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Evaluation of the concordance of pharmacogenomic information in the RCM and FI with the international recommendations of CPIC and PharmGKB
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Orientador(es)
Resumo(s)
Pharmacogenomics plays an increas-ing role in optimizing antiviral therapy, allowing the choice and dosage of drugs to be tailored to the pa-tient’s genetic profile. However, the integration of this information into regulatory documents, such as the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL), remains inconsistent. To evaluate the degree of concordance between the pharmacogenomic information present-ed in the SmPC and PIL of antiviral drugs with the international recommendations of the Clinical Phar-macogenetics Implementation Consortium (CPIC) and the evidence levels reported in PharmGKB. An analysis was conducted on a set of 146 marketed antiviral drugs, assessing the presence of pharmacogenomic recommendations in their respec-tive SmPCs and PILs. These data were compared with CPIC guidelines and the pharmacogenomic evidence levels assigned by PharmGKB. Results: Only 14 out of the 146 drugs analysed pre-sented recommendations based on CPIC. Regarding PharmGKB evidence levels, most active substanc-es exhibited level 3. Complete agreement with CPIC guidelines was observed in only 2 SmPCs, while other 5 did not consider any genetic polymorphisms. The re-maining documents contained incomplete or partially aligned pharmacogenomic information relative to in-ternational recommendations. The results show that, with the excep-tion of abacavir, there is a discrepancy between the available pharmacogenomic evidence and its inte-gration into the SmPCs of antiviral medicines. This misalignment reinforces the need for more compre-hensive studies and effective harmonization between international guidelines and the content of SmPCs, promoting the adoption of personalized medicine.
Descrição
Palavras-chave
Pharmacogenomics Antiviral cpic smpcs Abacavir Atazanavir
Contexto Educativo
Citação
Almeida, N., Vasconcelos, A., Lacerda, I., & Santos, M. (2026). Evaluation of the concordance of pharmacogenomic information in the RCM and FI with the international recommendations of CPIC and PharmGKB. Book of Abstracts of the 8th Meeting on Medicinal Biotechnology, 34. https://edicoes.ipp.pt/index.php/books/catalog/book/251
Editora
Politema