To investigate the clinical efficacy of sofosbuvir combined with ledipasvir antiviral therapy in renal transplant recipients with HCV infection.

The clinical data of 11 HCV-infected recipients treated with sofosbuvir combined with raltegravir after renal transplantation at the First Affiliated Hospital of Xi′an Jiaotong University from July 1, 2011 to May 1, 2016 were retrospectively analyzed. The main observation indexes included rapid virological response, early virological response and sustained virological response (SVR). Indicators of treatment efficacy and safety included serum HCV RNA, AST, ALT, estimate glomerular filtration rate (eGFR), serum creatinine and immunosuppressive drug blood trough levels. The incidence of adverse effects caused by antiviral drugs such as nausea, dizziness and insomnia was also recorded. The repeated measurement data analysis of variance or the mixed linear model were used for comparison. P<0.05 was considered statistically significant.

All 11 recipients completed antiviral treatment and were followed up to 12 weeks after the end of antiviral treatment. All recipients achieved SVR and none had detectable HCV RNA at the end of treatment. HCV RNA loads were 2.1×10⁶ IU/mL (5.6×10³, 7.3×10⁶) before treatment and 4.5×10² IU/mL (3.2×10², 5.7×10²) IU/mL and 1.2×10² IU/mL (0.8×10², 2.5×10²) IU/mL at week 8 and at the end of treatment in 11 recipients, with statistically significant difference (F=0.515, P<0.05). ALT, AST and glutamyl transpeptidase levels were (58±31) U/L (18-211 U/L) , (47±29) U/L (21-109 U/L) and (147±68) U/L (32-404 U/L) respectively before anti-HCV treatment, and (17±8) U/L (10-38 U/L) , (19±7) U/L (12-36 U/L) and (32±22) U/L (17-106 U/L) respectively at the end of antiviral treatment in 11 recipients, all with statistically significant differences (t=4.350, 2.159 and 7.251, P<0.05). The eGFR was (71±23) mL·^-1·(1.73 m²)^-1[38-106 mL·min^-1·(1.73 m²) ^-1] before anti-HCV treatment, and (70±25) mL·min^-1·(1.73 m²) ^-1 [41-110 mL·min^-1·(1.73 m²)^-1] at the end of treatment; the difference was not statistically significant (t=0.760, P>0.05). The trough values of tacrolimus blood concentrations before anti-HCV treatment, at week 4 of treatment and at the end of treatment were (7.3±2.8) , (7.2±2.6) and (6.9±1.9)ng/mL respectively, with no statistically significant difference (F=0.423, P>0.05). During the follow-up period, four recipients experienced adverse effects, including insomnia, dizziness, diarrhoea and lower limb pain in one case each.

Sofosbuvir combined with ledipasvir treatment regimen is well tolerated, safe and effective in renal transplant recipients with chronic HCV infection.