Renal safety after one year of sofosbuvir‐based therapy for chronic hepatitis C: A Brazilian “real‐life” study

Medeiros, Thalia; Rosário, Natalia Fonseca do; Saraiva, Geórgia Nascimento; Andrade, Thaís Guaraná de; Silva, Andréa Alice; Almeida, Jorge Reis

doi:10.1111/jcpt.12697

Cited by 10 publications

(14 citation statements)

References 32 publications

(58 reference statements)

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“…In a real-life experience study, Medeiros et al showed that patients with kidney dysfunction did not experience significant changes in renal parameters after full dose SOFbased therapy in patients with either eGFR ≥ 45 ml/mn/1,73 m 2 or eGFR< 45 ml/mn/1,73 m 2 [24]. Our results were in accordance to this study, as we did not notice any significant alteration of renal function in non hemodialysis patients.…”

Section: Discussionsupporting

confidence: 91%

“…Several controlled studies have evaluated the use of sofosbuvir in more severe renal dysfunction, identifying dose adjustments in advanced renal disease and hemodialysis [22], [23], [24]. In cases where novel DAAs are not available and the use of sofosbuvir is an option, a full dose of sofosbuvir (400 mg/day) seems more appropriate than a half dose or a full dose on alternate day [25].…”

Section: Discussionmentioning

confidence: 99%

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Safety and Efficacy of Antiviral Therapy of Chronic Hepatitis C in Chronic Kidney Disease and Hemodialysis Patients

Fadili

Errami

Zaoui

et al. 2021

EJMED

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Background and Aims: To assess the efficacy and tolerability of sofosbuvir-based antiviral therapy for viral hepatitis C (HCV) patients with chronic kidney disease and on maintenance hemodialysis. Methods: We retrospectively reviewed all treated patients with HCV from January 2015 to November 2020. They were treated either with standard Interferon/Ribavirin or with Sofosbuvir combined to Daclatasvir or to Ledipasvir. We evaluated the sustained virologic response at 12 weeks (SVR12). Data were analyzed using SPSS 20.00. Results: Out of 61 patients, the mean age of our patients was 56,8±12,56 years and 42,6% were males. Six patients had eGFR< 60 ml/mn/1,73 m2 (9,8%) and 26 patients were on maintenance hemodialysis (42,6%). The majority had genotype 1 and overall SVR12 was 70,1% with a rate of 75% in the Sofosbuvir-regimen subgroup. The adverse events were minor. On multivariate analysis, genotype, viral load and rapid virologic response were independent factors that significantly predicted treatment success. Conclusion: Sofosbuvir-based regimen appears to be safe and efficious in patients with chronic kidney disease and on maintenance hemodialysis, especially in countries with limited resources.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Antiviral Therapy of Chronic Hepatitis C in Chronic Kidney Disease and Hemodialysis Patients

Fadili

Errami

Zaoui

et al. 2021

EJMED

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“…However, the use of SOF had no significant renal impact and treatment showed good efficacy and safety in this population. This fact was also observed in patients with stage 4 and 5 CKD, with slight improvement of GFR 12 weeks after the end of treatment in some cases (27)(28)(29) . Within this context, Desnoyer et al found no significant accumulation of the inactive metabolite of SOF (GS-331007) in dialysis patients, with the drug being a good option for the treatment of this population (30) .…”

Section: Discussionsupporting

confidence: 55%

Hepatitis C Treatment of Renal Transplant and Chronic Kidney Disease Patients: Efficacy and Safety of Direct-Acting Antiviral Regimens Containing Sofosbuvir

Michels

Feldner

Carvalho-Filho

et al. 2020

Arq. Gastroenterol.

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BACKGROUND: Direct-acting antivirals have revolutionized hepatitis C treatment, also for patients with chronic kidney disease (CKD), but some controversy exists regarding the use of sofosbuvir (SOF) in patients with glomerular filtration rate (GFR) <30 mL/min. OBJECTIVE: To evaluate the efficacy and safety of these regimens for hepatitis C treatment of patients with CKD and after renal transplantation, as well as the impact of SOF on renal function in non-dialysis patients. METHODS: All patients with hepatitis C and CKD or renal transplant treated with direct-acting antivirals at a referral center in Brazil between January 2016 and August 2017 were included. Efficacy was evaluated based on viral load (HCV RNA) and a sustained virological response (SVR) consisting of undetectable RNA 12 and/or 24 weeks after the end of treatment (SVR12 and SVR24) was defined as cure. Safety was determined by adverse events and ribavirin, when combined, was administered in escalating doses to all patients with GFR <60 mL/min. The impact of SOF on renal function was determined by the measurement of baseline creatinine during and after the end of treatment and its increase was evaluated using the Acute Kidney Injury Network (AKIN) classification. RESULTS: A total of 241 patients (52.7% females) with a mean age of 60.72±10.47 years were included. The combination of SOF+daclatasvir was the predominant regimen in 75.6% of cases and anemia was present in 28% of patients who used ribavirin (P=0.04). The SVR12 and SVR24 rates were 99.3% and 97.1%, respectively. The treatment was well tolerated and there were no major clinically relevant adverse events, with the most prevalent being asthenia (57.7%), itching (41.1%), headache (40.7%), and irritability (40.2%). Among conservatively treated and renal transplant patients, oscillations of creatinine levels (AKIN I) were observed in 12.5% of cases during treatment and persisted in only 8.5% after the end of treatment. Of these, 2.0% had an initial GFR <30 mL/min and this percentage decreased to 1.1% after SOF use. Only 0.5% and 1.6% of the patients progressed to AKIN II and AKIN III elevation, respectively. CONCLUSION: The direct-acting antivirals were safe and efficacious in CKD patients treated with SOF-containing regimens, with the observation of high SVR rates, good tolerability and few severe adverse events. The combination with ribavirin increased the risk of anemia and the administration of escalating doses seems to be useful in patients with GFR <60 mL/min. In patients with GFR <30 mL/min, SOF had no significant renal impact, with serum creatinine returning to levels close to baseline after treatment.

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“…In summary, the renal safety for patients in real world with moderate CKD on DAA treatment till SVR96 can be assured as other published studies announced. [19,30] Patients with DM history could have less benefit from HCV clearance by DAA treatment. Active malignancy is not very associated with the eGFR decrease, but it could be a risk to serum Creatinine level increase during the treatment course, especially those who were treated with systemic treatments than local treatments.…”

Section: Factors On Daa Treatment To Renal Function At Svr12mentioning

confidence: 99%

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 after one year of sofosbuvir‐based therapy for chronic hepatitis C: A Brazilian “real‐life” study

Abstract: In a "real-life experience" of a Brazilian centre, SOF therapy appears to guarantee renal safety for patients with chronic hepatitis C followed until one year after treatment.

Cited by 10 publications

References 32 publications

Safety and Efficacy of Antiviral Therapy of Chronic Hepatitis C in Chronic Kidney Disease and Hemodialysis Patients

Safety and Efficacy of Antiviral Therapy of Chronic Hepatitis C in Chronic Kidney Disease and Hemodialysis Patients

Hepatitis C Treatment of Renal Transplant and Chronic Kidney Disease Patients: Efficacy and Safety of Direct-Acting Antiviral Regimens Containing Sofosbuvir

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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