title: Peginterferon α-2a plus ribavirin in Latino and Non-Latino Whites with HCV genotype 1: Histologic outcomes and tolerability from the LATINO Study.
abstract: OBJECTIVE
  We sought to compare the histologic response, safety, and tolerability in Latino and non-Latino patients with hepatitis C virus (HCV) genotype 1 treated with peginterferon α-2a plus ribavirin (LATINO study).
  
  
  METHODS
  LATINO was a prospective, open-label, multicenter study that enrolled 269 Latinos and 300 non-Latinos receiving peginterferon α-2a 180 μg/week and ribavirin 1,000/1,200 mg/day for 48 weeks. Liver biopsies were obtained within 18 months of baseline and at week 72. Improved or worsened liver fibrosis and necroinflammatory activity were assessed by the Ishak-modified histologic activity index scoring system. Efficacy and safety parameters were monitored during treatment and the 24-week follow-up period.
  
  
  RESULTS
  The primary study results published elsewhere showed a higher sustained virologic response (SVR) rate among non-Latinos than Latinos (49% vs. 34%; P<0.001). Paired biopsy data were available for 157 Latinos and 201 non-Latinos. At baseline, more Latinos vs. non-Latinos had alanine aminotransferase (ALT) >3 × the upper limit of normal (20% vs. 18%) and cirrhosis (13% vs. 10%). Both groups experienced improvement in Ishak activity at week 72, although the improvement rates were higher in non-Latinos than Latinos (59% vs. 47%; P=0.03). For both groups, more patients with SVR compared with non-responders had improved Ishak fibrosis scores. In both groups, baseline Ishak activity score (P<0.0001 for both) was predictive of Ishak activity response. Additional predictors in Latinos were age (P=0.0023), body mass index (BMI) (P=0.068), baseline ALT quotient (P=0.031), and baseline Ishak fibrosis scores (P=0.021). There were no significant differences in steatosis changes between the two groups. Adverse events (AEs) and withdrawals due to AEs were more frequent in non-Latinos.
  
  
  CONCLUSIONS
  Significant proportions of patients in both groups had histologic response to peginterferon α-2a plus ribavirin. However, histologic response was higher in non-Latinos than in Latinos regardless of virologic response. This study highlights the need for additional strategies to improve virologic response in Latinos.
authors.affiliation: Tulane University Health Sciences Center, New Orleans, Louisiana 70112, USA. lbalart@tulane.edu
authors.forename: Luis A
authors.initials: LA
authors.lastname: Balart
authors.forename: Mauricio
authors.initials: M
authors.lastname: Lisker-Melman
authors.forename: Fayez M
authors.initials: FM
authors.lastname: Hamzeh
authors.forename: Ambrose
authors.initials: A
authors.lastname: Kwok
authors.forename: Ellen
authors.initials: E
authors.lastname: Lentz
authors.forename: Maribel
authors.initials: M
authors.lastname: Rodriguez-Torres
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use; D005260:Female; D005838:Genotype; D016174:Hepacivirus; D006526:Hepatitis C / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D006630:Hispanic or Latino; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008099:Liver / Q000187:drug effects* / Q000473:pathology; D008103:Liver Cirrhosis / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a