Abstract
Purpose
Hepatitis C virus (HCV) infection in kidney transplant recipients (KTRs) is common and can impact on patient and graft survival rates. The efficacy and safety of direct-acting antivirals (DAAs) to treat genotype-4 HCV-infected KTRs have not been fully established.
Methods
A prospective, single-arm, single-center study was conducted at Mansoura Urology/Nephrology Center (Mansoura University, Egypt). 114 HCV RNA(+) genotype 4 KTRs were enrolled in this study after a hepatology consultation and consented to start treatment with interferon-free DAAs. A sofosbuvir-based regimen was given to 109 recipients that had creatinine clearance (Crcl) of > 30 mL/min/1.73 m2. Ritonavir-boosted paritaprevir/ombitasvir was prescribed to five recipients with Crcl < 30 mL/min/1.73 m2.
Results
The mean age of the cohort was 45.2 ± 11.2 years; most were male. The mean duration with a transplant was 14.2 ± 3.5 years, with different immunosuppressive regimens, mostly based on calcineurin inhibitors. A rapid virological response (RVR), i.e., clearance of viral load, was achieved in 100% at 4 weeks after starting treatment. All patients had a sustained virological response (SVR) at 12 and 24 weeks posttreatment, with one exception. During DAA therapy serum creatinine increased in 12 patients. In three, this was concomitant with elevated calcineurin inhibitor and sirolimus trough levels. Graft biopsies were performed in 8 of these 12 patients: these revealed an acute rejection in 4 cases (acute cellular rejection grade-1A: n = 2, and grade-1B: n = 2). The rejection episodes occurred at 4–6 weeks after starting treatment.
Conclusion
DAAs were highly efficacious and safely treated genotype-4 HCV-infected KTRs and had no significant adverse effects on graft function/survival.
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Acknowledgements
HCV working group:Urology and Nephrology team: Professor Mohamed Adel Bakr, Professor Mohamed Ashraf Foda, Professor Ayman Refaie, Professor Ahmed Donia, Professor Samir Sully, Professor Hussein Sheashaa, Professor Khaled Eldahshan, Dr Salwa Elwasif, Dr Ahmed Kamal, Dr Hanzada El Maghrabi, Dr Mohamed Zahab, Dr Mohamed Hamed, Dr Mohamed Saftawy, Dr Mohamed Mashaly, Dr Yasser Matter, Dr Ahmed Elmowafy, Dr Mohamed Taher, Dr Mohamed Hosny, Dr Eman Refaie, Dr Ahmed Naguib, Dr Hazem Saleh.
Egyptian Liver Research Institute and hospital team: Professor Gamal Elsayed Shiha, Dr Reham Elsayed Soliman, Dr Mohamed Adel Elbassiony. Thanks also to the Egyptian Medical Insurance System for financing the direct-acting antivirals.
Funding
No funding was received for this study. The Mansoura Urology and Nephrology Center fully supported the immunosuppressive drug therapies and all laboratory and radiological investigations. The Egyptian Liver Research Institute and Hospital directly collaborated with the Egyptian Health Insurance System regarding funding the antiviral drugs.
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Elmaghrabi HM collected the data, Refaie AF analyzed the data, Elmowafy AY wrote the article, Elbassiony M followed the patients regarding hepatology, and Shiha GM enabled providing DAAs and obtaining Egyptian medical insurance. The work was supervised by Bakr MA, and Rostaing L who also reviewed the completed article.
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This study was conducted according to compliance with ethical standards.
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Maghrabi, H.M.E., Elmowafy, A.Y., Refaie, A.F. et al. Efficacy and safety of the new antiviral agents for the treatment of hepatitis C virus infection in Egyptian renal transplant recipients. Int Urol Nephrol 51, 2295–2304 (2019). https://doi.org/10.1007/s11255-019-02272-5
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DOI: https://doi.org/10.1007/s11255-019-02272-5