Evidence map›Paper›PMID 39131108›Full record

ArticleMiddle East journal of digestive diseases2024

A Quick and Sensitive LC-MS/MS Method for Simultaneous Quantification of Sofosbuvir Metabolite (GS-331007) in Human Plasma: Application to Hepatitis C Infected Patients with End-Stage Renal Disease.

Sara Majd Jabbari, Maryam Dibaie, Khadije Maajani, Shahin Merat, Sadaf Ghajarieh Sepanlou, Mohammad-Reza Rouini

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Article in Middle East journal of digestive diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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5 · Who and what money

Authors and funding

6 authors.

Sara Majd JabbariLiver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.ORCID https://orcid.org/0000-0002-0752-4160
Maryam DibaieDepartment of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Khadije MaajaniDepartment of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
Shahin MeratLiver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Sadaf Ghajarieh SepanlouLiver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Mohammad-Reza RouiniDepartment of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Sofosbuvir (SOF) is a revolutionary treatment for patients with hepatitis C virus (HCV). However, its efficacy and safety among patients with end-stage renal disease (ESRD) remains controversial. In this study, we examined the levels of SOF metabolite (GS-331007) (SOF-007) in human plasma of patients infected with HCV having ESRD using an optimized liquid chromatography-mass spectrometry (LC-MS) analytical method. Methods: In this case-control study, 10 clinically confirmed cases and five controls were enrolled. SOF-007 was extracted from plasma using methanol precipitation. The limit of detection (LOD) for the drug and its metabolite were 0.85 and 2.3, respectively. Such a wide range of quantification in a period of separation time shorter than 3.0 minutes (run time) allowed monitoring of the plasma concentration of analytes up to 4 hours (pre-dialysis and post-dialysis) for 12 weeks in non-cirrhotic patients with HCV infection undergoing dialysis. Results: SOF-007 in the plasma of HCV patients with healthy kidneys showed no cumulative effect. An analysis comparing patients with ESRD and healthy participants showed that their behaviour was similar, followed by dialysis with a relatively small cumulative effect. Conclusion: The plasma concentrations of SOF-007 decreased significantly after the 4-hour period of dialysis compared with the plasma concentrations hemodialysis of pre-dialysis in HCV patients with ESRD.

Indexed as

HemodialysisHepatitis CSOF metabolitesSofosbuvirUPLC-MS/MSValidation

Identifiers

PMID39131108
PMCPMC11316195

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