Sofosbuvir-Based Antiviral Therapy Is Highly Effective In Recurrent Hepatitis C in Liver Transplant Recipients: Canadian Multicenter "Real-Life" Experience. Issue 5 (May 2016)

• Record Type: Journal Article
• Authors: Faisal, Nabiha; Bilodeau, Marc; Aljudaibi, Bandar; Hirsch, Geri; Yoshida, Eric M.; Hussaini, Trana; Ghali, Maged P.; Congly, Stephen E.; Ma, Mang M.; Leonard, Jennifer; Cooper, Curtis; Peltekian, Kevork; Renner, Eberhard L.; Lilly, Leslie B.
• Is Part Of: Transplantation. Volume 100:Issue 5(2016)
• Publication Date: 2016-05
• Subjects: Transplantation of organs, tissues, etc -- Periodicals; Transplantation immunology -- Periodicals; 617.95
• DOI: 10.1097/TP.0000000000001126
• Languages: English
• ISSNs: 0041-1337

Abstract

Abstract : Background: This study evaluates the efficacy, safety, and tolerability of regimens containing sofosbuvir (SOF) in the treatment of hepatitis C virus (HCV) recurrence in all genotypes in patients outside of clinical trials in all Canadian transplant centers. Methods: One hundred twenty liver transplantation recipients from across Canada with HCV recurrence were started on SOF-based regimens (SOF + simeprevir ± ribavirin (RBV), n = 53; SOF + pegylated interferon + RBV, n = 25; SOF + RBV, n = 36; and SOF + ledipasvir, n = 6) between January and November 2014. Mean age 58 ± 6.85 years, majority (83%) were genotype 1, male (81%), and treatment experienced (82%). Twenty-seven percent had fibrosing cholestatic hepatitis/early aggressive HCV in the graft, and 48% had F3/4 fibrosis. The primary outcomes included patient and graft survival, on- and end-of-treatment response and sustained virological response at 12 weeks after treatment end (SVR12), and adverse events. Results: One hundred thirteen of 120 (94%) patients were HCV RNA undetectable at end of treatment, and SVR12 was achieved in 102/120 (85%) patients, with 7 relapses, 1 nonresponder, and 10 deaths (liver-related complications). Sixty-three percent had HCV RNA levels below the lower limit of quantification at week 4. Serum creatinine levels remained stable throughout the treatment. Severe anemia occurred in 13% of patients, primarily in RBV-based regimens. Conclusions: Sofosbuvir-based antiviral therapy for HCV recurrence after liver transplantation was well tolerated, with an overall high SVR12 rate (85%) including patients with severe disease recurrence and F3-4 cirrhosis. The response rate was higher (91%) in mild HCV recurrence, suggesting earlier treatment might be beneficial. Abstract : New HCV therapies result in sustained viral eradication (SVR) in most immune-competent and immune-compromised patients. In liver transplant recipients (LTR), data mainly come from clinical trials. This real-life Canadian multicenter study (n=120) confirms the excellent results (SVR 85%) in LTR started on sofosbuvir-based regimens.