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Pharmacokinetics profile of serum and cellular Sofosbuvir along with its concentration effect analysis in HCV patients receiving Sofosbuvir and Ribavirin

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dc.contributor.author Ahmed, Bilal
dc.contributor.author Munir, Bushra
dc.contributor.author Ghaffar, Abdul
dc.contributor.author Yameen, Muhammad
dc.contributor.author Jalal, Fatima
dc.contributor.author Farooq, Muhammad Umar
dc.contributor.author Shehzadi, Saba
dc.contributor.author Ashraf, Sara
dc.contributor.author Liaqat, Ayesha
dc.date.accessioned 2022-12-07T07:49:45Z
dc.date.available 2022-12-07T07:49:45Z
dc.date.issued 2019-05-20
dc.identifier.citation Ahmed, B., Munir, B., Ghaffar, A., Yameen, M., Jalal, F., Farooq, M. U., ... & Liaqat, A. (2019). Pharmacokinetics profile of serum and cellular Sofosbuvir along with its concentration effect analysis in HCV patients receiving Sofosbuvir and Ribavirin. Pakistan Journal of Pharmaceutical Sciences, 32. en_US
dc.identifier.issn 1011-601X
dc.identifier.uri http://142.54.178.187:9060/xmlui/handle/123456789/14848
dc.description.abstract Sofosbuvir along with ribavirin is being widely used for treatment of HCV in Pakistan but it may show delayed response and reoccurrence of disease in some cases. The aim of the study was to investigate pharmacokinetics and concentration effect analysis of sofosbuvir. HCV patients (n=100) received 400 mg sofosbuvir along with low dose or weight based ribavirin (400 mg). Nonlinear mixed effects modeling (NONMEM) and unpaired t-test were used for the association of concentrations and treatment outcomes. Average day 10 sofosbuvir metabolite BM 331007 concentration was higher in patients having haemoglobin nadir value <10 g/dl compared to the patients having heamoglobin nadir value >10 g/dl (5.34 versus 4.87 pmol/106 cells; p=0.03). The average concentration trends of GS331007 at day 10 was towards being higher in the patients achieved sustained virologic response (SVR) as compare to the patients relapsed (5.19 versus 4.86 pmol/106 cells; p=0.05). Sofosbuvir (GS331007) thresholds concentration (suggested at day 10 through receiver operating characteristic curve) was 5.4 pmol/106 cells for SVR (p=0.05) and haemoglobin nadir cells was 6.3 pmol/106 with sensitivity and specificity of ≥60%. Dosing simulations shows that 400 mg sofosbuvir twice daily produce day 10 concentration range of 5.4 to 6.7 pmol/10 6 cells. The range of therapeutic values was identified for HCV patients receiving sofosbuvir in combination with ribavirin for 24 weeks, suggesting a potential pharmaceutical basis for individualized therapeutic dosing. en_US
dc.language.iso en en_US
dc.publisher Karachi: Faculty of Pharmacy & Pharmaceutical Sciences, Karachi en_US
dc.subject Hepatitis C virus (HCV) en_US
dc.subject Sustained Virologic Response (SVR) en_US
dc.subject GS 331007 en_US
dc.subject sovaldi en_US
dc.title Pharmacokinetics profile of serum and cellular Sofosbuvir along with its concentration effect analysis in HCV patients receiving Sofosbuvir and Ribavirin en_US
dc.type Article en_US


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