Peginterferon alpha -2a Plus Ribavirin in Latino and Non-Latino Whites With HCV Genotype 1: Histologic Outcomes and Tolerability From the LATINO Study

• Published in: The American journal of gastroenterology Vol. 105; no. 10; pp. 2177 - 2185
• Main Authors: Balart, Luis A, Lisker-Melman, Mauricio, Hamzeh, Fayez M, Kwok, Ambrose, Lentz, Ellen, Rodriguez-Torres, Maribel
• Format: Journal Article
• Language: English
• Published: 01.10.2010
• Subjects: Age; Hepatitis C virus
• ISSN: 0002-9270
• DOI: 10.1038/ajg.2010.157

OBJECTIVES: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 alpha -2a plus ribavirin (LATINO study). METHODS:LATINO was a prospective, open-label, multicenter study that enrolled 269 Latinos and 300 non-Latinos receiving peginterferon alpha -2a 180 mu g/week and ribavirin 1,000/1,200mg/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 alpha -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.