Safety and efficacy of sofosbuvir‐based treatment of acute hepatitis C in end‐stage renal disease patients undergoing haemodialysis

He, Yingli; Yang, Shujuan; Hu, Chengguang; Dong, Jun; Gao, Hongbo; Tu, Yan; Liu, J. F.; Yang, Yonghua; Ren, Danfeng; Zhu, Li; Zhao, Yan; Chen, Tianyan

doi:10.1111/apt.14429

Cited by 17 publications

(19 citation statements)

References 21 publications

(25 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In our study, all patients were treated with full-dose SOF-based regimen for 12 weeks and they demonstrated excellent SVR12. The previously reported data and our data suggested that the dose of SOF could be an important variable to reach SVR in HD patients and that a reduced dose might lead to sub-therapeutic exposure and the risk of treatment failure [15,17]. Therefore, full-dose SOF regimen might be more effective to reach SVR in HD patients.…”

Section: Discussionsupporting

confidence: 50%

Full-dose sofosbuvir plus low-dose ribavirin for hepatitis C virus genotype 2-infected patients on hemodialysis

Seo

Yoon

et al. 2020

Korean J Intern Med

View full text Add to dashboard Cite

Background/Aims: New direct-acting antivirals have shown surprising success in the treatment of hepatitis C, not only in the general population, but also in difficult-to-treat cohorts. However, there is still limited data regarding direct-acting antivirals, including sofosbuvir (SOF), in the context of hemodialysis. The aim of this study was to investigate the safety and outcome of administering full-dose SOF (400 mg/day) plus low-dose ribavirin (RBV, 100 to 200 mg/day) in hemodialysis patients with hepatitis C virus (HCV) genotype 2 (GT2) infection. Methods: Patients with chronic HCV GT2 infection and end-stage renal disease on maintenance hemodialysis treated with full-dose SOF plus low-dose RBV were retrospectively identified from a database of patients with HCV GT2 who were treated in Konkuk University Chungju Hospital between February 2017 and February 2018. Medical records were reviewed for demographics, medical history, laboratory data, and radiologic and electrocardiographic findings. Results: All nine patients completed a full course of 12 weeks of treatment with a full-dose SOF plus low-dose RBV regimen. Two had compensated cirrhosis. Seven patients were treatment-naïve, and two had a relapse following previous interferon-based therapy. All patients had a sustained viral response at 12 weeks post-treatment. There was no discontinuation of treatment because of side effects. Conclusions: In hemodialysis patients with HCV GT2 infection, the full-dose SOF plus low-dose RBV regimen appears to be safe and well tolerated, and yields high rates of sustained virologic response.

show abstract

Section: Discussionsupporting

confidence: 50%

Full-dose sofosbuvir plus low-dose ribavirin for hepatitis C virus genotype 2-infected patients on hemodialysis

Seo

Yoon

et al. 2020

Korean J Intern Med

View full text Add to dashboard Cite

show abstract

“…The included studies were published from 2015 to 2020 and contained extractable data on 514 patients enrolled from 2014 to 2016. Four studies were retrospective [10][11][12][13] and 16 were prospective [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] . Nine of the studies were conducted in India 10,12,14,16,18,20,22,25,29 , 2 in the USA 15,21 , 2 in Pakistan 24,28 , 2 in China 19,27 , 1 in France 17 , the Czech Republic 11 , Korea 13 , Iraq 26 , and 1 enrolled patients from multiple countries 23 .…”

Section: Resultsmentioning

confidence: 99%

Efficacy and safety of sofosbuvir in the treatment of hep C among patients on hemodialysis: a systematic review and meta-analysis

Shehadeh

Kalligeros

Byrd

et al. 2020

Sci Rep

View full text Add to dashboard Cite

Hepatitis C virus (HCV) infection among maintenance hemodialysis patients is implicated in increased morbidity and mortality compared to uninfected patients. Sofosbuvir (SOF)-based regimens may not be optimal among patients requiring hemodialysis. Several studies, however, provide evidence that use of SOF among HCV-positive patients with renal impairment, is effective and safe. We searched Pubmed and Embase to identify studies reporting the efficacy and safety of SOF-based regimens for the treatment of HCV-positive patients on maintenance hemodialysis and performed a random effects meta-analysis. The overall pooled estimate of the efficacy of SOF-based therapy was 95% (95% CI 91-98%). The efficacy of the SOF-based regimen was 92% (95% CI 80-99%), 98% (95% CI 96-100%), and 100% (95% CI 95-100%) for the following doses: 400 mg on alternate days, 400 mg daily, and 200 mg daily, respectively. The most frequent adverse event was fatigue with a pooled prevalence of 16% (95% CI 5-29%), followed by anemia 15% (95% CI 3-31%), and nausea or vomiting 14% (95% CI 4-27%). Anemia was more prevalent in treatment regimens containing ribavirin (46%, 95% CI 33-59%) compared to ribavirin-free regimens (3%, 95% CI 0-9%). This study suggests that SOF-based regimens in the treatment of HCV infection among hemodialysis patients are both effective and safe. Patients requiring hemodialysis are at an increased risk of acquiring hepatitis C virus (HCV) 1. Approximately 5% of patients on hemodialysis are diagnosed with HCV, compared to 1% in the United States population 2,3 and, among hemodialysis patients, HCV infection is associated with poor outcomes with substantially higher rates of hepatic-related mortality and hospitalizations, and lower health-related quality of life scores, compared to HCV negative hemodialysis patients 4. National guidelines for the treatment of HCV infection among hemodialysis patients recommend several direct-acting antivirals (DAA) 5,6. Sofosbuvir (SOF)-based regimens are not recommended for patients requiring hemodialysis since renal clearance of SOF is the major elimination pathway, although since the recent U.S. Federal Drug Administration change in label, removing restrictions on its use in renal impairment, this will undoubtedly change 7. Nevertheless, clinical studies provide evidence that use of SOF, among HCV positive patients with renal impairment, is effective and safe 8,9. Data focusing only on patients requiring maintenance hemodialysis are limited. Thus, we performed a systematic review and meta-analysis to quantify the efficacy and safety of SOF-based regimens among the subset of patients with severe renal impairment that required maintenance hemodialysis.

show abstract

“…Since this drug is eliminated by renal pathway, its use in patients with renal impairment raised the concerns of drug accumulation. Among the included studies in this meta-analysis, the majority used a standard dosing, that is, 400 mg per day, and only two studies 23,30 used half-dose sofosbuvir, which also achieved satisfactory SVR12 rates. A reduced dose of sofosbuvir might help to alleviate the risk of further renal impairment, however, well-designed comparison studies of standard and reduced dosing are needed to further elucidate the efficacy and safety profile of sofosbuvir at reduced dose.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of direct‐acting antiviral‐based treatment in hepatitis C virus infected patients with chronic renal function impairment: An updated systemic review and meta‐analysis

Yang

Liao

et al. 2020

Nephrology

View full text Add to dashboard Cite

Objective: To further determine the efficacy and safety of direct-acting antiviral (DAA)-based treatments in hepatitis C virus (HCV) infected patients with renal function impairment. Methods: MEDLINE, EMBASE and the Cochrane Library were searched for relevant studies. All studies assessing the efficacy and safety of DAA-based treatments against HCV infection in patients with renal impairment and HCV infection were eligible for inclusion. Outcomes assessed included efficacy outcomes and safety outcomes. Summary estimates were obtained using an inverse-variance weighted random effect model and Freeman-Tukey double arcsine transformation. Results: Twenty-seven studies (n = 1048 participants) were included. The majority of included studies were of fair quality with Newcastle-Ottawa scale scores between 4 and 6. The pooled virologic response rates at the end of treatment or 4, 12, 24 weeks after treatment (ie, EOTR, SVR4, SVR12 and SVR24 rates) were 97.0% (95% confidence interval [CI], 94.0%-99.0%), 80.9% (95% CI, 49.3%-98.7%), 94.1% (95% CI, 91.6%-96.3%) and 89.6% (95% CI, 75.5%-98.1%), respectively. The pooled relapse rate was 6.4% (95% CI, 3.4%-10.4%). The pooled incidence of adverse events and severe adverse events leading to discontinuation were 47.6% (95% CI, 35.0%-60.4%) and 2.9% (95% CI, 1.4%-5.0%), respectively. High heterogeneity among studies exists for SVR4 and SVR24 rates. Formal statistical testing did not identify the presence of publication bias for all measured outcomes except the relapse rate. Conclusion: The results support the efficacy and safety of DAA-based treatments in this population. Future studies with better design, larger sample size and longer follow up will be the next step.

show abstract

Safety and efficacy of sofosbuvir‐based treatment of acute hepatitis C in end‐stage renal disease patients undergoing haemodialysis

Abstract: A half dose of sofosbuvir (200 mg once daily) plus a full dose of daclatasvir (60 mg once daily) were suitable for the treatment of acute HCV-infected patients who were undergoing end-stage renal disease and were on haemodialysis.

Cited by 17 publications

References 21 publications

Full-dose sofosbuvir plus low-dose ribavirin for hepatitis C virus genotype 2-infected patients on hemodialysis

Full-dose sofosbuvir plus low-dose ribavirin for hepatitis C virus genotype 2-infected patients on hemodialysis

Efficacy and safety of sofosbuvir in the treatment of hep C among patients on hemodialysis: a systematic review and meta-analysis

Efficacy and safety of direct‐acting antiviral‐based treatment in hepatitis C virus infected patients with chronic renal function impairment: An updated systemic review and meta‐analysis

Contact Info

Product

Resources

About