Introduction
Recurrent hepatitis C virus (HCV) infection after transplantation is aggressive, and its progression to cirrhosis is more rapid than in nontransplant settings. As pegylated interferon based therapies for HCV treatment after transplantation have poor tolerance, poor efficacy, and significant interactions with immunosuppression medications, and this developed the need for a new safe and effective oral regimen.
Aim
To evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF) in combination with ribavirin (RBV) in treating recurrent hepatitis C after transplantation and also to detect any significant interaction with immunosuppressive therapy.
Patients and methods
Between August 2014 and January 2016, a single-center, prospective, nonrandomized, open-labeled study was conducted, in which the patients with post-transplant recurrent HCV infection were enrolled. All patients received 400 mg once-daily SOF for 24 weeks with variable dose of RBV. After treatment, patients underwent follow-up for 12 weeks.
Results
Sixty patients were enrolled, and their mean age was 57.67 years, with 78.3% were male. Overall, 70% had genotype 1 and 61.7% had received previous HCV treatment. At baseline, 21 patients had severe fibrosis. Median time interval from liver transplantation was 51 months, and immunosuppressive therapy was tacrolimus based in 78.3%. Median baseline HCV-RNA was 2.341.172 IU/ml. Among the patients, 12-week sustained virological response was achieved in 43 (71.7%) patients. There was no significant difference in dose and level of tacrolimus during course of therapy. Absence of hepatic encephalopathy, treatment-naive patients, nonsevere fibrosis, and low pretherapy Liver stiffness (LS) values were predictors for sustained virological response.
Conclusion
Interferon-free regimen containing SOF and RBV is generally safe, well tolerated, and reasonably effective in post-transplantation settings.