Add-on effects of fluvastatin in simeprevir/pegylated-interferon/ribavirin combination therapy for patients with genotype 1 hepatitis C virus infection: A randomized controlled study

作者：Suda Goki; Ito Jun; Nagasaka Atsushi; Yamamoto Yoshiya; Furuya Ken; Okamoto Munenori; Terashita Katsumi; Kobayashi Tomoe; Tsunematsu Izumi; Yoshida Junichi; Meguro Takashi; Ohara Masatsugu; Kawagishi Naoki; Kimura Megumi; Umemura Machiko; Izumi Takaaki; Tsukuda Yoko; Nakai Masato; Sho Takuya; Natsuizaka Mitsuteru; Morikawa Kenichi; Ogawa Koji; Sakamoto Naoya^*

来源：Hepatology Research, 2018, 48(3): E146-E154.

DOI：10.1111/hepr.12938

• add-on
• fluvastatin
• hepatitis C virus
• simeprevir

Background: The Japan Society of Hepatology guidelines indicate that hepatitis C virus (HCV) protease inhibitor combination therapy with simeprevir (SMV), pegylated-interferon (Peg-IFN), and ribavirin (RBV) is a therapeutic option for patients who fail to respond to a direct direct-acting antiviral-containing regimen. However, treatment outcomes have room for improvement. Fluvastatin (FLV) add-on treatment in Peg-IFN and RBV combination therapy for HCV-infected patients significantly improved the sustained virologic response (SVR), but the add-on effect of FLV on SMV combination therapy is not well understood.
Methods: This was a prospective, randomized, multicenter study in which a total of 61 HCV genotype 1b-infected patients were recruited and 60 eligible patients were randomly allocated to two groups that received 12 weeks of SMV/Peg-IFN/RBV followed by 12 weeks of Peg-IFN/RBV with or without 24 weeks of FLV. The SVR rate and adverse events were compared between the two groups.
Results: Thirty-one patients were allocated to the FLV add-on group and 29 patients were allocated to the control group. Baseline clinical factors, including median age, baseline platelet count, alanine aminotransferase level, HCV RNA titer, Fibrosis-4 index, and rate of IL28B minor genotype, were all similar between the two groups. The rapid virologic response, end-of-treatment response rates, SVR rates at 24 weeks after treatment, and safety profiles were also similar between the two groups.
Conclusions: This prospective, randomized, multicenter study indicated that FLV had no add-on effect when given with SMV/Peg-IFN/RBV combination therapy for genotype 1b HCV-infected patients.

• 出版日期2018-2