title: A Protease Inhibitor with Induction Therapy with Natural Interferon-β in Patients with HCV Genotype 1b Infection.
abstract: The restoration of innate immune responses has potential as a novel therapeutic strategy for chronic hepatitis C (CHC). We compared the efficacy and safety of induction therapy (IT) with natural interferon-β (n-IFN-β) followed by pegylated-IFN-α/ribavirin (PR) alone (group A, n = 30) and IT with a protease inhibitor (PI) (simeprevir or vaniprevir)/PR (group B, n = 13) in CHC patients with genotype 1b and high viral loads. During IT with nIFN-β, virologic response rates in group A and group B were 10% and 8% (p = 0.6792) at week 4, 30% and 16% (p = 0.6989) at week 12 and 47% and 20% (p = 0.0887) at week 24 respectively. During and after the treatment with PR alone or PI/PR, virologic response rates in groups A and B were 50% and 82% (p = 0.01535) at week 4, 53% and 91% (p = 0.006745) at week 8, 57% and 91% (p = 0.001126) at week 12, 57% and 100% (p < 0.001845) at the end of the treatment and 57% and 80% (p < 0.005166) after treatment cessation. IT with PI/PR linked to the restoration of innate immune response was tolerated well, overcame virological breakthrough, enhanced early virologic responses, and resulted in a sustained virologic response in difficult-to-treat CHC patients. IT with PI/PR is beneficial for treating difficult-to-treat CHC patients.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Osaka Kaisei Hospital, Osaka City, Osaka 532-0003, Japan. y-kishida@muse.ocn.ne.jp.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kishida
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Osaka Kaisei Hospital, Osaka City, Osaka 532-0003, Japan. nao.p@f6.dion.ne.jp.
authors.forename: Naohiko
authors.initials: N
authors.lastname: Imaizumi
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Osaka Kaisei Hospital, Osaka City, Osaka 532-0003, Japan. dd9341715tam@yahoo.co.jp.
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Tanimura
authors.affiliation: Laboratory of Host Defenses Institute for Advanced Medical Science, Hyogo College of Medicine, Nishinomiya City, Hyogo 668-8501, Japan. shinchan@hyo-med.ac.jp.
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Kashiwamura
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Osaka Hospital of Japan Community Healthcare Organization, Osaka city, Osaka 553-0003, Japan. kashiwagi.toru@zeus.eonet.ne.jp.
authors.forename: Toru
authors.initials: T
authors.lastname: Kashiwagi
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003521:Cyclopropanes; D004334:Drug Administration Schedule; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000627:therapeutic use*; D016899:Interferon-beta / Q000008:administration & dosage / Q000627:therapeutic use*; D054833:Isoindoles; D047029:Lactams, Macrocyclic; D007930:Leucine / Q000031:analogs & derivatives; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use*; D011392:Proline / Q000031:analogs & derivatives; D011480:Protease Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use*; D000069616:Simeprevir / Q000008:administration & dosage / Q000627:therapeutic use*; D013449:Sulfonamides
chemical_list: D000998:Antiviral Agents; D003521:Cyclopropanes; D007211:Indoles; D054833:Isoindoles; D047029:Lactams, Macrocyclic; D011480:Protease Inhibitors; D013449:Sulfonamides; D011092:Polyethylene Glycols; D012254:Ribavirin; D016899:Interferon-beta; D011392:Proline; D000069616:Simeprevir; C540393:vaniprevir; D007930:Leucine; C428112:peginterferon beta-1a
keywords: Peg-IFN-α; chronic hepatitis C; induction therapy; interferon-β; protease inhibitor; ribavirin