Background: Outcome data on sofosbuvir (SOF)-based therapy in patients with kidney transplantation (KTx) with hepatitis C virus infection are limited with individual studies having a small sample size and limited SVR12 (sustained virological response) data. In this work, we aimed to perform a systematic review and meta-analysis to evaluate the efficacy and tolerability of SOF-based DAAs in KTx recipients.

Methods: We conducted a systematic literature search in MEDLINE, EMBASE, The Cochrane Library, Web of Science, and ClinicalTrials.gov as well as major transplantation meetings. We included studies with SVR data in HCV infected KTx recipients treated with SOF-based DAAs. All statistical analyses were conducted by R 3.3.1 (The R Foundation for Statistical Computing).

Results: We included eleven studies with a total of 360 KTx recipients. Most KTx recipients (208/236=88.1%) had HCV-1 infection. The overall rate of SVR12 reached 94% (95%CI: 88% to 97%). No publication bias was observed (p=0.11). The clearance rate of HCV RNA at the end of treatment (EOT) (12 weeks) was 94% (95%CI: 87% to 97%). SVR4 reached 99% (95%CI: 93% to 100%) in a total of 117 KTx recipients. The rate of rapid virological response (RVR) was 73% (95%CI: 55% to 85%). The SOF-based DAAs did not impact the kidney function, whereas the liver enzyme parameters (such as ALT, ATS) had decreased during and after anti-HCV therapy. The most frequent AEs were headache 6.9% (n=25/360), asthenia 4.4% (n=15/360), fatigue 3.3% (n=12/360) and gastrointestinal symptoms (nausea or diarrhea) 1.7% (n=6/360).

Conclusion: SOF-based treatment is highly effective and well tolerated in KTx recipients with HCV infection.

CITATION INFORMATION: Wang X., Tan P., Xiang T., Qiu Y., Song T., Lin T. Safety and Efficacy of Sofosbuvir-Based Direct-Acting Antiviral Agents in Kidney Transplant Recipients with HCV: A Systematic Review and Meta-Analysis Am J Transplant. 2017;17 (suppl 3).

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