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Sources of Funding: This study was supported by the National Natural Science Foundation of China (Grant No. 81370855, 81200551, 81300627, 81200551 and 81470980), the Prostate Cancer Foundation Young Investigator Award 2013 and Foundation of Science & Technology Department of Sichuan Province (Grant No. 2013SZ0006 and 2015SZ0230).

Introduction

Hepatitis C Virus (HCV) infection affects more than 200 million people worldwide. The infection rate of HCV reaches approximately 1.8% to 8% in kidney transplant (KTx) recipients, which is much higher than that of normal people because of the repeated blood transfusion, dialysis, and immunosuppression. In current work, we aimed to perform a systematic review and meta-analysis to evaluate the efficacy and tolerability of sofosbuvir (SOF)-based Direct-Acting Antiviral Agents (DAAs) in KTx recipients.

Methods

A systematic literature search of MEDLINE, EMBASE, The Cochrane Library, Web of Science, and ClinicalTrials.gov was performed to identify clinical trials evaluating SOF-based DAAs in KTx with HCV infection published or in press from 2012 to present. Effect sizes were collected as pooled event rates (sustained viral response, SVR12 or SVR4) with corresponding 95% CIs. All statistical analyses were conducted by R 3.3.1.

Results

Eleven studies with a total of 360 KTx recipients were finally included. Most KTx recipients (88.1%) had HCV-1 infection. A total of 24 patients who received dual or combined organs transplants were reported. The overall rate of SVR12 reached 94% (95%CI: 88% to 97%). No significant heterogeneity was observed (p=0.92). SVR4 reached 99% (95%CI: 93% to 100%). The clearance rate of HCV RNA at the end of treatment (EOT) (12 weeks) was 94% (95%CI: 87% to 97%). The rate of rapid virological response (RVR) was 73% (95%CI: 55% to 85%; I2=58.9%, P=0.045). The SOF-based DAAs did not impact the kidney function, whereas the liver enzyme parameters (such as ALT, ATS) had decreased during. The most frequent AEs were headache 6.9% (n=25/360), asthenia 4.4% (n=15/360), and fatigue 3.3% (n=12/360).

Conclusions

In summary, our meta-analysis represented the first systematic review to evaluate the efficacy and safety of SOF-based DAAs in the post-KTx setting for a total of 360 patients from eleven individual studies. Data from current analysis suggest that SOF-based DAAs therapy is a highly effective treatment with an SVR12 rate (94%) and excellent tolerability, compared to prior interferon therapy for KTx recipients.

Funding

This study was supported by the National Natural Science Foundation of China (Grant No. 81370855, 81200551, 81300627, 81200551 and 81470980), the Prostate Cancer Foundation Young Investigator Award 2013 and Foundation of Science & Technology Department of Sichuan Province (Grant No. 2013SZ0006 and 2015SZ0230).