Renal safety in 3264 HCV patients treated with DAA-based regimens: Results from a large Italian real-life study

D’Ambrosio, Roberta; Pasulo, L.; Giorgini, Alessia; Spinetti, Angiola; Messina, Emanuela; Fanetti, I.; Puoti, Massimo; Aghemo, Alessio; Viganó, Paolo; Vinci, M.; Menzaghi, Barbara; Lombardi, Andrea; Pan, Angelo; Pigozzi, Marie Graciella; Grossi, Paolo; Lazzaroni, Sergio; Spinelli, Ombretta; Invernizzi, Pietro; Maggiolo, Franco; Terreni, N.; Monforte, Antonella d’Arminio; Poggio, P. Del; Taddei, M.T.; Colombo, Silvia; Pozzoni, Pietro; Molteni, Chiara; Brocchieri, Alessandra; Bhoori, Sherrie; Buscarini, Elisabetta; Centenaro, Riccardo; Mendeni, Monia; Colombo, Alberto; Marco, Mariella Di; Dionigi, Elena; Bella, Daniele; Borghi, Marta; Zuin, Massimo; Zaltron, S.; Noventa, Franco; Silvestri, Annalisa De; Lampertico, Pietro; Fagiuoli, S.

doi:10.1016/j.dld.2019.11.006

Cited by 15 publications

(14 citation statements)

References 28 publications

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“…The same result has been recently reported in a real‐life cohort of 931 patients after a 12 weeks treatment with DAAs 51 . Moreover, treatment with sofosbuvir was associated with a reduction of e‐GFR in CKD stage 1 patients 52 and sustained e‐GFR decreases 12 weeks after treatment in one more series of patients 53 . Longer follow‐up is needed to explore the time trend of e‐GFR in patients treated with DAAs, but the potential benefits of DAA treatment outweigh the potential harms for patients with CKD stages 1‐3b, independently of the choice of DAA 54 …”

Section: Discussionsupporting

confidence: 86%

HCV cirrhotic patients treated with direct‐acting antivirals: Detection of tubular dysfunction and resolution after viral clearance

Biliotti

Palazzo

Tinti

et al. 2020

Liver International

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Background/Aims: Hepatitis C virus (HCV) has been identified in tubular epithelial cells of infected patients; however, the presence of tubular dysfunction, which is a risk factor for chronic kidney disease (CKD), has never been examined in vivo. The present prospective longitudinal study aimed to estimate the prevalence of tubular dysfunction alone or with glomerular damage and its evolution after HCV clearance in cirrhotic patients. Methods: One hundred and thirty-five consecutive Child-Pugh A cirrhotic patients were evaluated before antiviral treatment and 6 months after the end of therapy. Tubular dysfunction was evaluated by urinary alpha1-microglobulin to creatinine ratio (α1-MCR), and glomerular damage was assessed by urinary albumin to creatinine ratio (ACR). Results: Almost all the patients (93.3%) showed a normal or mildly decreased e-GFR (KDIGO-G1/G2-categories). Tubular dysfunction was found in 23.7% (32/135) of patients, co-occurring with glomerular damage in 37.5% (12/32) of cases, while glomerular damage was found in 16.3% (22/135) of patients. In multiple logistic regression, glomerular damage and the concomitant presence of diabetes and hypertension were the only predictors significantly associated with tubular dysfunction. After HCV clearance, patients experienced a significant reduction of α1-MCR levels (21.0 vs 10.5 μg/mg, P = .009) and tubular dysfunction resolved in 57.1% of subjects. Conclusions: Tubular dysfunction is an unrecognized feature of HCV-related kidney disease in cirrhotic patients and its presence should be primarily investigated in subjects with glomerular damage, diabetes and hypertension, despite normal e-GFR. Tubular dysfunction resolves in the majority of cases after HCV clearance; however, | 159 BILIOTTI eT aL.

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Section: Discussionsupporting

confidence: 86%

HCV cirrhotic patients treated with direct‐acting antivirals: Detection of tubular dysfunction and resolution after viral clearance

Biliotti

Palazzo

Tinti

et al. 2020

Liver International

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“…The overall eGFR ( Fig 2A ) of DAA-treated CHC patients decreased from the BL to EOT and P12 after DAA treatment. Several studies have revealed similar phenomena [ 9 , 11 , 13 ]. However, a decreased eGFR may not reflect true renal injury.…”

Section: Discussionmentioning

confidence: 74%

“…However, the short-term effect of DAA on renal function is inconclusive [ 5 , 6 ]. Several studies have reported that the estimated glomerular filtration rate (eGFR) might be reduced during DAA therapy, especially sofosbuvir (SOF) -based regimens [ 7 – 13 ]. However, some studies have revealed that the eGFR change might be nonsignificant [ 10 , 11 , 13 – 16 ].…”

Section: Introductionmentioning

confidence: 99%

“…Several studies have reported that the estimated glomerular filtration rate (eGFR) might be reduced during DAA therapy, especially sofosbuvir (SOF) -based regimens [ 7 – 13 ]. However, some studies have revealed that the eGFR change might be nonsignificant [ 10 , 11 , 13 – 16 ]. The metabolite of SOF is mainly cleared from the body via the kidney, but other kinds of DAAs are primarily metabolized and cleared by the liver [ 1 ], SOF-based DAA could be nephrotoxic.…”

Section: Introductionmentioning

confidence: 99%

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Neutrophil gelatinase-associated lipocalin partly reflects the dynamic changes of renal function among chronic hepatitis C patients receiving direct-acting antivirals

Chen

et al. 2021

PLoS ONE

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Background Changes in renal function in chronic hepatitis C (CHC) patients receiving direct-acting antivirals (DAAs) are controversial. The evolution of neutrophil gelatinase-associated lipocalin (NGAL) in these patients remains unclear. Methods A total of 232 CHC patients receiving DAA at Dalin Tzu Chi Hospital from May 2016 to February 2019, were enrolled in this retrospective study. Grade 2/3 renal function deterioration, defined as a decrease in eGFR between 10% and 50% from baseline (BL) to 12 weeks after the end of treatment (P12), was investigated for its association with BL characteristics. The changes in renal function and NGAL levels were also analyzed at the SOF-base or nonSOF-base DAA. Results Sixty-two patients (26.7%) had grade 2/3 renal function deterioration at P12 after DAA therapy. Univariate analysis showed that it was associated with age (P = 0.038). Multivariate analysis indicated that age (OR = 1.033, 95% CI: 1.004–1.064, P = 0.027), sex (male; OR = 2.039, 95% CI: 1.093–3.804, P = 0.025), ACEI/ARB use (OR = 2.493, 95% CI: 1.016–6.119, P = 0.046), and BL NGAL (OR = 1.033, 95% CI: 1.001–1.067, P = 0.046) positively correlated with grade 2/3 renal function deterioration. Furthermore, eGFR was decreased (P = 0.009) and NGAL was increased (P = 0.004) from BL to P12 in CHC patients receiving SOF-based DAA. Conclusions Of the CHC patients receiving DAA therapy, 26.7% had grade 2/3 renal function deterioration at P12, and it was associated with older age, gender being male, ACEI/ARB use, and higher BL NGAL levels. In addition, NGAL might be a biomarker of nephrotoxicity at P12 in patients receiving SOF-based DAA.

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“…However, discordant results on renal function after HCV clearance by DAA were reported. In an Italian cohort study for 3264 patients treated with HCV by DAA with 96% achieved SVR [14], the eGFR was found decrease about 3 ml/min/1.73m 2 in all treated patients at SVR12, while the patients with CKD3A increased their eGFR about 2 ml/min/1.73m 2 and CKD3B increased about 1 ml/min/1.73m 2 at SVR12. Another cohort study for 1590 patients in Boston treated HCV with DAA and SVR12 (90.7%) [15] had overall eGFR improvement about 3 ml/min/1.73m 2 .…”

Section: Introductionmentioning

confidence: 97%

The eGFR Change and Risk Factors in Moderate Chronic Kidney Disease Patients after Successful HCV Clearance by Direct Anti-viral Agents

Lan

et al. 2021

Preprint

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Background –Chronic HCV infection is related not only to chronic kidney disease(CKD) but also accelerates renal deterioration. Treatment with Direct-acting antiviralagents (DAA) could slow renal function decline in some trials, but the long-termoutcomes of renal function changes following HCV elimination by DAA remainedinconclusive. Methods – This retrospective study analyzed the data of HCV infected patients withCKD stage 3 who were treated with DAA and achieved sustained virologic response at12weeks after treatment (SVR12) during 2017-2020 at a single medical center. Results – Among 130 HCV infection and CKD stage 3 patients treated with DAA, 77patients had no eGFR decline at SVR 12, and 53 patients had eGFR declined at SVR12. The eGFR change on SVR 12 can be predictor for eGFR change on SVR96 (Oddratio 3.088, p= 0.053). Patients with Diabetes Mellites (DM) (p=0.016, OR 2.6) ishighly associated with eGFR decline after DAA treatment. Renal functiondeterioration during DAA treatment is associated to long-term renal functiondecline(p=0.000). Lower HCV RNA titer(p=0.024), higher baseline MELD score(p=0.008), or con-current malignant disease under treatment(p=0.044) are more vulnerable to eGFR decrease upon DAA treatment. Conclusion –Among patients with HCV infection and CKD stage 3, comorbidity withDM, have less benefit to renal function after HCV elimination by DAA. Higherbaseline HCV RNA viral load and MELD score are precipitating factors to the renalfunction impairment. Treatment to malignant disease, either by systemic or localizedtreatment, increases the risk of renal function impairment during DAA treatment.The eGFR change on SVR 12 can be used to predict long-term eGFR change for theCKD stage 3 patients.

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Renal safety in 3264 HCV patients treated with DAA-based regimens: Results from a large Italian real-life study

Abstract: Background: Sofosbuvir (SOF)-based regimens have been associated with renal function worsening in HCV patients with estimated glomerular filtration rate (eGFR) ≤ 45 ml/min, but further investigations are lacking.

Cited by 15 publications

References 28 publications

HCV cirrhotic patients treated with direct‐acting antivirals: Detection of tubular dysfunction and resolution after viral clearance

HCV cirrhotic patients treated with direct‐acting antivirals: Detection of tubular dysfunction and resolution after viral clearance

Neutrophil gelatinase-associated lipocalin partly reflects the dynamic changes of renal function among chronic hepatitis C patients receiving direct-acting antivirals

The eGFR Change and Risk Factors in Moderate Chronic Kidney Disease Patients after Successful HCV Clearance by Direct Anti-viral Agents

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