Nirmatrelvir/ritonavir (Paxlovid®): French pharmacovigilance survey 2022

Bihan, Kévin; Lipszyc, Lorène; Lemaître, F.; Dautriche, Anne; Fédrizzi, Sophie; Atzenhoffer, Marina; Vitores, Aurélie; A, Page; Lebrun‐Vignes, Bénédicte

doi:10.1016/j.therap.2023.03.001

Cited by 7 publications

(1 citation statement)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This is consistent with a recent pharmacovigilance study reporting that 11 out of 14 tacrolimus overexposures were linked to a lack of compliance with the French national guidelines. In two other cases, no information was reported, and only one out of 14 patients seemed to present an overexposure episode while following the guidelines [ 21 ]. Fortunately, in our study, all episodes were reversible within a few days with dose adjustments.…”

Section: Discussionmentioning

confidence: 99%

Adaptative Strategy of Immunosuppressive Drugs Dosage Adjustments When Combined With Nirmatrelvir/Ritonavir in Solid Organ Transplant Recipients With COVID-19

Boland,

Devresse,

Monchaud

et al. 2024

Transpl Int

Self Cite

View full text Add to dashboard Cite

Nirmatrelvir/ritonavir is a promising option for preventing severe COVID-19 in solid organ transplant recipients with SARS-CoV-2 infection. However, concerns have arisen regarding potential drug interactions with calcineurin inhibitors (CNI). This two-phase multicentre retrospective study, involving 113 patients on tacrolimus and 13 on cyclosporine A, aimed to assess the feasibility and outcomes of recommendations issued by The French societies of transplantation (SFT) and pharmacology (SFPT) for CNI management in this context. The study first evaluated adherence to recommendations, CNI exposure, and clinical outcomes. Notably, 96.5% of patients on tacrolimus adhered to the recommendations, maintaining stable tacrolimus trough concentrations (C0) during nirmatrelvir/ritonavir treatment. After reintroduction, most patients experienced increased C0, with 42.9% surpassing 15 ng/mL, including three patients exceeding 40 ng/mL. Similar trends were observed in cyclosporine A patients, with no COVID-19-related hospitalizations. Moreover, data from 22 patients were used to refine the reintroduction strategy. Modelling analyses suggested reintroducing tacrolimus at 50% of the initial dose on day 8, and then at 100% from day 9 as the optimal approach. In conclusion, the current strategy effectively maintains consistent tacrolimus exposure during nirmatrelvir/ritonavir treatment, and a stepwise reintroduction of tacrolimus may be better suited to the low CYP3A recovery.

show abstract

Section: Discussionmentioning

confidence: 99%