title: An open-safety study of dual antiviral therapy in real-world patients with chronic hepatitis C.
abstract: OBJECTIVE
  Treatment of patients with chronic hepatitis C with alpha-interferon and ribavirin usually produces adverse events within the first 3 months. We aimed to assess safety and predictors of discontinuation or dose modification of these drugs.
  
  
  METHODS
  Observational study of 312 patients with predominantly genotype 1 chronic hepatitis C treated openly along 5 years in a clinical practice setting.
  
  
  RESULTS
  Eighty-four percent of patients experienced at least one adverse event (853 events in total, 3.3 per patient on average). Incidence rate was higher during the first 90 days and decreased thereafter (<5%). Discontinuation rates at 30 and 90 days and at end of treatment were 2, 4 and 8%, respectively. Seventy percent of discontinuation cases were due to adverse events rather than to laboratory abnormalities. Serious adverse events were rare (<1%). Dose modifications were made in 158 patients (51%) on 237 occasions. After adjusting for covariates, older age was a predictor of early discontinuation, whereas HCV genotypes 1-4 and daily ribavirin dose of 1000 mg or more were predictors of dose modification.
  
  
  CONCLUSIONS
  The majority of real-world patients with chronic hepatitis C tolerate acceptably dual therapy and very few discontinue it. Subjective decisions on dose reduction of either compound appears to have a major impact on adherence of patients. There is a need to better define, collect and analyse clinical features which may predict adverse events and safety-related decisions during therapy of chronic hepatitis C.
authors.affiliation: Unità operativa di Gastroenterologia e Medicina, Ospedali Riuniti Villa Sofia e Cervello, Palermo, Italy. fabiotinemd@virgilio.it
authors.forename: Fabio
authors.initials: F
authors.lastname: Tinè
authors.forename: Domenico
authors.initials: D
authors.lastname: Graviano
authors.forename: Gandolfo
authors.initials: G
authors.lastname: Giannuoli
authors.forename: Salvatore
authors.initials: S
authors.lastname: Madonia
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Malizia
authors.forename: Salvatore
authors.initials: S
authors.lastname: Patti
authors.forename: Salvatore
authors.initials: S
authors.lastname: Fasola
authors.forename: Mario
authors.initials: M
authors.lastname: Cottone
authors.forename: Gennaro
authors.initials: G
authors.lastname: D'Amico
mesh_terms: D000328:Adult; D000367:Age Factors; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012254:Ribavirin