Sofosbuvir-Based Therapy for Hepatitis C after Liver Transplantation

Abstract

Introduction: Evaluate outcomes of sofosbuvir-based antiviral therapy in liver transplant patients with recurrent hepatitis C in a single-center setting. Methods: All hepatitis C (HCV)-infected liver transplant (LT) recipients initiated on sofosbuvir-based therapies between December 2013 and April 2014 at our center were evaluated for treatment efficacy and safety. We collected baseline demographic data as well as data on the degree of fibrosis on liver biopsy, and prior treatment history. Laboratory evaluation included genotype, initial laboratory parameters, and hemoglobin nadir. Viral response included results on treatment at weeks 4 and 12, at end of treatment, and post=treatment sustained viral response at weeks 4 (SVR 4) and 12 (SVR 12). Results: A total of 18 patients initiated therapy. Mean age was 60 years. Average BMI was 27.6 kg/m2. Eight patients had Ishak fibrosis score 3 or higher on biopsy. Eight patients had genotype 1a, and 6 (75%) of them had undetectable virus at week 4. Nine patients had genotype 1b, and 4 (44%) had undetectable virus at week 4. One patient had genotype 4 and was undetectable at week 4. Four of 7 of the patients with detectable virus at week 4 had levels <43 IU/mL. All 10 patients reaching time-point had undetectable virus at week 12 and end of treatment. Mean length of treatment for those completing therapy was 12 weeks. Of the 8 patients reaching 4 weeks post treatment, 6 (75%) had SVR4. Mean initial hemoglobin was 13 g/dL (range: 10.2-16.2 g/dL). Average hemoglobin nadir was 2 g/dL lower than pretreatment hemoglobin. This was managed with ribavirin dose reduction with no discontinuation of therapy. Fatigue was the most common documented side effect, affecting 22% of patients. One patient died while on treatment secondary to severe plasma cell hepatitis leading to graft failure. Conclusion: Early results with the use of sofosbuvir in hepatitis C after liver transplantation are encouraging. Sofosbuvir-based therapy was generally well tolerated. Treatment complications included anemia, fatigue, and 1 case of plasma cell hepatitis with graft failure and death.Table 1: Rate of Undetectable Virus by PCR