Impact of ribavirin plasma level on sustained virological response in patients treated with pegylated interferon and ribavirin for chronic hepatitis C |
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Authors: | D BREILH † J FOUCHER‡ L CASTÉRA‡ P TRIMOULET§ S DJABAROUTI W MERROUCHE‡ P COUZIGOU‡ M-C SAUX & V DE LÉDINGHEN‡ ¶ |
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Institution: | Laboratoire de Pharmacocinétique et de Pharmacie Clinique EA2968, UniversitéVictor Segalen Bordeaux 2, Bordeaux, France;;Pharmacie, Centre Hospitalier Universitaire, Pessac, France;;Service d'Hépato-Gastroentérologie, Centre Hospitalier Universitaire, Pessac, France;;Laboratoire de Virologie, Centre Hospitalier Universitaire, Bordeaux, France;;INSERM U889, UniversitéVictor Segalen Bordeaux 2, Bordeaux, France |
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Abstract: | Background The main goal of therapy in hepatitis C virus (HCV) infection is to achieve a sustained virological response (SVR). However, the impact of the pharmacological properties of ribavirin on the SVR has not been fully investigated. Aim To evaluate, through a prospective study, the association between ribavirin plasma level and SVR response in HCV patients treated with pegylated interferon (PEG-IFN) and ribavirin. Patients and methods Patients treated with PEG-IFN and ribavirin had plasmatic ribavirin dosage at weeks 4 and 12. SVR was evaluated 6 months after the end of treatment. Results At week 4, a strong correlation was found between HCV-RNA and C min of ribavirin plasma level ( r = ?0.376, P = 0.002) and AUC 0→12h of ribavirin plasma level ( r = ?0.277, P = 0.018). At week 12, a strong correlation was found between HCV-RNA and C min of ribavirin plasma level ( r = ?0.384, P < 0.0001) and AUC 0→12h of ribavirin plasma level ( r = ?0.257, P = 0.002). In genotype 1 patients, AUC 0→12h ribavirin and C min were significantly correlated with negative HCV-RNA at week 12 and SVR. In the multiple logistic regression model, the only factor independently associated with SVR in genotype 1 patients was negative HCV-RNA at week 12. Conclusion Cmin of ribavirin at weeks 4 and 12 was significantly higher in sustained virological responders compared with relapser or nonresponder patients. However, in genotype 1 patients, plasma ribavirin level at weeks 4 and 2 was not associated with SVR. |
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