Asunaprevir and daclatasvir for recurrent hepatitis C after liver transplantation: A Japanese multicenter experience.

The safety and efficacy of an IFN-free regimen using asunaprevir ( ASV) and daclatasvir ( DCV) for recurrent hepatitis C virus ( HCV) infection after liver transplantation ( LT) have not been evaluated in Japan. A multicenter study of LT recipients (n = 74) with recurrent HCV genotype 1b infection treated with ASV- DCV for 24 weeks was performed. Medical history was positive for pegylated interferon and ribavirin (Peg- IFN/ RBV) in 40 (54.1%) patients, and for simeprevir ( SMV) with Peg- IFN/ RBV in 12 (16.2%) patients. Resistance-associated variants ( RAVs) were positive at D168 (n = 1) in the NS3, and at L31 (n = 4), Y93 (n = 4), and L31/Y93 (n = 1) in the NS5A region of the HCV genome. Sixty-one (82.4%) patients completed the 24-week treatment protocol. Although sustained viral response ( SVR) was achieved in 49 (80.3%) patients, it was achieved in only two (16.7%) patients among those with histories of receiving SMV (n = 12). Univariate analysis showed that a history of SMV ( P < .01) and the presence of mutations in NS5A ( P = .02) were the significant factors for no- SVR. By excluding the patients with either a history of SMV-based treatment or RAVs in NS3/ NS5A, the SVR rate was 96.4%. By excluding the patients with a history of SMV and those with RAVs in NS3/ NS5A, viral clearance of ASV- DCV was favorable, with a high SVR rate. [ABSTRACT FROM AUTHOR]