Sofosbuvir‐containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment

Eletreby, Rasha; El‐Serafy, Magdy; Anees, Mahmoud; Kasem, Gamal K.; Salama, Mohamed Abdelbaset; Elkhouly, Reham Abdelkader; Hamdy, Mostafa; Haleem, Hisham Abdel; Kamal, Ehab; Abdel-Razek, Waël; Salama, R; Elshenawy, Mohamed M.; Shafeek, Ayman; Hassany, Mohamed; El-Sayed, Manal Hamdy; Elshazly, Yehia; Esmat, Gamal

doi:10.1111/liv.14299

Cited by 23 publications

(14 citation statements)

References 35 publications

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“…Sofosbuvircontaining regimens were shown to be safe in patients with moderate to severe renal impairment, including those with estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m 2 and those with end-stage renal disease requiring haemodialysis, with or without hepatic decompensation. 27 A recent study has confirmed the safety of sofosbuvir in patients with stage 4-5 kidney disease who were not on dialysis. 28 Sofosbuvir exposure is not significantly changed in patients with mild liver impairment (Child-Pugh A cirrhosis), but it is increased 2.3-fold in those with moderate liver impairment (Child-Pugh B cirrhosis).…”

Section: Sofosbuvirmentioning

confidence: 93%

EASL recommendations on treatment of hepatitis C: Final update of the series☆

Pawlotsky¹,

Negro²,

Aghemo³

et al. 2020

Journal of Hepatology

732

632

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Hepatitis C virus (HCV) infection is a major cause of chronic liver disease, with approximately 71 million chronically infected individuals worldwide. Clinical care for patients with HCV-related liver disease has advanced considerably thanks to an enhanced understanding of the pathophysiology of the disease, as well as developments in diagnostic procedures and improvements in therapy and prevention. These therapies make it possible to eliminate hepatitis C as a major public health threat, as per the World Health Organization target, although the timeline and feasibility vary from region to region. These European Association for the Study of the Liver recommendations on treatment of hepatitis C describe the optimal management of patients with recently acquired and chronic HCV infections in 2020 and onwards.

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Section: Sofosbuvirmentioning

confidence: 93%

EASL recommendations on treatment of hepatitis C: Final update of the series☆

Pawlotsky¹,

Negro²,

Aghemo³

et al. 2020

Journal of Hepatology

732

632

View full text Add to dashboard Cite

show abstract

“…While recent Egyptian study conducted by Eleterby et al had studied the efficacy of sofosbuvir based regimen in chronic HCV patients with CKD with eGFR of less than 60 mL/min/1.73 m2, and they concluded that SVR was achieved in 97.5% of their study population, and that 18 patients of their patients had improved renal function at end of therapy, they also documented that patients group with more severe renal disease and those on dialysis showed lower SVR (80%) and they concluded that these regimens are safe and effective in treating patients suffering from chronic HCV with moderate to severe renal impairment. [ 31 ]…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of ombitasvir/paritaprevir/ritonavir/ribavirin in management of Egyptian chronic hepatitis C virus patients with chronic kidney disease

Abo-Amer¹,

El-Abgeegy²,

Elshweikh

et al. 2020

Medicine

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Treatment of hepatitis C virus (HCV) infection in patients with chronic kidney disease was difficult in the past because of the use of interferon (IFN). It was associated with high risk IFN-related adverse reactions due to reduced renal clearance of IFN. This study aimed to evaluate the antiviral efficacy, safety, and tolerability of ombitasvir/paritaprevir/ritonavir/ribavirin in chronic kidney disease patients infected with chronic HCV. This observational, open-label prospective study was carried out on 103 patients infected chronic HCV with different grades of renal impairment. Paritaprevir/ritonavir and ombitasvir (75/50/12.5 mg) twice daily plus ribavirin were given to the patients for 12 weeks. Dose adjustment of ribavirin was done according to degree of renal impairment. Sustained virological response (12 weeks after the end of treatment) occurred in 101 patients (98.1%). Anemia occurred in 48 patients. No serious adverse events were observed in any patient. Paritaprevir/ritonavir and ombitasvir plus ribavirin for 12 weeks was considered to be safe and effective in the treatment of chronic HCV infected patients with varying degrees of renal impairment.

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“…A drop in eGFR from baseline greater than 10 mL/min/1.73m 2 was noted in 16.5% (235/1427) and 15.9% (77/485) among patients with baseline stage 3 CKD who received sofosbuvir/ledipasvir with and without ribavirin, respectively [53]. Further evidence based on real life studies has been recently established [54][55][56][57][58][59]…”

Section: Sof-based Daas (Real World Studies)mentioning

confidence: 97%

An Updated View on the Antiviral Therapy of Hepatitis C in Chronic Kidney Disease

Fabrizi

Cerutti

2021

Pathogens

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Background: Hepatitis C virus infection remains common in patients with chronic kidney disease, including those on maintenance dialysis. The relationship between hepatitis C virus infection and chronic kidney disease is bi-directional; in fact, HCV is both a cause and consequence of chronic kidney disease. According to a systematic review with meta-analysis of observational studies (n = 23 studies) (n = 574,081 patients on long-term dialysis), anti-HCV positive serologic status was an independent and significant risk factor for death in patients with advanced chronic kidney disease on long-term dialysis. The overall estimate for adjusted mortality (all-cause death risk) with HCV was 1.26 (95% CI, 1.18; 1.34) (p < 0.0001). Interferon-based therapies are biased by low efficacy/safety in chronic kidney disease, but the advent of direct-acting antiviral drugs has made a paradigm shift in the treatment of HCV-infection. These medications give interruption of viral replication because they target specific non-structural viral proteins; four classes of DAAs exist-NS3/4A protease inhibitors, NS5A inhibitors, NS5B nucleoside and non-nucleoside polymerase inhibitors. All-oral, interferon-free, ribavirin-free combinations of DAAs are now available. Aim: The goal of this narrative review is to report the available treatment options for HCV in advanced chronic kidney disease. Methods: We have made an extensive review of the medical literature and various research engines have been adopted. Results: Some combinations of DAAs are currently recommended for HCV in advanced CKD (including patients on maintenance dialysis): elbasvir/grazoprevir; glecaprevir/pibrentasvir; and sofosbuvir-based regimens. Solid evidence, based on registration and “real life” studies supports their efficacy (SVR rates > 90%) and safety even in patients with advanced CKD. No dosage adjustment is necessary and treatment duration is 8–12 weeks. However, recent data highlight that many patients with advanced CKD remain untreated, and numerous barriers to antiviral treatment of HCV still exist. Whether successful antiviral therapy with DAAs will translate into improved survival in the advanced CKD population is another point of future research.

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Sofosbuvir‐containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment

Cited by 23 publications

References 35 publications

EASL recommendations on treatment of hepatitis C: Final update of the series☆

EASL recommendations on treatment of hepatitis C: Final update of the series☆

Efficacy and safety of ombitasvir/paritaprevir/ritonavir/ribavirin in management of Egyptian chronic hepatitis C virus patients with chronic kidney disease

An Updated View on the Antiviral Therapy of Hepatitis C in Chronic Kidney Disease

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