Sofosbuvir Use in the Setting of End-stage Renal Disease: A Single Center Experience

Aggarwal, Avin; Yoo, Eric R.; Perumpail, Ryan B.; Cholankeril, George; Kumari, Rita; Daugherty, Tami; Lapasaran, Alex S.; Ahmed, Aijaz

doi:10.14218/jcth.2016.00060

Cited by 9 publications

(9 citation statements)

References 23 publications

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“…Recent literature regarding the efficacy of DAAs in patients co‐infected with HIV/HCV also has high rates of cure with SVR rates of 91%‐94% . Likewise, patients on haemodialysis in our study were found to have an overall SVR of 93%, which is comparable to prior studies reflecting high response rates in this population . SVR rates were lowest in GT1 patients treated with SOF+SIM (75%‐83%), although this may be a reflection of our small number of haemodialysis patients, as prior studies have suggested better response rates with this regimen in other cohorts .…”

Section: Discussionsupporting

confidence: 77%

Real‐world experiences with direct‐acting antiviral agents for chronic hepatitis C treatment

Daniel

Saeian

Rizvi

2019

Journal of Viral Hepatitis

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As direct‐acting antiviral (DAA) agents become more readily available for the treatment of chronic hepatitis C, it is important to understand real‐world treatment experiences. In order to assess the effectiveness of DAA regimens and factors that influence sustained virologic response (SVR) rates in the Veterans Affairs healthcare system, we retrospectively identified veterans with chronic hepatitis C who were treated with DAAs from January 2014 to June 2015. We determined SVR rates and collected data on demographics, genotype (GT), previous interferon‐based treatment, antiviral regimens, and co‐morbidities (HIV, prior solid organ transplant, haemodialysis) for analysis. Of 15 720 veterans, the majority were infected with genotype 1a (GT1a, 60.5%). Excluding the special populations, the overall cohort SVR rate was 92%. Compared to treatment‐experienced patients, treatment‐naïve patients had significantly higher SVR rates (90% vs 92%, P = .006). Subgroups associated with lower likelihood of achieving SVR‐included African Americans (OR 0.79, 95% CI 0.69‐0.91), GT3 (OR 0.65, CI 0.50‐0.86), and cirrhosis (OR 0.91, CI 0.84‐0.99) or decompensated cirrhosis (ascites: OR 0.78, CI 0.67‐0.91, variceal bleed: OR 0.75, CI 0.57‐0.99). The only treatment regimen independently associated with lower SVR rates was SOF+RBV+IFN (OR 0.65, CI 0.50‐0.84). Special populations achieved high SVR rates: HIV 92%, haemodialysis 93%, liver transplant 96% and renal transplant 94%. In conclusion, overall SVR rates were comparable to those reported in clinical trials and carried over to historically more difficult‐to‐treat patients. Several patient‐ and treatment‐related factors were identified as independent predictors of treatment failure and suggest subgroups to target for efforts to improve therapeutic strategies.

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Section: Discussionsupporting

confidence: 77%

Real‐world experiences with direct‐acting antiviral agents for chronic hepatitis C treatment

Daniel

Saeian

Rizvi

2019

Journal of Viral Hepatitis

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“…of patientsNo. of dialysis recipientsHistory of Cirrhosis (%)mean/median baseline RNAGenotypeSOF-based regimenDose of SOFSVR12/24 (PP)NOS scoreAggarwal (2017) [19]USA141420% (F3,F4)8,375,588.6 IU/MLGT1–60%, GT2–6.7%, GT3–20%, GT4–13.3%SOF + SMV, SOF + RBV, SOF/LDV ± RBV, SOF + PR, SOF + DCV12–24 W200 mg QD92.8% 13/144Akhil (2018) [26]India2222NA2,642,495 IU/MLGT1–63.63%, GT3–27.27%,GT4–9%SOF + RBV 12 W400 mg QD80% 16/204Beinhardt (2016) [27]Austria101040% (30% decompensation)6.1 ± 0.8log IU/MLGT1a-20%, GT1b-40%, GT3a-20%,GT4–20%SOF + PR,SOF + SMV,SOF + DCV, SOF + RBV 12–24 W400 mg QD90% 9/104Bera (2017) [20]India252520%6.4 ± 0.57log IU/MLGT3–72%, GT1–24%,GT4–4%SOF + DCV 12–24 W400 mg/48 h100% 16/164Bhamidimarri (2015) [31]USA151260%9.7 × 10 6 IU/MLGT1a-67%,GT1b-33%SOF + SMV 12–24 W200 mg QD or 400 mg/48 h87% 13/154Butt (2108) [45]USA137NANANANASOF/LDV ± RBV 12–16 W400 mg QD95% 103/1083Choudhary (2017) [21]India161612.50%7 (5–8)log IU/MLGT1–69%,GT3–25%,GT-6%SOF + PR, SOF + DCV ± RBV12 W400 mg/48 h80% 8/104Desnoyer (2016) [32]France121283%6.59 (6.13–6.86)log IU/MLGT1–92%GT2–8%SOF + SMV, SOF + DCV, SOF/LDV, SOF + RBV 12–24 W400 mg QD or 400 mg TIW83% 10/125Dumortier (2017) [18]France503554%2,603,063 IU/ML…”

Section: Resultsmentioning

confidence: 99%

Sofosbuvir-based regimen is safe and effective for hepatitis C infected patients with stage 4–5 chronic kidney disease: a systematic review and meta-analysis

Chen

Fang

et al. 2019

Virol J

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BackgroundWhether sofosbuvir is suitable for hepatitis C virus (HCV) infected patients with severe renal impairment is inconclusive. This systematic review aims to evaluate the safety and effectiveness of SOF-based regimen in the setting of stage 4 and 5 chronic kidney disease (CKD).MethodsWe conducted a systematic literature search in PubMed, Web of Science, EMBASE and Google Scholar with searching strategy: (sofosbuvir OR Sovaldi OR Harvoni OR Epclusa OR Vosevi) AND (severe kidney impairment OR severe renal impairment OR end-stage renal disease OR dialysis OR renal failure OR ESRD OR renal insufficiency OR hepatorenal syndrome OR HRS). Sustained virological response (SVR12/24) rate and serious adverse event (SAE) rate with 95% confidence intervals were aggregated. Subgroup analysis was implemented to evaluate the impact of treatment strategy and patient characteristics.ResultsTwenty-one studies met inclusion criteria, totaling 717 HCV infected patients with CKD stage 4 or 5 (58.4% on dialysis). Pooled SVR12/24 was 97.1% (95% CI 93.9–99.3%), and SAE rate was 4.8% (95% CI 2.1–10.3%). There was no significant difference at SVR12/24 (97.1% vs 96.2%, p = 0.72) or SAE rate (8.8% vs 2.9%, p = 0.13) between subgroups applying full or decreased dose of sofosbuvir. Cirrhotic and non-cirrhotic patients achieved comparable sustained virological response (RR 0.93, 95% CI 0.85–1.02). Four studies reported eGFR/serum creatinine pre- and post- treatment, with no significant modification.ConclusionsOur study suggests SOF-based regimen might be used safely and effectively in patients living with HCV infection/stage 4–5 CKD, with normal and reduced dose of sofosbuvir. Prospective and well-controlled trials are needed to confirm these findings.Trial registrationPROSPERO CRD42018107440.Electronic supplementary materialThe online version of this article (10.1186/s12985-019-1140-x) contains supplementary material, which is available to authorized users.

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“…Such case series have generally reported favorable efficacy and safety. However, the results are often limited by the small number of patients . In a meta‐analysis with data pooled from 11 different studies comprising a total of 264 patients, the excellent efficacy and safety of sofosbuvir‐based therapies in patients with severe renal impairment has been demonstrated …”

Section: Introductionmentioning

confidence: 99%

The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment

Jabbari

Merat

Sharifi

et al. 2020

J of Gastro and Hepatol

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Background and Aim Many of the treatment regimens available for hepatitis C include sofosbuvir. Unfortunately, sofosbuvir has not been recommended for use in patients with severe renal impairment leaving these group of patients with very few options. Nevertheless, there are many reports in which these patients have been treated with sofosbuvir‐containing regiments without important adverse events. This study aims at determining the safety and effectiveness of a sofosbuvir‐based treatment in patients with severe renal impairment, including those on hemodialysis. Method We enrolled subjects with hepatitis C and estimated glomerular filtration rate under ml/min/1.73m2 from 13 centers in Iran. Patients were treated for 12 weeks with a single daily pill containing 400‐mg sofosbuvir and 60‐mg daclatasvir. Patients with cirrhosis were treated for 24 weeks. Response to treatment was evaluated 12 weeks after end of treatment (sustained viral response [SVR]). http://ClinicalTrials.gov identifier: NCT03063879. Results A total of 103 patients were enrolled from 13 centers. Seventy‐five patients were on hemodialysis. Thirty‐nine had cirrhosis and eight were decompensated. Fifty‐three were Genotype 1, and 27 Genotype 3. Twenty‐seven patients had history of previous failed interferon‐based treatment. Three patients died in which cause of death was not related to treatment. Six patients were lost to follow‐up. The remaining 94 patients all achieved SVR. No adverse events leading to discontinuation of medicine was observed. Conclusions The combination of sofosbuvir and daclatasvir is an effective and safe treatment for patients infected with all genotypes of hepatitis C who have severe renal impairment, including patients on hemodialysis.

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Sofosbuvir Use in the Setting of End-stage Renal Disease: A Single Center Experience

Cited by 9 publications

References 23 publications

Real‐world experiences with direct‐acting antiviral agents for chronic hepatitis C treatment

Real‐world experiences with direct‐acting antiviral agents for chronic hepatitis C treatment

Sofosbuvir-based regimen is safe and effective for hepatitis C infected patients with stage 4–5 chronic kidney disease: a systematic review and meta-analysis

The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment

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