title: HCV response in patients with end stage renal disease treated with combination pegylated interferon alpha-2a and ribavirin.
abstract: OBJECTIVE
  To determine the efficacy and safety of combination therapy in patients with hepatitis C virus (HCV) and end-stage renal disease (ESRD).
  
  
  BACKGROUND
  There is little data on the treatment of ESRD patients with pegylated interferon and ribavirin. We designed a pilot study to determine the initial and 12-week posttreatment viral response.
  
  
  METHODS
  A nonrandomized, prospective observational study of adjusted-dose combination therapy. Twenty patients were enrolled and began pegylated interferon at 135 microg/wk SC, and 4 weeks later ribavirin was started at 200 mg PO weekly, increasing gradually to 3 times a week for a total of 48 weeks.
  
  
  RESULTS
  Twenty patients: M:F 18:2; mean age 52.4 years; genotype 1: 18, non-genotype 1: 2. Of the 20 patients, 5 withdrew before starting treatment. Of the 11 patients who reached 3 months, 6 had early virologic response, defined as at least a 2-log drop in their HCV count (54.5%). Of the 5 patients who were treated for 1-year, only 1 patient had a response 12 weeks after treatment. Side effects included 4 cases of anemia and 1 patient with headache.
  
  
  CONCLUSIONS
  The initial response rate in individuals taking 3 months of treatment in our study is comparable with studies in non-ESRD patients with no serious adverse side effects. However, the sustained posttreatment rate was low. This demonstrates that combination therapy is a safe therapeutic option in the ESRD population with HCV infection which needs further testing to determine if increasing the length of treatment and/or the dose of ribavirin will affect posttreatment rates.
authors.affiliation: Department of Medicine, Yale University, New Haven, CT, USA.
authors.forename: Wyel
authors.initials: W
authors.lastname: Hakim
authors.forename: Shehzad
authors.initials: S
authors.lastname: Sheikh
authors.forename: Irteza
authors.initials: I
authors.lastname: Inayat
authors.forename: Cary
authors.initials: C
authors.lastname: Caldwell
authors.forename: Douglas
authors.initials: D
authors.lastname: Smith
authors.forename: Marc
authors.initials: M
authors.lastname: Lorber
authors.forename: Amy
authors.initials: A
authors.lastname: Friedman
authors.forename: Dhanpat
authors.initials: D
authors.lastname: Jain
authors.forename: Margaret
authors.initials: M
authors.lastname: Bia
authors.forename: Richard
authors.initials: R
authors.lastname: Formica
authors.forename: Wajahat
authors.initials: W
authors.lastname: Mehal
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006526:Hepatitis C / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000150:complications*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a