Oral Antiviral Treatment for COVID-19 in Patients With Systemic Autoimmune Rheumatic Diseases

Abstract

ObjectiveTo describe data on the safety and efficacy of molnupiravir (MP) and nirmatrelvir/ritonavir (NM/R) in patients with systemic autoimmune rheumatic diseases (SARD).MethodsAmong patients with SARD being followed in two tertiary outpatient rheumatology clinics, we retrospectively identified those infected with SARS-CoV-2 between February and August 2022 who received MP or NM/R. Patients' medical files were reviewed for demographics, disease-related characteristics as well as COVID-19 characteristics, including vaccination status, antiviral treatment, side effects and COVID-19 outcomes.ResultsSeventy-four SARD patients (52 females) were identified who had been infected with SARS-CoV-2 and received MP (n=26,35.1%) or NM/R (n=48,64.9%). Most patients were vaccinated against SARS-CoV-2 (n=62,83.8%). Among frequently used regimens were corticosteroids (n=43,58.1%), mycophenolate (n=26,35.1%), TNF-inhibitors (n=14,18.9%), methotrexate (n=13,17.6%) and rituximab (n=12,16.2%). Common adverse events were reported only by four patients receiving NM/R (metallic taste, gastrointestinal upset, hypertension), not leading to drug discontinuation. During follow up, all but two patients (n=72, 97.3%) recovered at home without COVID-19 related complications. Nonetheless, we describe two presumptive cases of COVID-19 rebound who progressed to severe COVID-19.ConclusionThis data argues in favor of a favorable outcome and acceptable safety profile of the two oral antiviral therapies among a high-risk SARD population. However, cases of COVID-19 rebound are being increasingly identified. These findings call for continuous surveillance in order to capture the realworld efficacy and safety profiles in our subpopulations of interest.

Efficacy and safety of paxlovid (nirmatrelvir/ritonavir) in the treatment of COVID‐19: An updated meta‐analysis and trial sequential analysis

“…A total of 79 studies from 42 different articles were included in the meta‐analysis 9,17–57 . These studies provided clinical information from countries around the world, mainly the USA, China, and Italy.…”

Case report: Paralytic ileus resulted from nirmatrelvir/ritonavir-tacrolimus drug-drug interaction in a systemic lupus erythematosus patient with COVID-19

“…There have been studies on the safety and efficacy of nirmatrelvir/ritonavir in patients with SARD. The results showed a favorable outcome and acceptable safety profile of nirmatrelvir/ritonavir among a high-risk SARD population, and common adverse events reported were metallic taste, gastrointestinal upset and hypertension, which will not lead to drug discontinuation ( Fragoulis et al, 2022 ; Gerolymatou et al, 2023 ). However, no detailed information about the DDIs between tacrolimus and nirmatrelvir/ritonavir in these patients were reported.…”

Molnupiravir and Nirmatelvir/Ritonavir in the Treatment of Patients With Systemic Autoimmune Rheumatic Disease With SARS-CoV-2

“…Although the side effect profile is desirable, drug-drug interactions are still a concern, especially with nirmatelvir/ritonavir, which can interact with CYP3A-dependent drugs, including tacrolimus, cyclosporine, and sirolimus. 21 Gerolymatou et al 20 mention that patients vaccinated and boosted with the Omicron variant may recover without event regardless of antiviral use due to vaccination status alone, as suggested by prior studies. 13,22 Molnupiravir in particular may not reduce hospitalization rates in vaccinated patients as demonstrated by the PANORAMIC trial 23 and by Yip et al 24 Nirmatelvir/ ritonavir, however, does seem to confer benefit for vaccinated individuals.…”

“…19 In this issue of The Journal of Rheumatology, Gerolymatou et al retrospectively reviewed 74 patients with SARD who had received either molnupiravir or nirmatelvir/ritonavir for COVID-19 between February and August 2022, corresponding to the Omicron wave. 20 Most patients were vaccinated with 3 doses of mRNA -based vaccines. Ninety-seven percent of patients recovered at home without complications, whereas 2 patients progressed to severe COVID-19, requiring hospitalization and high-flow nasal cannula supplemental oxygen.…”