title: Bacterial infection as an adverse effect of telaprevir-based triple therapy for chronic hepatitis C infection.
abstract: OBJECTIVE
  There is little information regarding the incidence of bacterial infections as an adverse effect of telaprevir (TVR)-based triple therapy. This study was performed in order to evaluate the baseline and on-treatment predictors of bacterial infections in patients treated with TVR-based triple therapy.
  
  
  METHODS
  This multicenter study evaluated 430 patients with chronic hepatitis C who received 12 weeks of TVR in combination with 24 weeks of pegylated interferon α2b plus ribavirin. The occurrence of a bacterial infection during anti-viral treatment was defined as the onset of local or systemic inflammation as a result of pathogenic bacteria.
  
  
  RESULTS
  Bacterial infections occurred in 21 of the 430 (4.9%) patients during TVR-based triple therapy. Among these subjects, 71.4% (15 of 21) experienced bacterial infections during the initial eight weeks of treatment. Urinary tract infections were the most frequent infection, observed in 2.8% of cases (12 of 430). The rate of urinary tract infection among women (11 of 215, 5.1%) was significantly higher than that observed among men (1 of 215, 0.5%) (p<0.0001). According to a multivariable logistic regression analysis, the only significant independent predictor was the pretreatment serum albumin level (p=0.0008). Of the 21 patients who experienced bacterial infections, only one (4.8%) had to discontinue the treatment; however, the others were able to continue anti-viral treatment in combination with antibiotic treatment.
  
  
  CONCLUSIONS
  Clinicians should be concerned regarding the incidence of bacterial infections among patients treated with TVR-based triple therapy, especially those with a low serum albumin level.
authors: Department of Internal Medicine, Kitakyushu Municipal Medical Center, Japan.
authors: Akira
authors: A
authors: Kawano
authors: Eiichi
authors: E
authors: Ogawa
authors: Norihiro
authors: N
authors: Furusyo
authors: Makoto
authors: M
authors: Nakamuta
authors: Eiji
authors: E
authors: Kajiwara
authors: Kazufumi
authors: K
authors: Dohmen
authors: Hideyuki
authors: H
authors: Nomura
authors: Kazuhiro
authors: K
authors: Takahashi
authors: Takeaki
authors: T
authors: Satoh
authors: Koichi
authors: K
authors: Azuma
authors: Yuichi
authors: Y
authors: Tanabe
authors: Shinji
authors: S
authors: Shimoda
authors: Kazuhiro
authors: K
authors: Kotoh
authors: Jun
authors: J
authors: Hayashi
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001424:Bacterial Infections / Q000139:chemically induced*; D015415:Biomarkers; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000009:adverse effects* / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D009842:Oligopeptides; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C417083:peginterferon alfa-2b