title: Efficacy and safety of pegylated interferon plus ribavirin in HIV and hepatitis C virus-coinfected patients with advanced immunosuppression.
abstract: BACKGROUND
  The aim of this study was to assess the efficacy and safety of pegylated interferon (IFN) plus ribavirin (RBV) in human immunodeficiency virus (HIV) and hepatitis C virus (HCV)-coinfected patients with severe immunodeficiency in a clinical cohort. BACKGROUND. A total of 542 HIV-infected patients receiving treatment with pegylated IFN plus RBV from June 2001 through April 2007 were included in this study. The outcome variables were sustained virologic response (SVR) rate and the emergence of AIDS-defining events during HCV infection therapy. SVR rates among patients with a CD4 cell count <or=250 cells/mm(3) at baseline were compared with those among patients with CD4 cell counts >250 cells/mm(3). The association between SVR and potential predictors was analyzed.
  
  
  RESULTS
  Ten (26%) of 39 individuals with a baseline CD4 cell count 250 cells/mm(3) and 198 (39%) of 503 with baseline CD4 cell counts >or=250 CD4 cells/mm(3) achieved SVR (P = .09). In a nested case-control study with populations matched at a 1:2 ratio, the SVR rate was 26% in the CD4 cell count 250 cells/mm(3) group and 32% in the CD4 cell count >250 cells/mm(3) group (P = .5). Baseline CD4 cell count (250 cells/mm(3) vs >250 cells/mm(3)) was not associated with SVR in the multivariate analysis. Two (5%) individuals in the CD4 cell count 250 cells/mm(3) group experienced opportunistic events during follow-up. In the CD4 cell count 250 cells/mm(3) group, severe hematological toxicity and pegylated IFN or RBV dosage reductions occurred in 16 (41%) and 12 (31%) patients, respectively. In the CD4 cell count >250 cells/mm(3) group, severe hematological toxicity and pegylated IFN or RBV dosage reductions occurred in 29% (P = .1) and 20% (P = .1) of patients, respectively.
  
  
  CONCLUSIONS
  The efficacy of pegylated IFN plus RBV in HIV-HCV-coinfected patients with advanced immunosuppression is substantial and not significantly different to that observed in the overall coinfected population. HCV therapy is generally safe in the population of coinfected patients with advanced immunosuppression.
authors.affiliation: Unidad de Enfermedades Infecciosas, Servicio de Medicina Interna, Hospital Universitario de Valme, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
authors.forename: José A
authors.initials: JA
authors.lastname: Mira
authors.forename: Alicia
authors.initials: A
authors.lastname: Gutiérrez-Valencia
authors.forename: Ignacio de los Santos
authors.initials: Ide L
authors.lastname: Gil
authors.forename: Dolores
authors.initials: D
authors.lastname: Merino
authors.forename: Antonio
authors.initials: A
authors.lastname: Rivero
authors.forename: María J
authors.initials: MJ
authors.lastname: Ríos-Villegas
authors.forename: Marcial
authors.initials: M
authors.lastname: Delgado
authors.forename: Mercedes
authors.initials: M
authors.lastname: González-Serrano
authors.forename: Antonio
authors.initials: A
authors.lastname: Collado
authors.forename: Manuel
authors.initials: M
authors.lastname: Torres-Tortosa
authors.forename: Mohamed
authors.initials: M
authors.lastname: Omar
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: López-Ruz
authors.forename: Juan
authors.initials: J
authors.lastname: Macías
authors.forename: Sari
authors.initials: S
authors.lastname: Arponen
authors.forename: Juan A
authors.initials: JA
authors.lastname: Pineda
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy*; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D016867:Immunocompromised Host; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; 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; C417083:peginterferon alfa-2b