As of May 25, 2023, Paxlovid (nirmatrelvir and ritonavir) is now fully approved for treating mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19, including hospitalization or death.
That would include all chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL / SLL) patients, regardless of their treatment status.
Recent studies have once again proven that Paxlovid continues to reduce the risk of hospitalizations and deaths into the Omicron era.
Until this full approval, Paxlovid was only available under an emergency use authorization (EUA).
Paxlovid is not approved for use as pre-exposure or post-exposure prophylaxis for the prevention of COVID-19.
Usually, when a medication is approved, it can be used “off-label” for other indications. However, that is not the case with Paxlovid, as the free supply that is still being distributed comes from the government-purchased stockpile.
Here is the link to the official FDA release: FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults, which outlines some of the research that led to this decision and reminds readers of potentially serious drug interactions. This is particularly true for those on treatment for CLL / SLL. Check with your doctor or pharmacist about potential drug-drug interactions before starting on Paxlovid.
CLL Society recommends all CLL / SLL patients discuss with their healthcare team whether Paxlovid should be part of their treatment “COVID-19 action plan” well before deciding.
This approval, welcome as it is, does not change the fact that the best treatment remains prevention with masking, hand sanitizing, and social distancing.