Those immunocompromised and/or immunosuppressed (IC/IS) who become infected with COVID-19 have always been at higher risk for hospitalization, ICU admission, and death throughout the pandemic. That includes all CLL/SLL patients regardless of the treatment status.
While the absolute risk of a poor outcome from COVID-19 has fallen in these high-risk individuals due to protections provided from vaccinations (at least for some), the use of COVID-19 monoclonal antibodies (CmAb), better inpatient and outpatient therapies, and the emergence of less virulent Omicron variants, the relative risk remains higher for those who are moderately or severely immunocompromised.
One of those protective pillars that reduced the risk is completely gone, with no remaining CmAbs authorized for treatment. Evusheld, the only mAb authorized for Pre-Exposure Prophylaxis (PrEP), is now overwhelmingly ineffective for the vast majority of circulating variants.
CLL Society is working to raise awareness of another very effective but less used treatment option known as COVID-19 Convalescent Plasma (CCP). Early in the pandemic, CCP obtained Emergency Use Authorization (EUA) from the FDA was subsequently revised to limit the use of CCP products only for the treatment of outpatients or inpatients with COVID-19 who have immunosuppressive diseases or who are receiving immunosuppressive treatments. They also updated guidance specifying that CCP should be limited to high-titer products, and any CPP products that are not labeled “High-Titer” should not be used.
High-Titer CCP (i.e., VaxPlasma or VaxCCP) is a blood product from both vaccinated and recovered patients from a breakthrough infection. It has been previously tested and found to have very high levels of antibodies that neutralize SARS-CoV-2. In addition, it is polyclonal, meaning it can recognize multiple variant mutations in the virus, including emerging variants that are not neutralized by previously authorized monoclonal antibody therapies. Similar in concept to immunoglobulin replacement therapy (IVIG), it more specifically replaces anti-COVID-19 antibodies for patients such as those with CLL/SLL who do not generate enough of their own after vaccination or previous infection.
A less potent and less uniform version of CCP was used early in the pandemic with mixed results that fell out of favor with the success of the mAb. Now that the CmAbs are all failing and we have data that demonstrates that when the right product (namely high-titer CCP) is given to the right type of patients, namely those who are immunocompromised, outcomes can be improved.
Since it is a blood product obtained from blood banks, the logistics, coding, and reimbursement can be slightly more complicated than ordering medication from the pharmacy.
To help simplify and explain the reimbursement process, a coalition of COVID-19 experts and patient advocates have put together an educational one-pager for healthcare providers called “Ordering High-Titer Convalescent Plasma for an Immunocompromised Patient with Active COVID-19,” which can be found here for healthcare providers that we hope you will print out or email to share and discuss with your local healthcare team.
While High-Titer COVID-19 Convalescent Plasma is not authorized to prevent infection (it is not a form of PrEP) and is not a magic bullet, it does have a beneficial role to play in an active COVID-19 infection, especially when given early, and can be a powerful aid for the immunocompromised.
COVID-19 is not going away any time soon for the most vulnerable. Without effective CmAb treatments, it is vital to be aware of other COVID-19 treatment options, such as High-Titer CCP. CLL Society encourages those who are IC/IS to discuss this option with their healthcare provider before ever becoming infected and consider incorporating CCP as part of your COVID-19 Action Plan.