Abstract

BACKGROUND AND RATIONALE: Black Americans are disproportionally infected with hepatitis C virus (HCV) and are less likely than whites to respond to treatment with peginterferon (PEG- IFN) plus ribavirin (RBV). The impact of race on HCV treatment eligibility is unknown. We therefore performed a retrospective analysis of a phase 3B multicenter clinical trial conducted at 118 United States community and academic medical centers to evaluate the rates of and reasons for HCV treatment ineligibility according to self- reported race.

MAIN RESULTS: 4469 patients were screened, of whom 1038 (23.2%) were treatment ineligible. While blacks represented 19% of treated patients, they were more likely not to be treated due to ineligibility and/or failure to complete required evaluations (40.2%) than were nonblack patients (28.5%; P<.001). After the exclusion of persons not treated due to undetectable HCV RNA or non-genotype 1 infection, blacks were 65% less likely than nonblacks to be eligible for treatment (28.1% > 17.0%; relative risk, 1.65; 95% confidence interval, 1.46- 1.87; P<.001). Blacks were more likely to be ineligible due to neutropenia (14% vs 3%, P<.001), anemia (7% vs 4%, P=.02), elevated glucose (8% vs 3%, P<.001), and elevated creatinine (5% vs 1%, P<.001).

CONCLUSIONS: Largely due to a higher prevalence of neutropenia and uncontrolled medical conditions, blacks were significantly less likely to be eligible for HCV treatment. Increased access to treatment may be facilitated by less conservative neutrophil requirements and more effective care for chronic diseases, namely diabetes and renal insufficiency.