Effectiveness and safety of sofosbuvir/ledipasvir ± ribavirin treatment in liver and/or renal transplant patients with chronic hepatitis C: A single-center experience.

OBJECTIVE

Successful treatment is possible with novel direct-acting oral antiviral agents in solid organ transplant patients with hepatitis C. In this study, the effectiveness and safety of sofosbuvir/ledipasvir ± ribavirin treatment in liver and/or renal transplant patients with chronic hepatitis C were evaluated.

MATERIALS AND METHODS

A total of 23 liver and/or renal transplant patients who received sofosbuvir/ledipasvir ± ribavirin for chronic hepatitis C over 12 or 24 weeks were enrolled in the study. The treatment response, clinical and laboratory adverse effects, and effect on immunosuppressive drug levels were assessed.

RESULTS

A total of 12 patients had undergone renal transplantation and 11 had undergone liver transplantation. All of the renal transplant patients and 91% of liver transplant patients had genotype 1. In total, 10 renal transplant patients and 4 liver transplant patients had treatment experience. Two renal transplant patients and one liver transplant patient had compensated cirrhosis. Nine renal transplant patients were on tacrolimus, and two were on cyclosporine; all of the liver transplant patients were on tacrolimus-based immunosuppressive therapy. While hepatitis C RNA was negative in 75% of renal transplant patients and 91% of liver transplant patients at week 4, it was negative in all of the patients at the end of treatment and 12 weeks after treatment. Significantly reduced hemoglobin levels were observed in patients administered ribavirin during treatment (p = 0.01). There were no significant differences between the baseline and treatment period values of mean creatinine, estimated glomerular filtration rate, bilirubin, and tacrolimus levels. There were no adverse effects leading to treatment discontinuation.

CONCLUSION

Sofosbuvir/ledipasvir ± ribavirin is quite safe and effective in hepatitis C treatment after liver and/or renal transplantation.