Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment

Liu, Chen–Hua; Chen, Chi-Yi; Su, Wei‐Wen; Tseng, Kuo‐Chih; Lo, Ching‐Chu; Liu, Chun‐Jen; Chen, Jyh-Jou; Peng, Cheng Yuan; Shih, Yu‐Lueng; Yang, Sheng‐Shun; Huang, Chia-Sheng; Huang, Ke-Jhang; Chang, Chi‐Yang; Tsai, Ming‐Chang; Kao, Wei‐Yu; Fang, Yo-Jen; Chen, Po‐Yueh; Su, Pei–Yuan; Tseng, Chih‐Wei; Huang, Jow-Jyh; Lee, Pei‐Lun; Lai, Hsueh‐Chou; Hsieh, Tsai‐Yuan; Chang, Chung‐Hsin; Huang, Ying-Zu; Lee, Fu‐Jen; Chang, Chi-Jen; Kao, Jia‐Horng

doi:10.1136/gutjnl-2020-323569

Cited by 33 publications

(39 citation statements)

References 44 publications

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“…A total of seven studies satisfied our pre-defined selection criteria and were included in the meta-analysis. 4,[17][18][19][20][21][22] The flow diagram for the search strategy is shown in Figure 1.…”

Section: Resultsmentioning

confidence: 99%

“…The seven studies that were finally incorporated in the meta-analysis included four single-centre studies (3 from India and 1 from Bangladesh) and three multicentric studies. 4,[17][18][19][20][21][22] One of the multicentric studies was conducted across 22 centres in Europe, North America and Australia, another was conducted in 18 haemodialysis centres of 3 Taiwanese cities, and the third study was conducted in 15 academic centres of Taiwan. 4,21,22 Five of the studies were prospective while the studies by Gaur et al and Liu et al were retrospective.…”

Section: Resultsmentioning

confidence: 99%

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Sofosbuvir plus velpatasvir combination for the treatment of chronic hepatitis C in patients with end stage renal disease on renal replacement therapy: A systematic review and meta‐analysis

Roy

Verma

et al. 2021

Nephrology

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Introduction: Sofosbuvir (SOF) and velpatasvir (VEL) is a pan-genotypic regimen for the treatment of Hepatitis C virus (HCV) infection. The data on the efficacy and safety of this regimen is end-stage renal disease (ESRD) is scanty. This systematic review and metaanalysis was done to ascertain the efficacy and safety of SOF and VEL in patients with chronic Hepatitis C (CHC) and ESRD on renal replacement therapy (RRT).Methods: Systematic search of Pubmed, Embase, Scopus, and Google Scholar was conducted using the search term (end-stage renal disease OR renal replacement therapy OR chronic kidney failure OR severe renal impairment OR chronic kidney disease OR haemodialysis OR dialysis OR peritoneal dialysis) AND (sofosbuvir OR velpatasvir OR NS5A inhibitors OR directly acting antivirals). Pooled sustained virologic response (SVR) and adverse event rates with 95% confidence intervals were estimated.Results: Seven studies (410 patients with CHC and ESRD on RRT) fulfilled our eligibility criteria. The overall pooled SVR rate of SOF and VEL in patients with HCV on RRT was 97.69% (95% CI: 95.71 to 98.92). There was no significant heterogeneity (I 2 : 39.3%, p-value of Cochran's Q = 0.13) among the studies. The pooled estimate of efficacy of SOF-VEL combination among patients with cirrhosis was 91.94% (95% CI 77.03-98.52). Pooled SVR rates in genotype 3 infection [94.6%, (95%: CI 81.3-99.4)] was comparable to that in those with documented non-genotype 3 infection [94.63%, (95% CI 87.12-98.44)]. No serious adverse event attributable to SOF and VEL was reported in the included studies. Conclusion:The fixed-dose combination of SOF and VEL is effective and safe in CHC patients with ESRD on RRT.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Sofosbuvir plus velpatasvir combination for the treatment of chronic hepatitis C in patients with end stage renal disease on renal replacement therapy: A systematic review and meta‐analysis

Roy

Verma

et al. 2021

Nephrology

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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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“…Second, we did not include patients with CKD stage 4 or 5 because we have demonstrated that the SVR 12 rates of SOF/VEL with low-dose RBV were 95% and 100% in the EP and PP analyses. 42 Third, this retrospective study lacked standardized report forms for AEs and were therefore prone to reporting biases.…”

Section: Changes Of Child-pugh and Meld Scores Before And After Antiviral Treatmentmentioning

confidence: 99%

Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis

Liu

Chen

et al. 2021

Clin Mol Hepatol

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Background/Aims: Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited. Methods:We included 107 patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 12 (SVR 12 ) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. The safety profiles were reported.Results: The SVR 12 rates in the EP, modified EP and PP were 89.7% (95% confidence interval (CI): 82.5%-94.2%), 94.1% (95% CI: 87.8%-97.3%), and 100% (96 of 96 patients; 95% CI: 96.2%-100%). No patients who failed to achieve SVR 12 were attributed to virologic failures. The SVR 12 rates were comparable regardless of patient characteristics. One patient discontinued treatment because of adverse events (AEs).Twenty-four patients had serious AEs and six died, but none were related to SOF/VEL or RBV. Among the 96 patients achieving SVR 12 , 84.4% and 64.6% had improved Child-Pugh and Model for End-Stage Liver Disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥ 15 was associated with an improved MELD score of ≥ 3 (odds ratio (OR): 4.13, 95% CI: 1.16-14.71; p = 0.02). Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate (eGFR) declines than patients with CKD stage 2 (-0.42 mL/min/1.73m 2 /month; p = 0.01) or stage 3 (-0.56 mL/min/1.73m 2 /month; p < 0.001). 8Conclusions: SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.

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Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment

Cited by 33 publications

References 44 publications

Sofosbuvir plus velpatasvir combination for the treatment of chronic hepatitis C in patients with end stage renal disease on renal replacement therapy: A systematic review and meta‐analysis

Sofosbuvir plus velpatasvir combination for the treatment of chronic hepatitis C in patients with end stage renal disease on renal replacement therapy: A systematic review and meta‐analysis

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

Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis

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