Moves by the FDA and NIH to revise treatment guidelines run up against a system of testing for COVID-19 that faces logistical hurdles.
The Omicron variant of COVID-19 keeps stirring things up. The US Food and Drug Administration (FDA) this week ruled that monoclonal antibody treatments are no longer an option when it comes to treating the COVID-19 variant. The National Institutes for Health (NIH) recently updated its guidelines for treating outpatients with mild-to-moderate COVID-19 to recommend several direct-acting antivirals.
The NIH guidelines panel highly favors the oral medication nirmatrelvir because “it has demonstrated antiviral activity against all coronaviruses that are known to infect humans.”
But it’s one thing to recommend a medication or treatment. It’s quite another to give patients access to them, or the education needed to decide whether to get the treatment.
Underlying factors influencing how effective treatments might be include the availability of testing (so patients can determine whether they need the treatments), the supply of treatments, and getting a provider to prescribe them in time to help the patient.
As Yale Medicine reports, testing during the Omicron surge has also become a “complicated issue.” Polymerase chain reaction (PCR) testing sites might be overcrowded and/or difficult to get to. At-home rapid tests have become difficult to find. There are so many brands out there because the FDA approved the tests under emergency use authorization (EUA). Are the tests accurate? And even if they are accurate, will patients act on test results showing that they have COVID-19?
Fibi Attia, MD, MPH, CIC, the infection prevention coordinator at Penn State Milton S. Hershey Medical Center and a member of Infection Control Today®’s (ICT®’s) Editorial Advisory Board (EAB), notes that in a pandemic, the fate of one patient influences the fates of others.
“Making COVID-19 tests available helps reduce the interaction a positive patient can make with someone else without knowing his COVID situation which leads to more people to trace as contacts to a positive case,” says Attia. “If a person has quick access to a test with a rapid result, that will make life easier and [result in] no symptomatic people spreading it till quarantine time.”
How patients with COVID-19 are treated doesn’t directly affect infection preventionists (IPs), says Attia, although she adds that patients getting medications in time and in the correct manner will decrease the workload on all health care professionals, including IPs.
Heather Saunders, MPH, RN, CIC, the research nurse program manager in charge of infection prevention and control at Johns Hopkins University School of Medicine and another ICT® EAB member, thinks that the “availability of COVID-19 tests does affect infection preventionists as they seek to identify COVID status in symptomatic staff.”
ICT® EAB member Robbie Hilliard, MSN, RN, CIC, is the infection prevention coordinator at the Carl Vinson V.A. Medical Center in Dublin, Georgia. Hilliard says that making COVID-19 tests available and hastening the administration of antiviral medications doesn’t really fall under an IP’s purview. “However, the two are correlatives,” says Hilliard. “Once a patient has COVID, how fast they can get tested/treatment may help decrease the spread by identifying and therefore isolating the patient and their contacts faster.”
Hilliard says that most of the veteran patients she sees have been vaccinated and although many have comorbidities and they’re 70 years old or older, they’ve been able to return home the same day that they’ve tested positive with COVID-19. “With no lasting health effects from COVID,” Hilliard adds. This is a much different experience than what she saw in 2020, when early COVID-19 patients flooded facilities, with some stay weeks, or even months on end.
“An IP’s work will continue to include encouraging the COVID vaccine just as much as hand hygiene and social distancing because it’s important for prevention of COVID related death,” says Hilliard. “Testing (and subsequent treatment) are important steps in the contact tracing process. IP’s don’t know who is at risk until a patient knows for sure they are positive.”
ICT® EAB member Lisa Waldowski, DNP, RN, CIC, is a regional director in infection prevention and control for Kaiser Permanente. Waldowski says that “employee health is involved/impacted by home tests. Data collection [was] based on PCR and rapid tests in the past. [Clinicians] will now have to consider including or excluding home tests for positivity rates.”
The NIH panel notes that nirmatrelvir is coupled with ritonavir as a treatment because “ritonavir is required to increase nirmatrelvir concentrations to the target therapeutic ranges.” The NIH panel states that “multiple therapeutic agents are now available for nonhospitalized patients with mild to moderate COVID-19 who are at high risk of disease progression. The panel favors the use of ritonavir-boosted nirmatrelvir (Paxlovid) in most high-risk, nonhospitalized patients with mild to moderate COVID-19.”
If nirmatrelvir can’t be used because of lack of supply or possible contraindications, other options the NIH suggests are infusions of sotrovimab or remdesivir, an oral medication.
There are caveats.
“Sotrovimab should be administered in a setting where severe hypersensitivity reactions, such as anaphylaxis, can be managed,” states the NIH guidelines “Patients should be monitored during the infusion and observed for at least 1 hour after infusion.”
Meanwhile, “because remdesivir requires IV infusion for 3 consecutive days, there may be logistical constraints to administering remdesivir in many settings,” the updated NIH guidelines state.
The last option the panel recommends is Molnupiravir, which it says “should only be administered when the other 3 options are either not available or cannot be used.”
Meanwhile, the FDA stated that monoclonal antibody treatments are unlikely to be effective against Omicron and wants to spare patients the risk of side effects such as injection site soreness or allergic reactions. The agency stated that it “revised the authorizations for two monoclonal antibody treatments—bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab)—to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.”
Again, though, testing matters.
Yale Medicine reports that “since the virus is new, all the tests are also new, meaning we have neither a long track record of comparing results, nor a true gold-standard test yet. Furthermore, with each new variant, new questions arise. Recently, there has been discussion about whether throat swabs or saliva samples are better at detecting Omicron compared to the more mainstream method of nasal swabs—or if rapid tests are less effective at detecting Omicron.”
Leana Wen, MD, an emergency physician and a professor at George Washington University, tells Axios that “early treatment depends on early testing, which means that people need to have access to reliable testing right after they start developing symptoms. The test has to come back ideally the same day, and there needs to be clear guidelines about what tests are acceptable.”
Saunders says that it will be interesting to see the “effect that at-home antigen tests have on our interpretation of this and future surges, as well as how infection preventionists respond to at-home antigen tests in staff and patients.”
ICT® EAB member Linda Spaulding RN-BC, CIC, CHEC, CHOP, says that the “role IPs might play is to monitor whether or not the doctors are ordering the medication, and just watching from a distance for any adverse reactions. The doctors and pharmacists will have to review the patient’s medical history to be sure they don’t have contraindications for taking the medication.”
In addition, says Spaulding, infection prevention consultants would possibly advise long-term care facilities to use the medications in a outbreak situation.