Real-world virological efficacy and safety of elbasvir and grazoprevir in patients with chronic hepatitis C virus genotype 1 infection in Japan

• DOI: 10.1007/s00535-018-1473-z
• Publication Date: 2018-05-08T14:43:59Z
• Authors: Hidenori Toyoda; Masanori Atsukawa; Koichi Takaguchi; Tomonori Senoh; Kojiro Michitaka; Atsushi Hiraoka; Shinichi Fujioka; Chisa Kondo; Tomomi Okubo; Haruki Uojima; Toshifumi Tada; Hirohito Yoneyama; Tsunamasa Watanabe; Toru Asano; Toru Ishikawa; Hideyuki Tamai; Hiroshi Abe; Keizo Kato; Kunihiko Tsuji; Chikara Ogawa; Noritomo Shimada; Etsuko Iio; Akihiro Deguchi; Ei Itobayashi; Shigeru Mikami; Akio Moriya; Hironao Okubo; Joji Tani; Akihito Tsubota; Yasuhito Tanaka; Tsutomu Masaki; Katsuhiko Iwakiri; Takashi Kumada
• Keywords: Regimen; NS5A; Daclatasvir

The real-world virological efficacy and safety of an interferon (IFN)-free direct-acting antiviral (DAA) therapy with elbasvir (EBR) and grazoprevir (GZR) were evaluated in Japanese patients chronically infected with hepatitis C virus (HCV) genotype 1.The rate of sustained virologic response (SVR) and safety were analyzed in patients who started the EBR/GZR regimen between November 2016 and July 2017. SVR rates were compared based on patient baseline characteristics.Overall, 371 of 381 patients (97.4%) achieved SVR. Multivariate analysis identified a history of failure to IFN-free DAA therapy and the presence of double resistance-associated substitutions (RASs) in HCV non-structural protein 5A (NS5A) as factors significantly associated with failure to EBR/GZR treatment. The SVR rates of patients with a history of IFN-free DAA therapy and those with double RASs were 55.6 and 63.6%, respectively. In all other subpopulations, the SVR rates were more than 90%. There were no severe adverse events associated with the treatment.The EBR/GZR regimen yielded high virological efficacy with acceptable safety. Patients with a history of failure to IFN-free DAA therapy or with double RASs in HCV-NS5A remained difficult to treat with this regimen.