scholarly journals Quantification of plasma levels of antiviral drug sofosbuvir and its metabolite GS331007 in patients of chronic hepatitis C with chronic kidney disease using UPLC-MS/MS method

2020 ◽  
Vol 8 (1) ◽  
pp. 59-66
Author(s):  
Ruchi Singhala ◽  
Pramil Tiwaria ◽  
Ajay Dusejab ◽  
Raja Ramachandranc ◽  
Ajay Patiald ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Hepatitis C ◽  
Kidney Disease ◽  
Formic Acid ◽  
Mass Spectrometer ◽  
Drug Concentration ◽  
Ammonium Acetate ◽  
Ion Trap ◽  
Hcv Infection ◽  
Linear Ion Trap

Sofosbuvir based regimens are the only treatment available in India and some other Asian countries for curing hepatitis C viral (HCV) infection. The main excretion route of sofosbuvir is renal so treatment of HCV infection is challenging in patients on hemodialysis. A simple and sensitive UPLC-MS/MS method was developed and validated according to USFDA guidelines on Linear Ion trap Quadrupole tandem mass spectrometer (QTRAP4500) which was applied to estimate the drug concentration of sofosbuvir and its metabolite GS331007 in patients of chronic kidney disease with HCV infection. Clopidogrel was used as internal standard (IS) for this study. All analytes and IS were separated on UPLC C18-HSS column (2.1mmX50mm, 1.7μm) with retention time of 2.07, 0.29 and 1.58 min, respectively, by using mobile phases of 5mM ammonium acetate in 0.2% formic acid in water (A) and 5mM ammonium acetate in 0.2% formic acid in methanol (B) on gradient elution mode at a flow rate of 0.6 mL/min. Calibration curve was plotted over the range of 10-200 μg/mL for both of the analytes and equation was calculated by applying linear regression method. Detections of daughter ions (sofosbuvir-530 to 243m/z, GS331007-261 to 112.1m/z and clopidogrel- 322 to 154.9m/z) were done in multiple reactions monitoring (MRM) mode and weights were analyzed by using Linear ion trap quadrupole mass spectrometer with turbo spray ion source. The developed method has been successfully used for quantification of drug concentration of sofosbuvir and GS331007 to see the safety of sofosbuvir in patients of HCV infection with renal failures.

scholarly journals Renal function trajectories in hepatitis C infection: differences between renal healthy and chronic kidney disease individuals

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Cheng-Kai Hsu ◽  
Tai-Shuan Lai ◽  
Yih-Ting Chen ◽  
Yi-Ju Tseng ◽  
Chin-Chan Lee ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Renal Function ◽  
Hepatitis C ◽  
Kidney Disease ◽  
Normal Renal Function ◽  
Elderly Women ◽  
Hcv Infection ◽  
Diabetic Patients ◽  
Subgroup Analyses ◽  
Egfr Decline

AbstractAssociations between hepatitis C virus (HCV) and chronic kidney disease (CKD) have been reported; however, differences of renal progression between general and CKD population remain to be elucidated in prospective studies. A total of 1179 participants, who have tested for anti-HCV antibody, were enrolled and prospectively followed for 3 years. The risks associated with HCV infection, in terms of incidence of CKD, annual estimated glomerular filtration rate (eGFR) changes and 50% decline of eGFR at 3-year from baseline, were compared between normal renal function subjects and CKD patients. Overall, 111 of 233 (47.6%) CKD patients and 167 of 946 (17.7%) non-CKD subjects had HCV infection. The crude incidence rates of CKD were 226.9 per 1000 person-years and 14.8 per 1000 person-years in in HCV and non-HCV infected patients, respectively. The adjusted hazard ratio of HCV infection for incident CKD was 7.9 (95% CI 5–12.7). The HCV-infected normal renal function subjects were independently associated with increased risks of eGFR decline in the 1-year, 2-year and 3-year, respectively. The risk associations remained significant in 50% decline of eGFR at 3 years models and in different subgroup analyses. The increases of risks of eGFR decline were also notorious among overall HCV-infected CKD patients. However, the risk associations were less prominent in subgroup analyses (elderly, women and diabetic patients). The findings highlighted the importance of viral diagnosis with not only prognostic but also public health implications for preserving kidney function.

scholarly journals Effects of Renal Impairment and Hemodialysis on the Pharmacokinetics and Safety of the Glecaprevir and Pibrentasvir Combination in Hepatitis C Virus-Negative Subjects

2017 ◽  
Vol 62 (3) ◽  
Author(s):  
Matthew P. Kosloski ◽  
Weihan Zhao ◽  
Thomas C. Marbury ◽  
Richard A. Preston ◽  
Michael G. Collins ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Renal Function ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Kidney Disease ◽  
Renal Impairment ◽  
Combined Treatment ◽  
Hcv Infection ◽  
Renal Elimination ◽  
Genotype 2

ABSTRACT Hepatitis C virus (HCV) infection is an independent risk factor for developing chronic renal impairment and end-stage renal disease. Limited treatment options are available for HCV genotype 2, 3, 5, and 6 infections in patients with an estimated glomerular filtration rate (eGFR) of <30 ml/min. Glecaprevir and pibrentasvir are active against all six major HCV genotypes, are primarily excreted in the bile, and have minimal renal elimination. Therefore, combined treatment with these direct-acting antivirals may be useful for patients with HCV infection and chronic kidney disease. A phase 1, multicenter, open-label study evaluated the effects of renal impairment on the pharmacokinetics and safety of glecaprevir-pibrentasvir. In substudy 1, 38 subjects with stage 2 to 5 chronic kidney disease who were not on dialysis or who had normal renal function received single doses of the combination of 300 mg glecaprevir and 120 mg pibrentasvir. In substudy 2, 8 subjects requiring hemodialysis received single doses of the combination of 300 mg glecaprevir and 120 mg pibrentasvir under dialysis and nondialysis conditions. Regression analyses demonstrated increased glecaprevir and pibrentasvir plasma exposures, as determined by the area under the curve, with decreasing renal function, up to 56% and 46%, respectively, in subjects with an eGFR of <15 ml/min/1.73 m 2 . In dialysis-dependent subjects, glecaprevir and pibrentasvir exposures were similar (≤18% difference) when study drugs were administered before hemodialysis or on a nondialysis day. Adverse events were mostly mild, with the most common being self-limited fatigue (3 subjects). The study findings support the clinical evaluation of glecaprevir-pibrentasvir without dose adjustment in HCV-infected subjects with renal impairment. (This study has been registered at ClinicalTrials.gov under registration number NCT02442258.)

Outcome of Direct Acting Antiviral Drugs (DAADs) for Hepatitis C Virus (HCV) in the Setting of Chronic Kidney Disease (CKD) in Upper Egypt

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Ahmed Abd El Monem Hassan ◽  
Iman Ibrahim Sarhan ◽  
Mostafa Abd Elnasier Abd El Gawad ◽  
Mohamed Mostafa Ali
Keyword(s):  
Chronic Kidney Disease ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Kidney Disease ◽  
Hcv Infection ◽  
Fever Hospital ◽  
Direct Acting Antiviral ◽  
Significant Difference ◽  
Direct Acting

Abstract Background The frequency of hepatitis C virus (HCV) infection remains high in patients with chronic kidney disease (CKD) and plays a detrimental role in mortality in this population, Patients on maintenance dialysis remain at risk of acquiring hepatitis C virus (HCV) infection and the prevalence of anti-HCV seropositive patients undergoing long-term hemodialysis is significantly greater than in those with normal kidney function. Aim and objectives the aim of the study was to assess outcomes (efficacy, side effects, and possible complications) of DAADs for HCV in presence of CKD, Subjects and methods this was retrospective cohort study that was conducted at Aswan Fever Hospital and Luxor fever hospital for anti HCV therapy between Jan 2018 and July 2018 including 60 patients with all stages of CKD whom receiving DAADs were be recruited from both Aswan fever hospital and Luxor fever hospital, Results the results revealed that Patient’s PC (%) in patients from Aswan was ranged between 61-100 with mean±S.D. 83.09±9.258 while in patients from Luxor was ranged between 66-100 with mean±S.D. 84.95±6.764. There was no statistically significant difference between groups where P = 0.458, Patient’s HCV PCR in patients from Aswan at baseline show that all patients were positive while after 3 months 27(90%) were negative and 3(10%) were positive and after 6months all patients were negative while in patients from Luxor all patients were positive while after 3 months 28(93.3%) were negative and 2(6.7%) were positive and after 6 months all patients were negative. There was no statistically significant difference between groups Conclusion Treatment with newer DAAs is effective and safe for the treatment of HCV-infected chronic kidney disease patients,

scholarly journals Efficacy of DAA-based Antiviral Therapies for HCV Patients with Chronic Kidney Disease: A Meta-analysis

2019 ◽  
pp. 1-10
Author(s):  
Peyman Sanjari Pirayvatlou ◽  
Seyyed Moayed Alavian ◽  
Sasan Sanjari Pirayvatlou ◽  
Pouyan Sanjari Pirayvatlou ◽  
Mina Mahboodi ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Hepatitis C ◽  
Kidney Disease ◽  
Observational Studies ◽  
Meta Analysis ◽  
Virologic Response ◽  
Hcv Infection ◽  
Antiviral Therapies ◽  
End Of Treatment

Context: HCV infection in patients with chronic kidney disease (CKD) is important to be treated because it's associated with increased healthcare costs, utilization and is pertained with decrease in survival rate of HCV-infected patients who also have chronic kidney disease. Direct acting agents (DAAs) are novel form of treatment of HCV infection in patients with CKD. The aim of this study is meta-analysis and comparison of the efficacy of different regimen of DAAs used in the treatment of HCV in such patients. Objective: Hepatitis C is a liver disease caused by the hepatitis C virus, the virus can cause both acute and chronic hepatitis. Hepatitis C virus (HCV) is a known risk factor for chronic kidney disease (CKD) and end-stage renal disease (ESRD). HCV infection in CKD patients is also associated with increased healthcare costs and utilization, with further increases in those with ESRD. It should be also noted that survival among HCV-infected patients with chronic kidney disease without undertaking any treatment is low, various mechanisms such as increased liver-related mortality, low quality of life and high cardiovascular risk can explain this finding. The benefits of treatment may extend beyond the liver, with improvements in both cardiovascular and renal outcomes in patient with chronic kidney disease. Previously PEG-INTERFRON Based regimens have been used for treatment of CKD or ESRD Patients with chronic Hepatitis C but this treatment plan was associated with higher adverse effects and less efficacy. Nowadays new researches have shown the efficacy of the Direct Anti-Viral Agents (DAAs) In such patients. Data Sources: A systematic literature searches in PubMed, EMBASE, Web of Science, and Scopus motor searches was done. Virologic response at 12 weeks after the end of treatment (SVR12) was extract from the included studies. Finally, SVR12 rate with 95% confidence intervals (CI) were pool analyzed with random-effects model. Study Selection: Studies were included if they satisfied the following criteria: Participants being adult HCV patients with stage 3–5 CKD (age≥18 years), Interventions being DAA-based antiviral therapies, Outcomes being sustained virologic response at 12 weeks after the end of treatment (SVR12). Studies were excluded if having incomplete outcome data and had no sufficient data to calculate SVR12. Data Extraction: The methodological quality of included observational studies was assessed by three reviewers independently by using the Newcastle–Ottawa scale (NOS), which is usually used for observational studies in meta-analyses. Results: 20 studies comprising a total of 628 patients (from 20 studies) were included for our meta-analysis. The pooled analysis for SVR12 rate was 0.95 (95% Cl 0.92-0.96, I2= 0.00%), 0.92 (95% Cl 0.82-0.96 I2= 0.00%) and 0.95 (95% Cl 0.93-0.97, I2= 0.0%) for total population, sofosbuvir base treatment group and non sofosbuvir base treatment group.   Conclusion: DDAs have high efficacy in treatment of HCV in patient with CKD and it seems that there is no different between sofosbuvir versus non sofosbuvir based regimens for treatment of HCV infection in this patients.

scholarly journals Prevalence of hepatitis C in patients with chronic kidney disease at a tertiary care hospital in north India: a retrospective analysis

2019 ◽  
Vol 7 (6) ◽  
pp. 2198
Author(s):  
Amrit Dhar ◽  
Vijant S. Chandail ◽  
Viney Sambyal ◽  
Vinu Jamwal
Keyword(s):  
Chronic Kidney Disease ◽  
Hepatitis C ◽  
Kidney Disease ◽  
Retrospective Analysis ◽  
Tertiary Care ◽  
False Negative ◽  
Hcv Infection ◽  
Hcv Rna ◽  
Care Hospital ◽  
Genotype 1

Background: Hepatitis C and chronic kidney disease (CKD) both present an unsolved public health problem Hepatitis C virus (HCV) is easily transmitted in haemodialysis units and by kidney transplantation. HCV leads to increased mortality and morbidity due to cirrhosis and hepatocellular carcinoma, while accelerating the progression of CKD. The aim of the  study was to describe the demographic, clinical/biochemical profile and prevalence of patients with CKD who have HCV infection.Methods: This was a retrospective analysis of patients with CKD who presented to out/in patient department of medicine in a tertiary care center in Jammu from a period of Feb 2016 to Nov 2018. Detailed clinical history along with previous lab reports were noted and tests for HCV infection were conducted in all patients. Diagnosis of HCV was made via HCV RNA(RT PCR) and positive  Anti HCV IgG serology.Results: Total 67 patients were included with median age of 54 years (range 43-72 years) with majority 76.1% being males, and 71.6% within 41-60 years age group. 31.4% were HCV positive out of which 81% were males. 7 patients were found to have co-infection with HIV and HBsAg. Genotype 1 (72%) was found to be more common than Genotype 3. Ultrasonography and Upper GI endoscopy showcased 57% with dilated spleenoportal axis  and oesophageal varices respectively.Conclusions: Prevalence of HCV infection in CKD patients is high with genotype 1 being commonest. False negative Anti HCV antibody is common hence screening with HCV RNA is recommended. Strict universal precautions should be employed in hospitals and dialysis units to prevent transmission.

scholarly journals Seroprevalence of Anti-HCV Antibody in Patients with Chronic Kidney Disease before Starting Dialysis Therapy

2017 ◽  
Vol 7 (1) ◽  
pp. 20-24
Author(s):  
Fareha Jesmin Rabbi ◽  
Kaniz Fatema ◽  
Md Morshed Alam
Keyword(s):  
Risk Factors ◽  
Chronic Kidney Disease ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Kidney Disease ◽  
Hcv Infection ◽  
Disease Stage ◽  
Dialysis Therapy ◽  
Increased Risk ◽  
End Stage

Background: Hepatitis C virus (HCV) infection and chronic kidney disease are common and potentially serious medical problems throughout the world. In recent years, it has become clear that these two conditions are linked in several important ways. Indeed, some forms of renal diseases are precipitated by HCV infection and patients with end-stage renal disease (ESRD) are at increased risk for acquiring HCV infection. Patients with chronic kidney disease typically show an impaired immune response compared with healthy individuals and also other risk factors related with treatment and management. CKD patients ultimately undergo end stage renal therapy like dialysis for their treatment and survival. Risk factors for the infections are more in dialysis period than in predialytic stages. Like other developing countries CKD patients with HCV infection are very common in our country. For this reason the CKD patients should be properly diagnosed knowing the infection status before dialysis which would help both the patient and doctor to choose their proper treatment approach.Objective: This cross-sectional study was done to know the prevalence of HCV infection in the CKD patients before starting dialysis therapy.Materials and Methods: A total of 197 patients with chronic kidney disease stage five (CKD-V) before starting dialysis therapy were included as subjects of this study. Among the CKD patients anti-HCV was detected to see prevalence of hepatitis C virus infection. The patients were also tested for HBsAg to assess co-infection. After collecting all the data of different test results analyses were done by SPSS version 15.0.Results: In this study 195 (99%) patients were anti-HCV negative and only two patients (1%) were found positive.Conclusion: HCV infection in CKD patients before dialysis should be taken into account so that HCV negative CKD patients would not get the infection during dialysis and standard screening procedures should be taken to prevent transmission of infection.J Enam Med Col 2017; 7(1): 20-24

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