title: Multicenter study of pegylated interferon α-2a monotherapy for hepatitis C virus-infected patients on hemodialysis: REACH study.
abstract: Many studies have reported poor vital prognosis in hepatitis C virus (HCV)-infected dialysis patients. The rate of HCV-infected dialysis patients in Japan is as high as 9.8%, and antiviral therapy is believed to be important for improving vital prognosis. We conducted a multicenter study to examine the administration method for pegylated interferon α-2a (PEG-IFNα-2a) monotherapy in HCV-infected dialysis. We studied 56 patients: 14 with low viral loads (HCV RNA < 5.0 log IU/mL) were treated with 90 μg PEG-IFNα-2a weekly, 42 with high viral loads (HCV RNA ≥ 5.0 log IU/mL) were treated with 135 μg PEG-IFNα-2a weekly. We examined the sustained virological response (SVR), factors affecting the SVR, and treatment safety. The overall SVR rate was 39% (22/56); that for genotype 1, genotype 2, low viral loads, and high viral loads was 29%, 67%, 93%, and 21%, respectively. From receiver operating characteristic (ROC) analysis, the HCV RNA cutoff values likely to achieve SVR for genotypes 1 and 2 were <5.7 log IU/mL (SVR rate: 64% 9/14) and <6.5 log IU/mL (SVR rate: 88% 7/8), respectively. If there was HCV RNA negativation at 4 weeks (rapid virological response), the SVR rate was 94% (16/17), whereas it was 6% (1/16) if there was HCV RNA positivity at 24 weeks. The rate of treatment discontinuation from adverse events or aggravated complications was 25% (14/56). High SVR rates can potentially be achieved with PEG-IFN monotherapy by identifying the target patients, based on virus type and viral load before initiating treatment and by modifying therapy during treatment according to responsiveness.
authors.affiliation: Department of Blood Purification, Kidney Center, Tokyo Women's Medical University, Tokyo, Japan; Shimoochiai Clinic, Tokyo, Japan.
authors.forename: Kan
authors.initials: K
authors.lastname: Kikuchi
authors.forename: Takashi
authors.initials: T
authors.lastname: Akiba
authors.forename: Kosaku
authors.initials: K
authors.lastname: Nitta
authors.forename: Ikuto
authors.initials: I
authors.lastname: Masakane
authors.forename: Ryoichi
authors.initials: R
authors.lastname: Ando
authors.forename: Namiki
authors.initials: N
authors.lastname: Izumi
authors.forename: Masanori
authors.initials: M
authors.lastname: Atsukawa
authors.forename: Chikao
authors.initials: C
authors.lastname: Yamazaki
authors.forename: Fumi
authors.initials: F
authors.lastname: Kato
authors.forename: Naoki
authors.initials: N
authors.lastname: Hotta
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Tominaga
authors.forename: Etsuro
authors.initials: E
authors.lastname: Orito
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Hora
authors.forename: Masaki
authors.initials: M
authors.lastname: Nagasawa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kasahara
authors.forename: Masanori
authors.initials: M
authors.lastname: Kawaguchi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kimura
authors.forename: Norisato
authors.initials: N
authors.lastname: Ikebe
authors.forename: Hideki
authors.initials: H
authors.lastname: Kawanishi
authors.forename: Misaki
authors.initials: M
authors.lastname: Moriishi
authors.forename: Kenichiro
authors.initials: K
authors.lastname: Shigemoto
authors.forename: Takashi
authors.initials: T
authors.lastname: Harada
authors.forename: Hideki
authors.initials: H
authors.lastname: Hirakata
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Watanabe
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Nosaki
authors.forename: Hirohito
authors.initials: H
authors.lastname: Tsubouchi
authors.forename: Michio
authors.initials: M
authors.lastname: Imawari
authors.forename: Tadao
authors.initials: T
authors.lastname: Akizawa
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011379:Prognosis; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D006435:Renal Dialysis; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a
keywords: Hemodialysis; Hepatitis C virus; Pegylated interferon α-2a; Rapid virological response; Sustained virological response