivors to attack the virus in a sick patient.
A series of studies concluded the natural antibodies in donated plasma fed through an IV have no benefits for critically ill COVID-19 patients in hospitals. This week, a research team including University of Pittsburgh School of Medicine physician-scientists concluded the CP treatment is futile for the sickest COVID patients, who mostly struggle with an inflammatory immune response to the disease.
In another study, the National Institutes of Health called off a clinical trial looking at convalescent plasma treatment in COVID-19 patients with mild to moderate illness. According to a Stanford Medicine blog in August, the patients receiving the convalescent plasma progressed to severe symptoms in about the same numbers as patients getting the placebo.
Krista Deans, a spokeswoman for Doctors Medical Center in Modesto, said the hospital administered convalescent plasma to patients on a case-by-case basis when doctors thought it was appropriate. She said the hospital can no longer order the plasma from the American Red Cross, which is the supplier of blood and plasma to the hospital.
“We were notified in August that the American Red Cross is no longer testing all routine blood donations for COVID-19 antibodies and discontinued distribution of COVID convalescent plasma on Sept. 1,” Deans said in an email.
Deans said plasma donations can’t be accepted from COVID-survivor friends or family members hoping to assist a patient in the hospital. The convalescent plasma previously used at Doctors came directly from the American Red Cross after it was tested for bacteria, HIV and other contaminants.
This story was originally published October 7, 2021 at 8:43 AM.
