title: Antiviral effects of peginterferon alpha-2b and ribavirin following 24-week monotherapy of telaprevir in Japanese hepatitis C patients.
abstract: OBJECTIVE
  Anemia is commonly observed as a side effect in a treatment with protease inhibitors combined with peginterferon alpha and ribavirin for hepatitis C virus infection. This study assessed the safety, tolerability, viral kinetics, and selection of variants in telaprevir monotherapy for 24 weeks, and outcomes of the off-study treatment with peginterferon alpha-2b and ribavirin among Japanese female patients at a median age of 54 years who were difficult to treat with the standard therapy (peginterferon alpha-2b and ribavirin) alone in Japan.
  
  
  METHODS
  Four treatment-naïve patients with chronic hepatitis C virus subtype 1b infection received telaprevir (750 mg every 8 h) alone for 24 weeks. All patients then started the off-study treatment with peginterferon alpha-2b and ribavirin. Safety, tolerability, hepatitis C virus RNA levels, and emergence of telaprevir-resistant variants were monitored.
  
  
  RESULTS
  During the 24 weeks of telaprevir monotherapy, there was no discontinuation due to adverse events, but 2 patients stopped the intake at weeks 6 and 15 because of viral breakthrough. Emergence of telaprevir-resistant variants was observed in 3 patients who showed viral breakthrough. These variants were eliminated by the off-study treatment, and sustained virological response was achieved in all patients.
  
  
  CONCLUSIONS
  Anemia was manageable by carefully adjusting the ribavirin dosage in the standard therapy that followed telaprevir monotherapy. This sequential regimen seems to be safer and more tolerable than the triple combination of telaprevir, peginterferon alpha, and ribavirin, especially among elderly females with low baseline hemoglobin.
authors.affiliation: Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, Sapporo, Hokkaido, 060-0033, Japan.
authors.forename: Itaru
authors.initials: I
authors.lastname: Ozeki
authors.forename: Jun
authors.initials: J
authors.lastname: Akaike
authors.forename: Yoshiyasu
authors.initials: Y
authors.lastname: Karino
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Arakawa
authors.forename: Yasuaki
authors.initials: Y
authors.lastname: Kuwata
authors.forename: Takumi
authors.initials: T
authors.lastname: Ohmura
authors.forename: Takahiro
authors.initials: T
authors.lastname: Sato
authors.forename: Naohiro
authors.initials: N
authors.lastname: Kamiya
authors.forename: Ichimaro
authors.initials: I
authors.lastname: Yamada
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Chayama
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Kumada
authors.forename: Joji
authors.initials: J
authors.lastname: Toyota
mesh_terms: D000740:Anemia / Q000139:chemically induced / Q000517:prevention & control; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D005260:Female; D056914:Genomic Structural Variation; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage* / Q000009:adverse effects; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000187:drug effects; D011994:Recombinant Proteins; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D009842:Oligopeptides; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C417083:peginterferon alfa-2b