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• W3136751317 abstract "Prtreatment characterization of patients starting antiviral regimens has been one of the mainstays of treatment of chronic hepatitis C virus (HCV) infection in the last 30 years. In the pegylated interferon era, the ultimate aim of pretreatment assessment was to identify patients who would benefit and were fit for treatment, as the efficacy and safety of those regimens were suboptimal. With the introduction of interferon-free direct-acting antiviral agents (DAA), pretreatment assessment has been simplified given the nearly 100% achievable sustained virological response rates (SVR) and the lack of major contraindications to treatment that could lead to HCV elimination worldwide in the next years.1 Scientific societies’ recommendations identify liver disease severity, concomitant medications (including vitamins, herbal preparations, and over-the-counter products) and comorbidities that might influence the natural history or progression of liver disease as factors that need to be systematically investigated before treatment.2 Chronic kidney disease (CKD) falls into the main comorbidities to assess for two reasons. The first is that CKD is more prevalent in patients with HCV infection compared to the general population. Secondly, renal clearance constitutes the main elimination pathway of the RNA-dependent polymerase (NS5B) inhibitor sofosbuvir (SOF).3, 4 Therefore, creatinine and estimated glomerular filtration rate (eGFR) should routinely be assessed before starting DAA regimens.2 While the safety of SOF has never been questioned in patients with mild to moderate renal dysfunction, the optimal dose and the benefit of using SOF in patients with severe renal impairment (eGFR <30 mL/min) have been debated since its first introduction in monotherapy with ribavirin.5 In pharmacokinetics studies, subjects with eGFR <30 mL/min showed a higher SOF and GS-331007 area under the drug concentration-time curve (AUC 0-inf) compared to healthy controls.4 Moreover, 1 hour after haemodialysis, a 20-fold increase in GS-331007 exposure was described in patients administered with a single 400 mg dose of SOF.4 Thereby, international guidelines and the summary of product characteristics recommend caution in using this DAA in patients with eGFR <30 mL/min or end-stage renal disease on haemodialysis and only when no other relevant treatment options are available.2, 6 Real-life cohorts such as the TARGET study focused on patients with renal impairment provided further important incremental knowledge on the topic.7 After comparing 1716 patients with eGFR >45 mL/min to 73 with eGFR ≤45 mL/min, including 5 on haemodialysis, Saxena and co-workers found higher rates of worsening renal function (1% vs 10%, P < .004) and any serious adverse events (5% vs 18%, P = .005) in the latter cohort.7 SVR rates were not affected by renal dysfunction (88%, 95% CI: 64%-99% in those with eGFR ≤30 mL/min), but at multivariate analysis baseline eGFR ≤45 mL/min was identified as a relevant predictor of worsening renal function (incident rate ratio [IRR]: 4.71, 95% CI: 1.85-12.0, P = .001), suggesting that caution should be exerted by physicians in the management of these patients.7, 8 Another pharmacokinetic study by Desnoyer et al reported for the first time the safety and tolerability of full-dose (400 mg) SOF once daily (QD) or three times a week (TIW) in 12 CKD patients, requiring haemodialysis.9 Plasma concentrations of GS-331007 prior and after dialysis were higher in patients receiving SOF QD than TIW (prior: 6020 ng/mL vs 2394 ng/mL; after: 3254 ng/mL vs 998 ng/mL respectively; P < .001).9 Notably, the accumulation of this metabolite did not lead to the occurrence of any relevant adverse event, thus supporting the use of full-dose SOF-regimens in patients with CKD.9 A growing body of evidence from real life studies supports the safety and efficacy of SOF-based regimens in patients with CKD, including those with eGFR <30 mL/min and end-stage renal disease requiring haemodialysis.10-15 A recent prospective cohort study by Lawitz et al have confirmed the safety of SOF plus ribavirin or ledipasvir in 38 patients with eGFR ≤30 mL/min, who were not on dialysis. SOF-based regimens did not affect renal function, with no clinically significant changes in creatinine clearance despite increased levels GS-331007.11 SOF (400 mg) combined with velpatasvir (100 mg) has been evaluated in another multicentric prospective study including 59 patients with end-stage renal disease on haemodialysis.12 In this setting, exposure of the SOF metabolite GS-331007 was increased 20-fold, exceeding levels where adverse reactions have been observed in preclinical trials.12 In this clinical safety data set, the rate of serious adverse events was not higher than expected in patients with end-stage renal disease (19%) and 56 out of 59 obtained SVR12 (95%).12 Consistently, a retrospective study including patients with end-stage renal disease or on haemodialysis treated with SOF (400 mg) and velpatasvir (100 mg) fixed-dose combination therapy did not report any major adverse effects with 96.8% SVR rates.13 More recently, SOF has been confirmed safe by another real-life prospective cohort from India, including 51 patients with end-stage renal disease on maintenance haemodialysis who were treatment naive or experienced.14 The primary end-point of SVR was achieved in 49 (96%) patients after 12 weeks of full-dose SOF plus velpatasvir combination and no safety concerns were recorded. Interestingly, none of patients experienced worsening of kidney disease over the entire length of the study.14 Lastly, a multicentre study recruiting 191 patients with severe renal impairment, including those with eGFR <30 mL/min not on haemodialysis, and those with compensated and decompensated liver disease, reported SVR12 rates in line with previous studies: 95.0% and 90.0% in patients with compensated and decompensated liver disease respectively. In addition, no serious adverse events related to DAA therapy were described.15 Table 1 summarizes studies on SOF-containing regimens in patients with severe CKD. Saxena et al (2016) 73 pts eGFR ≤45 receiving 400 mg SOF-containing regimens (18 with eGFR ≤30, 5 on HD) vs 1716 pts with eGFR >45 Desnoyer et al (2016) GS-331007 pre-HD, post-HD were higher with SOF QD than SOF TIW (6020 vs 2394, 3254 vs 998 and 4415 vs 1525 ng/mL respectively) (P < .001) No serious AEs were reported during the treatment course Eletreby et al (2019) 4944 pts eGFR <60 receiving SOF-based regimens 400 mg QD or EOD 96.7% eGFR <30 85.7% with hepatic decompensation 80% on HD Lawitz et al (2020) 38 pts eGFR ≤30 not on HD receiving SOF 200 mg/400 mg plus either RBV or ledipasvir 40% SOF 200 mg + RBV 24 wks 60% SOF 400 mg + RBV 24 wks 100% SOF + ledipasvir 12 wks Serious AEs rate = 19% All cases unrelated to SOF/velpatasvir Gaur et al (2019) Taneja et al (2020) 51 pts ESRD on HD receiving SOF/velpatasvir (400 mg/100 mg) Liu et al (2021) 94.8% by EP analysis 100% by PP analysis The multitude of studies confirming the safety and efficacy profile of full-dose SOF in patients with severe CKD and on haemodialysis, was accepted by the most recent European Association for the Study of the Liver (EASL) HCV guidelines which now endorse the use of SOF-based regimens in CKD patients.2 This recommendation is particularly relevant in resource-limited countries and in patients with decompensated cirrhosis where SOF-based regimens with or without ribavirin might represent the best and sometimes the only possible option. None. Virginia Solitano declares no conflict of interest. Alessio Aghemo has served as a speaker, a consultant and advisory board member for Gilead, MSD, Abbvie, Mylan, Intercept and Alfasigma and has received research funding from Gilead and Abbvie." @default.
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• W3136751317 date "2021-03-17" @default.
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• W3136751317 title "Sofosbuvir in HCV patients with chronic kidney disease: No time for caution" @default.
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