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Meta-Analysis
. 2019 Mar 14;16(1):34.
doi: 10.1186/s12985-019-1140-x.

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

Mingshu Li  1   2 , Jun Chen  3 , Zhixiong Fang  4 , Yi Li  5 , Qian Lin  6
Affiliations
Meta-Analysis

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

Mingshu Li et al. Virol J. .

Abstract

Background: Whether 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).

Methods: We 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.

Results: Twenty-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.

Conclusions: Our 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 registration: PROSPERO CRD42018107440 .

Keywords: Dose; HCV infection; Meta-analysis; Sofosbuvir; Stage 4–5 chronic kidney disease.

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Conflict of interest statement

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

MSL works for Gilead while concurrently enrolled in Ph.D.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram of literature search and selection
Fig. 2
Fig. 2
Forest plots showing the results of pooled SVR12/24
Fig. 3
Fig. 3
Forest plots showing the results of meta-analysis comparing SVR12/24 in patients with cirrhosis versus patients without cirrhosis
Fig. 4
Fig. 4
Forest plots showing the results of pooled SAE rate
See this image and copyright information in PMC

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