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

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,

2020 ◽  
Vol 10 (3) ◽  
pp. e29-e29
Author(s):  
Wedad Adel Mahmoud ◽  
Iman Ibrahim Sarhan ◽  
Osama Mahmoud Mohamed ◽  
Hayam Ahmed Hebah ◽  
Ossama Ashraf Ahmed ◽  
...  

F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 223 ◽  
Author(s):  
Sara Sobhy Kishta ◽  
Reem El-Shenawy ◽  
Sobhy Ahmed Kishta

Recent improvements have been made in the treatment of hepatitis C virus (HCV) infection with the introduction of direct-acting antiviral agents (DAAs). However, despite successful viral clearance, many patients continue to have HCV-related disease progression. Therefore, new treatments must be developed to achieve viral clearance and prevent the risk of HCV-related diseases. In particular, the use of pitavastatin together with DAAs may improve the antiviral efficacy as well as decrease the progression of liver fibrosis and the incidence of HCV-related hepatocellular carcinoma. To investigate the management methods for HCV-related diseases using pitavastatin and DAAs, clinical trials should be undertaken. However, concerns have been raised about potential drug interactions between statins and DAAs. Therefore, pre-clinical trials using a replicon system, human hepatocyte-like cells, human neurons and human cardiomyocytes from human-induced pluripotent stem cells should be conducted. Based on these pre-clinical trials, an optimal direct-acting antiviral agent could be selected for combination with pitavastatin and DAAs. Following the pre-clinical trial, the combination of pitavastatin and the optimal direct-acting antiviral agent should be compared to other combinations of DAAs (e.g., sofosbuvir and velpatasvir) according to the antiviral effect on HCV infection, HCV-related diseases and cost-effectiveness.


2017 ◽  
Vol 62 (3) ◽  
Author(s):  
Matthew P. Kosloski ◽  
Weihan Zhao ◽  
Thomas C. Marbury ◽  
Richard A. Preston ◽  
Michael G. Collins ◽  
...  

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.)


2018 ◽  
Vol 41 (7) ◽  
pp. 363-370 ◽  
Author(s):  
Rebeca García-Agudo ◽  
Sami Aoufi-Rabih ◽  
Mercedes Salgueira-Lazo ◽  
Carmen González-Corvillo ◽  
Fabrizio Fabrizi

Background and Aims: The advent of direct-acting antiviral agents promises to change the management of hepatitis C in patients with end-stage renal disease, a patient group where the treatment of hepatitis C was historically challenging. We investigated the safety and efficacy of all-oral, interferon-free direct-acting antiviral agents for the treatment of hepatitis C in a ‘real-world’ group of patients with end-stage renal disease. Methods: We performed a single-arm, multi-centre study in a cohort (n=30) of patients with advanced chronic kidney disease (mostly on dialysis) who underwent antiviral therapy with direct-acting antiviral agents. The primary end-point was sustained virologic response (serum hepatitis C virus RNA < 15 mIU/mL, 12 weeks after treatment ended). We collected data on on-treatment adverse events, serious adverse events and laboratory abnormalities. Results: In total, 23 (77%) and 7 (23%) patients underwent regular dialysis and had chronic kidney disease at pre-dialysis stage, respectively. Six regimens were adopted: elbasvir/grazoprevir ( n = 6), ledipasvir/sofosbuvir ± ribavirin ( n = 4), PrOD regimens ± ribavirin ( n = 10), simeprevir + daclatasvir ( n = 3), sofosbuvir + daclatasvir ± ribavirin ( n = 3), sofosbuvir + ribavirin ( n = 4). The SVR12 rate was 90% (95% confidence interval, 74%; 96%). A total of 27 (90%) patients achieved SVR12; there were three virologic failures – two were non-responders and one had a viral breakthrough while on therapy. Adverse events occurred in 53% (16/30) (95% confidence interval, 0.39; 0.73) of patients and were managed clinically without discontinuation of therapy or hospitalization. The most common adverse event was anaemia ( n = 12) that required blood transfusions in seven individuals; deterioration of kidney function occurred in one (14%). Conclusion: All-oral, interferon-free therapy with direct-acting antiviral agents for chronic hepatitis C virus in advanced chronic kidney disease was effective and well tolerated in a ‘real-life’ clinical setting. Careful monitoring of haemoglobin and serum creatinine during therapy with direct-acting antiviral agents is suggested. Studies are under way to address whether sustained viral response translates into better survival in this population.


F1000Research ◽  
2017 ◽  
Vol 5 ◽  
pp. 223
Author(s):  
Sara Sobhy Kishta ◽  
Sobhy Ahmed Kishta ◽  
Reem El-Shenawy

Recent improvements have been made in the treatment of hepatitis C virus (HCV) infection with the introduction of direct-acting antiviral agents (DAAs). However, despite successful viral clearance, many patients continue to have HCV-related disease progression. Therefore, new treatments must be developed to achieve viral clearance and prevent the risk of HCV-related diseases. In particular, the use of pitavastatin together with DAAs may improve the antiviral efficacy as well as decrease the progression of liver fibrosis and the incidence of HCV-related hepatocellular carcinoma. To investigate the management methods for HCV-related diseases using pitavastatin and DAAs, clinical trials should be undertaken. However, concerns have been raised about potential drug interactions between statins and DAAs. Therefore, pre-clinical trials using a replicon system, human hepatocyte-like cells, human neurons and human cardiomyocytes from human-induced pluripotent stem cells should be conducted. Based on these pre-clinical trials, an optimal direct-acting antiviral agent could be selected for combination with pitavastatin and DAAs. Following the pre-clinical trial, the combination of pitavastatin and the optimal direct-acting antiviral agent should be compared to other combinations of DAAs (e.g., sofosbuvir and velpatasvir) according to the antiviral effect on HCV infection, HCV-related diseases and cost-effectiveness.


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