Background: The use of interferon-based regimens for HCV infection in KT recipients is limited due to the increased risk of acute graft rejection (AR), poor tolerance and low rates of sustained virological response (SVR). Newer DAA-based therapies represent a promising option, although data in this population are scarce.

Methods: We prospectively analyzed all KT recipients with chronic HCV infection that received any DAA-based therapy in our institution between November 2014-November 2015. The DAA combination was selected by the treating hepatologist. The primary end-point was SVR at 12 weeks after the end of therapy (EOT) (SVR12). We also assessed other virological (rapid virological response [RVR]: undetectable HCV-RNA at 4 weeks after the initiation of therapy) and safety outcomes (graft function and immunological [AR] and non-immunological adverse events).

Results: We included 48 patients (34 males; age: 57.3 ± 10.0 y), with a median interval since KT of 9.3 years (interquartile range [IQR]: 6.4-14.0). The median viral load at the time of treatment initiation was 6.1 log₁₀ copies/mL (IQR: 5.7-6.7). Liver fibrosis according to transient elastography was mild (F1), moderate (F2) and severe (F3-F4) in 40.4%, 12.8% and 46.8% of patients. The combinations used were sofosbuvir plus ledipasvir (87.5% [n = 42]) or daclatasvir (6.3% [n = 3]), and dasabuvir plus ombitasvir/paritaprevir/ritonavir (6.3% [n = 3]). Ribavirin was co-administered in 56.3% (n = 27) of patients. The rate of RVR among patients that had completed 4 weeks of therapy at the time of analysis was 72.2% (26/36). The rates of undetectable HCV-RNA at EOT and SVR12 were 100.0% (20/20) and 100.0% (13/13), respectively. There were no differences between baseline and EOT in graft function (50.8 vs. 48.6 mL/min; P-value = 0.293) or 24-hour proteinuria (0.43 vs. 0.38 g; P-value = 0.540). The treatment was well tolerated, with no episodes of AR while on therapy or relevant adverse events.

Conclusion: Interferon-free, DAA-based anti-HCV regimens leaded to optimal rates of SVR among KT recipients with no significant safety concerns.

CITATION INFORMATION: Fernandez Ruiz M, García Santiago A, Polanco Fernandez N, Muñoz R, Hernandez A, González Monte E, Mercado V, Fernández I, Aguado J, Praga M, Andrés A. Efficacy and Safety of Direct Antiviral Agents (DAA)-Based Therapies for Hepatitis C Virus (HCV) Infection in Kidney Transplant (KT) Recipients. Am J Transplant. 2016;16 (suppl 3).

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