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• W2979199114 abstract "Purpose: Telaprevir, a Hepatitis C Virus (HCV) NS3/4A protease inhibitor, is a substrate and inhibitor of cytochrome P-450 3A (CYP3A) and a substrate and inhibitor of P-glycoprotein (P-gp). A number of studies were conducted to examine the clinical significance of drug interactions between telaprevir and other medications. Methods: Multiple clinical studies were conducted in healthy volunteers to determine the drug interaction potential of telaprevir with substrates, inhibitors, and inducers of CYP3A as well as digoxin, a substrate of P-gp. Results: Drugs that had substantially increased exposure (AUC) when coadministered with telaprevir included atorvastatin (8-fold), cyclosporine (4.6-fold), oral midazolam (9-fold), and tacrolimus (70-fold). Other notable interactions included a significant reduction in the exposure of the ethinyl estradiol (28%) component of oral contraceptives and in the exposures of ritonavir-boosted HIV protease inhibitors, darunavir (40%) and fosamprenavir (47%), when telaprevir was co-administered. Rifampin, an inducer of CYP3A, caused a substantial (92%) reduction in telaprevir exposure. Telaprevir exposure was also reduced significantly by efavirenz (26%) and by ritonavir-boosted HIV protease inhibitors, lopinavir (54%), darunavir (35%), and fosamprenavir (32%). Other drugs that had increased exposures in the presence of telaprevir were alprazolam (1.35-fold), amlodipine (2.8-fold), digoxin (1.85-fold), i.v. midazolam (3.4-fold), and tenofovir (1.1 to 1.3-fold); drugs that had lowered exposure in the presence of telaprevir were escitalopram (35%), zolpidem (47%) and R-methadone (29%). For methadone, while the total levels of R-methadone in the plasma were reduced in the presence of telaprevir, the protein-unbound levels were similar before and after co-administration of telaprevir, suggesting a lack of clinically significant interaction based on protein-binding displacement. Conclusion: The interaction profile of telaprevir was similar to that of protease inhibitors for HIV and has been well characterized in drug interaction studies with a broad range of commonly used drugs. Based on the degree of interaction and the clinical consequences, certain drugs are contraindicated with telaprevir and several others require dose modification and/or monitoring for adverse events. Health practitioners should consult the full prescribing information prior to and during treatment for potential drug interactions. Disclosure: Drs. Garg and Kauffman are employees and stock holders of Vertex Pharmaceuticals Incorporated Drs. Beumont and van Heeswijk are employees and stock holders of Tibotec BVBA." @default.
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• W2979199114 date "2011-10-01" @default.
• W2979199114 modified "2023-09-23" @default.
• W2979199114 title "Drug Interaction Profile of Telaprevir: 2011 ACG Presidential Poster" @default.
• W2979199114 doi "https://doi.org/10.14309/00000434-201110002-00281" @default.
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