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.)

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.

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 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

Progress in hepatitis C virus management in chronic kidney disease

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Abraham Cohen-Bucay ◽  
Jean M. Francis ◽  
Craig E. Gordon
Keyword(s):  
Chronic Kidney Disease ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Kidney Disease ◽  
Virus Management

scholarly journals The Unravelled Link between Chronic Kidney Disease and Hepatitis C Infection

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Fabrizio Fabrizi ◽  
Piergiorgio Messa ◽  
Paul Martin
Keyword(s):  
Chronic Kidney Disease ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Kidney Disease ◽  
Renal Disease ◽  
Chronic Renal Disease ◽  
World Health ◽  
Adjusted Relative Risk ◽  
Hepatitis C Infection ◽  
Increased Risk

The 2011 report of the World Health Organization General Assembly on noncommunicable diseases identified chronic kidney disease as a worldwide health issue posing a heavy economic burden. Hepatitis C virus infection, which is responsible for over 1 million deaths resulting from cirrhosis and liver cancer, is linked to chronic kidney disease in several ways; some forms of renal disease are precipitated by hepatitis C and patients with end-stage chronic renal disease are at increased risk for acquiring HCV. The aim of this review is to update the evidence on the relationship between hepatitis C infection and chronic kidney disease. Information has been accumulated in the last decade indicating that HCV plays an adverse effect on the incidence and progression of chronic kidney disease; a novel meta-analysis of observational studies (seven longitudinal studies; 890,560 unique individuals) found a relationship between hepatitis C seropositivity and incidence of reduced estimated glomerular filtration rate (adjusted relative risk, 1.70; 95% CI, 1.20; 2.39; P=0.002) in the adult general population. In addition to conventional risk factors, hepatitis C may be an additional factor for the development of chronic kidney disease, and an atheromasic activity of hepatitis C virus has been mentioned. The link between hepatitis C and atherosclerosis could also explain the excess risk of cardiovascular mortality that has been observed among hepatitis C virus seropositive patients undergoing maintenance dialysis. A number of biologically plausible mechanisms related to hepatitis C virus have been hypothesized to contribute to atherosclerosis. Implementation of effective treatment intervention towards hepatitis C is required to decrease the healthcare burden of hepatitis C and to prevent the progression of chronic renal disease.

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